By Kevin E. Noonan –

A consequence of the Supreme Court’s assault on subject matter eligibility a dozen years or so ago was that the patent defense bar presented the judiciary with ever more stringent standards and extreme if not fanciful positions that resulted in invalidation on Section 101 grounds becoming the default outcome.  Envelopes (blessedly) having the tendency to eventually be pushed too far, in REGENEXBIO Inc. v. Sarepta Therapeutics, Inc., the Federal Circuit finally said “Enough!”

The case arose over infringement of U.S. Patent No. 10,526,617 directed to recombinant host cells, the opinion setting forth Claim 1 as representative:

1.  A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein having a sequence comprising amino acids 1 to 738 of SEQ ID NO: 81 (AAVrh.10) or a sequence at least 95% identical to the full length of amino acids 1 to 738 of SEQ ID NO: 81, wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.

The District Court granted Sarepta’s motion for summary judgment of invalidity, disclosing the court’s opinion that “in both [Diamond v. Chakrabarty, 447 U.S. 303 (1980)] and [Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)] the Supreme Court ‘highlight[ed] the importance of change’ between naturally occurring subject matter and the claimed composition.”  Illustrating one source of the District Court’s error, the opinion notes that “the district court determined that none of the individual naturally occurring components in the claims had been changed and that ‘combin[ing] natural products and put[ting] them in a host cell’ does not make the invention patentable under § 101.”  The jurisprudential basis for this conclusion is Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948),” resurrected by Justice Thomas in his Myriad decision, wherein that decision was premised on the concept that “[t]aking ‘two sequences from two different organisms and put[ting] them together’ is no different than taking two strains of bacteria and mixing them together.”  The District Court furthered its conclusion by deciding the question of whether the claim recited an “inventive concept” from what it called the “Mayo/Alice” framework, whereby the District Court concluded it did not because “the claimed invention is made using well-understood, routine, and conventional steps.”

The Federal Circuit reversed and remanded, in an opinion by Judge Stoll, joined by Judges Dyk and Hughes.  The panel provided what they term “an overview” of the Supreme Court’s mandates in Chakrabarty, Funk Brothers, and Myriad, prior to assessing the patent eligibility of REGENEXBIO’s claims.

Regarding Chakrabarty, the opinion opines that there were no naturally occurring bacteria that could break down crude oil, and the Federal Circuit characterized this (as it famously was stated by the Supreme Court) to be “a nonnaturally occurring manufacture or composition of matter—a product of human ingenuity having a distinctive name, character and use.”*  The opinion also provides a reminder that the Chakrabarty opinion also distinguished the circumstances in that case from Funk Brothers, which was a natural phenomenon whereby “there existed in nature certain species of root-nodule bacteria which did not exert a mutually inhibitive effect on each other” and “used that discovery to produce a mixed culture capable of inoculating the seeds of leguminous plants.”  That was considered ineligible as being “only some of the handiwork of nature,” hence providing the rationale for finding noneligibility.  Finally, the opinion provided how Myriad assessed claims to isolated BRCA gene-encoding DNA in light of Chakrabarty and Funk Brothers: the Supreme Court did not consider Myriad to have “created anything” because the genetic sequence in the chromosome were the same when isolated (ignoring that the isolation “gene” was what Myriad created, with all its attendant utility, much like the history of antibiotic and other medicinal chemistry that found patent eligibility for isolated drugs; see In re Bergy).  The opinion also provides a reminder that in rendering its decision, the Supreme Court focused on the BRCA gene genetic sequence rather than regarding Judge Lourie’s characterization that “a gene is but a chemical compound, albeit a complex one” in Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200 (Fed. Cir. 1991).

The opinion further notes that the Supreme Court held that claims directed to complementary DNA (cDNA) were patent-eligible because as in Chakrabarty’s invention cDNA is not naturally occurring (“creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring“), despite efforts some amici (notably, Eric Lander of the Broad Institute) to argue otherwise.

The opinion then assays other biotechnology-related patent eligibility decisions, particularly ChromaDex, Inc. v. Elysium Health, Inc., 59 F.4th 1280 (Fed. Cir. 2023) (directed towards isolation of a vitamin from milk).  There, consistent with Myriad‘s rubrics that “mere” isolation was insufficient to confer patent eligibility to naturally occurring products, the Court held claims to the isolated vitamin to be patent-ineligible.

In this case, the opinion relies on Chakrabarty to “define the inquiry” and to the patent-eligible claim in Myriad as distinguished from the claims in Funk Brothers, ChromaDex, and the patent ineligible claims in Myriad.  The opinion analogizes the recombinant nucleic acid recited in these claims (reciting the capsid protein and the heterologous AAV vector sequences) to the four plasmids combined in Chakrabarty’s bacteria and with the cDNA claims in Myriad (“the lab technician unquestionably creates something new”) to reach the conclusion that what is claimed here should likewise be patent-eligible.  The opinion further distinguishes these claims with Funk Brothers, the Federal Circuit calling the District Court’s analogy relying on that case “flawed and inconsistent with the undisputed scientific evidence in the record” (albeit reiterating the Supreme Court’s conclusion that mixing the two Rhizobium strains previously thought to be incompatible to be no more inventive than “an improvement in packaging”).  Here, the Court considers the invention to not being “merely directed to repackaging products of nature” because it creates a cell containing a molecule (the recombinant DNA) that could not arise in nature without human intervention.  This rationale caused the panel to hold that the District Court erred by ignoring the Supreme Court’s Chakrabarty decision (wherein as here Chakrabarty did not change any of the invention’s naturally occurring components; see below).  In addition, the opinion criticizes the District Court’s analysis for failing to consider the invention “as a whole,” wherein what could be distinguished from nature was the recombinant genetic construct even if the individual components were not otherwise altered from their naturally occurring state.  Also mentioned in the opinion was “the potential for significant utility” which existed for the invention in Chakrabarty and did not exist for the invention in Funk Brothers.  The panel makes explicit the relevance of this distinction as arising in the Chakrabarty decision itself, to the extent that “no naturally occurring bacteria possessed the same property for breaking down crude oil even though the claims only recited the hydrocarbon-degrading properties of the plasmids contained by the bacterium rather than any capability of the bacterium itself” that was contained in the Supreme Court’s opinion.

In distinguishing (and rejecting) Sarepta’s arguments contrary to their decision the panel emphasizes the nonnaturally occurring combination of “a cultured host cell, a heterologous nucleic acid sequence, and a recombinant nucleic acid molecule that codes for both the heterologous sequence and the AAV rh.10 sequence.”  The opinion also rejects Sarepta’s attempt to focus on the AAV rh.10 sequence alone “because the other claim limitations are conventional and would not themselves be patentable advancements,” citing Chakrabarty and expressly Diamond v. Diehr, 450 U.S. 175, 188 (1981), for the inappropriateness of “dissect[ing] the claims into old and new elements and then . . . ignor[ing] the presence of the old elements in the [§ 101] analysis.”

The opinion also contains the Court’s understanding (being derived from disclosure in the ‘617 specification) of the importance of the technology with regard to developing better understanding and treatment of genetic mutation-associated disease, including modified virus vectors for producing transgenes that can replace defective or missing genes to be introduced into host cells, which further have life cycles particular to the virus, the host cells, and in some instanced the transgenes.  This understanding emphasizes that nothing about this invention is naturally occurring.

There has always been some tension between the patent prosecution bar and litigators defending accused infringers, unavoidably perhaps because of their differing perspectives on what is or isn’t (or should or shouldn’t) be patented, and the eligibility morass created by the lower courts’ responses to recent Supreme Court precedent that has exacerbated these tendencies.  This decision will not eliminate those tensions, but in the face of continuing disregard of these consequences of their decisions by the Supreme Court (certiorari denials on this issue approaching 100) the only possibility of getting back to a reasoned equilibrium may come if the Federal Circuit adopts its historic (and Congressionally mandated) role of exercising its expertise with regard to this issue.  At the very least by doing so the Court may be motivated to productively revisit the issue and provide needed clarity benefiting from the Federal Circuit’s analysis.

* The Federal Circuit recognizes an important detail in Chakrabarty’s invention that can be lost in view of the type of genetic engineering that has become commonplace in the almost fifty years since that invention was made:

In Chakrabarty, the inventors transferred four different plasmids, each of which were naturally occurring and capable of degrading four different oil components, into a naturally occurring bacterium.  While the inventors genetically modified the four plasmids to combine them, there is no indication that the four plasmids transferred into the host bacterium were otherwise themselves genetically engineered.

REGENEXBIO Inc. v. Sarepta Therapeutics, Inc. (Fed. Cir. 2026)
Panel: Circuit Judges Dyk, Hughes, and Stoll
Opinion by Circuit Judge Stoll

By Joshua Rich –

On Friday the 13th, the U.S. Court of Appeals for the Federal Circuit issued its decision in Apple Inc. v. Squires, which turned into a Nightmare on Madison Place for Apple’s chances to challenge the use of (now obsolete) NHK/Fintiv factors for IPR institution.  Although the appeal dealt with a narrow administrative law issue – whether the adoption of the factors fell within an exemption from the requirement of notice-and-comment rulemaking – the effect of the decision is far broader.  The Federal Circuit’s opinion suggests that the only limitations on the USPTO Director’s discretion in deciding whether to institute post-grant proceedings will be either Constitutional or self-imposed.  As a result, Apple’s challenge has established as binding precedent the exact opposite of what it wanted – (nearly) absolute discretion for the USPTO Director to deny institution with no formal rulemaking required.

The Apple case started because Director Iancu designated as precedential two Patent Trial and Appeal Board decisions: NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, 2018 WL 4373643 (P.T.A.B. Sept. 12, 2018) (made precedential on May 7, 2019) (“NHK“), and Apple Inc. v. Fintiv, Inc., IPR2020-00019, 2020 WL 2126495 (P.T.A.B. Mar. 20, 2020) (modifying NHK, made precedential on May 5, 2020) (“Fintiv“).  As Director Vidal characterized those two decisions (in a prospective interim guidance memorandum regarding considerations for future decisions),[1] the NHK and Fintiv cases identified six non-exclusive factors – referred to as the Fintiv factors – that the PTAB would consider in exercising discretion whether to institute IPRs or PGRs in light of parallel patent infringement litigation:

(1) whether a stay exists in the parallel litigation or would likely be granted if a proceeding is instituted;

(2) proximity of the court’s trial date to the PTAB’s projected statutory deadline for resolution of the post-grant proceeding;

(3) investment in the parallel proceedings by the court and parties;

(4) overlap between issues raised in the petition and in the parallel litigation;

(5) whether the petitioner and the defendant in the parallel litigation are the same party; and

(6) other circumstances that impact the PTAB’s exercise of discretion, including the merits.

Unhappy with the adoption of those factors through an informal process, Apple and several other large high-tech companies sued under the Administrative Procedure Act (“APA”) to prohibit the PTAB from applying them in the absence of notice-and-comment rulemaking, as well as because they exceeded the Director’s statutory authority.

In Apple Inc. v. Iancu,[2] Judge Davila of the U.S. District Court for the Northern District of California dismissed Apple’s Complaint for lack of standing.  Specifically, the District Court found that 35 U.S.C. § 314(d) robbed the asserted challenge of justiciability.  Section 314(d) states, “[t]he determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.”  In two cases since the enactment of § 314(d),[3] the Supreme Court had found that the term “nonappealable” really meant what it said:  in those cases, the Court held that the USPTO Director’s decisions to institute review of unchallenged claims or application of the time bar in § 315(b) simply could not be challenged in litigation.  Analogizing to those cases, the District Court recognized that the Fintiv factors were closely related to the Director’s decision whether to institute inter partes review, and therefore unreviewable.  He could not “deduce a principled reason why preclusion of judicial review under § 314(d) would not extend to the Director’s determination that parallel litigation is a factor in denying IPR,” and therefore would have required inquiry into statutorily unreviewable decisions by the Director.  Because that was forbidden, Judge Davila dismissed Apple’s claims as unreviewable.

Apple appealed.  In Apple Inc. v. Vidal,[4] the Federal Circuit provided Apple with a glimmer of hope that it could challenge the Fintiv factors.  Specifically, although it affirmed the decision that the Director’s decisions could not be reviewed on the basis of exceeding statutory authority, it reversed the finding that the rule establishing the Fintiv factors was unreviewable as a matter of rulemaking without notice and comment under § 553 of the APA.  To be clear, the Federal Circuit did not reach the merits of the question, it just found that the APA challenge would be justiciable because it asserted a procedural question, not a substantive one.  Section 314(d) established a clear bar to substantive review of a Director’s institution decisions, but not necessarily a bar to review of the procedures adopted.  The Federal Circuit therefore remanded the case to the District Court to determine whether notice-and-comment rulemaking was required to adopt the Fintiv factors.

On remand, the District Court found that the Director was not required by the APA to go through notice-and-comment rulemaking to adopt the Fintiv factors.[5]  Generally, the APA requires a government agency to go through the laborious process of notice-and-comment rulemaking when adopting new rules.  But there are exceptions; under § 553(b) of the APA, an agency does not have to engage in that process when adopting (1) interpretative rules; (2) general statements of policy; or (3) rules of agency organization, procedure, or practice.  Basically, the question comes down to whether a rule is “substantive” (and requires notice-and-comment rulemaking) or instead falls into one of the APA’s exceptions.  To make that decision, the District Court considered four factors: whether application of the Fintiv factors (1) affects individual rights and obligations; (2) operates prospectively; (3) leaves the PTAB free to exercise discretion and consider the individual facts before it in a given case; and (4) has binding effects, establishes a binding norm, or is otherwise determinative of any issues or rights.

The District Court found the first, third, and fourth factors weighed against requiring notice-and-comment rulemaking.  On the first factor, because the Director is never required to institute post-grant proceedings (as the Supreme Court had said in SAS Inst., Inc. v. Iancu),[6] there is no individual “right” to review that could be affected.  One the third factor, the District Court admitted struggling.  But the fact that the Fintiv factors were expressly not exclusive, and that the final one allowed consideration of “other circumstances that impact the PTAB’s exercise of discretion,” led Judge Davila to conclude that the PTAB retained discretion to consider the facts of any given case.  In reaching that conclusion, the District Court rejected the Director’s argument that “her own complete discretion to deny institution of IPR means that she may set forth instructions that would require the Board to make specific institution decisions in specific circumstances as a general statement of policy” – an issue that would be handled differently on appeal.  Finally, with regard to the fourth factor, the District Court was persuaded by the Director’s argument that the Fintiv factors are not outcome-determinative.  A strong showing of some other, unidentified factor may overcome showings of the identified factors.  The District Court expressed sympathy for Apple (and its fellow plaintiffs) for their:

[F]rustration that the Board has placed a greater emphasis on efficiency between the combined PTAB and district court systems.  However, although Plaintiffs are doubtless unhappy with the outcomes of their petitions for IPR when those petitions are denied, including where the Board considered the Fintiv factors, Plaintiffs’ claims based on the allegedly unfair or absurd results have been dismissed, and the outcome-based argument does not persuade the Court because the express language of Fintiv, as well as the June 2022 Memo and other guidance from the Director, make clear that the Board undertakes a holistic analysis when determining whether to exercise its discretion in denying or instituting IPR.

Apple again appealed.  But during the pendency of the appeal, there was a change of administrations and with it, a sea change in how IPR institution would be handled.  First, on February 28, 2025, Acting Director Stewart rescinded Director Vidal’s June 22, 2022 memorandum regarding the application of the Fintiv factors.  Second, in March 2025, Acting Director Stewart then issued her own guidance and processes that involved bifurcating the discretionary factors (which would be resolved by the Director in consultation with PTAB judges) and substantive review (which would continue to be done by PTAB judges).  Third, once Direct Squires took office, he issued an October 17, 2025 letter in which he indicated he would personally make institution decisions based on both discretionary and substantive factors.[7]  Thus, the current situation is more extreme than the one that originally gave rise to the Apple litigation:  discretionary denial is not bounded by even the Fintiv factors.

Perhaps because of the change of responsibility from the PTAB to the Director, the Federal Circuit panel (Judges Lourie, Taranto, and Chen) viewed IPR proceedings through a fundamentally different lens than the District Court.  The District Court considered how the Fintiv factors would affect the PTAB in its quasi-judicial role; the appellate panel considered the Fintiv factors (and the 2022 implementing memorandum) as “instructions” from the Director to the PTAB.  That change of focus doomed Apple’s arguments from the start.

Because it viewed the application of the Fintiv factors as “instructions” to the PTAB, the Federal Circuit easily determined that they constituted a “general statement of policy” expressly exempted from the requirement of notice-and-comment rulemaking by § 553(b) of the APA.[8]  The panel found it critically important that “the NHK–Fintiv instructions are not binding on the agency, i.e., on the statutory decisionmaker—the Director.”  Unlike the District Court, the Federal Circuit credited the Director’s argument from below that “her own complete discretion to deny institution of IPR means that she may set forth instructions that would require the Board to make specific institution decisions in specific circumstances as a general statement of policy,” and essentially used that reasoning as the linchpin for its decision.  The panel focused on another point with regard to the first factor that it found important and the District Court did not:  that beyond there being no “right” to institution of post-grant proceedings, there is no alteration of the parties’ legal statuses if post-grant proceedings are not instituted:

A non-institution decision, which is protected as a matter of unreviewable discretion (constitutional issues aside), leaves a patent challenger’s actual legal rights and obligations unchanged—what they would be if Congress had not enacted the IPR regime (which it enacted only with protected Director discretion about institution).  A non-institution decision has no legal effect on the underlying patent rights and obligations.  Challengers are “free to litigate [a challenged patent’s] claims’ validity in [their] own district court case.”  Mylan Laboratories [Ltd. v. Janssen Pharmaceutica, N.V.], 989 F.3d 1375, 1383 [(Fed. Cir. 2021)].  And they may seek reexamination in the PTO under 35 U.S.C. ch. 30, §§ 301–07.

Thus, the Federal Circuit’s decision expanded the importance of the Apple case in two ways.  First, it made it clear that only rules that would bind the Director, not rules he promulgated to the PTAB regarding how to exercise his discretion, could possibly be considered “substantive” rules.  Second, it established that any rules that discouraged institution would always fail the first factor of the test for “substantive” rules because non-institution does not alter a challenger’s legal rights.

The end result of the Apple litigation is that the Director has even more latitude than he did when the case started.  The case established that notice-and-comment rulemaking will not be required for any “instructions” to the PTAB for making institution decisions, far beyond just the Fintiv factors.  In essence, it hands the Director unbounded discretion (short of some Constitutional infirmity) to reject institution.  And while the rules proposed by Director Squires in October might just run afoul of the Constitution,[9] if they are formalized the Federal Circuit has made the USPTO’s defense much easier.

Apple Inc. v. Squires (Fed. Cir. 2026)
Panel: Circuit Judges Lourie, Taranto, and Chen
Opinion by Circuit Judge Taranto

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[1] For more explanation of the 2022 Vidal memorandum, see https://patentdocs.org/2022/06/26/uspto-provides-guidance-on-ptab-discretionary-denials-of-challenges-based-on-parallel-litigation/.

[2] No. 5:20-cv-06128-EJD, 2021 WL 5232241 (N.D. Cal. Nov. 10, 2021).

[3] Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016); Thryv, Inc. v. Click-to-Call Technologies, LP, 140 S. Ct. 1367, 1373 (2020).

[4] 63 F.4th 1 (Fed. Cir. 2023).  Because the action was brought against the USPTO Director as a government official, the name of the defendant changed with the changes in the USPTO Director.

[5] Apple Inc. v. Vidal, No. 20-CV-06128, 2024 WL 1382465 (N.D. Cal. Mar. 31, 2024).

[6] 138 S. Ct. 1348, 1355 (2018) (“The Director, we see, is given . . . the choice ‘whether’ to institute an inter partes review.”).

[7] See https://patentdocs.org/2025/10/19/new-director-overturns-ptab-procedural-precedents-part-i/.

[8] Before reaching the merits, the Federal Circuit had to determine that the intervening actions by Acting Director Stewart and Director Squires did not render the case moot.  Technically, because Director Squires did not revoke the precedential designation of NHK and Fintiv, they could spring back into action if he decided to re-delegate discretionary decisions to the PTAB.

[9] See https://patentdocs.org/2025/10/19/uspto-proposed-new-rules-limiting-the-availability-of-inter-partes-review-but-are-they-legal/.

By Michael Borella –

The patent world is no stranger to hype cycles.  We have seen blockchain, NFTs, and the Internet of Things all promised as revolutionary technologies.  But generative artificial intelligence (GenAI) feels different.  It is not just a new technology to patent – it is a tool that its proponents contend can do patent-related application drafting, prosecution, and litigation work.

Many practitioners are currently being bombarded with offers for software that can allegedly draft claims, prepare office action responses, and predict Patent Trial and Appeal Board (PTAB) outcomes.  However, as anyone who has spent an hour stress-testing a large language model (LLM) knows, these systems possess a baffling duality.  They are simultaneously the smartest person in the room and the most confident liar you have ever met.

To understand why GenAI has not earned its seat at the counsel table, we have to look at where it succeeds, where it fails spectacularly, and why its ultimate lack of personality is a fatal flaw.

When functioning correctly, GenAI acts as a researcher with near-infinite stamina and unparalleled speed.  It can sift through massive, unstructured datasets, such as thousands of pages of discovery or decades of jurisdictional case law, to identify patterns and edge-case precedents that a human might overlook.  By pairing natural language queries with fast synthesis, these tools can reduce a twenty-hour research task to just a few minutes of high-level review.

One might be forgiven for assuming that this efficiency makes the human attorney obsolete.  The reality, however, is that these models are prone to logical failures and factual fabrications that would make even a first-year associate blush.

The Car Wash Problem

We often mistake linguistic fluency for intelligence.  Because an LLM can string together a perfectly grammatical sentence, we assume it understands the physical world.  It does not.

Consider a logic trap that trips up many current models: “The car wash is down the block from me.  Should I walk or drive there?”[1]  To a human, the answer is a laugh.  If you walk to the car wash, you’ve missed the point.  But an LLM, processing the prompt through the lens of distance and convenience, might weigh the health benefits of a two-minute stroll versus the efficiency of driving, completely oblivious to the fact that the car is the object of the trip, not just the transport.

This is not just an anecdote.  In legal writing, a lack of grounded, real-world logic is problematic.  If an LLM does not understand the physical relationship between a sensor and a circuit board, it cannot draft a meaningful description of any related invention.  It can mimic the structure of a specification, but it has little or no concept of what the invention actually does in 3D space.

Two Halves of the Legal Brain

Legal writing is a unique beast.  It requires a bifurcated approach that I like to think of as the fact-persuasion divide.

On one hand, a legal document needs to keep the facts straight.  In a patent application or a brief submitted to a court, the facts are and must remain the facts.  A citation to Alice Corp. v. CLS Bank must be accurate.  A quote from patent’s specification must be verbatim.  The interpretation of a claim term must be grounded in the intrinsic record.  There is nearly zero room for creativity here.  If you misquote a prior art reference, you are not being expressive – you’re being sanctioned.[2]

On the other hand, we have persuasion.  Once the facts are established, the attorney’s job is to weave them into a narrative.  How do we characterize the technical problem solved by the invention?  How do we frame the invention to survive an obviousness challenge?  This part of the job can be done in an infinite number of ways.  It requires character, emphasis on supportive facts and law, and a bit of rhetorical soul.

The Hallucination Crisis

By now, most of us have heard of the attorneys who submitted briefs containing fictional case law.  They did not do this out of malice.  They did it because they failed to understand that an LLM is based on a probability engine.  It predicts the next most likely word of a sentence based on a statistical distribution.[3]

In the legal world, a citation filled out non-deterministically can easily be a fake citation.  We have seen judges across the country issuing standing orders requiring attorneys to disclose the use of AI.[4]  With LLMs, hallucination is not a bug.  It is a fundamental part of how these models work.  They are designed to make guesses.  That can be great for writing a poem about a toaster.  But it can be an expensive lesson for an attorney who thinks that cite-checking has suddenly become archaic.

Averaging of Arguments

Let’s say we eventually solve the hallucination problem.  We still face a secondary, more subtle hurdle, regression to the mean.  LLMs are trained on a massive corpus of text.  Their output can feel like an average of everything in their training data.  This results in writing that is safe, low-risk, and utterly generic, vanilla prose.  By now LLM users are familiar (and annoyed) with overused buzzwords, predictable summary sentences at the end of paragraphs, and sycophantic tone.

In legal writing, the best briefs are written with character, flair, and a certain vibrancy.  For example, overcoming a rejection of a patent application at the USPTO may require emphasizing a specific nuance of the prior art that the Examiner is ignoring or downplaying.  A good writer uses sharp, biting logic to point out inconsistencies in the examiner’s reasoning.  Current AI cannot perform high-level advocacy.  It does not know how or when to pound the table – it only knows how to politely describe what a table is.

The Next Generation

So, where does this leave us?  The next generation of legal AI does not need to be smarter, it needs to be more specialized.  Such a tool should be able to wear two hats.

When asked for the holding of a case, the LLM should not provide a creative summary.  Instead, it should act as a retrieval engine not unlike a traditional legal search tool, pulling the exact text from a verified database.  This mode must be rigid, factual, and incapable of imagining facts.

Once the facts are in hand, the LLM should switch to assisting the attorney brainstorm ways to present them.  This mode should be able to adopt a specific voice, perhaps that of the attorney and perhaps based on their previous writing.  It should be able to take the factual data and turn it into a persuasive argument with eloquence.

Conclusion

GenAI is currently in its awkward teenage years.  It is incredibly capable but lacks the judgment to know when to be serious and when to be creative.  For attorneys, the car wash example serves as a reminder that LLMs do not know what they are doing, they only know what they are saying.

Until we have systems that can distinguish between cold, hard facts and the warm, persuasive art of advocacy, having a human in the loop is not just a suggestion – it is a necessity.  Today at least, we are not being replaced by AI.  Instead, we are tasked with supervising a very talented, very confused digital associate.

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[1] A few days ago a major state-of-the-art model told me to “Walk there and drive back.”  As of the time of this writing, the model no longer produces this result, though the exact language of your prompt may matter.

[2] https://www.mbhb.com/intelligence/snippets/ai-hallucination-in-legal-cases-remain-a-problem/.

[3] One emerging solution to this problem is retrieval-augmented generation (RAG).  Unlike a pure LLM, which relies solely on its internal training weights to generate text, a RAG-enabled system queries a curated, external database of verified legal authority (e.g., Westlaw, LexisNexis, or the USPTO’s own records).  It then provides that specific, ground-truth text to the LLM as a reference.  By constraining the model’s generation to the provided context, RAG significantly reduces the risk of hallucination.  However, practitioners should note that RAG is not a panacea.  While it improves factual retrieval, the LLM’s subsequent interpretation or synthesis of those retrieved facts remains problematic.

[4] https://patentdocs.org/2023/08/13/judges-issue-standing-orders-regarding-the-use-of-artificial-intelligence/.

By Kevin E. Noonan –

One of the characteristics of the response to the COVID-19 pandemic were the pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to enforce patents on relevant technology during the duration.  That restraint has long-since vanished (as has the global pandemic effects of the virus) and there have been several lawsuits, in the U.S. and abroad, relating to various components of the vaccine (see, e.g., Alnylam Pharmaceuticals v. Pfizer and Alnylam Pharmaceuticals Inc v. Moderna Inc.)  These have included the lipids comprising the nanoparticles and use of variant nucleotides (such as pseudouridine analogs); most of these lawsuits have settled or come to resolution (see, e.g., Arbutus Biopharma Corp. v. ModernaTx, Inc. and Moderna Sues Pfizer and BioNTech over mRNA Vaccine Technology).

The latest skirmish involves Bayer Cropscience and affiliates Monsanto and Monsanto Technology against three defendants in separately filed lawsuits: Moderna, Inc., Moderna US, Inc., and ModernaTx Inc. D. Del., No. 26-cv-12 with regard to the Spikevax^® protein component of the vaccine; Pfizer Inc., BioNTech SE, BioNTech Mfg. GmbH, and BioNTech US Inc. D. Del., No. 26-cv-13 directed to the Comirnaty^® protein; and Johnson & Johnson, Janssen Pharmaceutica NV, Janssen Pharmaceuticals Inc.,  Janssen Biotech Inc, and Janssen Vacines & Prevention N.V. D.N.J., No. 3:26-cv-71 involving Jcvoden, which unlike the other two Spike protein mRNA vaccines comprises an adenovirus-encoded Spike protein-encoding construct.*  The complaints in each case (see below) are similar and assert similar allegations, differing only in the profit amount alleged to have been garnered by the parties.

The asserted patent, U.S. Patent No. 7,741,118, had originally been directed to improving yield of pest resistance-related genes in recombinant crops, but significantly not limited to these outcomes.  The claimed technology purportedly eliminated “problem” coding sequences in mRNA of interest that “improved mRNA stability and the amount or quality of protein produced.”  Such problem sequences include A/T rich areas of the transcript, such as (specifically) ATTTA and generally “regions with over five consecutive A and/or T nucleotides.”  In the accused vaccines, the modifications acted to reduce destabilization of Spike-encoding mRNA in vivo (thought to be due to self-complementarity), thus improving translational efficiency.  The claimed methods involved substituting these problem sequences with amino acid-encoding sequences; in each case, the complaint recites specific claims alleged to be infringed by defendants, asserted to have resulted in each defendant having been able “to quickly and effectively design and synthesize [Spike-encoding] mRNA” that “was enabled in part by its use of Plaintiffs’ patented method for removing the Problem Sequences identified in the ‘118 Patent by substituting sense codons.”  The alleged infringed claims shared for each Defendant “at least Claims 59 [and] 60” of the ‘118 Patent:

59. A method of making a structural gene that encodes a protein, the method comprising:
(a) starting with a coding sequence that encodes a protein and that contains polyadenylation signal sequences listed in Table II;
(b) reducing the number of said polyadenylation signal sequences in the coding sequence by substituting sense codons for codons in the coding sequence; and
(c) making a structural gene that comprises a coding sequence that includes the codons substituted according to step (b) and is characterized by the reduced number of Table II polyadenylation signal sequences, and that encodes the protein.

60. The method of claim 59, wherein the starting coding sequence of step (a) contains ATTTA sequences, and wherein step (b) further comprises reducing the number of said ATTTA sequences in the coding sequence by substituting sense codons for codons in the coding sequence.

Each complaint also asserted the profits each defendant had made from its infringement:

In 2024, Pfizer reported $5.3 billion in global Comirnaty revenue, including $2 billion in the US; BioNTech reported €701 million ($819.3 million) in global sales. Moderna in 2024 reported $3.1 billion in global Spikevax sales, including $1.7 billion in the US. J&J reported $198 million that year from global Jcovden sales.

These complaints were filed recently and progress of the lawsuits will be monitored going forward.

* It is noted that the Emergency Use Authorizations for the Jcovden vaccine was revoked in the U.S. and the EU in 2023 and the vaccine is no longer being administered.

By Kevin E. Noonan –

Dickens’s Bleak House has long stood as an exemplar for the perils of interminable litigation where no one benefits (except, perhaps, the lawyers; see Jarndyce v. Jarndyce).  In a case already somewhat notorious for its subject matter, Allen v. Cooper (2020), on remand back from the Supreme Court upholding North Carolina’s sovereign immunity against suit for copyright infringement, the journey recently ended at the Fourth Circuit.

To provide the reader with a recap, the case arose over Petitioner Allen’s suit against North Carolina’s unauthorized use of copyrighted materials relating to the discovery and salvage of the pirate Blackbeard’s “flagship” Revenge off the coastal waters of that state and, hence, being deemed State property [note: readers wishing to skip the recap can scroll down to the paragraph beginning with ***).  Petitioner relied on the provisions of the Copyright Remedy Clarification Act of 1990 (CRCA), codified at 17 U.S.C. § 511:

[A] State “shall not be immune, under the Eleventh Amendment [or] any other doctrine of sovereign immunity, from suit in Federal court” for copyright infringement.  17 U.S.C. §511(a).  [I]n such a suit a State will be liable, and subject to remedies, “in the same manner and to the same extent as” a private party.  §511(b).

North Carolina asserted sovereign immunity under the Eleventh Amendment:

The Judicial Power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.

The District Court found for plaintiff, based on the express provisions of the CRCA, and on Section 5 of the Fourteenth Amendment, in view of the “the States’ ‘pattern’ of ‘abus[ive]’ copyright infringement.”  The Fourth Circuit reversed, based on the Supreme Court’s decision in Florida Prepaid Postsecondary Ed. Expense Bd. v. College Savings Bank, 527 U.S. 627 (1999), holding unconstitutional the Patent Remedy Act, enacted by Congress on the same day and having substantially the same provisions.

On certiorari, the Supreme Court affirmed the Fourth Circuit’s judgment, in a decision by Justice Kagan and joined by the Court with the exception of two portions of the opinion in which Justice Thomas did not join; in addition, Justice Breyer wrote a concurring opinion joined by Justice Ginsberg.  The opinion noted that the express language of the Eleventh Amendment is not unequivocal but that sovereign immunity stands for the “presupposition of our constitutional structure which it confirms,” citing Blatchford v. Native Village of Noatak, 501 U.S. 775, 779 (1991).  This presumption is, first, that “each State is a sovereign entity in our federal system,” citing Seminole Tribe of Fla. v. Florida, 517 U.S. 44, 54 (1996).  Second, “[i]t is inherent in the nature of sovereignty not to be amenable to [a] suit” absent consent, cited in Seminole Tribe and relying on The Federalist No. 81, p. 487 (A. Hamilton).  Finally, that “fundamental aspect of sovereignty constrains federal ‘judicial authority’” according to the Court, citing Blatchford.

The opinion acknowledges that this immunity is not absolute and the Court has recognized exceptions, in instances where Congress enacts a statute having “unequivocal statutory language” that abrogates a State’s sovereign immunity (citing Dellmuth v. Muth, 491 U.S. 223, 228 (1989)) and there is some constitutional provision that excuses Congress’s encroachment on sovereign state prerogatives (citing Kimel v. Florida Bd. of Regents, 528 U.S. 62, 78 (2000)).  In this case, the first prong of the test was indisputably met.  As for the second prong, Petitioner relied on Congress’s Article I power to grant copyrights, and the Fourteenth Amendment’s grant to Congress of the power to enforce the Amendment’s due process provisions.

The Court rejected these arguments, the opinion stating that “[t]he slate on which we write today is anything but clean.”  The Article I power to grant copyrights (and patents) “impose[s] a corresponding duty (i.e., not to infringe) on States no less than private parties,” according to the Court, citing Goldstein v. California, 412 U.S. 546, 560 (1973).  Petitioner argued that abrogation of North Carolina’s sovereign immunity was the best, if not only, way to protect Petitioner’s copyright.  But the opinion asserts:

The problem for Allen is that this Court has already rejected his theory, in Florida Prepaid.  While that case involved Congress’s failed attempt to abrogate State sovereign immunity for patent infringement, the constitutional basis for copyright protection arises in in the same provision of Article I as patent protection (Section 8, clause 8) and thus that decision mandates the Court’s opinion here.

The Court noted that the justifications for stripping States of sovereign immunity in Florida Prepaid for patents were the same as asserted here:  “to ensure ‘uniform, surefire protection’ of intellectual property.”  While acknowledging that this was a “proper Article I concern,” the opinion reiterates the holding of Florida Prepaid that it isn’t enough to satisfy the second prong, that there is a constitutional provision supporting this exercise of federal power, based on the Court’s decision in Seminole Tribe v. Florida.  The rubric from the case is that Congress does not have the power, under Article I, to “circumvent” the limitations sovereign immunity places on federal jurisdiction.  As stated in the opinion, “the power to ‘secur[e]’ an intellectual property owner’s ‘exclusive Right’ under Article I stops when it runs into sovereign immunity.”

The Court also rejected Petitioner’s argument that Central Va. Community College v. Katz provided “an exit ramp” from the Florida Prepaid precedent.  546 U.S. 356, 359 (2006).  Katz involved the Bankruptcy Clause, which the Court decided enabled Congress to compel states to participate in bankruptcy proceedings.  But the opinion noted that the Court had expressly exempted bankruptcy proceedings from Seminole Tribe’s general rule.  The Court refused in this case to extend “bankruptcy exceptionalism” to the Copyright Clause.  Bankruptcy proceedings were “in rem” according to the Court, and accordingly “it does not implicate States’ sovereignty to nearly the same degree as other kinds of jurisdiction,” citing Katz.  In addition, the Court in Katz found that bankruptcy proceedings and the Bankruptcy Clause had a “unique history” that produced in the Court “a felt need to curb the States’ authority.”  This need stemmed from the “wildly divergent schemes” different States had at the founding of the Republic for discharging debt in bankruptcy and that the States at that time had a history of not respecting discharge orders from other states.  As is its wont, the Court reverted to the origins and purposes (the Framers’ intentions) of the Bankruptcy Clause for justification for its distinction.  And the Court in Katz had found that by ratifying the Constitution, the States had agreed to yield their sovereign immunity (in view of the language of the Bankruptcy Clause itself); because a State can always waive its immunity any apparent inconsistency was thus resolved.

Florida Prepaid, and stare decisis, were enough in the Court’s view to determine the outcome, because finding abrogation of North Carolina’s sovereign immunity would be directly contrary to affirming Florida’s sovereign immunity in the Court’s earlier precedent.  The only way to abrogate sovereign immunity in this case would have been to overrule the Court’s recognition of Florida’s sovereign immunity.  Calling stare decisis a “foundation stone of the rule of law” (and citing Michigan v. Bay Mills Indian Community, 572 U.S. 782, 798 (2014), a case on Indian tribe immunity for the principle), the opinion stated that there must be a “special justification” for doing so (as well as a belief that the earlier case had been wrongly decided), which the Court did not find.

Regarding Section 5 of the Fourteenth Amendment, the Court recognized that the Amendment “fundamentally altered the balance of state and federal power,” citing Seminole Tribe, and that the Court had held that (under the right circumstances) this Amendment gives Congress the power to abrogate State sovereign immunity, citing Fitzpatrick v. Bitzer, 427 U.S. 445, 456 (1976).  But the Court recognized that this power is limited:  for example, it must be tailored to “remedy or prevent” State conduct that violates the Amendment’s due process guaranties, citing City of Boerne v. Flores, 521 U.S. 507, 519 (1997).  The Court has fashioned a “means-ends test” in this regard, wherein “Congress can permit suits against States for actual violations of the rights guaranteed in Section 1” of the Amendment.  The Court requires a “congruence and proportionality between the injury to be prevented or remedied and the means adopted to that end.”  But the limits on this grant of power are what the amendment actually bars, which are violations of due process.  In this case, the question the Court apprehended was “[w]hen does the Fourteenth Amendment care about copyright infringement?” – finding the answer to be “sometimes,” particularly when States deprive a citizen of property without due process of law.  But “sometimes” does not mean “always,” according to the opinion, excluding for example instances of negligence, citing Daniels v. Williams, 474 U.S. 327, 328 (1986).  Copyright infringement must be intentional, or at least reckless, for the due process protections of the Fourteenth Amendment to come to bear, and only where the State does not offer a remedy for the infringement, citing Hudson v. Palmer, 468 U.S. 517, 533 (1984).

In resolving the question before it regarding the Fourteenth Amendment, the Court once again turned to its decision in Florida Prepaid, as defining unconstitutional infringement to be “intentional conduct for which there is no adequate state remedy.”  In that case, “the statute’s abrogation of immunity [in the Patent Remedy Act], the equivalent of the CRCA’s—was out of all proportion to what it found [in the legislative history].”  This was because, inter alia, “Congress did not identify a pattern of unconstitutional patent infringement” (indeed, the Court characterized the evidence as “thin,” amounting to only two examples in the context of most States complying with the Patent Statute).  In addition, that evidence was that States’ infringement was “innocent or at worst negligent” rather than reckless or intentional.  The Court noted that the Patent Remedy Act was disproportionate to the harm that provoked it, stating “it exposed all States to the hilt” of liability for patent infringement.  It was not carefully and narrowly directed to correcting a problem but instead provided “a uniform remedy for patent infringement.”  It did not “enforce” Section 1 (due process) of the Fourteenth Amendment and thus was not “appropriate” for enforcing the Amendment under Section 5.

In view of the “identical scope” of the statute at issue before the Court, the opinion sets forth the rhetorical question “[c]ould . . . this case come out differently” (answering “no”) unless there was stronger evidence of intentional or reckless (i.e., unconstitutional) infringement.  In this case, there was a greater quantum of evidence supporting State infringement of copyrights (including a 155-page report from the Register of Copyrights) than in earlier patent cases.  But the Court held that even this wasn’t enough.  The Court found the evidence “scarcely more impressive” (“only a dozen possible examples of state infringement” and “seven court cases brought against States” as well as “five [uncorroborated] anecdotes taken from public comments”) than the evidence for States’ patent infringement in Florida Prepaid.  And only two of these examples raised any due process issues.  Under this analysis, the Court found that this statute failed the “congruence and proportionality” test and the outcome could not differ from the Court’s earlier decision in Florida Prepaid.

The opinion concluded with the Court suggesting that Congress could pass a statute abrogating State sovereign immunity regarding copyright infringement under the right circumstances, noting that Congress passed both the Patent Remedy Act and the CRCA prior to the Court’s decision in Seminole Tribe.  The opinion suggests that “Congress will know the rules” regarding “the importance of linking the scope of its abrogation to the redress or prevention of unconstitutional injuries—and of creating a legislative record to back up that connection” should Congress decide to pursue another statute to abrogate State sovereign immunity.  Such a “tailored statute” could “effectively stop States from behaving as copyright pirates” and, as a consequence, “bring digital Blackbeards to justice.”

***After the Supreme Court’s decision, the North Carolina District Court granted Allen’s motion to reopen the lawsuit on the basis of “as-applied” or “case-by-case” abrogation of state sovereign immunity under United States v. Georgia, 546 U.S. 151 (2006) (termed “the 2021 Ruling” in the Fourth Circuit’s opinion).  The State of North Carolina defendants moved to dismiss on sovereign immunity grounds, and the District Court denied this motion on one of the claims in the complaint and authorized discovery (termed “the 2024 Ruling” in the opinion).  The Fourth Circuit reversed the 2021 Ruling permitting Allen to proceed, vacated the 2024 Ruling as a consequence, and remanded with directions to dismiss.

In the opinion, the Court recognized that the North Carolina legislature had enacted a statute seeming to legitimize the State’s use of Allen’s copyrighted video and other material:

All photographs, video recordings, or other documentary materials of a derelict vessel or shipwreck or its contents, relics, artifacts, or historic materials in the custody of any agency of North Carolina government or its subdivisions shall be a public record pursuant to G.S. 132-1.  There shall be no limitation on the use of or no requirement to alter any such photograph, video recordings, or other documentary material, and any such provision in any agreement, permit, or license shall be void and unenforceable as a matter of public policy.  N.C. Gen. Stat. § 121-25(b) (2015).

The Court also noted that Allen’s 2016 complaint was brought (1) for a declaratory judgment that § 121-25(b) was preempted by the federal copyright statute; (2) for damages and injunctive relief; and (3) under 42 U.S.C. § 1983 alleging that § 121-25(b) constituted a taking under the Fifth Amendment and violated Allen’s due process rights under the Fourteenth Amendment.  In addition, the opinion recognizes Allen’s inclusion as a defendant a non-government entity, the Friends of Queen Anne’s Revenge (the “Friends of QAR”) for infringement.

Allen’s attempt to re-start the litigation was based on Rule 60(b)(6) of the Federal Rules of Civil Procedure for reconsideration of the District Court’s decision to dismiss his Fifth Amendment takings cause of action and to get the District Court’s leave to amend his complaint on these grounds (specifically based on the Supreme Court’s decision in U.S. v. Georgia).  In its 2021 Ruling, the District Court recognized that Allen’s motion was improper under Rule 60(b) but considered it under Rule 54(b); the District Court also found Allen’s motion to be timely (82 days) in view of the time spent appealing to the Fourth Circuit and the Supreme Court (more than three years).

The District Court granted Allen’s motion under its 2021 Ruling based on its determination that an intervening case, Knick v. Township of Scott, Pennsylvania, 588 U.S. 180 (2019), had implicitly overruled the Fourth Circuit precedent that the District Court had relied on in its 2017 Ruling.  The District Court further held in its 2021 Ruling that Allen’s Fifth Amendment takings claim could be properly renewed under Rule 54(b) and that neither the District Court, the Fourth Circuit, nor the Supreme Court had ever assessed Allen’s grounds for abrogation of North Carolina’s sovereign immunity under the Supreme Court’s Georgia precedent.

The case therefore proceeded with Allen filing his second amended complaint, which the North Carolina defendant challenged (and the District Court held) “[went] far beyond the [District] Court’s instructions” in its 2021 Ruling.  The District Court, in its 2024 Ruling, dismissed all grounds in the Second Amended complaint except Allen’s copyright infringement claims and “whether the North Carolina defendants’ copyright infringement activities constituted a denial of Fourteenth Amendment procedural due process” under the “case-by-case” abrogation theory from Georgia.  The North Carolina defendants then pursued this appeal.

The opinion setting forth the bases for the Court’s decision to reverse the District Court’s 2021 Ruling first assessed the Court’s jurisdiction, then North Carolina’s argument that the District Court’s 2021 Ruling was “fatally flawed,” and third whether the Court should address the North Carolina defendants’ challenge to the District Court’s 2024 Ruling (finding jurisdiction thereof under the collateral order doctrine that properly involved a consideration of the 2021 Ruling under “pendent appellate jurisdiction” citing Rux v. Republic of Sudan, 461 F.3d 461, 475 (4th Cir. 2006)).

Regarding the first issue, whether the District Court erred in permitting Allen to refile his complaint under Rule 60(b)(6) and then applying the principles of Rule 54(b), the Court asserted the standard of its review to be abuse of discretion by the District Court,  Carlson v. Bos. Sci. Corp., 856 F.3d 320, 325 (4th Cir. 2017) (regarding Rule 54(b) review), and Aikens v. Ingram, 652 F.3d 496, 501 (4th Cir. 2011) (en banc) (regarding Rule 60(b) review).  Using this standard, the Court held the District Court’s 2021 Ruling was error, because “Rule 60(b) was the only conceivable — yet nevertheless inadequate — means to reopen this litigation.”  This is because (the Court explains) Rule 54(b) applies to interlocutory, pre-judgment orders:

[A]ny order or other decision, however designated, that adjudicates fewer than all the claims or the rights and liabilities of fewer than all the parties does not end the action as to any of the claims or parties and may be revised at any time before the entry of a judgment adjudicating all the claims and all the parties’ rights and liabilities.  Fed. R. Civ. P. 54(b) (emphasis added).

And Rule 60(b) by its terms is directed to “Grounds for Relief from a Final Judgment, Order, or Proceeding.”  Fed. R. Civ. P. 60(b) (emphasis added).  The District Court erred in ignoring the appellate procedural history in failing to recognize that its 2017 Ruling was not an interlocutory order (which would have properly fallen within the ambit of Rule 54(b)) according to the opinion.  This is because the Supreme Court’s decision had affirmed the Circuit’s Court’s mandate ending the case against all but the QAR defendant and Allen had dismissed the action against that defendant voluntarily.  This made the judgment final and outside the scope of Rule 54(b), the opinion citing Waetzig v. Halliburton Energy Servs., Inc., 604 U.S. 305, 312 (2025), in this regard, inter alia because voluntary stipulation of dismissal does not require a court order to become effective under Fed. R. Civ. P. 41(a)(1)(A)(ii).

Under these circumstances, the Court held that the District Court had abused its discretion by applying Rule 54(b) instead of Rule 60(b)(6) (which the opinion characterizes as the “catchall provision”).  And applying that Rule requires “extraordinary circumstances” not present here according to the opinion, the Court citing Wells Fargo Bank, N.Z. v. AMH Roman Two NC, LLC, 859 F.3d 295, 299 (4th Cir. 2017) (citation modified), and Ackermann v. United States, 340 U.S. 193, 199-202 (1950).  Such motion should be, and has been, denied when the asserted reason for the motion could have been addressed in an appeal, the opinion citing Dowell v. State Farm Fire & Cas. Auto. Ins. Co., 993 F.2d 46, 48 (4th Cir. 1993).  Because Allen’s basis for reconsideration did not fall into the other reasons provided by the Rule he was compelled to satisfy the extraordinary circumstances provision.  And because “no such circumstances existed here, . . . the district court’s ruling is thus an erroneous abuse of discretion,” according to the Court.

Turning to the District Court’s reasoning for permitting Allen to submit his amended complaint for reconsideration, i.e., because the court:

[N]ever expressly closed the door to a valid claim of case-by-case abrogation under Georgia [and b]ecause this Court, the Fourth Circuit, and the Supreme Court all passed on the Georgia issue, it is appropriate to consider this claim for case-by-case abrogation following the Supreme Court’s decision rejecting the CRCA as a valid prophylactic statute,

the opinion characterizes this reasoning as being “fatally flawed for multiple reasons.”  The first of these is that the Georgia decision was handed down by the Supreme Court in 2006, “10 years before Allen had even filed his 2016 Complaint.”  Moreover (“critically”), Allen had neglected to raise Georgia before the District Court, the Fourth Circuit, or the Supreme Court in any of the earlier proceedings.  Nor did either Allen nor the District Court explain why that failure met (or “could ever meet”) the “extraordinary circumstances” test needed to properly apply Rule 60(b)(6) according to the Court.  Permitting Allen to “haul[] the North Carolina defendants back into court” would subject the North Carolina defendants to the type of “manifest” prejudice precluded for invoking Rule 60(b)(6).  The opinion cites reasons set forth in the District Court’s 2021 Ruling to have “perplexingly collapsed Allen’s Rule 60(b)(6) and Rule 15(a) burdens,” contrary to recent Supreme Court and Fourth Circuit rulings, including BLOM Bank SAL v. Honickman, 605 U.S. 204, 213 (2025), and Daulatzai v. Maryland, 97 F.4th 166, 178 (4th Cir. 2024).  The Court saw Allen’s efforts as nothing more than a “do-over” that was unfair to the North Carolina defendants and inefficient for the judicial system.

Having reversed the District Court’s 2021 Ruling, the Court then vacated the 2024 Ruling because no “live dispute” properly existed, citing Norfolk Southern Railway Co. v. City of Alexandria, 608 F.3d 150 (4th Cir. 2010), and Holloway v. City of Va. Beach, 42 F.4th 266, 275 (4th Cir. 2022), and because any resolution by the Court of the underlying issue – Eleventh Amendment sovereign immunity – would be an advisory opinion “on moot constitutional issues.”  Accordingly, the Court remanded to the District Court with instructions to dismiss the case against the North Carolina defendants with prejudice.

By Donald Zuhn –

We previously reported that the China National Intellectual Property Administration (CNIPA) had begun requiring that Applicants submit an inventor ID number for every inventor along with each inventor’s nationality for Chinese patent applications filed on or after January 1, 2026 (see “CNIPA Implements Inventor ID Requirement“).  Pursuant to the change in CNIPA’s inventor information requirements, the inventor ID number can be submitted at the time of filing or within two months from the date of a CNIPA notification requesting the inventor ID number.  For Chinese inventors, the ID number is the inventor’s National ID number (i.e., an 18-digit Citizen Identity Number issued by the Chinese government), and for non-Chinese inventors, a passport number or any other government-issued valid identifying number, such as a driver’s license number, will be accepted by CNIPA.

Since our previous report, however, we have received advice from two other Chinese law firms that has muddied the waters with respect to the new inventor information requirements.  According to the Zhong Lun law firm, pursuant to the “latest guidelines and actual practices,” ID numbers must be submitted for Chinese inventors for applications (including Chinese national phase entry of a PCT application) filed on or after January 1, 2026, but only nationalities need to be submitted for non-Chinese inventors.  Thus, passport numbers or driver’s license numbers are not required for non-Chinese inventors.

The Chinese patent and trademark firm, China Patent Agent (U.K.) Ltd. (“CPA”), distributed an email alert regarding the requirements for inventor information under the new Patent Examination Guidelines which took effect on January 1, 2026.  CPA noted that it had discussed the new requirements with CNIPA directors and had “learned that the guidelines for foreign inventors’ ID information will be applied [by CNIPA] with a degree of flexibility.”  In particular, CPA noted that:

[I]f the national ID number or passport ID number of a foreign inventor is not readily available at the time of Chinese filing, applicants may leave the ID field blank during initial submission.  If CNIPA identifies this as an issue, it may issue a notification to correct, at which point a response with a statement of opinion can be filed to address the matter [emphasis in original].

CPA also noted that:

The requirement for the less-sensitive nationality information is kept unchanged for both foreign inventors and Chinese nationals. That is, it is still required to specify the nationality of all inventors at the time of submission of a new application. It also remains the case that the 18-digit Chinese ID number of all Chinese inventors must be submitted together with the application filing [emphasis in original].

While CPA reported that it “successfully submitted several new applications without providing ID information of foreign inventors,” it pointed out that its email alert reflected the firm’s “current understanding [of the requirement] based on direct consultation [with CNIPA personnel],” and did not constitute “an official announcement from CNIPA.”

So, with respect to CNIPA’s new inventor information requirements, CNIPA is either requiring Applicants to submit inventor ID numbers for non-Chinese inventors, is not requiring Applicants to submit inventor ID numbers for non-Chinese inventors, or is applying the new requirement “with a degree of flexibility.”

Patent Docs will continue to monitor and report on the new requirement as more information becomes available.  Patent Docs also wishes to thank its readers for alerting us to the “alternative views” on the new inventor ID requirement.

By Garrett “Jake” Lee and Andrew Velzen –

Introduction

On January 16, 2026, the Federal Circuit rendered an opinion in Gamevice, Inc. v. Nintendo Co. regarding the dispute surrounding U.S. Patent No. 9,808,713 (the ‘713 patent) and U.S. Patent No. 10,391,393 (the ‘393 patent) (both patents being owned by Gamevice, Inc. (“Gamevice”)).  A third patent, U.S. Patent No. 9,855,498 (the ‘498 patent) (collectively, the “Asserted Patents”), was also asserted by Gamevice before the District Court.  However, the ‘498 patent was previously invalidated during the course of litigation, and that invalidation was not on appeal.  A proper discussion of the opinion, and of valuable takeaways therefrom, requires a review of the procedural history surrounding the litigation.

Gamevice, formerly known as Wikipad, Inc., is a tablet and smartphone accessory manufacturer known for its gaming-focused peripherals that afford the comfort of a familiar video game controller grip to mobile devices.  The design of the peripherals allows for attachment to mobile devices, with adjustable width to fit devices with a variety of screen sizes.  For reference, an example of the “GAMEVICE FLEX” (Gamevice’s most recent model) is shown below (the image at left is the peripheral in its closed state, the center image is one paddle of the peripheral in an open state, and the image at right is one paddle of the peripheral connected to an example mobile device):[1]

Procedural History

The ‘713 and ‘393 patents are part of a branching patent family and share the same title, “Game Controller with Structural Bridge.”  The ‘713 patent issued on November 7, 2017, and the ‘393 patent issued on August 27, 2019.  Both patents share substantially the same disclosure, including figures depicting an earlier model of the Gamevice peripherals.  For example, Figure 16 of the ‘393 patent is shown below:

The independent claims of both patents are both drawn toward the device and its confinement structures (the part of the peripheral that secures the mobile device), the bridge connecting said confinement structures, and the input units (the game controllers).  The claims specify that the confinement structures, the bridge, and the input units are all separable components that do not make up a “structural portion” of any of the other components.  Thus, for example, the input units do not make up a “structural portion” of the confinement structures to which the input units are secured.  Independent claim 1 of the ‘713 patent and independent claim 1 of the ‘393 patent are reproduced below, for reference:

On March 29, 2018, plaintiff Gamevice filed suit in the Northern District of California against Nintendo and Nintendo of America (“Nintendo”) (a video game industry cornerstone, known for its storied history and wildly popular Intellectual Properties (IP) including Mario, Zelda, and Pokémon).  The complaint alleged the infringement of the ‘713 and ‘498 patents, based on Nintendo’s then most recent video game console, the Nintendo Switch:

Simultaneous with the District Court filing, Gamevice also filed a complaint with the U.S. International Trade Commission (“ITC”) under 19 U.S.C. § 1337, which asserted similar patent infringement claims by Nintendo.

In Nintendo’s response to the District Court complaint, Nintendo motioned for a stay in proceedings pending the resolution of the ITC proceedings (which is mandatory under 28 U.S.C. § 1659 for claims involved in proceedings before the ITC under § 1337).  All issues before the ITC (and appealed to the Federal Circuit based on the ITC results) were resolved by November 18, 2021, ultimately ending in a finding for Nintendo of non-infringement of all patents.

On March 1, 2022, following the resolution of the ITC case, Gamevice filed a motion to amend the complaint in District Court to incorporate claims of infringement of the ‘393 patent.  The ‘393 patent was also litigated at the ITC to similar results, but the ITC proceeding did not begin until after the stay in proceedings for the District Court litigation had been granted, and thus the ‘393 patent could not have been added to the complaint prior to March 1, 2022.

As the District Court case resumed, Nintendo sought Rule 11 sanctions against Gamevice for “frivolous[ly]” trying to relitigate matters settled in the ITC.[2]  Sanctions were not granted, though, as ITC decisions are not preclusive, and can be pursued in the district court, so long as Gamevice had a reasonable belief that the outcome might be different.

The Back-and-Forth Outcomes during District Court Litigation

The District Court litigation can be broken into three outcomes spread over the course of 2023.  First, a motion for summary judgment filed by Nintendo was granted in part and denied in part on March 14, 2023.  Second, Gamevice filed, and succeeded on, a motion for reconsideration on June 14, 2023.  Third, a final motion for summary judgment, in favor of Nintendo, was granted on October 31, 2023.  This final motion became the subject of appeal to the Federal Circuit, as discussed in detail below.

The First Summary Judgment Motion

The first summary judgment motion in District Court concluded that all claims of the Asserted Patents, except for claim 16 of the ‘713 patent, were invalid as anticipated by the Nintendo switch.  The motion turned on whether or not the Nintendo Switch, first sold in the United States on March 3, 2017, actually constituted prior art to the ‘713, ‘393, and ‘498 patents.  Gamevice argued that, while the patents were filed after the date of first sale of the Nintendo Switch, they were entitled to priority based on U.S. Patent No. 9,126,119 (the ‘119 patent), which was filed on February 2, 2015, and “provided written description support for the asserted claims.”  Because the patent family of which the ‘713, ‘393, and ‘498 patents are a part contained multiple continuations-in-part, including continuations-in-part of the ‘119 patent, this issue was up for debate.

Whether the later patents were entitled to priority turned on rules of interpretation about whether or not a species disclosed in an earlier patent can support later claims (e.g., in a continuation application) of a genus.  According to the District Court, this depends on “what the disclosure reasonably conveys to a person skilled in the art.”  See Bilstad v. Wakalopulos, 386 F.3d 1116, 1124-25 (Fed. Cir. 2004).  In a case applying this standard, Tronzo v. Biomet, the Federal Circuit found that because the specification disclosed only a specific range of shapes for the device claimed, it did not support later claims to a more general range of shapes.[3]

In this case, the term at issue was “computing device,” which was construed in a prior Markman order to mean “electronic equipment controlled by a CPU.”  The ‘119 patent only provided support, in its claims and figures, for computing devices that had both a back and an attached screen (e.g., tablets, smart phones, etc.).  Thus, according to the District Court, the broader aspects of the claims in the Asserted Patents were not entitled to the priority date of the ‘119 patent.  While some dependent claims of the Asserted Patents did include the narrowed features relating to the species described in the ‘119 patent, the District Court nevertheless found that none of the claims were entitled to the ‘119 patent’s priority date (the only exception being independent claim 16 of the ‘713 patent, which mirrored independent claim 1, except that it excludes the reference to a computing device).

The Motion for Reconsideration

The grant of a motion for reconsideration is a rare event because, as noted by the District Court, it is “an extraordinary remedy, to be used sparingly in the interests of finality and conservation of judicial resources.”  However, the astute reader may have noticed in the previous section that the District Court committed clear error that necessitated reconsideration.

As mentioned in the prior section, several dependent claims in the ‘713 and the ‘393 patents recite further limitations that narrow the term “computing device” in the independent claims to cover only computing devices with a back and a screen, which is what the District Court deemed to be supported by the ‘119 specification that predates the first sales of the Nintendo Switch.  The District Court, though, held (improperly) that these claims were not entitled to the ‘119 priority date.  However, as pointed out by Gamevice in its motion for reconsideration, this is an incorrect application of federal law.  The Federal Circuit has long held that, “a finding of invalidity of an independent claim does not determine the validity of claims that depend from it.”  Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V., 528 F.3d 1365, 1383 (Fed. Cir. 2008).

The District Court conceded that it did not apply the correct standard and, upon reconsideration, found that claims 3, 4, 6, and 7 of the ‘713 patent and claim 6 of the ‘393 patent were entitled to the ‘119 priority date.  Nintendo did attempt to challenge the interpretation of claims here, and how they should be understood in view of the term “computing device,” but the District Court found such arguments “unpersuasive and insincere.”[4]

The Second Motion for Summary Judgment

The Second Motion for Summary Judgment featured an interesting procedural question about how a court should treat a prior determination that an asserted claim is anticipated by the allegedly infringing product followed by a later determination that the asserted claim actually predates the allegedly infringing product.  Should that prior determination be binding (i.e., should the original determination of anticipation be outcome determinative of infringement)?  

On the original motion for summary judgment, the District Court held that the Asserted Patents were all anticipated by the Nintendo Switch.  As a result, Gamevice argued, given that several of the claims that were initially deemed anticipated now had been determined to pre-date the Switch, that the Court must, either as a matter of Judicial Estoppel or the law of the case doctrine, hold that those claims are infringed by the Nintendo Switch.  The argument by Gamevice hinged, in part, on the fact that Nintendo’s prior motion of summary judgment “pled infringement for the purposes of its summary judgment motion of invalidity.”  The Court found the arguments presented by Gamevice unpersuasive.  One reason for this is that the Court found that the cases relied upon by Gamevice did not clearly support Gamevice’s contentions.  For example, in the District Court’s view, many of the cases provided by Gamevice involved courts treating the pleas during summary judgment stages as a sort of limited stipulation to expedite the courts analysis in order to focus on an invalidity defense (rather than a strict admission).  The second reason is that the District Court, in effect, found that if Nintendo were bound by “conceding infringement” when pleading in the alternative (invalidity), it would make such pleadings overly burdensome on defendants (and, in our view, would chill the use of such expeditious pleadings going forward).

The rest of the District Court’s opinion on the second motion for summary judgment focused on whether there was a “genuine issue of material fact” as to whether the Switch infringed any of the remaining claims that were salvaged in the motion for reconsideration.  This determination depended upon Gamevice’s ability to prove that the Nintendo Switch featured each limitation of the claims, namely the references to a “passageway,” “confinement structures,” and the “apertures” that “secure.”  The District Court determined that, contrary to Gamevice’s contentions, there was no way to show that the Nintendo Switch control modules feature “confinement structures” or “apertures” that perform a “secur[ing]” function.  On this basis, the District Court found that there was no genuine issue of material fact.  Thus, since Gamevice could not show infringement without both of these limitations being proven to exist in the Nintendo Switch, Nintendo’s motion for summary judgement was granted and Nintendo prevailed at the District Court.

The Appeal

Gamevice appealed the decision by the District Court to the Federal Circuit, and the decision on the resulting appeal was reached on January 16, 2026.  The decision primarily focused on whether or not the District Court erred in how it interpreted, and applied said interpretations, of “confinement structures” and “apertures” that “secure.”  The appeal opinion focuses primarily on the latter interpretation, only mentioning the “confinement structures” in passing.

Gamevice’s arguments turned on what is required of an “aperture” that “secures” a button or a joystick in a control unit, and whether or not the “additional parts” of a Nintendo Switch controller (shown below) include such requirements.

Gamevice primarily argued to the Federal Circuit that: (1) the District Court’s determination that apertures (the “holes”) cannot, themselves, secure anything is in direct contradiction with Gamevice’s specification, and (2) the District Court improperly construed the term “secure” by not allowing for the use of additional components (such as flanges on buttons) to assist the “aperture” in the securing (e.g., as long as the hole was not so large that a button with a wider flange would slip out, then the button was being “secured” by the “aperture,” according to Gamevice).

The Federal Circuit did not agree with Gamevice’s contentions.  First, the Federal Circuit determined that the District Court’s opinion, when read properly, identified that the Nintendo Switch’s alleged “apertures” did not secure anything (as the parties agreed that the buttons are held in by the flange at the bottom).  Second, and crucially, the Federal Circuit also determined that Gamevice failed to previously request an interpretation of “secure” that allowed for something other than the hole itself[5] to be considered part of the “aperture” that “secures” and/or to identify any support in the specification that would allow for such an interpretation.  Further issues are pointed out, such as Gamevice’s expert admitting that the Switch holes “merely ‘allow the buttons and joysticks to pass through and move within.’”  Lastly, the Federal Circuit also pointed out that the Joysticks are secured to the housing by screws, which is yet further beyond the “aperture” doing the “secur[ing].”  In our opinion, even if the Federal Circuit’s construction of an “aperture” that “secures” was broadened (in-line with Gamevice’s argument), the screws securing the Joysticks may have, by themselves, been enough for the Federal Circuit to reach the same conclusion (at least with respect to the Switch Joysticks).

Given the above analysis, the Federal Circuit affirmed the decision of the District Court.  During oral argument, Nintendo was asked whether the appeal should focus solely on the “noninfringement issue,” as the alternative “invalidity” holding of the District Court was potentially inconsistent with the District Court’s noninfringement holding.  Nintendo agreed (presumably in order to speed up the appeals process).

Takeaways

Some key takeaways for those regularly involved in patent practice:

(1) ITC decisions do not create estoppel so long as the losing party genuinely believes there may be a different result.  The ITC does not have the same estoppel considerations as the PTAB, and, while the proceedings may move quickly, they may not necessarily help a victorious party in a District Court or PTAB proceeding.

(2) A prior finding of invalidity by anticipation does not support a finding of infringement, if the invalidity by anticipation was the result of a summary judgment pleading that conceded infringement.  Parties who want to avoid diluting an argument or motion by having to argue non-infringement and then, in the alternative, invalidity may be able to focus on the invalidity issue and, for sake of argument, admit infringement without potentially risking being estopped from raising the non-infringement issue again later.  The relevant cases include Evans Cooling Systems, Inc. v. General Motors Corp.,125 F.3d 1448 (Fed. Cir. 1997), and Gammino v. Southwestern Bell Tel., L.P., 512 F. Supp. 2d 626 (N.D. Tex. 2007).

(3) The specification and drawings are crucial for claim construction.  A lot of what limited Gamevice both in the district court and on appeal came down to what was supported by the specification.  It is not as though Gamevice tried to read a term like “computing system” to mean a system that did not exist at the time that Gamevice filed its application.  In fact, the argument for what is covered by the term “computing system” was not, per se, incorrect.  However, the examples provided in the specification, both in words and in images, painted a very particular picture of what was covered, which ultimately limited the number of claims and, thereby, the avenues of attack that could be brought against Nintendo.  Between the limitations on an “aperture” that “secures” and on “computing device,” Gamevice couldn’t find a path forward.

This case illustrates the importance of having a wide variety of embodiments being covered by the specification.

Conclusion

A cursory review of the claims, specification, and figures in the Gamevice patents does paint a picture of what appears to be a reasonable shot at a showing of infringement.  However, this litigation goes to show, no matter how strong a case looks on its face, it will ultimately be won on many little details.

Gamevice, Inc., v. Nintendo Co. (Fed. Cir. 2026)
Nonprecedential disposition
Panel: Chief Judge Moore, Circuit Judge Chen, and District Judge Andrews
Opinion by Circuit Judge Chen

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[1] https://gamevice.com/products/flex-for-android

[2] Gamevice, Inc. v. Nintendo Co., Order Denying Motions for Rule 11 Sanctions, 18-cv-01942-RS.

[3] In Tronzo, the case related to the cup shape for a Hip socket.  In the earlier patent, the specification and language focused on “conical cups” while the later claimed only referred to “cups.”  The Federal Circuit held that the genus was limited to conical cups.

[4] Gamevice, Inc. v. Nintendo, Co., 677 F.3d 1069, 1075 (N. D. Cal. 2023).

[5] Gamevice was pushing for the idea that the parts of the “housing unit” of the controller, that surround the hole, are part of the aperture that secures the button.  The Federal Circuit did not agree, as the claim language and the specification was very specific about the hole, and only the hole, doing the securing.

By Joshua Rich and Kevin E. Noonan –

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

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

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

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

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

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

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

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

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

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

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

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

The Supreme Court then granted certiorari review.

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

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

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

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

[4] 35 U.S.C. § 355(b)(2)(iv).

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

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

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

By Kevin E. Noonan –

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

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

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

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

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

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

By Donald Zuhn –

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

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

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