By Joshua Rich and Kevin E. Noonan –

The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to market as soon as possible and leverage previous marketing by the innovators as much as possible.  The strategies between the two involve a continual thrust and parry – most relevant here, generics can adopt so-called “skinny labels” by “carving out” patented uses of drugs, and innovators have then focused on the generic drugmakers’ marketing of those skinny-labeled drugs as “generic versions” of the branded drug (with a wink and a nod) and argued that the marketing pulls back in what the skinny label carves out.  In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.,[1] the Federal Circuit decided that those types of allegations could potentially support a claim for inducement of infringement; the Supreme Court has now granted certiorari to decide the question for itself.[2]

The basis for the dispute begins with the language of the Hatch-Waxman Act.  Concerned with the possibility that innovator drug companies could extend patent exclusivity by obtaining a series of patents on different uses of a drug, Congress codified the possibility of a generic drug being approved for less than all of the indications identified in the label of the reference-listed drug.[3]  By carving out the patented uses of the listed drug and leaving only the unpatented uses (whether patent protection was never obtained or had expired for those uses), the generic drug can come to market with a “skinny label.”  Congress intended that result, preventing innovator drug companies from making the label a game of whack-a-mole that would keep generic companies from bringing drugs to market for the treatment of conditions that are subject to no patent protection.

However, generic drug companies’ interaction with the public is not limited to the label alone.  If it were, there would be no question that the generic companies do not actively induce infringement of the patented methods by marketing a skinny labeled drug.  On the other hand, if the generic companies were to market the same drug for the patented treatment method, they would not only be potentially subject to punishment by the FDA (because marketing a drug for a use not on the approved label would generally be considered to be “adulteration”), they would also be actively inducing infringement of the patent.  But the question arises when their conduct and public pronouncements fall somewhere in between: where is the line between fair marketing practices and inducing infringement?

This dispute arises out of Amarin’s Vascepa^® (icosapent ethyl) drug, a omega-3 fatty acid purified from fish oil.  In 2012, Amarin obtained FDA approval for use of Vascepa^® for the treatment of severe hypertriglyceridemia (referred to as “SH” – triglyceride levels of over 500 mg/dL, more than three times the “normal” level), an indication for which it had obtained patent protection.  Four years later, Hikma filed an ANDA seeking approval to market its generic version of the drug based on the original Vascepa® label with a “Paragraph IV”[4] certification that the patents covering the method of treating SH were invalid.  Amarin sued Hikma; while that litigation was pending, Amarin obtained approval and patents on another indication relating to reducing cardiovascular (“CV”) disease risk.

Instead of changing its draft label to include the new CV indication, Hikma left its label essentially the same as the original SH-only label.[5]  It prevailed in the litigation, proving the patents covering the method of treating SH were invalid as obvious, and launched its generic drug with the (now) skinny label limited to the SH indication.  In launching its product, however, Hikma issued press releases that called its drug a “generic equivalent” of Vascepa^®, touted the market size for Vascepa^® – which was predominantly based on the CV indication – and referred on its website to the drug’s use as a treatment for “hypertriglyceridemia,” which was broader than the approved SH indication.  Nowhere in Hikma’s promotional materials, however, did it say that the generic drug was approved for the CV indication.

Amarin sued Hikma again (this time post-launch), arguing that the press releases and website language was intended to, and did, actively induce doctors to prescribe Hikma’s generic drug for the patented treatment within the CV indication.  Hikma moved to dismiss, arguing that Amarin failed to state a claim because nothing Hikma did in obtaining approval and marketing the skinny labeled generic drug would constitute active inducement of infringement.  The U.S. District Court for the District of Delaware agreed, finding that the skinny label was itself not even arguably infringing and that Hikma’s marketing statements were – at best – evidence of intent to get doctors to prescribe the drug in an infringing manner, but uncombined with any instruction to use the drug to treat CV.  As the District Court phrased it, Hikma’s conduct could not be considered anything more than describing the infringing use and “does not rise to the level of encouraging, recommending, or promoting taking Hikma’s generic for the reduction of CV risk.”  Accordingly, the District Court granted Hikma’s motion to dismiss.

Amarin appealed the dismissal, and the Federal Circuit ultimately decided that Amarin’s allegations could potentially support a finding of active inducement to infringe and reversed.  The Federal Circuit may have been motivated in part by the unusual posture of the case:[6] this was not an ANDA case based solely on the product label, or even a case based primarily on the indication in the product label – there really was no solid grounds for making such an argument.  Instead, it was the public statements by Hikma in combination with (or even perhaps, despite) the product label that gave rise to Amarin’s claim.  Because there was also very little dispute that the allegations of underlying direct infringement by doctors and Hikma’s intent to have doctors infringe were sufficient, the decision turned on the question of whether Hikma’s alleged statements and marketing actions could plausibly be considered “actively” inducing doctors in service of that intent.

The Federal Circuit found that the allegations of Amarin’s complaint provided enough plausibility to support a claim for active inducement of infringement.  First, other portions of the label (which Hikma was not empowered to alter when filing an ANDA) reported data on both SH and CV populations.  Second, Hikma altered the original SH-only label by removing the CV Limitation on Use and adding warnings of potential cardiovascular side effects from the newer label; those warnings would be relevant only if the drug were prescribed for the CV indication.  Even so, the Federal Circuit found those portions of the product label alone would not support a claim for active inducement of infringement – merely not discouraging infringement is not the same as actively inducing it.  Rather, it was only when the product label was viewed in combination with Hikma’s public statements that the package could be read as potentially providing the basis for a claim of active inducement of infringement.  The panel believed it could not resolve the questions of fact underlying the interpretation of the public statements and their relation to the product label on a motion to dismiss.  Thus, while it recognized that Amarin’s claim might fail on a motion for summary judgment, it reversed the District Court’s decision and remanded for further proceedings.

Hikma petitioned for certiorari, noting that some commentators viewed the case as a fundamental shift in the ground between branded drugs and generics versions thereof and a potentially chilling message to generic companies.  It argued that the Federal Circuit’s decision was not only wrong on the application of the pleading standards, but also that its approach conflicted with the Ninth Circuit’s interpretation of the pleading requirements for active inducement of infringement (as applied in the copyright context) and that it completely undermined the Hatch-Waxman Act’s skinny labeling option.  It argued that the decision would severely harm the generic drug market, raising drug prices and creating great uncertainty as to when generic drugs could launch.  Amarin opposed the petition, arguing that the case was tied tightly to very specific facts, that the Federal Circuit correctly applied the pleading standards (and in a manner that did not conflict with any other circuit’s application of the law), and that Hikma’s claims of harm to the market were overblown.  As Amarin put it:

Petitioners act like they were hit with a judgment, but this case is just beginning.  Infringement and any defenses to it are not yet decided, nor are any remedies.  What  petitioners really want is a safe-harbor from having to litigate at all—a sort of qualified immunity for generic pharmaceuticals that has no basis in statute or case law.

In its reply, Hikma pointed out that it was not the only one who foresaw the sky falling due to the decision here; in the certiorari process in an earlier, similar case,[7] the then-Solicitor General had asserted that even “the potential for inducement liability in these circumstances may significantly deter use of the section viii pathway even if such liability is rarely imposed.”  The Supreme Court then solicited the current Solicitor General’s views on the case, and he placed his thumb squarely on the scale against the Federal Circuit and for review (and reversal) by the Supreme Court.  As he argued:

The decision below subverts Congress’s balance between competing interests by subjecting Hikma to a substantial threat of infringement liability for statements that either (a) are integral to the section viii pathway or (b) have no meaningful likelihood of increasing the prevalence of infringing off-label uses.  The contents of Hikma’s “skinny label” are largely dictated by the Hatch-Waxman Amendments, and Hikma’s description of its drug as the “generic equivalent” of Vascepa is central to the Hatch-Waxman scheme.  And while the Federal Circuit identified a handful of other statements to investors that accurately described the generic drug and its brand-name counterpart, the complaint in this case did not describe any plausible sequence of events by which those statements could have led a healthcare professional to engage in direct infringement.

The Supreme Court then granted certiorari review.

Given the facts and posture of the Hikma case, it is likely that the Supreme Court will reverse the Federal Circuit’s decision.  But in doing so, it is unlikely that it will pronounce the lower court decision “merely wrong” – such cases are rarely considered by the Court – but more likely will involve establishment of a clearer boundary between what is fair to include in a skinny label and marketing information and what might give rise to an infringement claim.  That makes this situation especially rare, as it is usually the case that the Federal Circuit creates bright-line tests and the Supreme Court strikes them down in favor of a “totality of the circumstances” approach.  But here, where generic drug companies are tied to the language of the product label and the ubiquitous description of a “generic equivalent” of a reference label drug, it seems more important that the Court remove the chill that could be placed on the generic drug market by a vague pleading standard.  As a result, it is likely to find that a skinny label that does not mention a patented use will be judged to fall within a safe harbor from liability.

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[1] https://patentdocs.org/2024/08/07/amarin-pharma-inc-v-hikma-pharmaceuticals-usa-inc-fed-cir-2024/

[2] https://patentdocs.org/2026/01/16/solicitor-general-proves-persuasive-supreme-court-grants-hikmas-certiorari-petition/

[3] 21 U.S.C. § 355(j)(2)(A)(viii) provides that a generic drug company can submit an Abbreviated Drug Application and “if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, [the ANDA can include] a statement that the method of use patent does not claim such a use.”

[4] 35 U.S.C. § 355(b)(2)(iv).

[5] One difference proved important to the Federal Circuit: the original Vascepa® label excluded the CV indication in the form of a CV Limitation on Use.  Hikma’s label did not include the CV Limitation on Use.  Hikma’s label also included warnings of potential cardiovascular side effects which were not included in the original Vascepa® label.

[6] The appellate panel itself was a bit unusual, as it included U.S. District Court Judge Alan Albright of the Western District of Texas, sitting by designation.  Judge Albright is one of the most prolific patent judges, and one of the ones most sought by patentees.

[7] Glaxo-SmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021).

By Kevin E. Noonan –

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-called “off-label” prescribing for indications not covered in their approved label (known as a “skinny label; see “GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)“).  In the latest instance (see “Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)“), the Solicitor General filed its amicus brief (at the Supreme Court’s behest) regarding the issue, once again (as has been done before; see “Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation“) arguing that the Court should grant certiorari.

Today, the Court granted Hikma’s certiorari petition, which recited the following Questions Presented:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use?

2. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use?

This case follows patterns found before in instances where the Court has granted cert: the Federal Circuit has rendered decisions with competing stances taken by members of the Court and the decision has “real world” implications on important societal matters (i.e., it isn’t just a patent dispute between the parties but will influence important policy outcomes; here, regarding the availability of generic drugs).

The Court’s Order does not specify which flavor of these Questions they have deigned to consider, and how Hikma crafts the questions it actually argues will be seen in coming months.  However, the universal sentiment on both sides of the aisle are that drugs cost too much, and to the extent this sentiment resonated with the Justices (and whether such resonance with common sentiment is, as in other instances, a factor in their decision to hear the case) will also become evident in time.  In this way, this certiorari decision is reminiscent of the Court’s grant in Association of Molecular Pathology v. Myriad without the predictably fraught outcomes arising therefrom.  After all, what could be bad about lower drug costs (other than reducing the availability of innovator drugs to be copied by generic drugmakers)?  We shall see.

By Donald Zuhn –

The China National Intellectual Property Administration (CNIPA) has instituted a change in its inventor information requirements.  For Chinese patent applications filed on or after January 1, 2026, Applicants must submit an inventor ID number for every inventor along with each inventor’s nationality.  The nationality of each Inventor mustbe submitted at the time an application is filed.  For inventors holding dual nationality, the Applicant must choose one nationality for submission to CNIPA.

The inventor ID number can be submitted at the time of filing or within two months from the date of a CNIPA notification requesting the inventor ID number.  For Chinese inventors, the ID number is their National ID number (i.e., an 18-digit Citizen Identity Number issued by the Chinese government).  For non-Chinese inventors, a passport number or any other government-issued valid identifying number, such as a driver’s license number, is acceptable.

Patent Docs thanks Chinese intellectual property firm AFD China for alerting us to the new inventor ID requirement.

By Kevin E. Noonan –

The preclusive scope of 35 U.S.C. § 314(d) regarding decisions on instituting post grant review proceedings (specifically, inter partes review or IPR) has been decided several times by the Supreme Court since enactment of the Leahy-Smith America Invents Act in 2013 to be very preclusive (see Cuozzo Speed Technologies, LLC v. Lee, 579 U. S. 261 (2016); Thryv, Inc. v. Click-to-Call Techs., LP, 590 U.S. 45 (2020)).  Indeed, the only exception to the statutory mandate that institution cannot be subject to judicial review are in circumstances where there may be “appeals that implicate constitutional questions.”  Nevertheless the temptation to seek judicial review (and reversal) of institution decisions by the Patent Trial and Appeal Board (PTAB) has persisted (albeit unsuccessfully) as shown in the Federal Circuit’s decision last month in Ethanol Boosting Systems, LLC v. Ford Motor Co.

This case arose in inter partes review proceedings of certain claims in three related patents owned by Ethanol Boosting Systems (EBS): U.S. Patent Nos. 10,619,580; 10,791,760; and 9,708,965, all held to be invalid for obviousness by the PTAB.  Claim 1 of the ‘581 patent is cited in the opinion as representative:

1.  A fuel management system for a spark ignition engine, comprising:
a first fueling system that uses direct injection;
a second fueling system that uses port fuel injection; and
a three-way catalyst configured to reduce emissions from the spark ignition engine,
wherein the fuel management system is configured to provide fueling in a first torque range, the first torque range being a first range of torque values at which both the first fueling system and the second fueling system are operable throughout the first range of torque values,
wherein the fuel management system is further configured such that a fraction of fueling provided by the first fueling system is higher at a highest value of torque in the first torque range than in a lowest value of torque in the first torque range,
wherein the fuel management system is further configured to provide fueling in a second torque range, the second torque range being a second range of torque values at which the second fueling system is operable throughout the second range of torque values and the first fueling system is not operable throughout the second range of torque values,
wherein the fuel management system is further configured such that when the system provides fueling at a torque value that exceeds the second range of torque values, the spark ignition engine is operated in the first torque range, and
wherein the spark ignition engine is configured to operate at a stoichiometric air/fuel ratio in at least part of the first torque range and in at least part of the second torque range.

As noted in the opinion, the case between the parties has been before the Court before, wherein a claim construction decision by a district court was vacated (and the details including the timing of those proceedings are relevant to the decision here; see Ethanol Boosting Sys., LLC v. Ford Motor Co., No. 21-1949, 2022 WL 2798395 (Fed. Cir. July 18, 2022) (nonprecedential)).  In that case, at issue were claim limitations for embodiments comprising direct fuel injection mechanisms, specifically the words “fuel” in the phrase “directly inject[ed] fuel” and “fueling system that uses direct injection”; these terms were generically called “DI Fuel terms” in the opinion.  Before the District Court, EBS asserted construction of these terms under the “plain and ordinary” meaning rubric, whereas Ford argued that the term encompassed fuel that was different from what was used in an alternative, port injection system and contained an antiknock agent other than gasoline itself.  When Ford filed its petitions for instituting the IPRs, it argued that the DI Fuel terms be construed under the plain and ordinary meaning; the Board stayed its institution decision while awaiting the District Court’s claim construction.

The District Court handed down its claim construction decision before the PTAB instituted these IPRs, construing the DI Fuel terms (as Ford argued) to mean “(1) different fuel for direct injection and port injection and (2) an anti-knock agent other than gasoline.”  Pursuant to the parties’ stipulation, the District Court entered judgment of non-infringement based on this construction.  Several months later the PTAB denied institution of the IPRs, holding that the DI Fuel terms required different fuel than was used in the port injector as claimed.  This construction defeated Ford’s prior art-based invalidity arguments in its petitions.  This construction apparently did not take into account the District Court’s construction nor the EBS appeal to the Federal Circuit, because shortly after the Court vacated the District Court’s construction, the PTAB granted Ford’s petitions to institute based on that decision’s claim construction.

In the earlier opinion, the Federal Circuit had vacated the distinction drawn by the District Court between the fuel used in the direct injection and the port injection embodiments of the claimed fuel management system, finding no basis for requiring such differences.  Moreover, the Court considered the disclosure in the specification of fuel comprising 100% ethanol to be excluded from claims construed to require differing fuels in the two alternative embodiments.  The opinion notes that EBS only appealed the first portion of the District Court’s construction, i.e., that there was different fuel used for direct injection and port injection, thereby leaving unchallenged the second portion, that gasoline cannot provide the antiknock component of directly injected fuel.  Accordingly, the Federal Circuit did not consider in that opinion this second portion of the District Court’s claim construction.

Having instituted the IPRs, the PTAB construed the DI Fuel terms according to their plain and ordinary meaning and rejected EBS’s argument that gasoline cannot be the [sole] antiknock agent because the Court’s earlier construction was “controlling law,” on the grounds that the Court had not considered the second portion of the definition of the DI Fuel term.  Having come to these claim construction determinations, the PTAB recognized there was a motivation to combine the asserted prior art references and that the combinations disclosed the claim limitations in dispute.  On those grounds the Board issued a Final Written Opinion invalidating all challenged claims as being obvious, and this appeal followed.

The Federal Circuit affirmed in an opinion by Judge Chen joined by Judges Clevenger and Hughes.  The first of three arguments made to the Court by EBS was that the Board had exceeded its authority (acted ultra vires) by staying its institution decision while awaiting the District Court’s claim construction.  The panel considered this argument as a request for the Court to effectively “de-institute” the IPRs, and that this request was in direct conflict with 35 U.S.C. § 314(d), which precludes courts from reviewing IPR institution determinations.  The opinion supports this interpretation and its consequences by citing Thryv, Inc v. Click-To-Call Techs., LP, 590 U.S. 45, 52–53 (2020); IGT v. Zynga Inc., 144 F.4th 1357, 1365 (Fed. Cir. 2025); and ESIP Series 2, LLC v. Puzhen Life USA, LLC, 958 F.3d 1378, 1386 (Fed. Cir. 2020).  EBS crafted its challenge less specifically against institution, directing that challenge to the question of whether the Board was entitled to stay its institution decision (i.e., thereby not directly targeting the institution per se).  The opinion rejects this characterization of there having been a stay, which is not how the Court has previously considered the time taken by an agency to issue a reconsideration decision, citing CyWee Grp. Ltd. v. Google LLC, 59 F.4th 1263, 1267 (Fed. Cir. 2023).  At least one basis for this position is that there is no law or regulation cited by EBS nor known to the Court that requires a definite amount of time for a reconsideration request to be deliberated.  Even though EBS’s argument was focused on the propriety of the “stay,” the panel considered the argument to be a challenge of the propriety of the PTAB’s institution decision, barred under § 314(d).  And the Court found such grounds for challenge to have been distinguished and rejected by prior precedent, including Thryv, IGT, and ESIP Series 2.  The Court also rejected the “special dispatch” requirements enunciated in Ethicon, Inc. v. Quigg, 849 F.2d 1422 (Fed. Cir. 1988), based on procedural (that case involved reexamination proceedings) and factual (the IPR in this case had not been instituted) differences.  The Court recognized that the Supreme Court has only held “narrow exceptions” to the statutory bar under § 314(d), including “‘appeals that implicate constitutional questions, that depend on other less closely related statutes, or . . . present other questions of interpretation that reach, in terms of scope and impact, well beyond’ § 314,” citing Cuozzo Speed Techs. v. Com. for Intell. Prop., 579 U.S. 261, 275 (2016).  EBS analogized the Board’s delaying its institution decision to “shenanigans” identified as being outside the reach of the § 314 preclusion, which the panel rejected under Cuozzo in view of their earlier decision in SIPCO, LLC v. Emerson Electric Co. (which concerned the Board exceeding its authority to institute a Covered Business Method (CBM) review on a purportedly non-CBM patent (980 F.3d 865, 869 (Fed. Cir. 2020)).  This decision was directly applicable to EBS’s argument here, according to the opinion because in that case as here the argument was that the Board exceeded its statutory authority, which the Court held was not outside the § 314 preclusion.  In addition, the Court found that the Board had “sound reasons” for delaying its institution decision because the Court’s earlier decision “would address the very claim term that the Board hinged its initial denial of institution upon.”

(In this context, the recent proclamations by incoming U.S. PTO Director John Squires may take on more significance (see “New Director Overturns PTAB Procedural Precedents: Parts I and II“).  Under the recently promulgated interpretation of the statute, Congress has conferred decisions regarding IPR institution exclusively to the Director.  While Directors can delegate (and have delegated) institution decisions to the PTAB and three- or five-judge panels thereof, such delegation is discretionary with the Director.  In view of Cuozzo, Thryv, and this decision, current practice will now give the Director unfettered authority to render such decisions, with consequences that may (and likely will) have IPR institution occur at the whim of the policy (and political) whims of particular Directors.  Under current jurisprudence, only modification of the statute by Congress can prevent such an outcome; the likelihood thereof will undoubtedly depend on how prudently Directors exercise such plenary powers.)

EBS’s second grounds for appeal were directed at the Board’s claim construction regarding the “fuel” term.  In those arguments EBS maintained that the Board was compelled to adopt the portion of the unchallenged portion of the District Court’s construction (regarding the antiknock properties of the DI fuel), that the Board did not perform its own “substantive analysis” of its construction, and additional arguments directly on the merits.  Regarding the unchallenged and previously unconsidered (by the Federal Circuit) second portion of the DI fuel term, EBS relied on the Court’s mandate and waiver doctrines to argue that the Board was limited by the Court’s earlier decision as “controlling law.”  However, the panel rejected this argument on the basis that these doctrines did not apply “across different litigations and proceedings” and in particular “for a non-appealed district court construction” (emphasis in opinion), citing Musacchio v. United States, 577 U.S. 237, 244–45 (2016), Hyatt v. Stewart, 148 F.4th 1376, 1382 (Fed. Cir. 2025), and TecSec, Inc. v. Int’l Bus. Machs. Corp., 731 F.3d 1336, 1344 (Fed. Cir. 2013), as relating (“closely related,” according to the opinion) to the “law of the case” doctrine.  The opinion did not deign to address EBS’s judicial estoppel argument which it had “briefly allude[d to]” and for failure to identify any unfair advantage to Ford as well as having been forfeited thereby.

With regard to EBS’s argument that the Board failed to “engage in any meaningful claim construction analysis” or “fail[ed] to adequately explain why it substantively reached a different outcome than the non-appealed portion of the district court’s construction,” thereby violating the provisions of 37 C.F.R. § 42.100, the panel identified these arguments to involve “unraised issues” which the opinion asserts the Court did not typically find fault in instances where the Board did not consider them, for example under Apple Inc. v. Gesture Tech. Partners, LLC, 127 F.4th 364, 370 n.2 (Fed. Cir. 2025).  The Court found no evidence that EBS had asked the Board to construe the DI fuel terms (and strongly stated that in the panel’s view EBS had asked the Board to “expressly forego any construction of its own” in favor of the non-appealed portion of the construction by the district court (emphasis in opinion), which it had characterized as “controlling law” (see above).  (Indeed, neither party had made a claim construction request to the Board, according to the opinion).  The Board thus did not abuse its discretion according to the panel.

Turning to the substance of claim construction of the term “DI fuel,” the Court first held that EBS had forfeited the issue by its already-noted failure to request that the Board construe the claims.  Further, “on the merits,” the opinion states that there is no evidence on the record that the DI fuel term disavows the use of gasoline as an antiknock agent, citing examples of embodiments where gasoline can be so used when other antiknock agents, such as ethanol, have been exhausted.  The opinion also rejects any arguments that such embodiments have been disclaimed, and cites instances in the earlier appeal where EBS “explained” that the specification disclosed embodiments where gasoline was an acceptable antiknock agent.

Regarding the Board’s obviousness determinations, the opinion identifies two prior art combinations that are relevant to the appeal:
1.  U.S. Patent No. 6,505,603 (Schray) and Japanese Patent Application Publication No. JP2003013785 (Miura); or

2.  German Patent Application No. DE19853799, Japanese Patent Application Publication No. JPH10252512 and Bosch Auto. Handbook (3d ed.). 

According to the assessment presented in the opinion, in the references cited in Ford’s first obviousness challenge the ‘603 patent discloses “an internal combustion engine to reduce engine knocking” comprising “directly injecting the fuel twice during each cycle, with the first occurring in the induction phase and the second occurring in the compression phase.”  The ‘785 Japanese patent application discloses suppressing engine knocking using a port injector.  In Ford’s second challenge for obviousness, German patent application ‘799 teaches a “method for creating fuel mixtures in an internal combustion engine” and “drawing a greater percentage of the fuel from the direct injector at greater loads.”  The ‘512 Japanese patent application teaches “an engine that contains both a port injector as well as a direct injector” and a “fuel map” wherein is disclosed “which of those two injectors operate (as a function of torque).”  The Bosch reference is a “general-purpose automotive handbook.”

The panel rejected EBS’s contention that the Board erred in its motivation-to-combine determination regarding the first combination, homogeneity and heterogeneity of fuel/air mixing, the Court maintaining that Ford’s arguments did not rely on any such distinctions.  The Board had agreed with Ford’s actual arguments according to the opinion, that “a skilled artisan would swap Schray’s first injector with Miura’s port injector because Miura’s port injector would ‘provide the engine of Schray with additional benefits related to mixing and stable combustion at low loads.’”  Moreover the panel did not consider EBS to have challenged that argument in this appeal.  Additionally, the panel appreciated the Board’s rationale regarding motivation to combine that these two references provided different approaches to solving the engine knocking problem and that a skilled worker would be motivated to combine them.  Accordingly, the panel held that there was substantial evidence supporting the Board’s determination that there was sufficient motivation to combine in reaching its obviousness determination.

The Court also rejected EBS’s challenges to particular claim limitations in ground 1 of the IPR, which asserted the first combination of references, on the grounds that the Board had “strayed from” the unpatentability theories asserted in Ford’s petitions regarding the “three way catalyst” limitation.  The panel disagreed with EBS on the grounds that the Board would properly consider the “proposed combination” of the references (emphasis in opinion) in reaching the obviousness determination that was the basis for ground 1 in its petition.

The panel also rejected EBS’s arguments regarding Ford’s second ground, under the second combination of references, because “[u]nder the circumstances here, where the Board also provided a full explanation for why it rejected EBS’s multiple counter-arguments, the Board’s reasoning is readily discernible, and therefore, it satisfied its obligation to adequately explain its motivation finding.”

Finally, the Court rejected EBS’s arguments regarding the Board’s rejection of rebuttal arguments they had made, because “on this record, the Board found that Ford satisfied its burden” to assert adequate invalidity grounds for obviousness.

Ethanol Boosting Systems, LLC v. Ford Motor Co. (Fed. Cir. 2025)

Panel: Circuit Judges Chen, Clevenger, and Hughes
Opinion By Circuit Judge Chen

By Kevin E. Noonan –

The D.C. Circuit Court today denied Judge Pauline Newman’s request for rehearing en banc of the panel decision handed down by the Court on August 22, 2025 (see “Judge Newman’s Challenge Fails at D.C. Circuit“).  That decision affirmed the D.C. District Court’s dismissal of Judge Newman’s complaint against the Judicial Council over the Federal Circuit’s continuing suspension under the Judicial Conduct and Disability Act of 1980.  The Judge’s en banc petition was aimed at McBryde v. Committee to Review Circuit Council Conduct & Disability Orders of the Judicial Conference of the United States, 264 F.3d 52 (D.C. Cir. 2001), wherein the panel held that “Congress precluded our jurisdiction over statutory and as-applied constitutional challenges to judicial council orders.”  It was provoked in no small measure by what the Judge (and others) considered the panel’s “implicit invitation” for the en banc Court to overrule or at least cabin McBryde, being literally littered with quotes, citations, and dicta from the D.C. Circuit’s opinion suggesting this course of action.

Despite these circumstances, the D.C. Circuit Court rejected the petition in a per curiam opinion (see below) with no further explanation.

The Judge’s forthright challenge to what her briefing has characterized as the constitutional questions regarding separation of powers for removing Article III judges raised by the actions of the Judicial Council suggests a likelihood of a certiorari petition in the New Year.

By Donald Zuhn –

In an email Patent Alert that was distributed this afternoon, the U.S. Patent and Trademark Office announced that it has issued the one millionth electronic patent grant (eGrant), which the Office stated “mark[ed] a major milestone in the agency’s modernization of the patent grant process.”  The Office highlighted the benefits of eGrants, which include:

• Faster protection: Inventors receive enforceable patent rights sooner, providing greater certainty to invest, grow, and compete.
• Operational efficiency: The transition to eGrants streamlined publication times, getting groundbreaking technologies to the marketplace sooner.
• A modern USPTO: The eGrant reinforces the USPTO’s role as a forward-thinking, digital-first IP office committed to secure, high-quality digital services.
• Benefit to applicants and practitioners: The eGrant program also provides applicants with enhanced security, simplified digital records management, and global compatibility across IP systems. These improvements allow inventors and attorneys to access, share, and act on granted patents immediately, supporting faster enforcement, licensing, and commercialization.

The authors and contributors of Patent Docs wish their readers and families a Happy Holidays!  It is also our hope that all of our readers, along with their families and friends, have a healthy and safe holiday.

By Donald Zuhn –

In an email USPTO Alert that was distributed this afternoon, the U.S. Patent and Trademark Office announced that its offices will be closed on December 24 and December 26.  Because December 25 is listed as one of eleven federal holidays on the U.S. Office of Personal Management web site (as it is annually), the USPTO will also be closed on Christmas Day.  According to the USPTO announcement, the closures on Wednesday, December 24 and Friday, December 26 are the result of “the official closing of the Federal Government offices, including the United States Patent and Trademark Office (USPTO)” on those days.  The Office also noted that “the USPTO will consider actions or fees due on Wednesday, December 24, through Friday, December 26, to be timely if taken or paid no later than 11:59 p.m. ET on Monday, December 29, which is the next business day on which the USPTO is scheduled to be open.”

According to the announcement, notices regarding the additional days on which the USPTO will be closed will be published in the Official Gazette and on the Office’s Patent Related Notices webpage “in due course” (these notices were not yet available at the time this article was posted).

While not intended to be a comprehensive list of other patent office closures, Patent Docs has become aware of the following patent office closures during the upcoming holidays:

• The European Patent Office (EPO) will be closed from Wednesday, December 24, 2025 through Thursday, January 1, 2026 (see “Office holidays“)

• The Instituto Nacional da Propriedade Industrial (INPI; Brazilian Patent and Trademark Office) will be closed from 1:00 pm on Wednesday, December 24, 2025 through December 26, 2025 and then from 1:00 pm on Wednesday, December 31, 2025 through January 2, 2026.

• The Instituto Mexicano de la Propiedad Industrial (IMPI; Mexican Patent and Trademark Office) closed its offices on Monday, December 22, 2025 and will reopen on Wednesday, January 7, 2026.

Patent Docs readers aware of other patent office closures are invited to submit comments with the dates of those other office closures.

By Mike Borella –

One might be forgiven for assuming, based on a cursory reading of the Constitution or perhaps a fleeting bout of logic, that the U.S. patent system exists to promote the progress of science and useful arts. Historically, this meant incentivizing inventors to create tools that reduced human drudgery, increased accuracy, and generally made life less miserable for the species.

However, under the current jurisprudence of the Federal Circuit, patent law lives in a fascinating dystopia – the more an invention is described in terms of its utility to human beings (e.g., saving time, organizing data, reducing errors), the more likely it is to be summarily executed under 35 U.S.C. § 101. Welcome to the usefulness paradox, where the very benefits of an invention are used as evidence against its eligibility.

To understand the absurdity of the current moment, we first look at what the Patent Office used to consider worthy of protection. Let us review a few inventions that, under today’s Section 101 analysis, would likely be categorized as abstract “fundamental practices” or “methods of organizing human activity.”

• Eli Whitney’s Cotton Gin (1794). The invention was a machine that separates cotton fibers from their seeds. Today, a § 101 contention would write itself: “The act of separating desirable objects from undesirable objects is an abstract practice performed by humans since the dawn of agriculture. The rollers and brushes are merely generic mechanical components performing their expected functions.”
• Alexander Graham Bell’s Telephone (1876). The claim covers “the method of, and apparatus for, transmitting vocal or other sounds telegraphically.” Under the modern interpretation of § 101, this invention could be viewed as the abstract concept of human communication over a distance with the electric wire just a generic conduit.
• Thomas Edison’s Light Bulb (1880). Another loser in view of the current law that is drawn to the abstract idea of “generating incandescence by heating a resistive wire through conduction of electricity.” Further, the additional elements of metallic wires, glass, and a closed chamber, were in routine use at the time of the invention.

These inventions defined the modern world. They were patentable because they provided a solution to a physical problem formerly performed by humans (e.g., separating seeds from cotton, sending messages from place to place, and providing illumination in dark environments, respectively). They involved some degree of making a human task more efficient and useful through machinery. In each case, the machinery performed the task differently than humans had previously.

This notion of new and useful machines being patentable was prevalent in the Industrial Age, but has not survived unscathed in today’s Information Age. The Federal Circuit appears to view computer-implemented methods as being fundamentally different from those carried out by other types of non-computer automation. Indeed, a thread running through the last 11 years of § 101 jurisprudence is that if a human could perform a task (no matter how slowly or poorly), a computer doing it differently and better is likely ineligible. The fact that the computer can, in practice, achieve a useful result that a human could not appears to be irrelevant. Let’s consider some examples.

In Yu v. Apple Inc., the invention was a digital camera system that used two separate image sensors and lenses to create a single, higher-quality image. This is a classic hardware-software hybrid invention designed to overcome the physical limitations of single camera lenses. The Federal Circuit found it ineligible. Why? Because photographers have been taking pictures for a long time. The Court reasoned, “[t]he claim is directed to the abstract idea of taking two pictures . . . and using one picture to enhance the other in some way . . . the idea and practice of using multiple pictures to enhance each other has been known by photographers for over a century.” By this logic, the fact that a human could manually overlay two film negatives in a darkroom renders a real-time, digital signal processing invention abstract. The court reduced a complex technical configuration of sensors and lenses to the fundamental human activity of taking photos.

In IBM Corp. v. Zillow Group, Inc., the patent involved a method for displaying search results in a way that contextually adjusted based on user input – an improvement in how humans interact with database systems. The Federal Circuit affirmed invalidity, stating, “[t]he claims . . . do nothing more than improve a user’s experience while using a computer application [and fail to] do anything more than identify, analyze, and present certain data to a user, which is not an improvement specific to computing.”[1] The Court is effectively saying that making a computer easier for a human to use is not a technical improvement to the computer. In doing so it separates user experience from technology, as if the entire purpose of a computer isn’t to be used by and provide utility to humans.

The inanity escalates with Recentive Analytics Inc. v. Fox Corp. The invention was a machine learning method for optimizing event schedules (like TV broadcasts) by analyzing vast arrays of constraints. This replaces a logistical nightmare with an optimized, AI-driven schedule. The Federal Circuit found it ineligible because optimizing a schedule is a human concept, and using AI to do it (differently) is just generic. Notably, “the use of machine learning to achieve this result is merely the application of a generic computer tool.” This holding suggests that if AI is used to solve a problem that a human understands (like scheduling), the AI itself is just a generic tool for an abstract idea. The Court punished the invention for being useful in a domain that humans care about.

The tragic irony of this jurisprudence is that it incentivizes patent practitioners to draft applications that obfuscate the actual benefit of the invention. If you write a patent application today that states that the invention helps the user take better photos, you have handed the examiner a loaded gun. They can cite Yu and say you are merely automating the abstract idea of picture enhancement. If you write, “this invention makes the interface more intuitive,” they can cite IBM and contend that the invention is focused on user experience rather than technical functionality. We have reached a point where the usefulness requirement of § 101 is being used to negate eligibility.

The downside to the public good is palpable. We are effectively telling innovators in consumer electronics, user interface design, and applied AI that their work is not technology, but merely convenience. This outcome ignores the fact that in an information economy, the ability to process, visualize, and interact with data is the technology. If we continue to interpret abstract ideas as anything that a human could theoretically do regardless of time, error rate, or physical capability we are not protecting the public from monopolization of fundamental truths. We are preventing the public from accessing the specific applications that make those truths usable.

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[1] Even a casual glance at the detailed claims of the patent in question calls this statement into question.

By Kevin E. Noonan –

Over several years and two administrations (see “FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior“; “FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy“; “Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book“), the Federal Trade Commission has maintained a campaign against listing in the FDA Orange Book patents claiming devices for administering approved drugs (and frequently not reciting any particular drug in the patent claims therein).  On Wednesday, the Commission announced that one of its targets, Teva Pharmaceuticals, had agreed to remove over 200 such “improper patent listings” from the Orange Book, in response to these FTC efforts.

Teva was only one such FTC target, there having been ten pharmaceutical companies and 100 patents identified by FTC under former Chairwoman Lina Khan, which number expanded to 300 so-called “junk patents” by the end of her tenure.  This campaign against Teva was aided by a decision in the New Jersey District Court (Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024)), affirmed by the Federal Circuit (Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC (Fed. Cir. 2024)) holding that five device patents owned by Teva and asserted against Amneal Pharmaceuticals were improperly listed in the Orange Book (the FTC having filed an amicus brief relied upon by the District Court in coming to its decision).

The press release ascribed the current administration’s asserted policies to be part of its efforts to reduce drug prices, referencing an Executive Order on Lowering Drug Prices.  FTC Chairman Andrew N. Ferguson was quoted as saying that “[t]he Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need” (pursuing a policy started by the Biden Administration).  Further, in the press release (also echoing the sentiments of the Biden administration) the FTC stated that:

Improper patent listings can limit competition by preventing generic alternatives from entering the market.  This can keep drug prices artificially high and prevent patients from accessing lower-cost alternatives.  The removals of more than 200 improper listings will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors.

While reducing drug prices is a goal shared by policymakers on both sides of the aisle, it is difficult not to respond to assertions such as those in the FTC’s press release with “Not so fast, FTC.”  Because as appealing as declaring victory may be, it ignores the realities of the structure provided by the Hatch-Waxman Act that has greatly increased the availability of generic drugs since it was enacted in 1984.  Some of the reasons for these successes is that the Orange Book contained the patents a branded drug maker could assert in obtaining a thirty-month stay in FDA approval for a generic drug who had filed an ANDA (abbreviated new drug application).  In addition, because of that stay, infringement (by filing the ANDA) was constructive under the statute (35 U.S.C. § 271(e)(2)) so that money damages were not available for the branded drug maker (unless at the expiration of the 30 months the generic company launched “at risk,” which also provided the branded drugmaker with the possibility of obtaining treble damages for willful infringement under 35 U.S.C. § 284)).

Having delisted any patents now determined by the FTC to be improperly listed, none of these protections (for either party) exist regarding those patents.  After all, they have not evaporated or been deemed unenforceable, and the capacity for branded drugmakers to assert them still exists under 35 U.S.C. § 271(a) should the generic drugmaker enter the market after its ANDA was approved. It remains an open question, but despite FTC’s triumphant rhetoric that delisting has improved the likelihood of generic entry it may on the contrary inhibit it; although having no Orange Book listed-patents precludes a branded drug maker from asserting infringement under § 271(e)(2), it is unlikely that they would not bring suit under §271(a).  With the attendant risks of enhanced liability under § 284, it seems equally likely that potential generic drugmakers, even having obtained FDA approval for their generic version of the “more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors” cited in the FTC press release, would prudently pause to consider their best strategic path to bringing their product to market.  And the possibility of reaching a licensing agreement with the branded drugmaker might be less appealing in view of the protracted (and ultimately somewhat successful; see FTC v. Actavis) efforts by the FTC over a decade ago to thwart certain of these types of licenses (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“) (albeit those that delayed rather than facilitated generic market entry).

But the possibility of FTC scrutiny even of efforts to bring generic drugs to market being an uncertain eventuality, it is at least possible that the unadorned benefit of the FTC’s success in getting some (but by no means all, at least not yet) of the threatened listed patents and companies having listed them may not be quite the policy coup that is being touted by the administration this week.  Time will tell.