• 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.

  • By Kevin E. Noonan –

    USPTO SealLast November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to be used by examiners to comply with the dictates of Executive Order 14036 from the Biden Administration related to drug patents and the purported abuse thereof that results in inflated drug prices.

    To recap, in one of its first acts, the Administration promulgated Executive Order 14036 (July 9, 2021), which contained the assertion that "Americans are paying too much for prescription drugs and healthcare services — far more than the prices paid in other countries" and the allegation that "too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs" (this despite 40 years of generic drugs being available under the Hatch-Waxman Act (1984) and biosimilar copies of biologic drugs for over a decade under the BPCIA, enacted as part of "Obamacare" in 2010).  The purported remedy was that "it is the policy of my Administration to enforce the antitrust laws to combat the excessive concentration of industry, the abuses of market power, and the harmful effects of monopoly and monopsony — especially as these issues arise in . . . prescription drug markets" and "to support aggressive legislative reforms that would lower prescription drug prices, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and through other related reforms."

    One aspect of this policy, under Sec. 5(p)(vi), intended "to help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law," was to have, "not later than 45 days after the date of this order, . . . the Commissioner of Food and Drugs write a letter to the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office enumerating and describing any relevant concerns of the FDA."  There followed a series of letters between these officials that were directed to:

    • Enhancing collaboration with other agencies on key technology areas, including pharmaceuticals and biologics
    • Improving procedures for obtaining a patent to ensure that the USPTO issues robust and reliable patents
    • Improving the process for challenging issued patents before the Patent Trial and Appeal Board (America Invents Act proceedings)and improving public participation in the patent system
    • Considering new proposals for incentivizing and protecting innovation while minimizing unnecessary delays in getting more affordable drugs to market

    These aspirations were further voiced in a joint blog post almost a year later, on July 7, 2022, from Director of the USPTO Kathi Vidal and FDA commissioner Robert M. Califf that, while crediting the pharmaceutical industry for creating, testing, and bringing to market lifesaving drugs, and that 13 of the top 20 "most innovative and inventive pharmaceutical companies" in the U.S., and recognizing the "delicate balance" with generic companies in providing competition and "driving down prices," insisted that "while the issuance of robust and reliable patents to incentivize pharmaceutical innovations is critical, our patent system must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law."  These efforts were directed to "striking [an] appropriate balance" by "encouraging meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines," a truly Goldilocks objective.

    These officials further enunciated their goal to "protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents" so that "companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product."  This was to be done, inter alia, by the PTO giving examiners "time and resources" needed to thoroughly review applications for pharmaceutical inventions (raising the questions, of course of whether examiners had not been given the T&R for the job now and whether so doing would come at the expense of proper T&R for all other areas of technology, and not specifying the resources that would be provided).  The FDA information to be made available to examiners under this policy was to be only from unspecified "publicly available sources" (with updated information on these efforts being available on the USPTO-FDA Collaboration Initiatives webpage).

    The latest Guidance is specific to Technology Center 1600 for drugs, formulations, and methods of treatment/use, and concerns methods for searching NIH and FDA databases identifying which databases should be searched.  The Guidance also directs the Examiners to the searching requirements in M.P.E.P. § 904 (§ 904.02) as well as the importance of compliance for examiner review in performance and quality appraisals (i.e., involving their bonuses, raises, and opportunities for advancement).  The Guidance identifies the following "search resources," their properties and characteristics and what information can be gleaned from them:

    FDALabel: this database contains drug labeling information for 140,000 human drugs (including biologics and over-the-counter drugs) and a small number of animal drugs, disclosing prescribing information, patient labeling, and carton/container labeling for the drugs and biologics, as well as label documents for homeopathic remedies, medical devices, dietary supplements, cosmetics, and medical foods.  The Guidance directs that this database can be used to find information on indications, dosage and administration, contraindications (including warnings, adverse reactions, drug interactions, or information about use in particular populations of patients).  The Guidance also includes information on how to use the database and search capabilities, down to level of the interface and ways to use it including navigating the search results obtained (e.g., identifying the approval date for establishing prior art status).

    DailyMed & DailyMedArchive (NIH):  provides labels for FDA-approved products including prescription drug and biological products for human use; nonprescription (e.g., over-the-counter) drug and biological products for human use; certain medical devices for human use; medical gases for human and animal use; and prescription and nonprescription drugs for animal use.  These are labels submitted by drugmakers to FDA (not limited to labels for approved drugs) and the Guidance notes that there are almost 146,000 entries in the database.  The Guidance sets forth detailed search protocols and further cautions Examiners that prior art-relevant info might be in archives and not on the main page.

    Drugs@FDA:  this database contains more information that the DailyMed database according to the Guidance, including regulatory history, FDA reviews, and previously approved labeling.  Information regarding drug approval dates can be parsed by month, and the database includes most approved drug products since 1939, with more robust information on drugs approved since 1998, and is updated daily.  Further this database includes information about approval year and any revisions as well as therapeutic equivalents thereof.

    The Guidance includes comparisons between what is available in these databases to further aid Examiners in searches:

    Table 1
    The Guidance also recommends using Google to search FDA.gov domain(s), as a way to use the power of the Google search engine to search specific sites that can be used to "group drugs with like regulatory pathways or omit outliers."  The Guidance provides a tabular synopsis of how a combination of these resources can be used to identify specific information related to prior art searching for patents related to drug products:

    Table 2
    The Guidance concludes with the Office's intention to "provide additional examiner training and guidance this year to biotech and pharmaceutical patent examiners on examination of declaratory evidence of unexpected results."

    At the same time the Office announced that, as part of or ancillary to the duty of candor under 37 C.F.R. § 1.56 there would be applied a "duty of reasonable inquiry . . . to perform an inquiry that is reasonable under the circumstances, including reviewing documents to identify information that is material to the patentability of a claimed invention," falling within scope of 37 C.F.R. § 11.18(b) (part of the ethical duties regarding standards for submitting papers to the Office as part of patent prosecution.  The scope of parties having this duty imposed was the same as Rule 56 as well as individuals involved in re-examination and PGR/IPR proceedings, and included a duty to disclose Para IV positions from generic competitors in pending proceedings before PTO and PTAB.  Further, this policy expressly prohibited "ethical walls" that would prevent patent practitioners from being aware of inconsistencies in representations taken before the Office and the FDA or other agencies.  The impetus for the new duty came, at least in part, in response to a letter from Sens. Leahy (D-VT) and Tillis (R-NC) that USPTO should "take steps to reduce patent applicants' making inappropriate conflicting statements in submissions to the [USPTO] and other federal agencies," specifically in cases where "inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market— can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product."  The scope of enforcement of this duty has not been further defined.

  • By Andrew Velzen and Joshua Rich

    As discussed previously on this blog (see "USPTO Proposed Rule Change to Terminal Disclaimer Practice" and "The USPTO's Proposed Terminal Disclaimer Rule: A Litigator's Perspective") and elsewhere, the U.S. Patent and Trademark Office has announced a proposed rule change to the required form for terminal disclaimers in an attempt to rein in abusive serial litigation practices.[1]  Since the proposal was announced, the public commentary about the proposed change has been overwhelmingly negative.[2]  Recently, several former high-ranking USPTO officials (including former directors) joined that chorus in a letter to Director Vidal.[3]  In their words, just the Notice of Proposed Rulemaking (NPRM) alone — let alone adoption of the proposed rule — "destabilizes the patent system and advances anti-innovation policies."

    The letter attacks both the proposed rule on numerous grounds, both substantive and procedural.  At the most fundamental level, the former officials echoed our previous doubts that the proposed rule is proper exercise of agency discretion in rulemaking, albeit from a slightly different angle.  Their letter argues that the proposed rule would constitute a "substantive" rule and that implementing such a rule is beyond the USPTO's statutory authority (i.e., illegal).  Under 35 U.S.C. § 2(b)(2)(A), the USPTO "may establish regulations, not inconsistent with law, which . . . shall govern the conduct of proceedings in the Office."[4]  This is frequently interpreted as giving the USPTO the authority to make procedural rules but not substantive rules.[5]

    According to the letter, because the proposed rule "impacts the scope of patent rights in one application based on validity determinations in another," it should be considered a "substantive," rather than a "procedural," rule.  In other words, because the proposed rule telescopes validity between patents after examination, it is beyond the USPTO's proper purview.

    The USPTO has, unsurprisingly, preemptively disagreed with this contention.  For example, in the Federal Register Notice regarding the proposed change, the USPTO cited to In re Van Ornum, 686 F.2d 937 (CCPA 1982), as authority for the assertion that a rule regarding enforcement conditions resulting from terminal disclaimers filed to obviate nonstatutory double patenting rejections is within the USPTO's rulemaking authority.[6]  In addition, some Federal Circuit cases have suggested that the USPTO's interpretation of what the phrase "in the Office" means in the context of rulemaking authority should be entitled to Chevron deference, which (if it still exists) would suggest deference to the USPTO's determination of the proper scope of rulemaking.[7]  Further, the USPTO might argue that even current nonstatutory double patenting practice inherently can affect validity after issuance (e.g., since terminal disclaimers filed to overcome nonstatutory double patenting rejections include a "common ownership" requirement).  If so, the change could be argued to be a practical distinction without a legality difference.

    In addition to arguing that the adoption of the proposed rule would be illegal because it exceeds the USPTO's statutory authority, though, the letter also uses the term "illegal" when discussing the way in which the proposed rule would render entire families of patents invalid or unenforceable whenever a single claim in an entirely different patent tied to it by a terminal disclaimer was found invalid or unenforceable.  That is, they are raising the same argument we did earlier (see "The USPTO's Proposed Terminal Disclaimer Rule: A Litigator's Perspective").  Using the term "illegal" here is not hyperbole, since the proposed rule likely runs afoul of the validity provisions of 35 U.S.C. § 282(a), which states:

    A patent shall be presumed valid.  Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim.  The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity [emphasis added].

    The proposed rule turns that calculus on its head and links the validity of all members of a terminal disclaimer family together.  If one claim falls, it would pull all of the others down with it.

    In addition to criticizing the legality of the proposed rule, the letter also discusses the alleged justification (or lack thereof) for the proposed change.  In the authors' views, the USPTO did not conduct sufficient studies to justify this change.  Without any such studies, there is simply insufficient data to lend credence to any suggestion that present terminal disclaimer/nonstatutory double patenting practice is detrimental to innovation (let alone that the proposed change would remedy the alleged detriment).  In the authors' words, "[t]he proposal seeks to solve a problem that does not exist."

    The USPTO did provide some "Rulemaking Considerations" under § IV of the Federal Register notice. However, most of these sections appear to be boilerplate language to satisfy bureaucratic requirements for rulemaking.  For example, under § IV(K), the USPTO states, without citing any evidence, that "[t]he changes proposed in this rulemaking are not expected to result in . . . significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets."  If this were indeed the case, I think many opponents of the proposed change would be put somewhat at ease.  Yet, there is simply no evidence cited in support of this assertion.

    Importantly, some of the only data the USPTO did provide in the NPRM seems to highlight the substantial magnitude of the issue.  According to § IV(B) of the NPRM, roughly 14% of Office Actions include at least one nonstatutory double patenting rejection.  This number was provided only in the context of small entity applicants.  Thus, while 14% is not negligible in that context, the percentage would likely be even larger when considering all applicants (especially because non-discounted entities have larger patent budgets and may, on average, have larger patent portfolios with more overlapping patents, which are more susceptible to nonstatutory double patenting rejections).

    While the evidence cited in the NPRM may not go far enough, the authors of the letter go too far.  There are parties that have used extended families in combination with sequential litigation (or the threat thereof) to chill the entry of other parties into the market.  This has been seen most clearly in the biosimilar and generic drug fields, where branded companies have kept patent families alive — as is the best practice — and rolled patents out one after another to be fought over by the non-branded companies. The result has been a war of attrition in which the branded company has more to lose than the non-branded has to gain, and the non-branded generally leave the field of battle or yield ground simply because of the cost of litigation.  The result is a net loss to the public, even if the USPTO did not cite specific examples.

    Lastly, the letter highlights some of the unintended consequences that could result from the adoption of the proposed rule.  First, the letter asserts that the expected cost of obtaining and enforcing a patent will necessarily increase.  This is because, for example, applicants will be forced to amend claims in response to or argue against nonstatutory double patenting rejections instead of simply filing terminal disclaimers, given the risks involved with terminal disclaimers under the proposed rule.  According to the authors, this additional cost represents a greater burden to small companies and individual inventors (given their relative available resources).  But that assumes that applicants will be seeking more than one patent per family, or patents from continuations instead of divisionals (or otherwise prosecuting overlapping subject matter across a portfolio).

    Under the Regulatory Flexibility Act (RFA), the USPTO actually had to estimate the costs to small entities based on the proposed change in the NPRM.  According to the USPTO in § IV(B) of the NPRM, the changes "will . . . not affect a substantial number (approximately 20%) of small entities" and that these 20% of small entities will be impacted by, at most, ~$26 Million a year, in total.  There are numerous assumptions that go into the math of how the USPTO came up with that figure, but even if it is a reasonable estimate, whether or not it is acceptably de minimis is certainly not a given.  Further, that figure only includes obtaining a patent for small entities (i.e., does not include enforcement for small entities or obtaining and enforcing patents for non-discounted entities), so it may not be representative of the total cost to all innovators.

    As the former USPTO officials point out, one result related to enforcement may be a strong shift of the expense of enforcement from a relatively even split to strongly in favor of accused infringers.  In particular, under the proposed regime, an infringer can take an invalidity shortcut by attacking a single claim in the weakest patent in a grouping in order to render the strongest patents obsolete.  This means that, in order to assert one patent against an infringer, a patentee might need to successfully defend against two, three, five, ten, or more invalidity judgments depending on how many patents are tied together by terminal disclaimers.  Clearly, this would be a pricey endeavor for the patentee.

    In addition to all the substantive commentary provided by the five distinguished individuals, the letter asserts an underlying urgency for action.  The authors assert that their plea represents an "unusual step" as a result of their being "deeply concerned."  Further, the letter goes beyond merely arguing against the ultimate implementation of the rule change.  It also calls on the USPTO to "withdraw [the proposal] immediately" because the NPRM "creates uncertainty every day that it remains under consideration."  So they suggest the extremely unusual step of withdrawing the proposed rule before the comment period even closes to mitigate the harm — essentially an admission that the USPTO was wrong to even propose the rule.

    [1] Full text of the proposed rule change can be found at https://www.federalregister.gov/public-inspection/2024-10166/terminal-disclaimer-practice-to-obviate-nonstatutory-double-patenting.

    [2] As of writing, 22 public comments have been submitted at https://www.regulations.gov/, most of which oppose the change.

    [3] The letter was signed by former directors Andrei Iancu, David Kappos, and Drew Hirshfeld and former deputy directors Laura Peter and Russell Slifer.  A copy of the full letter can be found here.

    [4] https://www.law.cornell.edu/uscode/text/35/2.

    [5] See also Merck & Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996); Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (Fed. Cir. 1991).

    [6] The USPTO also stated, in § IV(A) of the Federal Register Notice, that the proposed changes "involve rules of agency practice and procedure, and/or interpretative rules, and do not require notice-and-comment rulemaking" (citing to Perez v. Mortg. Bankers Ass'n, 575 U.S. 92 (2015); Cooper Techs. Co. v. Dudas, 536 F.3d 1330 (Fed. Cir. 2008)).

    [7] Response to "Request for Comments on Eliciting More Complete Patent Assignment Information," Arti K. Rai (citing Bender v. Dudas, 490 F.3d 1361 (Fed. Cir. 2007)).

  • By Michael Borella

    This Internet has gone through many revolutions, technical and otherwise.  Each time it has emerged stronger and more robust than before.  One can trace the origins of the Internet to the connection of four computers in 1969.  The advent of email a few years later, the standardization of TCP/IP as its communication protocol in the mid-1980s, commercial dialup service providers not long after that, the popularization of the World Wide Web in 1993, and the immediately-following rise of ecommerce gave us the main aspects of what we currently think of as the Internet.  Inexpensive broadband, the search engine, online gaming, social media, widespread mobile access, and videoconferencing bring us to today.

    The next Internet revolution is being driven by generative AI, and it is happening right now.  While we cannot say what is going to be in place on the other side of this inflection point, we do know that our online experience will be different in a few years.

    Consider just the web.  It relies on an economic model that has been largely static for over two decades.  But generative AI is already beginning to disrupt this model.  Today, publishers and search engines have a mostly symbiotic relationship.[1]  They need each other.  But what happens when AI is used to subsume publisher content?

    Publishers (including small and independent publishers, blogs, businesses, and so on) seek to be highly ranked in search engines, especially for search terms that are relevant to their content.  For example, an independent newsletter that reviews cars (as just one example) would want to appear as high as possible (preferably in the top ten) search results for queries involving the word "car", "automobile", "motor", and so on.  This will drive traffic to the publisher's newsletter, allowing the publisher to sell ads and/or subscriptions.  With the resulting revenue, the publisher can grow its newsletter by hiring more writers and editors, who in turn produce more content.  This content, if of sufficient quality, makes it more likely that the publisher will be highly ranked in search results — a virtuous cycle.

    Search engines (or more correctly, search engine providers) crawl the web and use sophisticated algorithms to rank publishers in terms of their sites' relevance to search terms.  A successful search engine may receive billions of search requests per day from users who want to be referred to relevant publishers.  Each page of search results may be an ordering of links to publishers and perhaps a short description or summary of the content that can be found by following each link.  Search engines make money by displaying advertisements as sponsored links.  They also allow publishers to bid on search terms in a form of auction.  The publisher who bids the highest for a given search term often ends up at the top of the search result as a sponsored link, assuming that their content is indeed relevant to the search term.

    While this symbiosis has not yet been broken, it is getting wobbly.  It is no coincidence that the largest investors in generative AI are the companies that own and operate the largest search engines.  OpenAI, which is nearly half-owned by Microsoft, has admitted to training its GPT series of models on content that it absorbed from publishers on the Internet, often without their permission.  Some would contend that the models that underlie the popular ChatGPT generative AI tool have been trained on the Internet as a whole.[2]  Indeed, The New York Times and other publishers have sued OpenAI and Microsoft for allegedly violating their copyrights and (at least in the case of the Times) allegedly producing near-verbatim copies therefore in response to large language model (LLM) prompts.[3]

    Search engine results recently changed from being a series of links to publisher sites (with ad-sponsored results on top and clearly flagged) to leading with a generated AI overview as the leading result.  This overview seeks to answer the searcher's question or address their need without requiring them to click on links and visit publisher web sites.  So far, AI overview sections have also been displaying what the underlying AI model infers to be the most relevant publisher links and/or those used a source material for the overview.

    In isolation, AI-generated search results are neither here nor there.  Users might appreciate having them summarize publisher content to provide results in a more convenient and readily-consumable form.  Of course, the generation and providing of these results is still clearly experimental and subject to the same incorrectness, hallucinations, and bias that plague LLMs.  But users may further appreciate not having to navigate to certain publisher sites that display annoying ads or are sophisticated clickbait.

    At this point it seems safe to assume that the quality of these AI summaries will continue to improve.  If so, at what point does this impact the publishers?  The news industry — one of the biggest and most important publishing sectors — has lost one-third of its newspapers and two-thirds of its news journalists in the last two decades, mostly in the area of local news.[4]  AI is likely to accelerate this decline, with search engines absorbing user traffic rather than directing it to publisher sites.  As a result, publishers are likely to have less ad revenue and fewer subscriptions, putting their businesses at risk.

    Given that a sea change toward AI-generated search results is playing out in real time, it is difficult to predict what the economic model the web will be based on five years from now.  However, we can game out a few possible scenarios.

    • Search engines use AI to subsume the publishing industry.  Publishers go out of business en masse, leaving only the LLMs that generate news-like search results.  Many view this possible future as dystopian and potentially dangerous for society without the fourth estate, as there would be fewer incentives to subsidize investigative journalism that seeks to root out corporate and governmental corruption.  In a world without news organizations, it would be extraordinarily difficult to determine "the truth" as we would rely mostly on second and third hand accounts and other forms of hearsay.  Ironically, this would also reduce the utility of search engines, likely resulting in a revenue drop for those companies as well.

    • In a slightly less dystopian future, publishing does not die but instead gets sorted into two camps.  The first are traditional publishers with large audiences, like the Times, who survive due to their name recognition and quality journalism.  The second consists of small independent publishers with niche audiences that survive on subscriptions.  Both have the ability to be a source of real-time "hot" news that is too fresh for the AI models to ingest.  They also can serve as destinations for users (e.g., the users check their apps or bookmarked links frequently), allowing the publishers to flourish even without referrals from search engines.  This has been referred to as the "barbell" strategy, where the sweet spots for publishers are at either end of the spectrum in terms of size (the very large media companies or the very small independents) with very little in between.

    • Another dark scenario is that the search engines buy up most or all major publishers, reorienting the publishing business from serving the public directly toward generating training data for AI models.  While the incentives here are complex, it is likely that the search engine companies would have at least some control over reporting.  This could lead to less reporting on any negative externalities associated with these companies or — even worse — different "facts" being used to train different search engines.  If this notion seems far-fetched, keep in mind that the Washington Post is owned by Amazon founder Jeff Bezos[5] and that Meta was considering the purchase of Simon & Schuster to train its models.[6]

    • A more likely path forward is that the search engine providers (and AI companies in general) sign licensing deals with major publishers in order to access and use their content.  This is already happening, as the Financial Times, News Corp., Axel Springer, Le Monde, Prisa Media, and The Associated Press have all agreed to license their content to OpenAI.

    • Another possibility is that search engine providers are legally prohibited from unauthorized ingestion of publisher content without permission, which makes the licensing discussed above even more appealing.  This might be a consequence of a victory for the Times in its dispute with OpenAI.

    Right now, it is too early to tell which of these scenarios may play out, or if a different one arises.  If anything, we can be certain that the business model of the Internet will be different in five years or less.  Search engines will return AI-generated answers with less emphasis of links to source material, publishers will need to engage more directly with their audience and supply a continuous stream of high-quality content, and search-engine optimization may become obsolete.

    Like all disruptions, AI search comes with opportunities as well. As the technological and legal landscape evolves we should not be surprised if new models of publishing emerge, adapted to this evolution.

    [1] This is an admittedly a simple overview of the relationship.  There is quite a bit more nuance, but this level of detail is sufficient for the discussion that follows.

    [2] https://futurism.com/the-byte/ai-training-data-shortage.

    [3] https://www.patentdocs.org/2024/02/the-new-york-times-case-against-openai-is-different-heres-why.html.

    [4] https://localnewsinitiative.northwestern.edu/posts/2024/05/08/ai-local-news-report/index.html.

    [5] https://www.theguardian.com/media/2023/jan/29/tech-moguls-media-jeff-bezos-washington-post.

    [6] https://www.theguardian.com/books/2024/apr/09/meta-discussed-buying-publisher-simon-schuster-to-train-ai.