• Federal Circuit Calls "No Bet" on Beteiro's Asserted Patents

    By Andrew Velzen —

    Federal Circuit SealRecently, the Court of Appeals for the Federal Circuit (CAFC) issued an opinion in Beteiro, LLC v. DraftKings Inc.[1]  This case is yet another case where the Federal Circuit upheld invalidity under § 101.  Here, the patents in question were directed to monitoring gaming / gambling activities at various physical locations, primarily with the idea that a user can be located in one location, but place wagers at a computer in a different location.

    In my view, the opinion illustrates what is, at best, a strained § 101 analysis.  The court simply could not get past what it viewed as a substantial imbalance of non-technical content to technical content in the specification.  Notwithstanding, though, there are certainly ways in which Beteiro could have better structured their claims and specification to withstand § 101 scrutiny.  Herein, I'll briefly discuss both of these points.

    Case Summary

    As a preliminary point, I think it's prudent to at least briefly summarize the procedural posture of the case and the Federal Circuit's decision.  The appeal to the CAFC arose based on multiple lawsuits filed by Beteiro against various gaming entities (DraftKings, PointsBet, BetMGM, Betfair, etc.) in the District of New Jersey.  In those lawsuits, Beteiro asserted patent infringement of four different patents.  Worth noting, despite claiming priority back to applications from 2002, 2003, and 2008, each of the asserted patents was filed in 2016 or later (i.e., each of the asserted patents was prepared and filed after the U.S. Supreme Court's decision in Alice Corp. v. CLS Bank International).  Notwithstanding, each of the defendants (now appellees) filed a motion to dismiss alleging that the asserted patents were invalid under § 101.  The District Court agreed and Beteiro appealed to the CAFC thereafter.

    Claim 2 of U.S. Patent No. 10,255,755 was deemed by the parties, the District Court, and the CAFC as representative of all the asserted claims for purposes of § 101 analysis.  This claim recites:

    2.  A computer-implemented method, comprising:
        detecting, with or using a computer which is specially programmed for processing information for providing for a placement of a bet on or regarding a gaming activity, a gambling activity, or a sporting event, a posting of information regarding the gaming activity, the gambling activity, or the sporting event;
        
    generating, with or using the computer, a notification message regarding the gaming activity, the gambling activity, or the sporting event;
        
    initiating, with or using the computer, a communication link with a first communication device and transmitting the notification message to the first communication device as an electronic transmission, or transmitting, from the computer, the notification message as an electronic mail message, wherein the electronic mail message is received by or received at a first communication device, wherein the first communication device is associated with an individual;
        
    receiving, with the computer, a bet message transmitted from the first communication device or from a second communication device, wherein the second communication device is associated with the individual, and further wherein the first communication device or the second communication device comprises a global positioning device, wherein the global positioning device determines a position or location of the first communication device or the second communication device, and further wherein the bet message contains information regarding a bet to be placed on or regarding the gaming activity, the gambling activity, or the sporting event, and information regarding the position or location of the first communication device or the second communication device; and
        
    determining, with or using the computer, whether the bet is allowed or disallowed using the information regarding the position or location of the first communication device or the second communication device and, if the bet is allowed, processing information for placing the bet for or on behalf of the individual, or, if the bet is disallowed, processing information for disallowing the bet [emphases added].

    The above-emphasized portions are where the CAFC focused the bulk of its analysis under § 101.  After said analysis, the CAFC ultimately affirmed the determination of invalidity.

    Court's § 101 Analysis

    As is rote at this point, in order to analyze whether a claimed invention is directed to patent-eligible subject matter, the Federal Circuit applied the Alice/Mayo test (i.e., Step 1 — Is the claim directed to a process, machine, manufacture, or composition of matter; Step 2A — Is the claim directed to a judicial exception to eligibility, such as an abstract idea; and Step 2B — Does the claim amount to significantly more than the judicial exception to eligibility).[2]  It bears noting that the patent examiner who examined these patent applications explicitly evaluated eligibility for the claims under § 101 and found them patent-eligible based on their recitation of a particular machine or processor.

    Step 2A

    Under Step 2A of the Alice/Mayo test, the CAFC agreed with the District Court that the claims were directed to the abstract idea of "exchanging information concerning a bet and allowing or disallowing the bet based on where the user is located."  In doing so, the CAFC indicated that the claims include many alleged "well-settled indicators of abstractness."  Setting aside the fact that that phrase borders on word salad, these so-called "indicators" included: (1) the claims broadly reciting generic steps of detecting information, generating and transmitting a notification based on the information, receiving a message, determining, and processing information; (2) the claims being drafted using largely result-focused functional language, while containing no specificity about how the purported invention achieves the results; (3) the claims being analogous to claims held abstract in other CAFC cases; and (4) the claims being analogous to longstanding "real-world" activities.

    Regarding item (1) above — Like many claims, if you abstract away all the substance and merely recite some gerunds, claims can quickly devolve into sounding rather patent-ineligible.  Regarding item (2) above — Whether something is described overly functionally is rather subjective.  Beteiro's claims recite "a computer," "a first communication device," "a second communication device," and "a global positioning device" and also describe communications among those devices.  Obviously, more detail can always be provided in a claim, but not without the cost of narrowing the claim.  Beteiro did not want to limit their claims to any particular type of communication protocol or type of communication devices, nor did Beteiro want to provide any additional unnecessary details about the "computer" or "communication devices."  Further, clearly Beteiro did not need to incorporate such narrowing details (at least in the patent examiner's opinion) in order to demonstrate that the claims were new and non-obvious.  Hence, the CAFC demanding that additional technical details be added to the claims for § 101 purposes when Beteiro already recited multiple devices performing different acts seems dubious.

    The CAFC's claim in item (3) is questionable, at best.  The Federal Circuit referenced Affinity Labs of Tex., LLC v. DIRECTV, LLC and Intell. Ventures I LLC v. Capital One Bank (USA) as allegedly containing analogous claims to Beteiro's.  The claims at issue in those cases, however, do not refer to any sort of "global positioning device" and are certainly much less tailored to communication protocols between devices.[3]  For example, the claim considered in Affinity Labs was:

    1.  A broadcast system, comprising:
        a network based resource maintaining information associated with a network available representation of a regional broadcasting channel that can be selected by a user of a wireless cellular telephone device; and
        
    a non-transitory storage medium including an application configured for execution by the wireless cellular telephone device that when executed, enables the wireless cellular telephone device:
            
    to present a graphical user interface comprising at least a partial listing of available media sources on a display associated with the wireless cellular telephone device, wherein the listing includes a selectable item that enables user selection of the regional broadcasting channel;
            
    to transmit a request for the regional broadcasting channel from the wireless cellular telephone device; and
            
    to receive a streaming media signal in the wireless cellular telephone device corresponding to the regional broadcasting channel, wherein the wireless cellular telephone device is outside of a broadcast region of the regional broadcasting channel, wherein the wireless cellular telephone device is configured to receive the application via an over the air download.

    Likewise, the claim considered in Intell. Ventures recites:

    1.  A system for providing web pages accessed from a web site in a manner which presents the web pages tailored to an individual user, comprising:
        an interactive interface configured to provide dynamic web site navigation data to the user, the interactive interface comprising:
        
    a display depicting portions of the web site visited by the user as a function of the web site navigation data; and
        
    a display depicting portions of the web site visited by the user as a function of the user's personal characteristics.

    These claims are only analogous to Beteiro's claims at a relatively high level of abstraction.  For example, neither relate to gambling / gaming in any sense.  Further, the primary purpose of both claims above is to determine what is displayed to a user, whereas the primary purpose of Beteiro's claims is to determine whether to allow or disallow a bet.

    Regarding claim (4) — Analogizing claim language to "real-world" activities, while sometimes done in § 101 cases, has always struck me as a bit ironic.  Namely, if claims are more akin to physical "real-world" activities, those claims are somehow less patent-eligible.  The "real-world" is the exact opposite of "abstract."  Thus, this flavor of analysis is essentially equivalent to saying "the claimed invention is not abstract, therefore it is an abstract idea and patent-ineligible."  It simply strains credulity.

    To illustrate the "real-world" nature of Beteiro's claims, the CAFC points to an analogy posited by the District Court of a teller at a casino that straddles state lines.  This analogy is absurd.  As an initial point, I'm not aware of any real casinos that actually fit this description (i.e., where you can place bets in two different states within the same casion).  In fact, I'd assume casinos intentionally avoid this issue so they don't have to simultaneously deal with multiple sets of state laws.  Hence, this issue rarely, if ever, comes up in the context of placing physical bets at a teller.  Oppositely, with modern technology, the issue of confirming location comes up in >90% of all sports bets placed.[4]  Further, even if the scenario proposed by the District Court / CAFC did come up in reality, there would be no "global positioning device" or "communication device(s)" needed or used because the bettor and the teller would be in the same physical location.  Hence, any attempted patent claim to this fabricated "real-world" scenario would look totally different than Beteiro's claims.

    On behalf of eligibility, Beteiro argued that their claims involved technological improvements and, therefore, are not directed to abstract ideas.  According to the CAFC, though, because the claims do not provide an improvement to the way computers operate nor do they solve a technical problem, the claims remain abstract ideas.

    Step 2B

    Under Step 2B of the Alice/Mayo test, Beteiro argued that the inclusion of a global positioning system (GPS) device in their claims was unconventional, which should provide for a path to patentability.  The CAFC attempted to refute this point by referring to the relatively limited discussion of GPS in the specification.  In particular, the lengthy specifications of the asserted patents only includes a single sentence concerning a mobile phone with an equipped GPS device.  Given this, the CAFC concluded that the inclusion of the GPS device on a mobile phone must have been conventional at the time.  This is, at the very least, a dramatic departure from the CAFC's Berkheimer decision.[5]  Regardless, in the CAFC's view, because the inclusion of a GPS on a mobile phone was routine, conventional, and well-understood, the inclusion of the GPS cannot convert a claim that is otherwise patent-ineligible into patent-eligible.

    This also raises an interesting procedural point.  Because this appeal arises from a motion to dismiss, any factual disputes need to be resolved in Beteiro's favor.  Further, Beteiro contended in its complaint that the use of GPS for gaming was unconventional in 2002 (their earliest priority date), and provided evidence to support this.  In 2002, for example, the iPhone had yet to be created.  Even so, the CAFC disregarded this contention based solely on what was (and was not) in the specification.  In doing so, the court cited to the recent AI Visualize case:[6]

    Conclusory allegations, or those "wholly divorced" from the claims or the specification, cannot defeat a motion to dismiss. And a patentee that emphasizes a claim's use of certain technology, for example, a general-purpose computer, fails at step two when the intrinsic record establishes that the technology is conventional or well-known in the art.

    While the Beteiro patents may not have described how one incorporates GPS devices into mobile phones, in detail, I think the court's reliance on the above precedent borders on dubious.  Beteiro's claims did specifically recite a "communication device" that "comprises a global positioning device, wherein the global positioning device determines a position or location of the first communication device or the second communication device."  Hence, Beteiro's allegations were not "'wholly divorced' from the claims."  Still, the court drew a distinction between Beteiro's complaint and the complaint in Cellspin Soft, Inc. v. Fitbit, Inc. where the contentions were purportedly much more rooted in the patent-in-suit.[7]

    Lastly, it is perhaps worth mentioning that the CAFC rightly wholly disregarded the patent examiner's previous consideration of § 101 issues under well-established law.  Regardless, though, the patent examiner apparently applied pre-Alice caselaw and relied on the existence of one or more physical components in deciding that the claims were patent-eligible.  This was clearly an overbroad view by the patent examiner.

    Suggested Improvements to Bolster Claims Under § 101

    The above clearly highlights, yet again, just how sticky § 101 is for patentees, even when physical devices (e.g., mobile devices and/or GPS sensors) are involved.  Perhaps, though, there are some ways that Beteiro could have reframed their specification or claims that would have provided a stronger bulwark for a § 101 analysis.  In that vein, let's highlight a few of them.

    One step that Beteiro could have taken, and which is explicitly contemplated by the CAFC opinion, would be to bolster the description of the GPS device in the specification.  Had the specification dedicated more space to technical details about the inclusion of the GPS device in a mobile device, the court clearly thinks that would help patentability (e.g., by demonstrating how the GPS device is a technical improvement) or, at the very least, would have provided fodder to get over a motion to dismiss under § 101 (i.e., because the additional technical details could raise a genuine question of material fact over whether inclusion of a GPS in a mobile device was truly well-understood, routine, and conventional).

    There are likely other technical details besides how a GPS device is integrated into a mobile device that could have been included in the specification to show that the use of a GPS device in the claimed way was unconventional.  For example, additional details on the ways in which the mobile device communicates the measured GPS data to the gaming facility computer (e.g., message communication protocols, formats in which the GPS data is communicated, where the GPS data is stored, how the GPS data is accessed / used by the gaming facility computer, etc.) could have been included.  Such additional details would not only serve to demonstrate the level to which the inventors had considered the importance of communicating the GPS data, but would also show why the inclusion of GPS data is central to the claimed invention serving its intended purpose.  Any of these technical details about the GPS could have been explicitly recited in the claims, as well, if Beteiro wanted to further strengthen their § 101 position.

    Additionally, as is sage advice these days in almost any patent application that might need to pass muster under § 101, the specification could have laid out a technical problem to be solved and how the claims provide a technical solution.  The claims and specification clearly address what is, in the eyes of the CAFC, non-technical problems (e.g., gambling jurisdiction and legal compliance).  This is simply not helpful based on current § 101 jurisprudence.  Instead, if the specification had couched the discussion in terms of the gaming facility computer being unable to reliably determine the location of the mobile device based on conventional messaging between the two, and then later provided the GPS device as a means of enabling a reliable determination of location in the invention, the court may have been more inclined to find that the claims amounted to "significantly more" (based on the claims providing an arguably technical solution to a technical problem).  While this borders on quibbling about semantic differences, unfortunately, that is the present state of the law under § 101.

    In addition to the changes to the specification described above, there are certainly some modifications that could have been made to the claims (many without requiring modification to the specification at all).  One that I would suggest, and this is purely psychological, is to remove references to "gaming activity," "gambling activity," "sporting event," etc. from the claims.  While these terms shouldn't impact a court's view or an examiner's view eligibility under § 101, they implicitly connote non-technical concepts to some readers.  Thus, anecdotally, their inclusion makes patent-eligibility a bit more of an uphill battle.  Hence, broadening the claims to only refer to things like "requests" and "confirmations" rather than "bets" could only help (at least in terms of § 101).

    Conclusion

    Ensuring compliance with jurisdictional regulations is of paramount importance to the gambling industry.  Further, Beteiro's claimed invention was, at least in the eyes of the patent examiner, a novel and non-obvious way of doing so using a GPS device. While it may seem pedestrian to use a GPS device for such purposes by modern standards, in 2002, it was likely anything but. Still, the morass that is post-Alice § 101 has claimed yet another victim.  If you're hoping to see more clarity in § 101 law soon, I wouldn't bet on it (pun intended).

    Beteiro, LLC v. DraftKings, Inc. (Fed. Cir. 2024)
    Panel: Circuit Judges Dyk, Prost, and Stark
    Opinion by Circuit Judge Stark

    [1] https://cafc.uscourts.gov/opinions-orders/22-2275.OPINION.6-21-2024_2337276.pdf

    [2] Note that the CAFC opinion basically glosses over Step 1 of the Alice/Mayo test.  Hence, what I am calling "Step 2A" is referred to as "Step 1" by the Federal Circuit and what I am calling “Step 2B” is referred to as "Step 2" by the Court. The nomenclature does not matter so much, but I prefer to go with the more traditional naming that contemplates the full eligibility analysis.

    [3] Affinity Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253 (Fed. Cir. 2016); Intell. Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)

    [4] https://www.gamingtoday.com/revenue/ (On July 14, 2024 – "In most markets, more than 90% of sports betting is online.  For markets where mobile wagering is heavily favored, like New York and New Jersey, more than 90% of betting happens online")

    [5] Berkheimer v. HP Inc., 890 F.3d 1369 (Fed. Cir. 2018) ("Whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.  Whether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art.  The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.")

    [6] AI Visualize, Inc. v. Nuance Commc’ns, Inc., 97 F.4th 1371 (Fed. Cir. 2024)

    [7] Cellspin Soft, Inc. v. Fitbit, Inc., 927 F.3d 1306 (Fed. Cir. 2019)

  • By Michael Borella —

    USPTO SealAs required by President Biden's Executive Order 14110 ("Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence"), the U.S. Patent and Trademark Office has published an update to its subject matter eligibility guidance for examiners regarding inventions employing artificial intelligence (AI).  As this is the first update to the USPTO's subject matter eligibility guidance in almost five years, there was some hope that it would address stakeholders' long-held concerns.  These include the difficulty of crafting claims and a specification directed to an invention that incorporates AI, especially in view of the dramatic disparity in how examiners apply the law in view of the USPTO's previous guidance.

    However, the updated guidance is remarkably non-substantive at best, and at worst appears to take the position that advances in AI and uses of AI are ineligible unless they are implemented in specific hardware circuitry or cause a significant change to the state of an ancillary system.  Moreover, the updated guidance largely reads as general eligibly guidance with few actual AI-specific considerations.

    Indeed, the updated guidance makes it painfully clear that it (like the USPTO's previous guidance on the topic) "does not create any right or benefit, substantive or procedural, enforceable by any party against the USPTO."  In other words, examiners are free to ignore the updated guidance as they see fit, which is how examiners have approached the USPTO's previous subject matter eligibility guidance over the last decade.

    In any event, it is not until the halfway point of the updated guidance that it addresses the USPTO's currently eligibility test.  In particular, the updated guidance focuses on Step 2A, prong one (determining whether a claim recites a judicial exception) and step 2A, prong two (determining whether the claim integrates the recited judicial exception into a practical application of the exception).  Unfortunately, the USPTO largely employs hypothetical examples in doing so.

    Regarding Step 2A, prong one, the USPTO reminds us that "USPTO personnel must draw a distinction between a claim that 'recites' an abstract idea . . . and one that merely involves, or is based on, an abstract idea."  In the former case, the claim requires further eligibility analysis and in the latter case the claim is eligible.

    The USPTO sets forth three hypothetical examples of claims that do not recite an abstract idea: (i) custom and specific circuits designed to implement arrays of neurons and synaptic weights, (ii) a processor, livestock herd monitor, and transmitter collectively arranged for monitoring health and activity in a herd of dairy livestock animals, and a "treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3."  Notably, only the first of these examples even relates to AI.

    The USPTO goes on to state that examiners should identify specific claim limitations that fall within the three groupings of abstract ideas:  mathematical concepts, certain methods of organizing human activity, and mental processes.  This leads to the rather absurd result that more specific recitations in a claim (which are encouraged by a large number of Federal Circuit eligibility opinions) can ultimately render a claim ineligible, whereas broader recitations of the same invention (which are discouraged by these Federal Circuit eligibility opinions) can result in a claim being eligible because it does not recite an abstract idea.

    Regarding math, the USPTO essentially repeats it's thin and unworkable distinction between claims that recite mathematical concepts and claims that are based on or involve a mathematical concept.  In practice, examiners do not understand this distinction and the USPTO's terse discussion in the updated guidance suggests that they are not alone.  To state what should be obvious, all science and engineering advances involve mathematical concepts in one way or another — a claim that recites "taking the sum of a first output and a second output" should not be subject to more scrutiny than a claim that recites "determining a result based on a first output and a second output."

    The certain methods of organizing human activity category has been viewed expansively by the courts and some examiners to include anything remotely related to human activity.[1]  Here, the USPTO relies on three recent Federal Circuit eligibility opinions to flesh out the category.  The problem is that all three examples found claims to be ineligible.  It would be nice if the USPTO could provide at least a hint of what might not fall within this gaping chasm of a category.

    On mental processes, the USPTO continues to apply what can only be considered a legal fiction.  In essence, the current practice is that any invention that, even in theory, could be performed by one or more human beings with thought, pencil and paper, or other tools, is a mental process even if it would take millions of years to obtain a useful result.  Indeed, the mental process category encompasses processes that are not performed mentally.

    Here, the USPTO at least gives us one example of an invention that (in its view) does not recite a mental process ("a specific, hardware-based RFID serial number data structure [that is] uniquely encoded").  However, when compared to the other examples that do recite a mental process (e.g., "the collection of information from various sources and understanding the meaning of that information"), the USPTO appears to be slicing the bacon transparently thin.[2]

    Moving on to Step 2A, prong two, the USPTO reiterates that examiners should determine whether "there are any additional elements recited in the claim beyond the judicial exception(s), and [evaluate] those additional elements individually and in combination to determine whether they integrate the exception into a practical application of that exception."  Despite the USPTO's reminder that claims are to be considered "as a whole" in this inquiry, such language is, in practice, a paper tiger.  Neither the USPTO nor the courts have ever explained what it means to consider claims as a whole, and both have routinely considered claims piecemeal while contending that they are actually considering claims as a whole.

    There are three ways to find a claim non-abstract under Step 2A, prong two — where the claim (i) improves the functioning of a computer, (ii) improves another technology or technical field, or (iii) is meaningfully limited to a particular technological environment.  But none of these have been defined in the case law, much less clearly defined.  The USPTO notes that specific solutions to specific problems are more likely to be eligible, but provides little insight that fleshes out this notion.  Instead, the USPTO again falls back on case law examples.

    These examples demonstrate that an eligible invention may look ineligible if you tilt your head three degrees to the left and vice-versa.  For example, a very specifically-worded claim for determining haplotype phase based on pedigree data in human genetic sequences was an improvement over prior attempts to do so, but not a "technical" improvement because the entire claim was putatively a mathematical process that ran on general-purpose computers.

    While the USPTO touted the claims of McRO, Inc. v. Bandai Namco Games America Inc. as an example of eligibility (which it is despite a lot of math being calculated by a general-purpose computer driving the thrust of the claimed invention), in practice it is rare that making an analogy to these claims will sway an examiner.  Instead (tilting their heads three degrees to the left), examiners typically conclude that any claim similar to McRO actually recites an ineligible abstract idea executing atop a non-specific chunk of silicon.[3]  In other words, there is little or no appreciable difference between the haplotype claim and those of McRO despite one being eligible and the other not.

    Toward the very end of the updated guidance, the USPTO addresses AI-assisted inventions.  It states:

    For the subject matter eligibility analysis under 35 U.S.C. 101, whether an invention was created with the assistance of AI is not a consideration in the application of the Alice/Mayo test and USPTO eligibility guidance and should not prevent USPTO personnel from determining that a claim is subject matter eligible.  In other words, how an invention is developed is not relevant to the subject matter eligibility inquiry.

    Thus, the words of the claim matter but the use of AI in developing the underlying invention does not.  Aside from this clear statement, the updated guidance is cagey in general and surprisingly thin on AI-specific content.[4]

    Practitioners have looked forward to iterations of the USPTO's subject matter eligibly guidance to add clarity and expedite prosecution.  After a decade of such guidance, it is clear that the USPTO's example-based approach has failed.  The chosen examples do not clarify the murky principles and distinctions that the words of the guidance set forth.  Moreover, the USPTO's reasoning regarding these examples is contradictory, muddled, opaque, and ultimately not helpful.  The greatest evidence for this is how different examiners apply the guidance in dramatically different ways.

    Again, the fault lies with the Federal Circuit's incoherent parade of patent eligibility horribles masquerading as judicial decisions.  But instead of acknowledging that the emperor is stark raving naked, the USPTO once again tries to pretend otherwise.

    It is time to stop.

    [1] One of my favorite examples is the examiner I spoke to who insisted that fully-automated navigation of a self-driving vehicle was a method of organizing human activity because the goal of the invention was to deliver people from point A to point B.

    [2] Credit for this confusion should be placed at the feet of the Federal Circuit, the decisions of which these examples are based.  

    [3] A relevant definition of "analogy" in the American Heritage Dictionary is "[a] form of reasoning based on the assumption that if two things are known to be alike in some respects, then they are probably alike in other respects."  Too many examiners seem to think that, to be analogous, two things must be exactly the same.

    [4] The USPTO has released three new sets of example claims to support the guidance.  They were not specifically addressed herein and may be discussed in a subsequent article.  In short, they do not provide enough further insight to render the updated guidance particularly helpful.

  • By Kevin E. Noonan –

    Judge Newman_1Today, D.C. District Court Judge Christopher R. Cooper put an end to Judge Pauline Newman's lawsuit against her colleagues, granting the Federal Circuit Judicial Council's motion to dismiss Judge Newman's suit on due process and 4th Amendment grounds (see "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit").

    To recap, Judge Newman filed a complaint in May 2023, asserting 12 claims:

    • Claim I asserted "improper removal [and] violation of separation of powers" based on Article III (life tenure of federal judges) and Article I (giving the House of Representatives the sole authority to remove a judge through impeachment after trial by the Senate).

    • Claim II asserted that the Judicial Complaint is ultra vires for "improper removal [and] violation of separation of powers."

    • Claim III alleged Fifth Amendment violations of due process because the members of the Special Committee are also purported witnesses to the alleged judicial misconduct.

    • Claim IV asserts a First Amendment violation for unlawful prior restraint for the gag order.

    • Claim V asserted that the gag order is also ultra vires as being an unlawful prior restraint on speech.

    • Claim VI asserted a Fifth Amendment violation for unconstitutional vagueness of the provisions of the Disability Act.

    • Claim VII asserted that the activities are ultra vires for unconstitutional examination because "[n]either the Act nor the U.S. Constitution authorizes compelling an Article III judge to undergo a medical or psychiatric examination or to surrender to any investigative authority her private medical records in furtherance of an investigation into whether the judge suffers from a mental or physical disability that renders her unable to discharge all the duties of office."

    • Claim VIII also asserted a Fifth Amendment violation for unconstitutional vagueness regarding the Act's investigative authority.

    • Claim IX alleged a Fourth Amendment violation for an unconstitutional search regarding the "compelled medical or psychiatric examination of an Article III judge without a warrant based on probable cause and issued by a neutral judicial official or a demonstration of constitutional reasonableness."

    • Claim X alleged a Fourth Amendment violation for an unconstitutional search and seizure of a "compelled surrender of private medical records."

    • Claim XI alleged a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to submit to an involuntary medical or psychiatric examination."

    • Claim XII alleged a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to surrender her private medical records none of which bear on her fitness to continue serving as an Article III judge."

    The District Court previously dismissed Counts II, III, IV, VI, X and XI for lack of subject matter jurisdiction and Count I and parts of Count VII under Fed. R. Civ. P. 12(b)(6).  Thus, only Counts V, VII (in part), VIII, and IX remained before the Court, which was the subject of Judge Newman's motion in opposition (see "Judge Newman's Suit Continues") and the Judicial Council's reply (see "Special Committee of the Judicial Council of the Federal Circuit Replies").

    Judge Newman's legal arguments were that, first, as an Article III judge she is "constitutional officer of this Republic, and not merely a federal employee" who "does not have a supervisor and does not need to meet any performance metrics to keep her job."  "Congress alone has the power to remove her," her brief in opposition asserted.

    Second, the operative statute, the Disability Act, lacks a definition of what constitutes a disability nor what factors are to be considered.  Rather than relying on medical professionals, her brief asserted, the determination is left "in the hands of lay people like Chief Judge Moore and her colleagues, all without providing them with any tools to determine when a disability exists."

    Third, there is no provision in the statute for judicial review of any Orders or actions taken pursuant to the statute, permitting violations of the Fourth Amendment, including "invasive searches of private medical information" and allowing "self-executing" administrative orders to be promulgated by the Judicial Council, "a wholly administrative body."  The result is a regime where the Council can "employ and manipulate entirely standardless criteria in order to start and to continue investigations into and to impose unconstitutional sanctions on Article III judges."  In this regard, the brief reminds the District Court that the putative grounds and factual justifications for the Council's Orders have "evolved" in the year since the proceedings began.

    The Judicial Council replied, arguing with regard to Counts VIII and IX that the orders it issued under the statute, 28 U.S.C. § 353(c), are per se reasonable and do not implicate the Fourth Amendment.  Regarding Judge Newman's Count V challenge of the disability provisions of the statute for vagueness, the Judicial Council argued that Judge Newman failed the requirement of a facial challenge to show that "the law in question is impermissibly vague in all of its applications," citing Crooks v. Mabus, 845 F.3d 412, 417 (D.C. Cir. 2017), and, on the merits, argued that the Act is not constitutionally vague because the Act permits a judicial council to "take action where a 'judge is unable to discharge all the duties of office by reason of mental or physical disability" under 28 U.S.C. § 351(a).  And with regard to Count VII, the Judicial Council argued that that Judge Newman has not asserted any reason "to doubt the sufficiency of [the standard that] "an investigation [is] as extensive as [a Judicial Council] considers necessary" (other than the implication that this is no standard at all, being entirely discretionary to the whims of the Court's Judicial Council), and that the constitutional clarity of the statute is "settled law."

    The District Court's opinion granting the Judicial Council's motion to dismiss addresses the four remaining Counts in two groups: Counts VII and IX on unconstitutionality grounds and Counts V and VII for vagueness.  For Count VIII and Count IX comprised facial challenges on 4th Amendment grounds against the Judicial Conduct & Disability ("JC&D") Act, 28 U.S.C. §§ 353(a), (c) empowering the Chief Judge to form a committee to investigate the allegations against Judge Newman.  Judge Newman alleged that § 353(c) "violates the Fourth Amendment to the extent it authorizes a compelled medical or psychiatric examination of an Article III judge" (Count VIII) or "a compelled surrender of medical records belonging to an Article III judge" (Count IX) "without a warrant based on probable cause."  The opinion recites the burden for prevailing on such a facial challenge to be that the statute is "unconstitutional in all of its applications," citing Wash. State Grange v. Wash. State Republican Party, 552 U.S. 442, 449 (2008).  The Court found the statute not to be facially invalid because a special committee under the statute could engage in investigations that "do[] not run afoul of the Fourth Amendment," citing Florida v. Bostick, 501 U.S. 429, 434 (1991); United States v. Miller, 425 U.S. 435, 443 (1976); and United States v. Simons, 206 F.3d 392, 395–96, 398 (4th Cir. 2000) (notably, all of which had to do with court employees, a status which Judge Newman argued does not properly describe an Article III judge ("it should be noted that Judge Newman is not an employee, but an independent constitutional officer and that neither Chief Judge Moore, nor the Special Committee, nor the Judicial Council are her 'supervisors'" as was the case in many of the decisions cited by Defendants in their Motion").  The opinion rejects the distinction Judge Newman drew that a Chief Judge could always interrogate a court employee, on the grounds that a special committee could not do so (but apparently ignoring the fact that this special committee had as a member the Chief Judge herself).  The Court also ignored Judge Newman's distinctions with the circumstances of City of Los Angeles, Calif. v. Patel, 576 U.S. 409, 415, 418 (2015), and further applies more general standards for facial challenges (e.g., regarding drones and the FAA; see Brennan v. Dickson, 45 F.4th 48 (D.C. Cir. 2022), that seem somewhat far afield from the case before the Court).

    Regarding Count V and Count VII for vagueness, Judge Newman's contentions were that the JC&D Act violates the due process clause of the Fifth Amendment and were unconstitutionally vague.  As for Count V, the Court says that statutes are not impermissibly vague "merely because they 'require[] a person to conform his conduct to an imprecise but comprehensible normative standard, whose satisfaction may vary depending upon whom you ask,'" citing United States v. Bronstein, 849 F.3d 1101, 1107 (D.C. Cir. 2017).  Based upon "the text, legislative history, and implementing rules of the JC&D Act, section 351(a)" the Court held the statute not to be unconstitutionally vague.  According to the Court, the text defines the standard of conduct to be the "duties of [judicial] office" (which is not vague inter alia because "judges, the only individuals against whom § 351(a) can be enforced, are well aware of their duties" and because judges swear an oath to "faithfully and impartially discharge and perform all the duties incumbent upon" them" under 28 U.S.C. § 453).  The Court also relies upon the legislative history to the effect that the statute is directed towards "judicial transgression" (which, on its face, seems to be more directed to outcome rather than process, which is what seems to be at issue here and behind Judge Newman's complaint).  Citations to the Code of Judicial Conduct and the Canons of Judicial Ethics of the American Bar Association also seem inappropriate in this case because, after all, the basis for Judge Newman's suspension was contrary to neither of these canons but was based on the Judge's allegations that the "independent neurological testing and provide it relevant medical records" was outside the scope of the special committee's powers and an infringement on her due process and privacy rights.  And the "[e]xamples of disability" including "substance abuse, the inability to stay awake during court proceedings, or impairment of cognitive abilities that renders the judge unable to function effectively" under JC&D R. 4(c) of the Rules for Judicial-Conduct and Judicial-Disability Proceedings do not seem to apply to Judge Newman's circumstances, either, although they are cited by the Court in support of the lack of vagueness in the statute.  The Court rejects Judge Newman's rebuttals to the special committee's arguments as being subjective ("which is not unconstitutional") and interprets the distinctions Judge Newman makes between a federal employee and an Article III judge by citing definitions of "judicial independence" as "not giv[ing] 'judges "absolute freedom from" discipline or sanctions that fall short of removal or salary diminution," quoting McBryde v. Comm. to Rev. Cir. Council Conduct & Disability Ords. of Jud. Conf. of U.S., 264 F.3d 52, 65 (D.C. Cir. 2001)), citing these as "accepted limits on judicial independence."

    Regarding Count VII, the Court asserts that the investigative provisions of the JC&D Act fall within the scope of prohibition in neither of two scenarios:  "[I]f it leaves judges and jurors free to decide, without any legally fixed standards, what is prohibited and what is not in each particular case, . . . or permits them to prescribe the sentences or sentencing range available," citing Beckles v. United States, 580 U.S. 256, 266 (2017), and  El-Shifa Pharm. Indus. Co. v. United States, 607 F.3d 836, 856 n.4 (D.C. Cir. 2010).  This is because, in the Court's view, "[i]t does not vest a special committee with authority to decide what judicial conduct is or is not permissible, nor does it allow a committee to choose the proper penalty for such conduct."  The Court finds the scope of the special committee's powers to be consistent with activities of federal prosecutors and agencies.  The Court further rejects what the opinion terms "tangential arguments" by Judge Newman, the first that the statute provides no standards (the opinion having set forth its opinion on these standards) and the second that the special committee can compel the Judge to disclose private documents and "directly sanction" her for not doing so (the opinion characterizing this argument as "repackaging" an argument made in an earlier round of motions that the Court rejected, and further that the special committee has no enforcement power, which is reserved to the Judicial Council which have such power).

    Thus ends Judge Newman’s attempts to regain her position on the Federal Circuit (absent appeals, of course).  This unfortunate situation has harmed the stature of the Court.  Judge Newman deserved better.  Her wonderful and admirable legacy, on the other hand, remains and will be long remembered.

  • By Kevin E. Noonan –

    Supreme Court Courtroom
    In addition to Justice Gorsuch's concurrence (to be discussed in a later post), the three "liberal" Justices on the Court differed from their colleagues and thought overturning the Chevron precedent to be both erroneous and unnecessary.  Their dissent, written by Justice Kagan and joined by Justices Sotomayor and Jackson, took a dim view of the majority's legal reasoning and the consequences of their decision.

    Instead of looking into the Court's distant past for support, the dissent begins by reminding the majority (and us) that "[f]or 40 years, Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc. . . . has served as a cornerstone of administrative law."  Unlike the majority, who apparently believe that the Chevron precedent renders judges unable to judge, the dissent apprehends that under this precedent "a court uses all its normal interpretive tools to determine whether Congress has spoken to an is­sue" (and if so "the agency's views make no difference").  It is in the instances where Congress has not spoken clearly, and "if the court finds, at the end of its interpretive work, that Congress has left an ambiguity or gap" that the issue is joined whether the agency or the courts, in the first instance decides how the law will be interpreted and applied.  The dissenting Justices believe that the agencies, not the courts, are (usually, but not exclusively) best equipped to make these choices and that this allocation of decision-making is the right choice ("the rule is right") and (inherently at least) consistent with Congressional intent.  This is because such decisions can involve "scientific or technical subject matter," or require an understanding of "complex and interdependent regulatory programs," neither of which are usually within a court's skill (or knowledge) set.  The current regime also accommodates the "chain of command" between the agencies and the President, "who in turn answers to the public for his policy calls" (and is accountable thereto; this, after all was the line of reasoning used by the Chief Justice in upholding the constitutional validity of the Affordable Care Act in National Federation of Independent Business v. Sebelius).

    The dissent accuses the majority of "flipping the script" on this "almost obvious choice," with "[a] rule of judicial humility giv[ing] way to a rule of judicial hubris."  This is the most recent of a pattern of the Court "too often tak[ing] for itself decision-making authority Congress assigned to agencies," the dissent citing National Federation of Independent Business v. OSHA, 595  U.S. 109 (2022), West Virginia v. EPA, 597 U.S. 697 (2022), and Biden v. Nebraska, 600 U.S. 477 (2023), in support of this allegation.  As a consequence, the majority has turned the Court "into the country's administrative czar" "[i]n one fell swoop."  And in doing so, the majority has made a "laughing-stock" of stare decisis, which the dissenting Justices assert "remind judges that wisdom often lies in what prior judges have done" and provide "a brake on the urge to convert 'every new judge's opinion' into a new legal rule or regime," Justice Kagan reciting the dissent in Dobbs v. Jackson Women's Health Organization, 597 U.S. 215, 388 (2022), quoting 1 W. Blackstone, Com­mentaries on the Laws of England 69 (7th ed. 1775) (trumping the majority's basis on our history with legal opinion contemporaneous with the Founders).  And paralleling the majority's suggestion that Congress could overrule their decision by statute (a false assertion based on the legal grounds for that decision), here the dissent asserts as one basis for considering erroneous the majority's dismissal of stare decisis in this case is that Congress, for the past forty years, has not done so by overruling Chevron (making the application of stare decisis "supercharged" in this instance).  The dissent characterizes the majority's opinion as "a bald assertion of judicial authority" that "disdains restraint, and grasps for power."

    The dissent also provides its own explication of the origins of the Chevron doctrine and consequences it has had on administrative law for the past four decades.  That origin is the unavoidable ambiguities that arise when Congress enacts laws and sometimes where those ambiguities are intentional; see, e.g., the Biologics Price Control and Innovation Act (the subject of a later post), where Congress could not have unintentionally delegated to the Food and Drug Administration responsibility for developing a biosimilar approval pathway (the statute is replete with instructions that "the Secretary" shall act to implement the specific provisions recited therein).  In addition, the dissent sets forth the myriad ways Congress through intent or mistake could so delegate, or for which the issue addressed by the agency could not have been anticipated by the drafters (indeed, at its core the issue is the extent to which Congress passes to the Executive branch the responsibility to execute and enforce the laws; for example, once Congress has declared war legislators do not then micromanage how the President or Secretary of Defense, much less military commanders prosecute the war on the battlefield).  The dissent discusses instances from the case law developed over the past four decades to illustrate the point, including Teva Pharmaceuticals USA, Inc. v. FDA, 514 F. Supp. 3d 66, 79–80, 93–106 (DC 2020) (regarding the definition of a protein under 42 U.S.C. § 262(i)(1); Northwest Ecosystem Alliance v. United States Fish and Wildlife Serv., 475 F. 3d 1136, 1140–1145, 1149 (CA9 2007) (defining "distinct populations" of certain species of squirrels); Bellevue Hospital Center v. Leavitt, 443 F. 3d 163, 174–176 (CA2 2006) (defining "geographic areas" related to hospital reimbursement); Grand Canyon Air Tour Coalition v. FAA, 154 F. 3d 455, 466–467, 474–475 (CADC 1998) (defining noise levels permissible by aircraft over the Grand Canyon); and Chevron itself, regarding "stationary sources" of air pollution).  The dissent recognizes that in each case the statutory language had more than one reading that would be "reasonable" and that the question that thus arises is "Who decides which of the possible readings should govern?"

    The answer over the past forty years has been that the agencies should decide, and courts defer in instances where there isn't a "single right answer" (otherwise neither the courts nor the agencies decide, because Congress has spoken; see Ki­sor v. Wilkie, 588 U. S. 558, 588 (2019)).  And under Chevron when a court, "after using its whole legal toolkit" finds that there is no unambiguous definition by Congress, the Court has (and should) defer to the agency tasked with implementing the law and (presumably) having the technical and experiential knowledge and expertise to be in the best position to do so, the dissent stating that "the court must cede the primary interpretive role").  The role of the courts, as the dissenting Justices see it, should be (and has been) "only as a backstop to make sure the agency makes a reasonable choice among the possible readings."  (In a footnote, the dissent explicates several routine instances and circumstances where what Congress intended is presumed, including ones against extraterritoriality of U.S. laws, prospective (rather than retrospective) application of the laws, and against repeal by implication.)  The rationale for agencies rather than courts to resolve ambiguities (the "why" the dissent provides) set forth in the dissenting opinion include the idea that "agencies often know things about a statute's subject matter that courts could not hope to" know (particularly when the statute implicates scientific or technical questions, illustrated by Justice Kagan by the portion of the biosimilar statute regarding when an amino acid polymer is considered a protein, the Justice posing that the first question facing a court trying to resolve the ambiguity would be "What even is an alphaamino acid polymer?").  Another example is the decision regarding distinct vel non species of squirrels; in this case, the dissent speculates that "[a] court could, if forced to, muddle through that issue and announce a result" but reasons that the specialized expertise of the Fish and Wildlife Service would "do a better job of the task."

    The dissent next addresses a different scenario, wherein the ambiguity arises from "a complex regulatory regime" and how it functions effectively.  Taking the squirrel example again, the dissent cites instances where prior decisions can be understood by the agency (but perhaps slightly less effectively, seeing as the cited earlier case law might be effectively understood by a court).  The dissent's better point is that an agency makes these distinctions all the time as part of its operations as an agency, while courts address these issues much more sporadically.  A similar scenario, and an agency's superior ability to reasonably interpret the law, cited in the dissent involves the Medicare reimbursement issue involving the term "geographic area" mentioned above, the dissent positing:

    It would make sense to gather hard information about what reimbursement levels each approach will pro­duce, to explore the ease of administering each on a nation­wide basis, to survey how regulators have dealt with simi­lar questions in the past, and to confer with the hospitals themselves about what makes sense[,]

    and suggesting that the Department of Health and Human Services is better equipped to make these assessments.  (In this regard, the majority's suggestion that evidence from the parties and amici can substitute seems particular jerry-rigged in comparison.)

    Turning to the policy rationale, the dissent minimizes the legal basis for the decisions the majority's decision shifts from the agency to the courts.  Using the regulation of noise levels over the Grand Canyon as an example, the dissent recognizes that the question of "How many flights, in what places and at what times, are consistent with restoring enough natural quiet on the ground?" is "a policy trade-off of a kind familiar to agencies—but peculiarly unsuited to judges."  In addition to expertise and familiarity, the dissent asserts that because Federal agencies are "subject to the supervision of the President, who in turn answers to the public," citing Kisor, Congress may rely on the "accountable actor" to better use "wise policy to inform its judgements" rather than an independent judiciary (turning on its head the majority's argument of the historical antecedents and necessity of judicial primacy).

    The dissent recognizes that deference is not always the answer, stating that the Chevron regime had been "fine-tuned" over time in recognition of this reality.  The majority's disparagement of these refinements as evincing flaws in the system "are anything but" according to the dissent, citing Epic Systems Corp. v. Lewis, 584 U.S. 497, 519–520 (2018) (which precludes an agency from interpreting a statute it does not implement); United States v. Mead Corp., 533 U.S. 218, 226–227 (2001); and Encino Motor­cars, LLC v. Navarro, 579 U. S. 211, 220 (2016) (for instances where the agency fails to use, or use properly, its "rulemaking or adjudicatory authority").  The dissent notes that the Court has even fashioned an "extraordinary cases" exception to Chevron's general rule of deference, in instances where questions of vast "economic and political significance" are involved, citing King v. Burwell, 576 U.S. 473, 485-486 (2015).

    The result of Chevron and its forty years of application has been a "carefully calibrated framework [that] 'reflects a sensitiv­ity to the proper roles of the political and judicial branches'" according to the dissenting Justices' assessment, citing Pauley v. Beth En­ergy Mines, Inc., 501 U.S. 680, 696 (1991).  That framework is expressly set forth in the dissent:

    Where Congress has spoken, Con­gress has spoken; only its judgments matter.  And courts alone determine when that has happened: Using all their normal interpretive tools, they decide whether Congress has addressed a given issue.  But when courts have decided that Congress has not done so, a choice arises.  Absent a legislative directive, either the administering agency or a court must take the lead.  And the matter is more fit for the agency.  The decision is likely to involve the agency's sub­ject-matter expertise; to fall within its sphere of regulatory experience; and to involve policy choices, including cost-benefit assessments and trade-offs between conflicting val­ues.  So a court without relevant expertise or experience, and without warrant to make policy calls, appropriately steps back.  The court still has a role to play: It polices the agency to ensure that it acts within the zone of reasonable options.  But the court does not insert itself into an agency's expertise-driven, policy-laden functions.  That is the ar­rangement best suited to keep every actor in its proper lane.  And it is the one best suited to ensure that Congress's stat­utes work in the way Congress intended.

    The dissent then addresses and rejects the majority's "points in reply."  First is the assertion that courts, not agencies, have any "specialized competence" in resolving the ambiguities that raise the questions before the Court.  The dissent responds, "Score one for self-confidence; maybe not so high for self-reflection or -knowledge" (and later calling the majority's position "malarkey") and while acknowledging a court's capacity to "construe legal texts, hopefully well" credits the first step of the Chevron test to "take full advantage of that talent."  The reason for deference under Chevron, the dissent asserts, is when a "court must admit that standard legal tools will not avail to fill a statutory silence or give content to an ambiguous term."  The question is not one of legal acumen but rather "one or more of: subject-matter expertise, long engagement with a regulatory scheme, and policy choice," in which courts "'have no special competence'—or even legitimacy."

    The majority's second argument is that the existence of an ambiguity or gap in statutory language does not "necessarily reflect a congressional intent that an agency" have "primary interpretive authority."  The dissent concedes the premise, but the basis for the Chevron regime is a presumption that is applied in a case-by-case basis because while it "does not maintain that Congress in every case wants the agency, rather than a court, to fill in gaps" there needs to be a "default rule" regarding which would be the best source of the best resolution of the ambiguity or gap.  The majority's contention that ambiguities and gaps are unintentional is an insufficient justification for the dissent, first because many are not unintentional (in the sense of being unforeseen) and second (the dissent asks) why should that matter, if it is merely an inherent consequence of the legislative process and execution of the statutes by the appropriate agency?  (And the dissent's rejoinder, as in the majority on the converse position is that if Congress doesn't want the agency to take this role "all it needs to do is say [so]").  Which Congress has never done (being "the proof . . . in the [legislative] pudding") and has in fact rejected proposed legislation that would have abolished the Chevron regime "across the board," citing S. 909, 116th Cong., 1st Sess., §2 (2019) (still a bill, not a law); H. R. 5, 115th Cong., 1st Sess., §202 (2017) (same).

    Turning to the majority's reliance on the Administrative Procedures Act (APA) and its putative incompatibility with Chevron purported in the majority opinion, the dissent asserts that Chevron and the APA are "perfectly compatible."  In the dissent's view, Section 706 (cited extensively in the majority opinion) merely provides for judicial review of agency actions.  Citing academic legal authorities, the dissent says that the text itself "does not resolve the Chevron question" as the majority interprets it to do.  As the dissent sees it, the deficiency is that Section 706 does not set forth any standard for judicial review, either deferential under Chevron or de novo as the majority opinion would have it.  The dissent notes that Section 706 does specify standards of review, for example deference to agency factfinding (substantial evidence) and policymaking (abuse of discretion).  The dissent differs with the majority's conclusion that Congress would have included similarly deferential review standards for legal questions if that was its intent; there are other portions of the Section where a de novo standard of review is set forth (resulting in references to standards of review "running around Section 706").  The dissent also notes that most "respected commentators" (including contemporaneous writers such as Professor Kenneth Culp Davis) agree with the preference in the Section for deferential review ("They did not see in their own time what the majority finds there today"), citing examples (perhaps not the commentators that the majority Justices read or respect) and conceding in a footnote that at least one such "respected commentator" took the contrary view agreeing with the majority.  But this is a new interpretation of the APA by the Supreme Court, which until this decision did not appreciate the invalidating contradictions between Chevron and the APA asserted by the majority (although this is a feature of most instances where the Court reverses longstanding precedent, perhaps accounting for the rarity thereof).  And history is not on the majority's side, either according to the dissent, insofar as courts had become more deferential to administrative agencies during the New Deal (and to be fair, World War II), citing Justice Breyer's contribution to an administrative law treatise for this information and Supreme Court decisions, Gray v. Powell, 314 U. S. 402 (1941) and NLRB v. Hearst Publications, Inc., 322 U.S. 111 (1944), as examples of deferential judicial review of agencies' statutory interpretation.  The dissent asserts additional cases (to counter the majority's allegation that these Justices "plucked" these two cases as exceptions) and dismisses the majority's reliance on purportedly inconsistent instances of deference pre-APA as making the majority's further argument that Section 706 prohibits deference "fall[] flat."

    Finally, the dissent addresses the abandonment of stare decisis by the majority on the basis that while not intended to be an "inexorable command" to do so requires "far more" than the majority provides in its opinion.  The extent of this "far more" for the dissent is "above and beyond thinking it wrong."  This is particularly the case where, as here, the decision "will cause a massive shock to the legal system, 'cast[ing] doubt on many settled constructions' of statutes and threatening the interests of many parties who have relied on them for years," citing Kisor.  Stare decisis is a doctrine of "judicial modesty" that, like Chevron itself, "tell judges that they do not know everything, and would do well to attend to the views of others."  As a practical matter, the dissent asserts that the Court itself has upheld Chevron "at least 70 times" and the inferior courts have made decisions based on Chevron on "thousands and thousands of occasions" (more than 18,000 at last count).  And the dissent criticizes the majority for "overruling-through-enfeeblement" of decisions a majority disagrees with by refusing to apply a precedent and disparaging it in those opinions as the basis to overrule (finding equally feeble the majority's argument/evidence that the Chevron regime is "unworkable" due to there being "no single 'answer' about what 'ambiguity' means," which seems to be a reasonable definition of ambiguity).  Paradoxically, the dissent contends, Chevron promotes agreement between how judges interpret ambiguous statutes (as compared with de novo review) and thus does not deserve the majority's contention that it causes "too much judicial divergence."  Perhaps equally paradoxically in the dissent's view the regime the majority impose to replace Chevron is itself problematic to implement, and these Justices see the deference to an agency's "body of experience and informed judgment" under Skidmore v. Swift & Co., 323 U. S. 134, 140 (1944), to be at future risk for judicial meddling (it would not take much to infer a similar judgment about the majority's opinion here).

    "At its core," the dissent concludes, "Chevron is about respecting that allocation of responsibility—the conferral of primary authority over regulatory matters to agencies, not courts" coming from a time when "when we [the Court] knew what we are not."  The majority, according to the dissent, does not respect that judgment, giving courts "power to make all manner of scientific and technical judgments," "the power to make all manner of policy calls, including about how to weigh com­peting goods and values," and "puts courts at the apex of the administrative process as to every con­ceivable subject—because there are always gaps and ambi­guities in regulatory statutes."  "In every sphere of current or future federal regulation," the dissent asserts, "expect courts from now on to play a commanding role" which "is not a role Congress has given to them" but "a role this Court has now claimed for itself, as well as for other judges."

    Albeit easy to cast along conventional philosophical lines, both the majority and dissenting opinions were outcome-oriented, although the dissent was frankly so while the majority opinion dressed up this aspect with a patina of history and how the Founders would consider the question (in an age where the modern concept of an administrative agency was unknown).  Indeed, the majority was almost disdainful toward the consequences of wiping out forty years of precedent to reach their outcome, showing somewhat flexible allegiance towards stare decisis and other legal principles.  This attitude is fraught with at least some danger, insofar as the Court's institutional authority is intimately related to and dependent upon its institutional integrity.  To the extent that the majority reject Chevron as being completely wrongly decided (even going so far as to dismiss the Court's judgment by six Justices in a decision supported by just as many (or few) here) both are brought into question.

  • The Demise of Chevron Deference

    By Kevin E. Noonan –

    Supreme Court Building #2Not surprisingly, the Supreme Court overturned the "Chevron deference" principle from its 1984 Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. decision in Loper Bright Enterprises v. Raimondo (and it did so expressly and with no equivocation, stating "Chevron is overruled").

    This case (decided below on Chevron principles) arose over a dispute involving regulation on fishing (and the amount thereof) in an area within 200 nautical miles beyond the U.S. territorial sea (12 nautical miles from shore).  The regulations were enacted under the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. § 1801 et seq.) and are administered by the National Marine Fisheries Service (NMFS).  These regulations are intended to prevent overfishing and are promulgated by the NMFC based on recommendations by eight regional councils comprised of coastal state representatives, stakeholders (e.g., fishermen), and members of the NMFC.  The NMFC, for its part, includes mandatory limitations on annual catch and specifies ("prohibit, limit, condition, or require") types and amount of fishing gear permitted to be used, as well as requiring a certain proportion of the catch to be used in scientific research.  At issue in this case was the requirement that "one or more observers be carried on board" domestic vessels "for the purpose of collecting data necessary for the conservation and management of the fishery" under § 1853(b)(8), the cost of which to be borne by "(1) foreign fishing vessels operating within the exclusive economic zone (which must carry observers), [under] §§1821(h)(1)(A), (h)(4), (h)(6); (2) vessels participating in certain limited access privilege programs, which impose quotas permitting fishermen to harvest only specific quantities of a fishery's total allowable catch, [under] §§1802(26), 1853a(c)(1)(H), (e)(2), 1854(d)(2); and (3) vessels within the jurisdiction of the North Pacific Council, where many of the largest and most successful commercial fishing enterprises in the Nation operate, [under] §1862(a)," albeit capping the costs for the latter two categories, with parties in noncompliance being subject to sanctions imposed by the Secretary of Commerce.  This case arose when the NMFC changed its practices to newly impose these fees on Atlantic herring fishermen (to which they objected because it could reduce their annual returns by up to 20%).  (The circumstances under which some of the petitioners fished included having to pay observers in some instances where no herring were caught at all, due to vagaries in their catch on a particular fishing trip.)

    Petitioners' argument was that while Congress provided the agency with "broad implicit authority" to impose this program it also expressly provided by statute a requirement for three industry funding programs that did not include herring fishing.  The Court granted certiorari expressly to decide whether Chevron should be "overruled or clarified."

    The opinion, written by the Chief Justice and joined by the five conservative Justices (with the three liberal Justices dissenting) first sets forth the relationships between the three branches of the federal government, starting with Article III, from which the Court recognizes that the judiciary is the final arbiter of the "interpretation of the law" (as the "the proper and peculiar province of the courts," citing Alexander Hamilton in The Federalist Papers No. 78).  The opinion recited, from Marbury v, Madison to the present day, its consistent allegiance to the supremacy of the courts in interpreting the laws Congress enacts while "according due respect to Executive Branch interpretations of federal statutes."  However, such respect cannot "supersede" the judiciary's judgment, "[o]therwise, judicial judgment would not be independent at all."

    The opinion then presents a disquisition regarding the expansion of the Executive branches de facto powers under President Roosevelt's New Deal, maintaining that from that time until the Chevron decision "the Court continued to adhere to the traditional understanding that questions of law were for courts to decide, exercising independent judgment."  The opinion notes that determinations of fact were a different matter (and it might be noted should remain so under Dickinson v. Zurko, at least with regard to factual matters before the Patent and Trademark Office), being binding on courts if there was "evidence to support the findings," citing St. Joseph Stock Yards Co. v. United States, 298 U.S. 38, 51 (1936), under the principle that Congress had the power to designate agencies for fact-finding within the ambit of their expertise.  However, the opinion reminds, the Court did not extend agency deference to questions of law, citing United States v. American Trucking Assns., Inc., 310 U.S. 534, 544 (1940); Social Security Bd. v. Nierotko, 327 U.S. 358, 369 (1946); and Medo Photo Supply Corp. v. NLRB, 321 U.S. 678, 681–682, n. 1 (1944), as examples, while reiterating the principle that decisions of the Executive Branch were entitled to "great weight" under American Trucking Assns.  In this regard, the opinion also assesses the Court's decision in Skidmore v. Swift & Co., 323 U.S. 134 (1944), having the effect that decisions by agencies based on their "specialized expertise" could be resorted to properly by litigants and courts for "guidance even on legal questions" under certain circumstances ("the thoroughness evident in its consideration, the validity of its reasoning, its consistency with earlier and later pronouncements, and all those factors which give it power to persuade, if lacking power to control").

    The opinion also sets forth what it considers cases decided anomalously wherein agencies' legal interpretations were given deference.  These include Gray v. Powell, 314 U.S. 402 (1941) (due to Congress having given the agency the authority to make the legal determination at issue), and NLRB v. Hearst Publications, Inc., 322 U.S. 111 (1944) (same).  But the opinion particularly identifies these cases as exceptions "cabined to fact-bound determinations," and thus consistent with the Court majority's general theme of judicial supremacy, including in other (legal) aspects of these outlier decisions.  Accordingly the opinion can place even these cases permitting agency legal determinations to be consistent with this general (and Constitutionally mandated) rule.  And even regarding factual agency decisions the opinion terms the Court's treatment thereof to be "far from consistent," citing several learned treatises and Davies Warehouse Co. v. Bowles, 321 U.S. 144, 156 (1944), for this assessment.

    Despite this history, the Court's judgment (leading to its overturning Chevron) of more  recent judicial history is that the degree of deference to agencies' legal interpretation was departure from this earlier jurisprudence, contrary to the provisions for judicial review under the Administrative Procedures Act (APA) and particularly 5 U.S.C. § 706.  The opinion cites as the political motivation for the APA Congress's appreciation for "a check upon administrators whose zeal might otherwise have carried them to excesses not contemplated in legislation creating their offices," albeit based on the Court's interpretation of that intent enunciated in United States v. Morton Salt Co., 338 U.S. 632 (1948); somewhat ironically the opinion also cites a decision, Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670–671 (1986), handed down only two years after Chevron that the APA was enacted as part of a "comprehensive rethinking of the place of administrative agencies in a regime of separate and divided powers" that impliedly did not impact the scope and reach of Chevron, at least at that time and that iteration of the Court.  In reciting the majority's appreciation of the parsing of responsibilities between agencies and the courts by the APA (§ 706), the opinion finds codification of "the unremarkable, yet elemental proposition" of judicial primacy as set forth earlier in the opinion "dating back to Marbury" and thus finding a legislative imprimatur on this principle the enunciation of which should be unnecessary under the majority's interpretation of the Constitutional grounds therefor.  The majority recognizes in contrast there are certain instances where  Congress "mandate[s] that judicial review of agency policymaking and factfinding be deferential" under § 706(2)(A)(abuse of discretion) and § 706(2)(E)(lack of substantial evidence).  But to the extent the APA was intended to be "the fundamental charter of the administrative state," Kisor v. Wilkie, 588 U.S. 558, 580 (2019), the opinion posits that "Congress surely would have articulated a similarly deferential standard applicable to questions of law had it intended to depart from the settled pre-APA understanding that deciding such questions was" reserved exclusively for the courts, which Congress in the majority's opinion did not do ("The text of the APA means what it says," an assertion supported to the majority's satisfaction by the legislative history and "various [contemporaneous] commentators").

    In something of a rhetorical aside, the majority opinion recognizes that when expressly authorized by Congress (citing in footnotes 29 U.S.C. § 213(a)(15) of the Fair Labor Standards Act, 42 U.S.C. § 5846(a)(2) of the Atomic Energy Act, and 33 U.S.C. § 1312(a) of the Environmental Protection Act), agencies can exercise "a certain degree of discretion," such as in giving meaning to statutory terms, citing Batterton v. Francis, 432 U.S. 416, 425 (1977), or to "'fill up the details' in a statutory scheme," citing Wayman v. Southard, 10 Wheat. 1, 43 (1825), in a way that gives agencies some "flexibility" regarding the scope and meaning of terms like "appropriate" and "reasonable," citing Michigan v. EPA, 576 U.S. 743, 752 (2015).  Nevertheless, the majority opinion asserts that "the best reading of a statute" is that even under these exceptional circumstances "the role of the reviewing court under the APA is, as always, to independently interpret the statute and effectuate the will of Congress subject to constitutional limits" (and of course, even recognizing these exceptions the majority's legal analysis, set forth below, precludes Congress from generally conferring broad interpretive powers on administrative agencies).

    With this explication as prelude, the majority contends and bases the opinion on "[t]he deference that Chevron requires of courts reviewing agency action cannot be squared with the APA."  In explaining their bases for this conclusion, the majority notes the history regarding legal review of agency decisions between enactment of the APA and Chevron as being on a "statute by statute" basis.  Chevron (ironically noted as being "decided . . . by a bare quorum of six Justices") changed all that, or course, in a "marked departure from the traditional approach."  In this regard, the opinion expressly setting forth the Chevron doctrine as it has been developed in the almost four decades since it was handed down by the Court.  The threshold question is whether Congress evinced a clear intent regarding ("ha[d] directly spoken to") the legal issue in question; if so, "that is the end of the matter."  If not, the Chevron Court enunciated (without "mentioning the APA, or acknowledging any doctrinal shift") a "two-step process":  first, "whether Congress has directly spoken to the precise question at issue" and second, in instances where a reviewing court has determined Congress did not so speak (or is ambiguous) to decide whether the agency's interpretation is "based on a permissible construction of the statute" and defer thereto, ignoring "traditional interpretive tools." Asserting that, initially the Chevron decision "seemed destined to obscurity," citing a retrospective law review article, the majority characterizes subsequent reading and application of the two-step test as the "governing standard" within a few years of the decision.  Moreover, this judicial metamorphosis was justified as being consistent with Congressional intent and based on agency expertise, citing in support Smiley v. Citibank (South Dakota), N. A., 517 U.S. 735, 740–741 (1996); Cuozzo Speed Technologies, LLC v. Lee, 579 U.S. 261, 276–277 (2016); Utility Air Regulatory Group v. EPA, 573 U.S. 302, 315 (2014); and National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U.S. 967, 982 (2005), raising at least some questions on the continued viability of these decisions.

    The doctrinal issue in the majority's view is the failure of subsequent decisions (and the impossibility thereof in the majority's view) for reconciling the Chevron framework with the APA.  The opinion sets forth the contradictions supporting the majority's view of that impossibility using the express statutory language of § 706.  This amounts to courts "mechanically afford binding deference to agency interpretations, including those that have been inconsistent over time" (emphasis in opinion), "even when a pre-existing judicial precedent holds that the statute means something else."  And in doing so the opinion asserts "Chevron turns the statutory scheme for judicial review of agency action upside down."  Chevron (and the dissent, according to the majority opinion) confuse ambiguities in a statute with a delegation of statutory interpretation to the agency.  It has been the role of the judiciary to "routinely confront statutory ambiguities in cases having nothing to do with Chevron—cases that do not involve agency interpretations or delegations of authority" according to the opinion, statutes often having ambiguities needing interpretation and this having always been the role of the judiciary to resolve.  Recourse to "permissible" agency interpretation "makes no sense" unless it is an interpretation by a court according to the opinion.  "Chevron gravely erred . . . in concluding that the inquiry [i.e., statutory construction] is fundamentally different just because an administrative interpretation is in play," the opinion states.  And when the issue is an ambiguity regarding the proper scope of an agency's powers "abdication in favor of the agency is least appropriate" (emphasis in opinion).

    The majority reject the government's justifications in favor of Chevron (being consistent with Congressional intent based on subject matter expertise, "uniform construction" of the law, and leaving policy decisions to political actors) based on the judiciary's greater expertise in deciding legal issues, as set forth in Kisor and here because the majority recognize that "[c]ourts . . . do not decide such questions blindly" and have the parties and amici to rely upon for such technical information.  Thus the majority find unnecessary courts deferring to agency interpretation of the law under Chevron (and as often in questions of judicial interpretation the Court notes that "to the extent that Congress and the Executive Branch may disagree with how the courts have performed that job in a particular case, they are of course always free to act by revising the statute").  Regarding uniform construction, the majority reject this reasoning, inter alia, because "there is little value in imposing a uniform interpretation of a statute if that interpretation is wrong."  And "[t]he view that interpretation of ambiguous statutory provisions amounts to policymaking suited for political actors rather than courts is especially mistaken" in the majority's view as misunderstanding ("a profound misconception") of the courts' role, if only because "the Framers crafted the Constitution to ensure that federal judges could exercise judgment free from the influence of the political branches."  The opinion sets forth succinctly the majority's view of judges' role in the process, having the obligation "to independently identify and respect such delegations of authority, police the outer statutory boundaries of those delegations, and ensure that agencies exercise their discretion consistent with the APA."

    Putting the final nail in Chevron's coffin, the opinion states that "Chevron's justifying presumption is . . . a fiction," citing judicial utterances from Justice Gorsuch and Justice Thomas and using a history of the Court's decisions "pruning its presumption[s]" underlying Chevron as evidence thereof "in an effort to match Chevron's presumption to reality," citing for procedural distinctions United States v. Mead Corp., 533 U.S. 218, 230 (2001), and Justice Breyer's quotation of Mead to that effect in Christensen v. Harris County, 529 U.S. 576, 597 (2000) (Breyer, J., dissenting), as well as the distinctions raised by the Court in Encino Motorcars, LLC v. Navarro, 579 U S. 211, 220 (2016), again relying on Mead, and for substantive applications (or refusal to apply Chevron) King v. Burwell, 576 U S. 473, 486 (2015).  The Court has required express delegation, as in West Virginia v. EPA, 597 U.S. 697, 723 (2022) (quoting Whitman v. American Trucking Assns., Inc., 531 U.S. 457, 468 (2001), and refused to apply Chevron principles to judicial review questions, Adams Fruit Co. v. Barrett, 494 U.S. 638, 649 (1990); or schemes not administered by the agency, Epic Systems Corp. v. Lewis, 584 U.S. 497, 519–520 (2018) (there being "mixed signals" by the Court in criminal applications, comparing Abramski v. United States, 573 U.S. 169, 191 (2014), with Babbitt v. Sweet Home Chapter, Communities for Great Ore., 515 U.S. 687, 704, n. 18 (1995).  These decisions amount to a "byzantine set of preconditions and exceptions, [wherein] some courts have simply bypassed Chevron, saying it makes no difference for one reason or another" (followed by a footnote setting forth six examples and a spate of scholarly assessments).

    This analysis ends with the reality that the Supreme Court "has not deferred to an agency interpretation under Chevron since 2016," citing Cuozzo.  And the majority's opinion that "[a]t best, our intricate Chevron doctrine has been nothing more than a distraction from the question that matters:  Does the statute authorize the challenged agency action?" while "at worst, it has required courts to violate the APA."

    The only remaining issue for the majority is the question of stare decisis, a doctrine whose relevance is fraught with ambiguity for the Supreme Court (see "Alternative Reasoning for Supreme Court's Life Sciences Subject Matter Eligibility Jurisprudence").  Here the majority rejects the contention that stare decisis requires the Court to uphold Chevron ("It does not").  Applying the stare decisis considerations ("the quality of [the precedent's] reasoning, the workability of the rule it established, . . . and reliance on the decision," citing Knick v. Township of Scott, 588 U.S. 180, 203 (2019) (quoting Janus v. State, County, and Municipal Employees, 585 U.S. 878, 917 (2018)) "all weigh in favor of letting Chevron go."  This is because the majority believe the principles enunciated in Chevron have been "fundamentally misguided," primarily because none of the cases applying this precedent have "grappled with the APA" (at least not how  these six Justices believe it needs to be grappled with).  The opinion cites the efforts to "revise its foundations and continually limit its application" and the "cottage industry" of legal scholars "attempting to decipher its basis and meaning," as well as concurring and dissenting opinions in earlier decisions by the Court "questioning its premises," with citations supporting this assertion.  With evident disdain, the majority assert that Chevron "[f]or its entire existence" was but a "rule in search of a justification," citing Knick, adding "if it was ever coherent enough to be called a rule at all."  As a practical matter, the majority believe the Chevron rule is "unworkable," due in part to the ambiguous meaning(s) to the requirement that a statute is ambiguous to justify deference to an agency's legal interpretation(s).  Legal principles that are "in the eye of the beholder" result in arbitrary decisions, the majority maintain, being "an impressionistic and malleable concept" (the majority citing the dissenting opinion here as "proving the point" insofar as the guidance for courts to "reach Chevron's second step when it finds, 'at the end of its interpretive work,' that 'Congress has left an ambiguity or gap'" as "being no guide at all").  "The statute still has a best meaning, necessarily discernible by a court deploying its full interpretive toolkit" is the majority's guiding principle and a case being an "agency case" does not relieve a court of its responsibility to interpret the statute (and excoriating the dissent's "test" as being "all the dissent can come up with, after four decades of judicial experience attempting to identify ambiguity under Chevron," as evidence of the "futility of the exercise").  The majority see nothing but failed attempts at clarifying the Chevron doctrine and in the process becoming "an impediment, rather than an aid, to accomplishing the basic judicial task of 'say[ing] what the law is'" under Marbury.  "At this point, all that remains of Chevron is a decaying husk with bold pretensions" in the majority's opinion, not worthy of being retained on stare decisis principles.

    Turning to reliance interests (which form another basis for retaining earlier decisions on stare decisis grounds), the majority do not find the characteristics of a "stable background rule" that would justify maintaining the Chevron precedent.  In addition to courts ignoring or turning away from the rule, the doctrine does not provide "a clear or easily applicable standard," citing Janus.  Indeed, the majority opine that Chevron "affirmatively destroys" reliance interests by granting "a license authorizing an agency to change positions as much as it likes, with '[u]nexplained inconsistency' being 'at most . . . a reason for holding an interpretation to be . . . arbitrary and capricious,'" citing Brand X Internet Services.  And Chevron "allows agencies to change course even when Congress has given them no power to do so," according to the majority, which "fosters unwarranted instability in the law," and leaving "an eternal fog of uncertainty" as a result.  It is the Court's responsibility to correct its mistakes and not an occasion for the law to change erratically; in order for the law to "develop in a principled and intelligible fashion," citing Vasquez v. Hillery, 474 U.S. 254, 265 (1986), the Court must "leave Chevron behind.

    Finally, the majority disavows any interpretation that this decision should call into question earlier decisions relying on or invoking the Chevron standard, based on statutory stare decisis principles and because "[m]ere reliance on Chevron cannot constitute a "'special justification'" for overruling such a holding, because to say a precedent relied on Chevron is, at best, "just an argument that the precedent was wrongly decided," citing Halliburton Co. v. Erica P. John Fund, Inc., 573 U.S. 258, 266 (2014) (quoting Dickerson v. United States, 530 U.S. 428, 443 (2000)).

    The closing paragraph provides Chevron's epitaph:

    Chevron is overruled.  Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.  Careful attention to the judgment of the Executive Branch may help inform that inquiry.  And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation, while ensuring that the agency acts within it.  But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.

    This decision has been met with predictions that it will result in release of an unbridled judiciary on the workings of the administrative state (the propensity for the judiciary to act in this fashion pre-Loper has been discussed; see "The Tyranny of the Judiciary").  That is not the only outcome, and alternatives and potential outcomes (as well as an explication of the dissent in Loper) will be the subject of future posts.

    Loper Bright Enterprises v. Raimondo (2024)
    Opinion by Chief Justice Roberts, joined by Justices Thomas, Alito, Gorsuch, Kavanaugh, and Barrett; concurring opinions by Justice Thomas and Justice Gorsuch; dissenting opinion by Justice Kagan, joined by Justice Sotomayor, joined by Justice Jackson as it applies to No. 22–1219; Justice Jackson took no part in the consideration or decision of the case in No. 22–451

  • By Michael Borella —

    USPTO Building FacadeAny patent attorney who has been in the business for more than a few years understands from experience that some USPTO examiners are tougher than others.  This should not be surprising, as each examiner is an individual who is applying their own experience and knowledge during the examination process, which inherently includes some degree of subjectivity.

    Nonetheless, we all have experienced examiners from time to time that appear to be exceptionally difficult.  These examiners are more likely than most to reject claims on multiple grounds and be less responsive to applicants' rebuttals.  Some are unwilling to engage in productive conversations during interviews.  Most have low allowance rates.

    With analytics tools now readily available to applicants and their attorneys, we can obtain concrete statistics about these examiners, and then analyze their prior prosecution histories in order to better understand their individual proclivities and nuances.  It has become generally accepted in the field that the examiner that is assigned to an application can be as determinative on its outcome as the application itself.  If an application is assigned an unusually tough examiner, there often is relatively little the applicant can do to obtain an allowance short of an appeal or filing a continuation in hope of obtaining a more reasonable examiner.

    In an effort to better understand these tough examiners, we undertook a study to identify and analyze what we call the low allowance rate examiner (LARE).  These are examiners who not only have a low allowance rate, but also have had an allowance rate significantly below that of their art unit for a non-trivial period of time.  In other words, we wanted to identify a handful of examiners who are true outliers in terms of their examination practice.  The goal is to determine just how difficult these examiners are and in which art units these examiners are found.

    For our purposes, a LARE is defined as an examiner who meets all of these criteria:

    • Has an overall allowance rate below 10%;
    • Has an overall allowance rate more than 25% below the average of their current art unit; and
    • Has examined more than 100 applications.

    These criteria help us identify examiners are not only outliers in general, but also outliers among their own art unit peers.  Further, rookie examiners who may not have examined enough applications to establish a pattern of behavior are omitted.  Additionally, we only considered applications that were filed on January 1, 2010 or later in this study to exclude considering too many examiners who have since retired.

    Notably, these criteria exclude many examiners who have low allowance rates.  In searching the Juristat USPTO database, we identified a large number of examiners with allowance rates below 25% (the current overall average allowance rate at the USPTO is 73%).  Further, many examiners with allowance rates below 10% are in art units with low allowance rates (more on that later), so these examiners are not exceptions when compared to their peers.  We also noticed many newer examiners with allowance rates below 10% but without the requisite number of applications examined.

    We used Juristat's database and its analytical tools to identify LAREs.  After manually eliminating some examiners whose statistics were extremely skewed based on what appeared to be administrative nuances,[1] we identified 24 LAREs.[2]

    We have to be careful here — just because an examiner is identified as a LARE does not mean that they have engaged in any malfeasance.  An examiner may have a low allowance rate because they specialize in examining subject matter that has a low allowance rate.  Further, the Juristat data is a reflection of the USPTO public database and is necessarily not up to date (e.g., it will only reflect Office actions mailed in 2023 or 2024 that are not subject to the 18-month publication delay).  Thus, some of these LAREs might not qualify if this unpublished data were considered.  Nonetheless, we are convinced that these LAREs are true outliers because we intentionally made the selection criteria extremely restrictive.

    First, some demographics.  The average number of examined applications for LAREs is 211.5 and two-thirds have 10 or more years of experience as examiners at the USPTO.  All LAREs have at least 4 years of experience.  This clearly establishes that most LAREs are highly-experienced examiners and very few are junior examiners.

    The average allowance rate for LAREs is 6.4%.  In other words, if your application is assigned to a LARE, there is a 93.6% likelihood that it will not be allowed — a devastating number.  Further, the average art unit allowance rates for these LAREs is 52.73%.[3]  So, even though these LAREs tend to be in art units with average allowance rates that are lower than the overall USPTO average, LAREs are still quite anomalous.

    As noted, all LAREs have an allowance rate that is at least 25% below that of their art unit average.  The difference between LARE allowance rates and their art unit averages ranged from 27% to 77%.  At the high end of this spectrum, we found an examiner with an 8% allowance rate in an art unit with an average allowance rate of over 85%.

    One LARE had an allowance rate below 1%, which was 50% lower than their art unit average.  Another LARE had an allowance rate between 1% and 2%, which was 38% lower than their art unit average.  Yet another LARE had an allowance rate between 3% and 4%, which was over 57% below their art unit average.  These were the most extreme examples in terms of low allowance rate.

    It should surprise nobody that 21 of 24 LAREs were in Tech Center 3600.  This area of the USPTO is notorious for low allowance rates as it is where most business method and many software applications are routed.  Since these types of applications are unusually susceptible to § 101 rejections, we see a rather high rate of such rejections from Tech Center 3600 LAREs.

    To add some color the § 101 issue, we considered the last 20 substantive Office actions from each LARE and calculated the rate of § 101 rejections for each.  Unsurprisingly, it was 70% for Tech Center 3600 LAREs and much lower (0%-5%) for the other 3 LAREs.  Two of the LAREs gave § 101 rejections 100% of the time and five more gave § 101 rejections 90%-95% of the time.

    One of the reasons for such high § 101 rates may go beyond the nature of the subject matter being examined.  Anecdotally, in conversations with Tech Center 3600 examiners, some have told me that they feel pressured by their supervisors to give § 101 rejections for every single application unless they have a really good reason to do otherwise.  Further, experienced examiners in Tech Center 3600 may understand that the PTAB is highly unlikely to reverse a § 101 rejection, especially for business method and software inventions.[4]  Thus, an appeal to the PTAB is not a viable option for applicants and the examiner has a very low likelihood of being reversed on appeal.

    Moreover, the USPTO has utterly failed to police the slop in some examiner' § 101 rejections, including conclusory reasoning, ignoring claim elements, not understanding the concept of the prima facie burden on examiners, employing vigorous hand waving over dependent claims, ignoring technical improvements in the claims and the specification, and erroneously thinking that concrete tangible inventions can be "abstract."[5]  These factors may incentivize examiners to provide § 101 rejections regardless of whether such rejections are truly warranted.

    Given that an application examined by a LARE is almost certainly not going to be allowed, what can applicants do?  While one can file a continuation or continuation in part with a different claiming strategy, this approach typically results in the continuation being assigned to the same examiner.  A better strategy is to do everything you can to front-load the application so that it does not get routed to art units known for having LAREs.  This involves avoiding business language in the specification, repeatedly describing the invention's technical benefits, and using art unit steering tools to avoid such art units.

    Notably, the LAREs identified in this study were all in the 1620 (organic chemistry), 2860 (printing, measurement and testing), 3620 (business methods), 3640 (aeronautics, agriculture, fishing, trapping, plant and animal husbandry, weaponry, nuclear systems), 3670 (construction), 3680 (business methods), 3690 (business methods), and 3710 (amusement and education) art units.  These art units should be avoided at all costs through careful up-front drafting.

    But the elephant in the room is why the USPTO allows LAREs to continue as examiners for years or decades.  The USPTO appears to have very little oversight of examiners, especially senior examiners.  If the USPTO is unable or unwilling to provide this oversight and to at least explain why so many LAREs and other examiners with low allowance rates exist, an independent oversight board should be established to conduct such a study and provide recommendations to the Department of Commerce.

    Finally, if the USPTO takes issue with any of this data or our methodology, it should conduct its own study of LAREs and make the results available to the public.  As noted above, the USPTO has access to examination data that is non-public and may be able to shed more light on this issue.

    [1] For example, we omitted an examiner with an allowance rate of 0.1% who appeared to have been associated with hundreds of applications that they did not examine.

    [2] We are going to be careful not to provide information that clearly identifies individual examiners.  Thus, while we have precise numbers for all of the metrics discussed herein for each LARE, we will apply some rounding up or down in order to make such identification harder. In all cases, however, LARE behavior is so extreme that any fuzziness that we add to their statistics is not significant and does not impact any of our conclusions.

    [3] This number is an average of an average and therefore is not a robust statistic.  Nonetheless, we present it for informational purposes and because producing a more accurate measure would require an excessive amount of manual effort.

    [4] In 2022, the PTAB affirmed examiner § 101 rejections from Tech Center 3600 at a blistering rate of 97%.  See https://www.patentdocs.org/2023/01/ptab-remains-hostile-to-section-101-appeals.html.

    [5] Much blame should be assigned to the Supreme Court's legislating from the bench, the Federal Circuit's self-contradictory lines of § 101 case law, and USPTO administration for not providing examiners with clear § 101 examination guidance.

  • D Young & CoD Young & Co will be offering its next European biotech patent law update on June 25, 2024.  The webinar will be offered at three times:  9:00 am, noon, and 5:00 pm (BST).  D Young & Co European Patent Attorneys Simon O'Brien and Nathaniel Wand will discuss the latest European biotech patent case law developments, including the following:

    T 910/21: New purpose of treating the same disease
    T 209/22: Novelty-sufficiency squeeze based on clinical trial
    T 1255/21: Lack of inventive step in view of clinical trial protocol
    T 1252/20: The definition of "substance or composition" in medical use claims
    T 1920/21: Limits to "diagnostic method" exclusion

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • By Kevin E. Noonan –

    U.S. Trade RepresentativeIn April, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2024 Special 301 Report.  In a press release, the USTR stated that "[m]any of the issues highlighted in the Special 301 Report demand collaborative efforts from our allies and partners" and additionally, "[m]any of my counterparts share the goal of making sure that trade supports the interests of our people, and one of the most dangerous types of IP violations involves counterfeit goods that pose health and safety risks."  Unlike last year, this version of the press release did not mention the Biden Administration's support for the WTO IP waiver, but instead noted that "the Biden-Harris Administration has continued its policy of declining to call out countries for exercising TRIPS flexibilities, including with respect to compulsory licenses, in a manner consistent with TRIPS obligations."

    The press release accompanying the Report notes that its review of Ukraine (which has been the subject of criticism in prior versions of the Report's "Watch List"; see below) continues to be suspended due to "full-scale invasion of Ukraine in February 2022."  It mentions removal from the Watch List of the Dominican Republic and Uzbekistan due to "significant" and "sustained" progress, respectively, in "addressing concerns" and resolving "longstanding issues" with regard to IP protection and enforcement.  On the other hand the People's Republic of China (PRC) was placed on the Priority Watch List (wherein a heightened level of scrutiny is applied) due to "many serious concerns regarding IP protection and enforcement," including stakeholder concerns about the PRC's implementation of its IP laws as well as "long-standing issues like technology transfer, trade secrets, bad faith trademarks, counterfeiting, online piracy, and geographical indications."  And while recognizing "progress" in India-U.S. trade policy involving "certain issues with trademark infringement investigations and pre-grant opposition proceedings" the press release notes that "numerous long-standing concerns remain" in "inadequate IP enforcement, including high rates of online piracy, an extensive trademark opposition backlog, and insufficient legal means to protect trade secrets" with this country.  The press release also announces placing Vietnam on the Watch List for becoming "a leading source of online piracy" including "currently host[ing] some of the most popular piracy sites and services in the world that target a global audience."

    Also included in the press release are a number of "cross-cutting issues" highlighted in this year's 301 Report, that include "counterfeit products, including counterfeit medicines, [that] can pose harms to the citizens of the trading partners where those counterfeit products are consumed"; that "the United States continues to respect its trading partners' rights to grant compulsory licenses in a manner consistent with the provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the Doha Declaration"; there being "ongoing concerns related to online piracy and broadcast piracy"; "[persistent c]oncerns with the European Union's aggressive promotion of its exclusionary geographical indications (GI) policies"; and that the USTR "continues to engage trading partners to address concerns on IP protection and enforcement" that include Trade and Investment Frameworks and bilateral agreements with "Armenia, India, Kazakhstan, Kyrgyz Republic, Paraguay, Peru, Tajikistan, Thailand, Turkmenistan, Ukraine, Uzbekistan, and Vietnam."

    According to the Executive Summary of the Report, "[a] priority of this Administration is to craft trade policy in service of America's workers, including those in innovation- and creativity-driven export industries."  The Summary further contains the exhortation that:

    The Report serves a critical function by identifying opportunities and challenges facing U.S. innovative and creative industries in foreign markets and by promoting job creation, economic development, and many other benefits that effective IP protection and enforcement support.  The Report informs the public and our trading partners and seeks to be a positive catalyst for change.  USTR looks forward to working closely with the governments of the trading partners that are identified in this year's Report to address both emerging and continuing concerns and to build on the positive results that many of these governments have achieved.

    The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The 1988 amendments were directed particularly "to provide for the development of an overall strategy to ensure adequate and effective protection of intellectual property rights and fair and equitable market access for United States persons that rely on protection of intellectual property rights" because "the absence of adequate and effective protection of United States intellectual property rights, and the denial of equitable market access, seriously impede the ability of the United States persons that rely on protection of intellectual property rights to export and operate overseas, thereby harming the economic interests of the United States."  The Report "provides an opportunity to put a spotlight on foreign countries and the laws, policies, and practices that fail to provide adequate and effective IP protection and enforcement for U.S. inventors, creators, brands, manufacturers, and service providers, which, in turn, harm American workers whose livelihoods are tied to America's innovation- and creativity-driven sectors."  Specific concerns motivating the Report include:

    (a) challenges with border and criminal enforcement against counterfeits, including in the online environment; (b) high levels of online and broadcast piracy, including through illicit streaming devices; (c) inadequacies in trade secret protection and enforcement in China, Russia, and elsewhere; (d) troubling "indigenous innovation" and forced or pressured technology transfer policies that may unfairly disadvantage U.S. right holders in markets abroad; and (e) other ongoing, systemic issues regarding IP protection and enforcement, as well as market access, in many trading partners around the world.  Combating such unfair trade policies can foster American innovation and creativity and increase economic security for American workers and families.

    The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for [intellectual property rights] (IPR) or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These Watch Lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

    Pursuant to the Act the USTR reviewed "more than 100" of this country's trading partners and identified seven countries on a "Priority Watch List" (increased by one from last year) and another 20 countries on the "Watch List" (decreased by two from last year), all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the 2024 Report includes Argentina, Chile, China, India, Indonesia, Russia, and Venezuela.  On the Watch List this year are Algeria, Barbados, Belarus, Bolivia, Brazil, Bulgaria, Canada, Colombia, Ecuador, Egypt, Guatemala, Mexico, Pakistan, Paraguay, Peru, Thailand, Trinidad & Tobago, Turkey, Turkmenistan, and Vietnam (Dominican Republic and Uzbekistan being removed from the list this year).

    The Report contains two Sections (on "Developments in Intellectual Property Rights Protection and Enforcement" and "Country Reports") and two Annexes on particular issues (the statutory bases of the Report, and government technical assistance and capacity building efforts).

    The Report cites (and emphasizes) significant progress in several U.S. trading partners, including:

    • Dominican Republic, which has made "significant progress on addressing concerns with intellectual property (IP) enforcement and transparency," including "increased enforcement actions and interagency cooperation on combating signal piracy, improved resource allocation for agencies, made publicly available enforcement-related statistics, increased the number of specialized IP prosecutors, and worked with various U.S. agencies to receive training and technical assistance."

    • Bulgaria, which passed legislation directed towards imposing criminal penalties for individuals who "create conditions for online piracy."

    • Peru, which amended its organized crime laws to apply to intellectual property crimes.

    • India, which finalized its patent law to permit pre-grant oppositions, updates reporting of patent working requirements, and decreased reporting time for foreign applications, which the Report asserts "have the potential to reduce long-standing burdens on patent applicants."

    • China, which established a new authorization procedure for foreign documents (previously subject to a lengthy apostille protocol) to shorten approval time to "a few days."

    • Indonesia, whose Directorate General for Intellectual Property and enforcement authorities collaborated with foreign enforcement agencies (including INTERPOL, the U.S. Department of Justice and Korean authorities) to arrest purveyors of an illicit Internet protocol television service.

    • Armenia acceded to the International Union for the Protection of New Varieties of Plants Convention, which mandates member countries to grant IP protection to breeders of new plant varieties.  There are now 62 member countries to the convention.

    • Saint Vincent and the Grenadines acceded to the WIPO Copyright Convention.

    Continuing on a positive note, the Report identifies "illustrative best IP practices" by U.S. trading partners.  These include "cooperation and coordination among national government agencies involved in IP issues is an example of effective IP enforcement," citing Saudi Arabia, Brazil, Indonesia, South Africa, and the Dominican Republic, for activities including "creat[ion of] the permanent National Committee for the Enforcement of Intellectual Property to coordinate IP enforcement" (Saudi Arabia), Brazil's National Council on Combating Piracy and Intellectual Property Crimes, Indonesia's expansion of its Intellectual Property Task Force, South Africa's coordination of agencies in enforcement raid against counterfeit goods, and the Dominican Republic's efforts to coordinate agencies for IP enforcement, cooperation and information sharing.  The Report also points out "specialized IP enforcement units" in the Philippines and India.

    IP awareness and educational campaigns were also discussed, including those in Spain, Algeria, the United Arab Emirates, Indonesia, Thailand, the Philippines, Uzbekistan, Kazakhstan, and Brazil, as well as "active participation of government officials in technical assistance and capacity building" in Indonesia, Morocco, Saudi Arabia, Oman, Qatar, Paraguay, the Philippines, Thailand, Kenya, Nigeria, the Dominican Republic, Peru, and Bulgaria.  The important role of micro, small, and medium-sized enterprises (MSMEs) in the global economy, and efforts by U.S. trading partners (including the United Kingdom, India, Liberia, and the Dominican Republic) to provide technical and other assistance, to these entities was also mentioned.

    Multilateral and bilateral initiatives are discussed in the Report.  This section of this year's Report focuses on initiatives under the World Trade Organizations TRIPS Council to "cover often unexplored areas connected to IP and innovation" which included "cross-border cooperation among IP offices, research collaboration across borders, and incubators' and accelerators' support of startups operating in a cross-border environment."  Also discussed were efforts by the U.S. towards a "positive" (presumably, more effective) pandemic response, mentioning a report on access to COVID-19 diagnostics and therapeutics by the U.S. International Trade Commission (see "International Trade Commission Issues Report on COVID-19 IP Waiver").  Bilateral efforts cited in the 301 Report include Trade and Investment Framework Agreements (TIFAs) with more than 50 U.S. trading partners, which include Peru, Thailand, Paraguay, Ukraine, Vietnam, India, Armenia, and a group of Central Asian countries.  Regional initiatives included in the Report are the Asia-Pacific Economic Cooperation (APEC) Intellectual Property Experts Group having the theme of "Creating a Resilient and Sustainable Future for All" and "discussions with APEC economies on effective practices for enforcement against illicit streaming in a U.S.-led initiative on illicit streaming" (each of which were also cited in last year's Report).  Also continued from last year are a series of workshops, including a "Roundtable on Copyright and Creativity in the Digital Economy," a "Workshop on Geographical Indications and Preservation of Common Names," one on "Leveraging Industrial Design Protections for Small-and-Medium Sized Enterprises," and a "Green Technology One Day Program."  Regarding what the Report terms "trade preference programs" are the Generalized System of Preferences (GSP) program, the African Growth and Opportunity Act, the Caribbean Basin Economic Recovery Act, and the Caribbean Basin Trade Partnership Act.  The Report mentions pending reviews under these programs of IP practices in South Africa and Indonesia.

    Turning to specific issues of concern, trademark counterfeiting is said to harm "consumers, legitimate producers, and governments . . . particularly [with regard to] medicines, automotive and airplane parts, and food and beverages that may not be subject to the rigorous good manufacturing practices used for legitimate products."  The Report accuses infringers, motivated by higher profit margins, of disregarding product quality and performance.  The Report recites a litany of negative consequences to legitimate producers and their employees (including diminished revenue and investment incentives), adverse employment impacts, and reputational damage when consumers purchase fake products, as well as increased costs for firms to enforce their intellectual property rights and loss of tax revenues generated by legitimate businesses to governments.  The potential for health and safety risks associated with counterfeiting are further discussed in the 2023 Review of Notorious Markets for Counterfeiting and Piracy according to the Report.

    Countries particularly called out in the Report in this regard include China, India, and Turkey, from whom counterfeit "semiconductors and other electronics, chemicals, medicines, automotive and aircraft parts, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods" enter the global stream of commerce.  Also involved are "transit hubs" in countries including Hong Kong, Kazakhstan, Singapore, and Turkey that distribute counterfeit goods to third-country markets that include Brazil, Kenya, Mauritius, Mexico, Nigeria, Paraguay, and Russia.  Citing a 2021 Organisation for Economic Co-operation and Development (OECD) and European Union Intellectual Property Office (EUIPO) study entitled Global Trade in Fakes:  A Worrying Threat, the Report states that the "global trade in counterfeit and pirated goods reached $464 billion in 2019, accounting for 2.5% of the global trade in goods for that year," with China (and Hong Kong) being the largest country of origin for counterfeit and fake goods.  Also of concern in the Report is Singapore border enforcement for weakness and "lack of coordination between Singapore's Customs authorities and the Singapore Police Force's Intellectual Property Rights Branch" (concerns voiced last year and earlier) and Bangladesh as "one of the top five source economies for counterfeit clothing globally."

    Counterfeit pharmaceuticals remain a particular concern as a growing problem with "important consequences for consumer health and safety [that are] exacerbated by the rapid growth of illegitimate online sales . . . [and] contributes to the proliferation of substandard, unsafe medicines that do not conform to established quality standards."  Most of these goods confiscated by the U.S. were sourced from India, Singapore, and China, the Report alleges, and transshipped through China, India, Pakistan, Indonesia, the Philippines, and Vietnam.  The Report also states that counterfeit U.S. brand-name medicines amount to 38% of global counterfeit medicine seizures and that "substandard or falsified medical products comprise 10% of total medical products in low- and middle-income countries" (although the Report qualifies this statement with the caveat that "it may not be possible to determine an exact figure" for the latter statistic).  These trends are increasingly exacerbated by use of on-line pharmacies, with illicit providers comprising "between 67% to 75% of web-based drug merchants" according to a 2020 study.  And these counterfeit items are being distributed by "legitimate express mail, international courier, and postal services to ship counterfeit goods in small consignments" rather than large cargo ships, making detection and enforcement more difficult.

    The Report addresses these concerns by summarizing U.S. efforts to combat these counterfeits:

    The United States continues to urge trading partners to undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods.  The United States engages with its trading partners through bilateral consultations, trade agreements, and international organizations to help ensure that penalties, such as significant monetary fines and meaningful sentences of imprisonment, are available and applied to deter counterfeiting.  In addition, trading partners should ensure that competent authorities seize and destroy counterfeit goods, as well as the materials and implements used for their production, thereby removing them from the channels of commerce. Permitting counterfeit goods, as well as materials and implements, to re-enter the channels of commerce after an enforcement action wastes resources and compromises the global enforcement effort.

    The Report identifies countries such as Turkey, Pakistan, Columbia, Ecuador, Indonesia, Canada(!), and Turkmenistan as having practices that fall short of adequate efforts to stem the flow of counterfeit goods across borders.

    Online and broadcast piracy are also discussed, the Report noting that "[t]he increased availability of broadband Internet connections around the world, combined with increasingly accessible and sophisticated mobile technology, has been a boon to the U.S. economy and trade."  But such "technological developments have also made the Internet an extremely efficient vehicle for disseminating pirated content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content."  Sources of online piracy mentioned in the Report include Argentina, Bulgaria, Canada, Chile, China, Colombia, India, Mexico, the Netherlands, Pakistan, Poland, Romania, Russia, Switzerland, Thailand, and Vietnam, estimated as costing the U.S. economy "at least $29.2 billion and as much as $71 billion in lost revenue each year."

    A particular form of copyright piracy (particularly of music), termed "stream-ripping," is practiced (or ineffectively prevented) in Canada, Korea, Mexico, Nigeria, Russia, South Africa, Switzerland, the Report asserts.  Illicit streaming devices (ISDs) "continue to pose a direct threat to content creators, sports leagues, and live performances, as well as legitimate streaming, on-demand, and over-the-top media service providers" while illicit Internet Protocol Television (IPTV) services "unlawfully retransmit telecommunications signals and channels containing copyrighted content through dedicated web portals and third-party applications that run on ISDs or legitimate devices."  These technologies contribute "notable levels of piracy" in high levels in Argentina, Brazil, Canada, Chile, China, Guatemala, Hong Kong, India, Indonesia, Iraq, Jordan, Mexico, Morocco, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and Vietnam, with China being identified as a "manufacturing hub" for these devices and Iraq as a source of satellite receivers "pre-loaded with pirate IPTV apps."  Signal theft remains a problem in Brazil, Argentina, and Honduras.

    Also noted were the use of camcorders to produce expropriated contend, in Russia, India, and China, with impediments to counteracting such illicit activities found in Argentina, Brazil, Ecuador, Peru, and Russia (which don't effectively criminalize such activities), in contrast to laws now in effect in Canada, Japan, the Philippines, and Ukraine; the Report cites approvingly a report from the Asia-Pacific Economic Cooperation (APEC) on effective practices for addressing these problems.

    The significance of the problem was synopsized in the Report as follows:

    In addition to the distribution of copies of newly released movies resulting from unauthorized camcording, other examples of online piracy that damage legitimate trade are found in virtually every country listed in the Report and include: the unauthorized retransmission of live sports programming online; the unauthorized cloning of cloud-based entertainment software through reverse engineering or hacking onto servers that allow users to play pirated content online, including pirated online games; and the online distribution of software and devices that allow for the circumvention of technological protection measures, including game copiers and mod chips that allow users to play pirated games on physical consoles. Piracy facilitated by online services presents unique enforcement challenges for right holders in countries where copyright laws have not been able to adapt or keep pace with these innovations in piracy.

    Difficulties in trade secret protection have its own subsection of the Report.  The problems of adequately protecting trade secrets have arisen "in a wide variety of industry sectors, including information and communications technology, services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing sectors, [that] rely on the ability to protect and enforce their trade secrets and rights in proprietary information" and include theft of "business plans, internal market analyses, manufacturing methods, customer lists, and recipes" that "are often among a company's core business assets," according to the Report.  The Report states that trade secret protection (or lack of it) is a particular problem in Russia, China, and India, and "[l]ack of legal certainty regarding trade secrets also dissuades companies from entering into partnerships or expanding their business activities in these and other countries.  While "[t]he United States uses all trade tools available to ensure that its trading partners provide robust protection for trade secrets and enforce trade secrets laws," according to the Report, only Taiwan was mentioned as having made successful efforts in protecting trade secrets since the last Special 301 Report.

    The United States-Mexico-Canada Agreement (USMCA) has "the most robust protection for trade secrets of any prior U.S. trade agreement" according to the Report.  The United States-China Economic and Trade Agreement (Phase One Agreement) has several trade secret commitments, the Report states, including "expanding the scope of civil liability, covering acts such as electronic intrusions as trade secret theft, shifting the burden of producing evidence, making it easier to obtain preliminary injunctions to prevent use of stolen trade secrets, allowing criminal investigations without need to show actual losses, ensuring criminal enforcement for willful misappropriation, and prohibiting unauthorized disclosure of trade secrets and confidential business information by government personnel or third-party experts."  The Report reiterates the U.S. government's support for continued work by international organizations (including the Organisation for Economic Co-operation and Development) to support trade secret protections.

    Another subsection of the Report involves "forced" technology transfer, indigenous innovation, and preferences for indigenous IP.  These include the following activities, many of which involved governmental action and all of which were mentioned in the 2022 and 2023 Special 301 Reports:

    • Requiring the transfer of technology as a condition for obtaining investment and regulatory approvals or otherwise securing access to a market or as a condition for allowing a company to continue to do business in the market;

    • Directing state-owned enterprises in innovative sectors to seek non-commercial terms from their foreign business partners, including with respect to the acquisition and use or licensing of IP;

    • Providing national firms with an unfair competitive advantage by failing to effectively enforce, or discouraging the enforcement of, U.S.-owned IP, including patents, trademarks, trade secrets, and copyright;

    • Failing to take meaningful measures to prevent or to deter cyber intrusions and other unauthorized activities;

    • Requiring use of, or providing preferences to, products or services that contain locally developed or owned IP, including with respect to government procurement;

    • Manipulating the standards development process to create unfair advantages for national firms, including with respect to participation by foreign firms and the terms on which IP is licensed; and

    • Requiring the submission of unnecessary or excessive confidential business information for regulatory approval purposes and failing to protect such information appropriately.

    China is particularly recognized for such practices.

    As in other years, geographical indications (i.e., country or region of origin limitations primarily for wine and foodstuffs) are discussed, specifically in the EU.  This is particularly troubling for trademarks, the Report stating that "[t]he EU GI agenda remains highly concerning because it significantly undermines protection of trademarks held by U.S. producers and imposes barriers on market access for U.S.-made goods that rely on the use of common names, such as parmesan or feta."  These practices are particularly troublesome for medium-sized enterprises (MSMEs), according to the Report, because their trademarks are "among the most effective ways for producers and companies . . . to create value, to promote their goods and services, and to protect their brands."  In addition, the Report asserts that "[t]rademark systems offer strong protections through procedures that are easy to use, cost-effective, transparent, and provide due process safeguards" and "[t]rademarks also deliver high levels of consumer awareness, significant contributions to gross domestic product and employment, and accepted international systems of protection," all of which are impeded by EU GI practices which "may result in consumer confusion to the extent that it permits the registration and protection of GIs that are confusingly similar to prior trademarks."  The Report specifically calls out EU protections for cheese varieties (including feta, danbo, and Havarti) as instances where EU protections fly in the face of these names having been used extensively throughout the world (Argentina, South Africa, and Uruguay for danbo; Australia, New Zealand, the United States, among others, for havarti), which actions undermine the benefits of international standards under the Codex Alimentarius.  The resulting trade deficits between the U.S. and EU caused by these restrictions are also mentioned, wherein the EU exported more than $1.1 billion of cheese to the United States last year while the United States exported only about $8.1 million of cheese to the EU.

    The EU's efforts are expanding the reach of these GIs from agricultural products and foodstuffs to "apparel, ceramics, glass, handicrafts, manufactured goods, minerals, salts, stones, and textiles," according to the Report.  The EU has also used instruments of international organizations (like WIPO) through the Lisbon Agreement for the Protection of Appellations of Origin and the Geneva Act thereof to expand the reach of GIs.

    While having little luck dissuading the EU from continuing and expanding its GI practices, the Report cites several bilateral agreements (with Argentina, Australia, Brazil, Canada, Chile, China, Ecuador, Indonesia, Japan, Kenya, Korea, Malaysia, Mexico, Moldova, New Zealand, Paraguay, the Philippines, Singapore, Taiwan, Thailand, Uruguay, and Vietnam, and others) that have a number of provisions aimed at curtailing some of the deleterious effects of GI protection as set forth in detail in the Report.

    With regard to pharmaceuticals and medical devices and market access for U.S. products, the Report contends that "[t]he COVID-19 pandemic has highlighted the importance of pharmaceutical, medical device, and other health-related innovation, as well as a lack of widespread, equitable distribution of these innovations," including the need for fighting current as well as future pandemics.  The Report thus seems to seek to strike a balance between "adequate and effective protection for pharmaceutical and other health-related IP around the world to ensure robust American innovation in these critical industries to fight" in this and future pandemics and "access to medicines in developing economies [that] is important to development itself."

    The Report notes that, paradoxically while the USITC Report evinces the reality that "the price of medicines can be untenably high for some countries" another report shows that "low and middle-income countries maintain the highest tariffs on medicines and pharmaceutical inputs among the World Trade Organization (WTO) Members" and that "large developing countries" (Brazil, India, and Indonesia) have the highest tariffs for these products.  Exacerbating these problems are "unreasonable regulatory approval delays and non-transparent reimbursement policies" that "discourage the development and marketing of new drugs and other medical products" according to the Report.  The U.S. in the past year has monitored, enforced, or engaged with trading partners (China, Canada, Mexico, Japan and India) in efforts to remedy these impediments to efficient global access to medicines while protecting IP rights.  The Report notes that stakeholders have "expressed concerns" about practices in Australia, Brazil, Canada, China, Colombia, Japan, Korea, Mexico, New Zealand, Russia, Saudi Arabia, and Turkey "on issues related to pharmaceutical innovation and market access," providing specific examples for each country.

    Trademark issues are also noted in the Report for China and Indonesia or a variety of impediments for protecting trademarks, and in Brazil, Ecuador, Egypt, Spain, Turkmenistan, and Uzbekistan, which "frequently impose unnecessary administrative and financial burdens on trademark owners and create difficulty in the enforcement and maintenance of trademark rights."  Formalities and "documentation requirements" (such as "obtaining traditional pen-and-ink signatures, notarized or legalized powers of attorney, and original documents") were noted for Algeria, China, Indonesia, Iraq, and the United Arab Emirates.  Other countries "do not provide the full range of internationally recognized trademark protections," including Argentina, Barbados, Belarus, and Indonesia, still others have "reportedly have slow opposition or cancellation proceedings" (India, Malaysia, Pakistan, and the Philippine) or no such proceedings at all (Panama and Russia), and Bangladesh, Iraq, and South Africa have "extreme delays" in processing trademark applications.

    In copyright matters, the Report cites "flawed or non-operational" copyright management organizations in several countries, naming India, Kenya and Nigeria, despite efforts in countries including the UAE to improve matters in this regard.

    Software concerns included in the Report involve government use of unlicensed software (costing $46 billion globally in 2018 according to The Software Alliance).  This issue is particularly noted in Argentina, China, Guatemala, Indonesia, Moldova, Pakistan, Paraguay, Romania, Turkmenistan, Uzbekistan, and Vietnam.  The United States "urges trading partners to adopt and implement effective and transparent procedures to ensure legitimate governmental use of software."  Under the heading of "Other Issues" the Report notes that the U.S. stakeholders have raised concerns regarding the EU's Copyright in the Digital Single Market and will continue to monitor copyright issues in the EU stemming from implementation thereof, particularly in Bulgaria, Denmark, Finland, Latvia, Poland, and Portugal.

    The Report spends less time than in other years on IP and the environment (under the heading of "Intellectual Property and Sustainability) and has a more extensive section on IP and health.  This section is focused (as it was last year) on the COVID pandemic and sequelae thereof.  The Reports states that the United States "continues to work to fight COVID-19 and is committed to building back a better world, one that is prepared to prevent, detect, and respond to future biological threats, and where all people can live safe, prosperous, and healthy lives."  These sentiments extend primarily to avoiding IP (or at least its purported costs), the Report stating that "[t]he United States recognizes the role of voluntary licensing as one mechanism to promote greater access to pandemic response products," specifically citing voluntary licensing through the Medicines Patent Pool (MPP) and licenses with generic manufacturers, with "agreements that do not require the generic manufacturers to pay a royalty to the right holder" (holding out as exemplary licenses to MPP for COVID-19 technologies through the COVID-19 Technology Access Pool (C-TAP) administered by the U.S. National Institutes of Health).  The Report identifies "[n]umerous comments in the 2024 Special 301 review process [that] highlighted concerns arising at the intersection of intellectual property (IP) policy and health policy," while at the same time recognizing that "IP protection plays an important role in providing incentives for the development and marketing of new medicines," requiring "[a]n effective, transparent, and predictable IP system . . . for both manufacturers of innovative medicines and manufacturers of generic medicines."  What follows these sentiments is a rather extensive discussion of how the WTO under the TRIPS regime has adapted to the dichotomy between international health concerns and IP protection, citing the Doha Declaration as an example (stating that "the United States respects a trading partner's right to protect public health and, in particular, to promote access to medicines for all") and further states that "[t]he United States also recognizes that the TRIPS Agreement provides for additional flexibilities in public health emergencies and other circumstances of extreme urgency within a Member's territory."  This section also emphasizes that the United States "also recognizes that the TRIPS Agreement provides for additional flexibilities in public health emergencies and other circumstances of extreme urgency within a Member's territory" under Articles Article 30, Article 31, and Article 31bis and specifically Paragraph 6 of the Doha Declaration.  What follows this in the Report is a history of the efforts of certain Member states to impose compulsory licenses on COVID-specific technologies, to which the U.S. has at least somewhat consented but also citing the ITC Report for its conclusions regarding the lack of a need for such licenses (at least at present).  The Report notes that in March 2024 the WTO did not extend these provisions (although "discussions in the WTO TRIPS Council have been and will continue to be held with respect to lessons learned regarding pandemic response and preparedness").  This section concludes with a pledge that provisions of U.S. agreements with its trading partners "do not impede its trading partners from taking measures necessary to protect public health."

    Perhaps paradoxically, this section is followed by one emphasizing U.S. commitment that the WTO effectively implement TRIPS provisions regarding "certain minimum standards of intellectual property (IP) protection and enforcement" for all Member states (including a discussion of those states that have not yet fully implemented these provisions) and extensions of deadlines in the Agreement for them to do so.

    This general portion of the Report concludes with dispute settlement and (IP) enforcement, wherein is announced that "[t]he United States continues to monitor the resolution of concerns and disputes announced in previous Reports" and that "[t]he United States will use all available means to resolve concerns, including bilateral dialogue and enforcement tools such as those provided under U.S. law, the World Trade Organization (WTO), and other dispute settlement procedures, as appropriate" (displaying the stick that is the alternative to the policy "carrots" extended in other portions of the Report).  Specifically mentioned are efforts towards China and the EU for activities set forth in other sections of the Report that the U.S. considers contrary to TRIPS IP provisions.

    Section II of the Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.

    As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative's 2024 Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with other countries to increase protection for IP rights of U.S. IP rights holders.  This by itself make the Report informative reading.

    For additional information regarding this and other related topics, please see:

    • "U.S. Trade Representative Releases 2023 Special 301 Report," May 29, 2023
    • "U.S. Trade Representative Releases 2022 Special 301 Report," April 28, 2022
    • "U.S. Trade Representative Releases 2021 Special 301 Report," May 23, 2021
    • "U.S. Trade Representative Releases 2020 Special 301 Report," May 10, 2020
    • "U.S. Trade Representative Releases 2019 Special 301 Report," April 29, 2019
    • "U.S. Trade Representative Releases 2018 Special 301 Report," April 29, 2018
    • "U.S. Trade Representative Issues 2017 Special 301 Report," May 4, 2017
    • "U.S. Trade Representative Issues 2016 Special 301 Report," May 19, 2016
    • "U.S. Trade Representative Issues 2015 Special 301 Report," April 30, 2015
    • "U.S. Trade Representative Issues 2014 Special 301 Report," May 19, 2014
    • "U.S. Trade Representative Issues 2013 Special 301 Report," May 30, 2013
    • "U.S. Trade Representative Issues 2012 Special 301 Report," May 1, 2012
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 4, 2011
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 19, 2010
    • "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
    • "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
    • "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008

  • By Kevin E. Noonan –

    Court of Appeals - 2d Cir. SealIn a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest Laboratories and several generic drug companies** for settlement agreements in ANDA litigation, in CVS Pharmacy Inc. v. Forest Laboratories Inc.

    The litigation arose over the generic drugmakers' ANDA filings involving Forest Laboratories' Bystolic (nebivolol hydrochloride) product, which is a beta blocker used for treating high blood pressure:

    Image 1
    The patent asserted in the litigation was U.S. Patent No. 6,545,040 (expired December 17, 2021), claim 1 thereof reciting:

    1.  A composition consisting of the compound [2R,αS,2′S,α′S]-α,α′-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] having the formula:
    Image 2or a pharmaceutically acceptable acid addition salt thereof.

    The parties settled the ANDA litigations, with settlement terms including delayed generic entry (until 3 months before patent expiry) and payments to generics for "goods and services" "such as ingredient supply and product development" (which the antitrust plaintiffs alleged were pretextual).

    Plaintiffs, consisting of direct purchasers, retail purchasers, and end-payor purchasers alleged violation of Sherman Act Sections 1 and 2, Clayton Act Section 16, and state antitrust and unfair competition laws.  The District Court granted defendants' motion to dismiss under Fed. R. Civ. Proc. 12(b)(6), first without prejudice (permitting the complaint to be refiled) and then with prejudice when the procedural defects identified by the District Court under Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), Ashcroft v. Iqbal, 556 U.S. 662 (2009), were not rectified.  This appeal followed, wherein the Second Circuit affirmed dismissal with prejudice.  The opinion notes that the FTC filed an amicus brief but did not file an action against Forest and the generic defendants.

    The Court's basis for affirming dismissal of the complaint was that plaintiffs did not plausibly allege that "any of Forest's reverse payments were unjustified or unexplained, instead of constituting fair value for goods and services obtained as a result of arms-length dealings."  The opinion relies upon the Supreme Court's decision in FTC v. Actavis which mandates that courts apply the antitrust "rule of reason" to reverse payment settlement agreements that "depends upon its size, its scale in relation to the payor's anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification," including "fair value for goods and services exchanged as part of a bona fide commercial relationship."  The reverse payments in the settlement agreements at issue ranged from $200,000 and $2,000,000, and each settling defendant was granted a "non-exclusive, royalty-free license to market its version of generic Bystolic beginning on September 17, 2021" (but with provisions that, if any of the seven entered the market earlier then the others were permitted to do so).  In addition, the settlements contained various supply agreements for goods and services (termed the "Commercial Transactions"), which plaintiffs argued were "side agreements" having large ($15 million) values.

    Appellate review was de novo, under Second Circuit law; as set forth in the opinion under Iqbal the facts alleged must support a "facially plausible claim" that would permit a court "to draw the reasonable inference that the defendant is liable for the misconduct alleged."  "Mere possibility" isn't enough, nor are allegations that are "merely consistent with" liability if they don't plausibly suggest liability under Twombly; further "labels and conclusions" are insufficient nor are "naked assertions" unsupported by "further factual enhancements."

    The Court focused on Twombly's plausibility requirement, the opinion noting that this standard does not permit a court to dismiss an antitrust complaint based on a "plausible version of the events merely because the court finds a different version more plausible" under Anderson News, L.L.C. v. Am. Media, Inc., 680 F.3d 162, 185 (2d Cir. 2012), because "plausibility" is a lower standard than "probability."

    The opinion provides a succinct synopsis of Supreme Court's Actavis decision:  "the Supreme Court made clear that reverse-payment settlements are not per se or presumptively illegal–rather, they may violate the antitrust laws only 'sometimes' . . . [requiring courts to] navigate the 'tension between the antitrust laws' objective of enhancing competition by preventing unlawful monopolies and patent laws' objective of incentivizing innovation by granting legal patent monopolies,'" citing New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 659 (2d Cir. 2015).

    Here, the Second Circuit found parallels between the circumstances and provisions in Actavis and in this case — "an agreed-upon date [of market entry] earlier than the expiry of [the branded company's patents]" and payment to the generic companies ("millions of dollars") as compensation for services.  The Supreme Court calculus the Second Circuit considered particularly applicable in this case involved the rule of reason wherein:  (1) the plaintiff has the initial burden to show that the challenged restraint of trade has actual anticompetitive effects; (2) if the plaintiff makes out a prima facie case, the burden shifts to the defendant to demonstrate the restraint's procompetitive benefits or justifications; and (3) if the defendant does so, the burden shifts back to the plaintiff to establish that there were less restrictive means for obtaining the procompetitive benefits."  Further, the opinion sets forth the Court's analysis of the rubrics the Second Circuit relied upon from Actavis: first, that the rule of reason is applied because reverse payment agreements have the "potential for genuine adverse effects on competition" and second that these agreements only violate the antitrust laws "sometimes" and thus "[t]he 'relevant antitrust question' is why the reverse payment was made," i.e., to cause anticompetitive harm, which is assessed using the analytical framework set forth by the Supreme Court in Actavis ("large," based on absolute size and relationship to avoided litigation costs, and "unjustified" or unexplained reverse payments based on "traditional settlement considerations" such as "fair value"), in the context of a general preference for settling lawsuits.

    The Second Circuit agreed with the District Court that plaintiffs did not "plausibly allege" that the settlements were unjustified and raised an antitrust violation, and had "properly applied the general pleading principles established in Twombly [and] Iqbal."  Regarding the justification standard, the Court held that "[t]here is no allegation plausibly showing that any of the six Commercial Transactions reflected anything other than 'fair value' for goods and services obtained as a result of good-faith business dealings," the plaintiffs rather relying ("mostly") on "speculation and supposition," terming them "atmospheric allegations" (heretofore rather more often the province of the FTC's rhetoric).

    Importantly, the Court asserts that "Actavis does not stand for the proposition that parties must reach the most procompetitive settlements possible," citing King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., 791 F.3d 388, 408–09 (3d Cir. 2015), nor does the Court's decision "compel antitrust scrutiny of a settlement regardless of whether its terms could reasonably be interpreted as a large and unjustified reverse payment," citing In re Actos End Payor Antitrust Litig., No. 13-cv-9244, 2015 WL 5610752, at *15 (S.D.N.Y. Sept. 22, 2015).

    The opinion recites as "overarching" the following reasons supporting dismissal in the terms of the Commercial Transactions that the Court opines reflect bona fide business considerations:

    • The size of payments is not sufficiently contextualized or compared to enable [the Court] to infer that the payments are plausibly unjustified.

    • Forest's need for alternative supplies of active pharmaceutical ingredients ("API") or finished pharmaceutical products was consistent with what Forest previously disclosed to investors.

    • A lack of public disclosures about business plans or investments does not necessarily bear upon whether those ventures are truly legitimate or genuine.

    • It is sensible for counterparties to enter into condensed term sheets with the expectation of subsequently negotiating definitive agreements that are more detailed.

    • Payments for developmental or commercial milestones, or research-and-development expenses, bespeak rational commercial incentives.

    • Provisions in the Commercial Transactions that are designed to ensure price competition do not fit with Forest's alleged intention to funnel secret overpayments to the Generic Defendants.

    • Agreements between Forest and other counterparties need not be identical to Forest's agreements with the Generic Defendants, or even closely resemble them.

    • The agreements' provisions trump allegations of unsupported speculation about nefarious motives.

    The opinion then illustrates how each of the six Commercial Agreements satisfy a sufficient combination of these considerations for the Court to affirm the District Court's decision to dismiss plaintiff's complaint with prejudice (calling one set of plaintiff's allegations "at once complicated and threadbare").

    Despite active support by the FTC, plaintiffs here failed to establish sufficient likelihood of an antitrust violation arising from any of the ANDA settlements at issue illustrating the burden such plaintiffs face and the dependence of that burden on the factual underpinnings of the settlement agreements at issue.

    * Plaintiffs included CVS Pharmacy, Inc.; Rite Aid Corporation and affiliates; J M Smith Corporation and affiliates; KPH Healthcare Services, Inc. and Kinney Drugs, Inc., Mayor and City Council of Baltimore, UFCW local 1500 Welfare Fund, Teamsters Western Region & Localv177 Health Care Plan, Fraternal Order Of Police Miami Lodge 20, Insurance Trust Fund, Law Enforcement Health Benefits, Inc., Teamsters Local No. 1150 Prescription Drug Benefit Plan, Teamsters Local 237 Welfare Fund and Teamsters; Local 237 Retirees Benefit Fund, Albertsons Companies, Inc., H-E-B L.P., The Kroger Co., Walgreen Co.

    ** Defendants included Forest Laboratories Inc. (innovator) and Allergan, Inc. and affiliates; Abbvie Inc.; Watson Pharma, Inc. and affiliates; Actavis, Inc.; Teva Pharmaceuticals USA, Inc.; Torrent Pharmaceuticals Ltd. and affiliates; Amerigen Pharmaceuticals Ltd and affiliates; Glenmark Generics Inc., USA and affiliates; Hetero Labs Ltd. and affiliates; Andchemie Health Specialties Private Ltd.; Alkem Laboratories Ltd.; Ascend Laboratories, LLC; and ANI Pharmaceuticals, Inc. (generic drugmakers), wherein Alkem, Amerigen, Glenmark, Indchemie, Hetero, Torrent and Watson were all first-filers.

  • By Kevin E. Noonan –

    Federal Trade Commission (FTC) SealPolicy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard.  The FTC is infamous for its uncontrolled venom towards industries they believe with religious fervor to be charging consumers prices higher that the FTC thinks they should be.  This tendency was evident in the fight over reverse payment settlements in ANDA litigation, leading to a Supreme Court decision imposing a "rule of reason" standard rather than the draconian per se standard the Commission espoused in determining whether an antitrust violation had occurred (see FTC v. Actavis).  And it is with similar rhetorical excesses that the Commission has begun its latest crusade involving listing on the Food and Drug Administration's Orange Book for patents claiming medical devices relating to administering FDA-approved drugs.

    It will be recalled that the FTC spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange Book-listed patents (see "The FTC's Thinking Does Not Make It So Regarding Reverse Payment Agreements"; "Federal Trade Commission Issues Report on Reverse Settlement Agreements in FY2010"; "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation"; "The FTC Is at It Again").  These agreements were termed "reverse payment" settlements because unlike in most patent suits, the defendant secured a payment from the patentee (as part of its campaign, the FTC termed these "pay-for-delay" agreements).  The Commission persisted in its efforts despite most Federal Courts of Appeal deciding that, rather than being anticompetitive, the agreements frequently resulted in generic drugs coming to market much earlier than would be expected (see "Valley Drug Co. v. Geneva Pharmaceuticals, Inc."; "Schering-Plough Corp. v. Federal Trade Commission"; "In re Tamoxifen Citrate Antitrust Litigation"; "In re Ciprofloxacin Hydrochloride Antitrust Litigation"; "Arkansas Carpenters Health & Welfare Fund v. Bayer AG"; and "Federal Trade Commission v. Watson Pharmaceuticals, Inc.").  One basis for the FTC's persistence was the belief that branded drug companies settled because they were aware that their patents were invalid and thus improperly tried to extend their "monopoly"; of course this position supposed not only that innovator drug companies were willing to contravene the antitrust laws but perhaps more importantly that the Commission's bureaucrats had a better understanding of the pharmaceutical industry than the executives making the decisions.  Persistence being what it is, the FTC finally prevailed in finding a Circuit Court (the Third) to accept its arguments (see "The Federal Trade Commission Finally Wins One"), leading to the Supreme Court deciding the issue in FTC v. Actavis.

    The FTC's latest foray into policing pharmaceutical companies and their patent behavior was set forth in a policy statement promulgated last fall, entitled "Statement Concerning Brand Drug Manufacturers' Improper Listing of Patents in the Orange Book," in a classic example of begging the question and one viewed through the Commission's prism of purported patent malfeasance by branded drug companies.

    As it did with the reverse settlement issue, the FTC's attitude seems to be that something might be happening and then to proceed as if it is.  This is evident from the first sentence of the policy statement, which asserts that "[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration's ('FDA') Approved Drug Products with Therapeutic Equivalence Evaluations, known as the 'Orange Book'" (emphasis added).  The statement then extols the benefits of generic competition (which is fine as far as it goes, but of course there needs to be something to copy in the first place for the generics regime to be effective).  There is a general allegation in the midst of this rhetoric — the statement asserts that "certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it," and if so, of course the Commission is empowered to and intends to pursue such manufacturers who are purportedly "abus[ing] the regulatory processes set up by Congress to promote generic drug competition" under the power to investigate unfair trade practices under 15 U.S.C. §§ 45(a), (n).

    The justification for the Commission's concerns stems apparently from the results of a 2002 study (FED. TRADE COMM'N., GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION: AN FTC STUDY 39-52 (2022), that supposedly involved improper listing, further citing an enforcement action in that year against Biovail (In re Biovail Corp., FTC Dkt. No. C-4060 (Oct. 2, 2002)).  Also cited are a total of four instances where the Commission filed amicus briefs in cases where there may have been improper listing, such as patents for a system to implement a REMS (not a medical device).  The consequence of such listings, the statement asserts, is to invoke the 30-month stay in approval attendant upon the NDA holder (or her licensee) filing suit against an ANDA applicant, because "even small delays in generic competition can generate substantial additional profits for brand companies at the expense of patients."  Patients would be harmed because they would be "deprived of the ability to choose between competing products and may be forced to pay inflated prices."  Of course the 30-month stay while statutory is not mandatory; should the infringement action be dismissed (for example, on motion that the patent asserted were improperly listed in the Orange Book), the FDA would be able to expeditiously approve the ANDA and the generic company enter the marketplace (with its own 180-day exclusivity if a first filer; under these circumstances the extent to which patients would pay deflated prices would be itself delayed).

    Having established at least to its own satisfaction the basis for the Commission's attention to this issue, the statement then announced the FTC's intention to "enforce the law against those companies and individuals who continue to improperly list patents in the Orange Book" using "its full legal authority to protect patient and payors . . . from business practices that tend to negatively affect competitive conditions."  This threatened exercise of the Commission's legal authority finds its basis in "the FTC's historical use of Section 5 [of the Clayton Act]" based on improperly listing a patent in the Orange Book being an unfair method of competition.  The statement goes on to speculate that improperly listing a patent in the Orange Book "may . . . constitute illegal monopolization," perhaps evincing a recognition that agency overreach was not greeted warmly by the Supreme Court in Actavis with regard to the FTC's position that reverse settlement agreements were a per se antitrust violation.  Treading cautiously, the statement further warns that "improperly listing patents in the Orange Book may also be worthy of enforcement scrutiny from government and private enforcers under a monopolization theory" and calls out the possibility (or likelihood) that it "may also scrutinize a firm's history of improperly listing patents during merger review" (emphasis added).  Finally, the statement suggested that "individuals" (presumably corporate officers) who "submit or cause the submission" of patents improperly to the Orange Book may be held liable individually, and that a finding of a false certification under 21 C.F.R. § 314.53(c)(2)(ii)(R) could be sent to the Department of Justice for investigation of criminal liability.  Should all else fail, the Commission also states that it "may" dispute individual Orange Book listings through the FDA process set forth in 21 C.F.R. § 314.53(f)(1) that permits "any interested person" to request patent information in the Orange Book be corrected.

    Mostly in footnotes, the statement identified no more than 10 cases in support of the statement (and one of those, Fed. Trade Comm'n v. Shkreli, 581 F. Supp. 3d 579, 637 (S.D.N.Y. 2022), involved the infamous "Pharma Bro" whose shenanigans can hardly be held up as a standard under which ethical branded drug companies conduct their businesses).  In view of the powers the Commission can wield, the assertions, allegations, and promises of future activities set forth in the statement cannot be ignored, but it also cannot help but raise the question of whether this tempest should not have remained in the teapot from whence it sprung, at least without further evidence that improper listing occurs frequently enough to significantly impact drug prices paid by the patients and payors the FTC is attempting to serve and protect from (in the Commission's view, apparently) predatory branded drug companies.

    Most recently, the FTC sent letters almost identical in substantive import to ten major drug companies (Amphaster Pharma, AstraZeneca, Boehringer Ingelheim, Covis Pharma, GlaxoSmithKline, Glaxo Group Ltd., Norton (Waterford) Ltd., Novartis, Novo Nordisk, and Teva Pharmaceuticals); the identical language of these letters indicates that presumption of wrongdoing rather than any individual, identified malfeasance prompted the campaign.  The letters were accompanied with the FTC's announcement and accompanying statements by Commission Chairwoman Lina Khan that:

    "By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on."

    "By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need"

    (appropriate in tone for the former enfant terrible author of "Amazon's Antitrust Paradox" (Khan, Lina M. (January 2017), Yale Law Journal, 126 (3): 710–805).

    The current spate of threatening letters is similarly devoid of evidence and long on supposition, quoting from the earlier Policy Statement that:

    ". . . patents improperly listed in the Orange Book may delay lower-cost generic drug competition" [and]

    "In addition to delays resulting from such a stay of approval, the costs associated with litigating improperly listed patents may disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive entry."

    The letters further warn that the FTC has chosen to use the statutory pathway under 21 C.F.R. § 314.53(f)(1)(i)(A) for disputing "the accuracy or relevance of patent information submitted" to FDA for Orange Book listing but that the Commission "retain[s] the right to take any further action the public interest may require, which may include investigating this conduct as an unfair method of competition under Section 5 of the FTC Act, 15 U.S.C. § 45."  These stratagems enable imposition of civil (monetary) penalties, but the earlier warning in the Policy Statement that "if the FTC encounters false certifications filed under 21 C.F.R. § 314.53(c)(2)(ii)(R) that may constitute a potential criminal violation for the submission of false statements, the Commission may refer such cases to the U.S. Department of Justice for further investigation" has not been abjured.

    This latest action raises the question of why these companies and what behavior prompted the Commission to act now?  Each letter contains a table of the patents whose listing the Commission calls into question, summarized as follows herein:

    Table
    A closer look shows that what these patents protect are, by and large, medical devices that provide either greater accuracy in administered dose or increased patient convenience and accompanying greater patient compliance; for example:

    U.S. Patent No. 7,654,986 (expiration expected July 12, 2024) (Novo Nordisk)

    Claim 1:  A needle mounting system for mounting and dismounting a needle assembly onto a needle mount of an injection device, comprising . . .

    Specification:
    Injection devices, also referred to as dosers, have greatly improved the lives of patients who must self-administer drugs and biological agents. Dosers may take many forms, including simple disposable devices that are little more than an ampoule with an injection means or they may be highly sophisticated instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self-administer injectable drugs and biological agents. They also greatly assist care givers in administering injectable medicines to those incapable of performing self-injections.

    U.S. Patent No. 8,161,968 (expiration expected February 5, 2028) (GSK)

    Claim 1:  A medicament dispenser for containing plural elongate form medicament carriers, each medicament carrier having multiple distinct medicament dose portions carried thereby,  . . .

    Specification:
    The Applicant has now found that in providing a medicament dispenser of this type a number of practical problems and design challenges are encountered.

    One problem is that of providing a dispenser device that is able to accommodate the plural medicament carriers, but is of sufficiently small overall size that it is conveniently portable (e.g. in the pocket or bag of a patient) and amenable to discrete use, by the patient.

    Another problem is that of providing a dispenser device, in which the distinct medicament dose portions of each of the plural medicament carriers may be indexed or accessed without the need for the user to apply undue indexing or accessing force. Particular challenges are faced when the plural medicament carriers are required to be moved through the dispenser device for indexing/accessing thereof, and where the indexing/accessing action is coupled (e.g. moving peelable blister strips through the dispenser device to both index a particular blister on each strip and peelably access that blister).

    U.S. Patent No. 8,182,838 (expiration expected October 20, 2028) (Novartis)

    Claim 19:  A pharmaceutical composition comprising composite active particles prepared in accordance with the method as claimed in claim 1, blended with carrier particles.

    Claim 36:  A dry powder inhaler containing a composition as claimed in claim 19.

    Specification:
    WO 00/74754 and many other publications over a period of more than twenty years have described how, particularly in powder inhalers, there is a considerable problem with moisture. Not only can moisture have a disadvantageous effect on the pharmaceutically active composition of the medicament, it can also impair in particular the interplay of physical and chemical parameters of the combination of active substance and auxiliaries. As a result, lumps may form, for example, or the breakdown of the inhaled powder into particles which can access the lungs may be impaired. All these circumstances can lead to problems affecting the metering and the efficacy of the administration of a powdered medicament.

    To minimize these disadvantages, various attempts have already been made in the past to reduce the penetration of moisture into a powder inhaler by using seals. Attempts have also been made to reduce the disadvantageous effects of penetrated moisture by providing desiccants to absorb the moisture, in particular to keep the air moisture in storage chambers to a minimum.

    And a close look at the frequency with which these patents have been asserted in an abbreviated new drug application (ANDA) litigation shows that most of them have not been so asserted.  Of the 61 patents identified in the FTC's letters (presumably indicating some level of differentiation to select somewhat- to particularly egregious-examples of bad behavior), 34 have never been asserted and eight others have been asserted in only five ANDA cases.  The anomaly are 19 patents asserted in 209 cases, with the majority of these being directed to Ozembic, Saxenda, and Victoza.  Whether this exemplifies over-exuberance, bad acting, or justifiable protection of devices providing patient-specific advantages remains to be determined.

    In at least one case, the FTC's crusade has proven to be persuasive to a district court, Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC (Civil Action No. 23-20964 (SRC), U.S. District Court of New Jersey) (Opinion & Order).  The decision arose in ANDA litigation over Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product, wherein Teva asserted U.S. Patent Nos. 8,132,712; 9,463,289; 9,808,587; 10,561,808; and 11,395,889.  These patents claimed devices for administering the drug product, and Amneal moved (and the District Court held) that these patents should be delisted from the Orange Book.  The basis for the court's decision was that these patents did not claim the drug product and thus were improperly listed under the requirements of 21 U.S.C. § 355(b)(1)(A)(viii)(I).  (The FTC garners credit, or blame, for the decision by its filing of an amicus brief heavily relied upon and cited in the opinion, for which Commission Chair Kahn was quick to publicly claim responsibility.  In rendering its decision, the Court relied on the First Circuit's decision in Cesar Castillo, Inc. v. Sanofi-Aventis U.S., LLC (In re Lantus Direct Purchaser Antitrust Litig.), 950 F.3d 1, 3 (1st Cir. 2020), that a listed patent must be directed to the drug product and the Second Circuit's decision in United Food & Commer. Workers Local 1776 v. Takeda Pharm. Co., 11 F.4th 118, 134 (2d Cir. 2021), that the question of proper listing was based on what the patent claimed and not what would infringe those claims (to the extent, unexplicated in the District Court's decision, that these would be different).  It must be recognized that the District Court's decision was based, inter alia, on Teva's assertion that these patents were listed as reciting the drug rather than reciting methods for administering the drug.

    (Perhaps more troubling is that the District Court denied Teva's motion to strike Amneal's counterclaim that improper listing can amount to an antitrust violation under 21 U.S.C. § 355(j)(5)(c)(ii)(II) and particularly rejected Teva's claim that such listing does not raise antitrust liability under the Supreme Court's decision in Verizon Communs., Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398, 398-99 (2004)).

    The circumstances surrounding this most recent FTC endeavor bring back to mind the circumstances in the reverse settlement situation, where the first case involved what apparently was in fact an abuse of the statute and could have been an antitrust violation (and in which private parties and "[t]he attorneys general of all 50 States, Puerto Rico and the District of Columbia (the 'attorneys general) eventually joined the litigation on behalf of their States and as parens patriae on behalf of the residents of their respective jurisdictions"; see "In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003)").  Thereafter, every such settlement was not just suspect but evidence of anticompetitive behavior merely by its existence, with the only motivation contemplated by FTC's philosophy being that patentees were aware of the invalidity of the patents at issue and were attempting to "buy off" challengers.  The counter-narrative (understood and explicated by the Chief Justice in his dissent in FTC v. Actavis), that the investment by innovative pharmaceutical companies and vagaries of any litigation mitigated against taking unnecessary business risks, was lost on the FTC and undoubtedly will be so again here.  How these ten pharmaceutical companies respond to the FTC's mandate will vary, no doubt (and asserting these patents in ANDA litigation is likely imprudent when routine avenues of recourse may suffice).  But these alternatives may involve a higher degree of disruption of markets and patient-availability of the medicines under NDA and also reduce investment into new and better ways of administering drugs known to be more difficult to administer than conventional drugs or that would provide real-world benefit for patients.  The Policy Statement and the FTC's actions in enforcing it being in their early stages it is impossible to predict the outcome.  But if earlier FTC ideology-based efforts are a guide it is likely to be a protracted struggle.