Technology & Information Law Blog by Charles Gideon Korrell

Tag: pharmaceuticals

  • Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics

    Hikma v. Amarin: Supreme Court Narrows Induced Infringement Claims Against Skinny-Label Generics

    A Significant Win for Generic Drug Manufacturers

    The Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Case No. 24-889 (Jun. 4, 2026), is one of the most important patent law decisions of the 2025-2026 Term. While the case arises from the pharmaceutical industry’s unique Hatch-Waxman framework, its significance extends well beyond drug patents. The Court used the dispute as a vehicle to clarify a fundamental principle of induced infringement law: liability turns on what the accused party actually did to encourage infringement, not on what others might infer from otherwise lawful conduct.

    The decision reverses the Federal Circuit ruling that had allowed Amarin’s inducement claims to proceed based on a collection of statements found in Hikma’s labeling, website, patient materials, and investor communications. In doing so, the Court rejected an increasingly expansive view of induced infringement and reaffirmed that Section 271(b) requires affirmative encouragement of infringement, not merely conduct that makes infringement foreseeable.

    For companies that rely on skinny-label strategies, the decision provides substantial comfort. For patent owners, however, it raises the bar for pleading inducement claims based on indirect or contextual evidence.

    The Skinny Label Framework

    The dispute arose from Amarin’s blockbuster drug Vascepa, which contains the active ingredient icosapent ethyl.

    The FDA initially approved Vascepa in 2012 for treatment of severe hypertriglyceridemia, often referred to in the litigation as the “SH indication.” Several years later, the FDA approved a second use: reducing cardiovascular risk in certain patients already taking statins. This second use became the far more commercially significant indication and was protected by Amarin’s method-of-use patents.

    Hikma sought FDA approval for a generic version of icosapent ethyl. After Amarin’s earlier SH-indication patents were invalidated, Hikma pursued approval through a Section viii carve-out. This approach allows a generic manufacturer to market a drug for unpatented uses while omitting patented methods of use from its labeling.

    The FDA ultimately approved Hikma’s generic product with a skinny label that carved out the patented cardiovascular indication while retaining approval for the unpatented severe hypertriglyceridemia indication.

    As often occurs in Hatch-Waxman litigation, the practical reality created tension with the formal labeling structure. Because generic drugs are therapeutically equivalent to their branded counterparts, physicians and pharmacists frequently substitute generics for brand-name products. Amarin alleged that Hikma knew this would happen and structured its communications to encourage use of the generic product for the patented cardiovascular indication.

    The Federal Circuit’s Approach

    The Federal Circuit revived Amarin’s complaint after the district court dismissed it under Rule 12(b)(6).

    Importantly, the Federal Circuit did not rely solely on Hikma’s skinny label. Instead, it looked at the “totality” of Hikma’s communications. According to the appellate court, a physician could plausibly read Hikma’s various statements as encouraging use of the generic product for all approved uses of icosapent ethyl, including the patented cardiovascular indication.

    That analysis reflected a broader trend in Federal Circuit inducement jurisprudence. In cases such as GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the court increasingly focused on how prescribing physicians might interpret a generic manufacturer’s statements.

    The Supreme Court viewed that framing as fundamentally incorrect.

    The Supreme Court Refocuses the Inquiry

    Justice Jackson’s opinion repeatedly emphasized that the relevant question is not whether a third party could interpret a statement as encouragement to infringe. Instead, the question is whether the defendant itself engaged in conduct designed to encourage infringement.

    That distinction drove the entire opinion.

    The Court began with established inducement precedent. Under Limelight Networks, Inc. v. Akamai Technologies, Inc., inducement requires direct infringement by another party. Under Global-Tech Appliances, Inc. v. SEB S.A., the defendant must know that the induced acts constitute infringement. Most importantly for this case, Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd. requires active steps to encourage infringement.

    The Court focused almost exclusively on that third requirement.

    Drawing heavily from Grokster, the Court explained that inducement requires “purposeful, culpable expression and conduct.” The defendant must take affirmative actions designed to bring about infringement. Ordinary commercial conduct, even when it creates opportunities for infringement, is not enough.

    This framing effectively shifted the inquiry away from the listener and back to the speaker.

    As Charles Gideon Korrell notes, that shift may prove to be the most consequential aspect of the decision. The Court did not merely reject Amarin’s allegations. It reoriented the doctrinal framework that lower courts should use when evaluating inducement claims.

    Foreseeability Is Not Inducement

    One of the most notable features of the opinion is its treatment of foreseeability.

    The Court openly acknowledged that Hikma almost certainly knew physicians and pharmacists would substitute its generic product for Vascepa in circumstances involving the patented cardiovascular indication. Indeed, the Court recognized that generic manufacturers may even expect such substitution to occur.

    Yet knowledge and expectation were not enough.

    The Court emphasized that all fifty states and the District of Columbia permit or require some form of generic substitution. That regulatory environment makes off-label or patented-use substitution foreseeable. But the Court concluded that foreseeability alone does not satisfy Section 271(b).

    Instead, the statute requires active encouragement.

    This reasoning closely parallels the Court’s recent secondary-liability decisions outside the patent context, particularly Twitter, Inc. v. Taamneh and Cox Communications, Inc. v. Sony Music Entertainment. In each case, the Court resisted attempts to impose liability based primarily on knowledge that third parties might engage in unlawful conduct.

    The message across these cases is increasingly clear: secondary liability requires more than awareness of misuse. It requires conduct directed toward producing that misuse.

    Why Hikma’s Statements Were Insufficient

    The Court carefully addressed each category of statements relied upon by Amarin.

    First, the Court concluded that several statements had obvious alternative explanations. Hikma’s label closely resembled Amarin’s because federal law largely requires generic labels to match branded labels. Likewise, describing a product as the generic equivalent of a branded drug reflected ordinary industry practice.

    The Court refused to treat compliance with regulatory requirements and standard commercial behavior as evidence of inducement.

    Second, the Court rejected Amarin’s reliance on omissions.

    Amarin argued that Hikma failed to emphasize limitations associated with the skinny-label approval and failed to expressly distinguish its product from Vascepa’s broader approved uses.

    The Court found that argument incompatible with inducement doctrine. Citing Twitter v. Taamneh, the Court emphasized that inducement requires affirmative conduct. Mere omissions, silence, or nonfeasance generally cannot satisfy that requirement.

    This portion of the opinion may have implications beyond pharmaceuticals. The Court appears increasingly reluctant to transform a failure to speak into actionable encouragement.

    Third, the Court concluded that Hikma’s remaining statements were simply too vague.

    Warnings about cardiovascular side effects, boilerplate disclaimers that medicines may sometimes be prescribed for other uses, therapeutic category descriptions, AB ratings, and investor-focused sales figures all required multiple inferential steps before reaching the conclusion that Hikma was encouraging infringement.

    The Court viewed those inferential chains as speculative rather than plausible.

    The Court’s Treatment of Federal Circuit Precedent

    Although the opinion never expressly overrules GlaxoSmithKline v. Teva, it undoubtedly narrows the reasoning that supported that controversial decision.

    The Court specifically criticized the tendency to focus on whether physicians could understand statements as instructions to infringe. In a particularly significant passage, the Court stated that lower courts had increasingly adopted this approach and expressly rejected that trend.

    Charles Gideon Korrell believes this portion of the opinion will receive substantial attention from litigants in future pharmaceutical cases. Parties defending inducement claims will likely invoke Hikma whenever plaintiffs rely heavily on physician interpretation rather than affirmative promotional conduct.

    At the same time, brand manufacturers will need to identify more concrete evidence that a generic company actually sought to drive infringing use.

    Practical Implications for Industry

    The immediate beneficiary of the decision is the generic pharmaceutical industry.

    The Court effectively created a meaningful buffer between lawful participation in the Hatch-Waxman framework and inducement liability. Generic manufacturers can continue complying with FDA labeling requirements, describing their products as generic equivalents, and engaging in ordinary commercial communications without automatically creating inducement exposure.

    The decision does not create absolute immunity. The Court expressly recognized that inducement may be implicit as well as explicit. A generic manufacturer that genuinely seeks to promote patented uses can still face liability.

    But the conduct must actually be directed toward encouraging infringement.

    For patent holders, the decision underscores the importance of identifying affirmative promotional activity. Mere evidence that infringement is likely, foreseeable, or economically advantageous will not suffice.

    Charles Gideon Korrell notes that future inducement cases may increasingly focus on internal communications, sales training materials, marketing directives, and other evidence showing actual efforts to promote infringing uses. Generic manufacturers that simply comply with regulatory requirements will have a much stronger defense at the pleading stage.

    Looking Ahead

    Hikma represents more than a pharmaceutical patent decision. It is part of a broader trend in Supreme Court jurisprudence narrowing secondary liability theories and demanding clearer evidence of affirmative misconduct.

    Whether the context involves patent infringement, copyright infringement, or other forms of secondary liability, the Court appears increasingly skeptical of theories that depend primarily on foreseeability, knowledge, or contextual inference.

    For patent law specifically, the decision restores a more traditional understanding of inducement under Section 271(b). Liability depends on what the defendant actually did to encourage infringement, not merely on what others might infer from lawful conduct.

    Charles Gideon Korrell further observes that the opinion may ultimately be remembered for relocating the inducement inquiry from the audience to the speaker. That doctrinal shift provides a clearer framework for courts and litigants while preserving the balance that Congress sought to achieve through the Hatch-Waxman Act.

    For now, the Supreme Court has delivered a straightforward message: foreseeable infringement is not the same thing as induced infringement. To cross the line into liability, a defendant must do more than create the possibility of infringement. It must actively encourage it.

    By Charles Gideon Korrell

  • Teva v. Lilly: Federal Circuit Limits Amgen by Distinguishing Method-of-Use Claims from Composition Claims

    Teva v. Lilly: Federal Circuit Limits Amgen by Distinguishing Method-of-Use Claims from Composition Claims

    The Federal Circuit’s decision in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, Case No. 24-1094 (Fed. Cir. Apr. 16, 2026), marks one of the most important post-Amgen v. Sanofi patent decisions involving antibody claims and Section 112. In a unanimous opinion authored by Chief Judge Prost, the court reversed a district court judgment that had invalidated Teva’s migraine-treatment patents for lack of written description and enablement.

    The opinion sharply narrows the reach of Amgen in at least one important respect. According to the Federal Circuit, broad disclosure requirements that apply to genus claims directed to antibody compositions do not necessarily apply with equal force to claims directed to methods of using a known class of compounds.

    That distinction ultimately restored a jury verdict worth hundreds of millions of dollars tied to Teva’s Ajovy product and Lilly’s competing Emgality product.

    The case is particularly important for biotechnology companies developing therapeutic antibodies, as well as litigators confronting the increasingly difficult Section 112 landscape after Amgen, Baxalta, Juno, and Idenix.

    The patents at issue (U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908) concerned methods of treating headache by administering humanized anti-CGRP antagonist antibodies. Claim 30 of the ’045 patent was representative:

    “A method for reducing incidence of or treating headache in a human … wherein said anti-CGRP antagonist antibody is a … humanized monoclonal antibody.”

    The specification disclosed only one humanized anti-CGRP antagonist antibody, known as “G1,” which became the active ingredient in Ajovy. But the specification also disclosed several murine anti-CGRP antagonist antibodies and described prior-art humanization techniques.

    At trial, the jury found the asserted claims valid and willfully infringed. The district court later granted JMOL, concluding that the patents failed both written description and enablement requirements under Section 112.

    The Federal Circuit reversed.

    The “Well-Known Genus” Framework

    The core of the Federal Circuit’s reasoning was that the invention was not the antibodies themselves. Instead, the invention was the use of anti-CGRP antagonist antibodies to treat headache.

    That distinction drove nearly the entire opinion.

    The court repeatedly emphasized that anti-CGRP antagonist antibodies were already well known in the prior art. Lilly itself had argued exactly that in parallel IPR proceedings involving related patents. Lilly had previously characterized anti-CGRP antagonist antibodies as “well known,” “replete,” and “extensively described” in the art, while also acknowledging that antibody humanization was a routine procedure by the 2006 priority date.

    Those prior positions became highly significant in the district court litigation.

    The Federal Circuit relied heavily on older precedent involving claims that incorporate known classes of compounds as components of a different invention. The court discussed Ajinomoto, In re Herschler, and In re Fuetterer at length.

    In particular, the court framed the case as involving “a well-known genus used as part of a different invention.”

    That framing allowed the court to conclude that the patents did not need to disclose every species within the genus of humanized anti-CGRP antagonist antibodies. Instead, the disclosure was sufficient because:

    1. anti-CGRP antagonist antibodies were already well known,
    2. methods of making them were well known,
    3. humanization was routine, and
    4. skilled artisans would understand that all such antibodies would treat headache.

    Charles Gideon Korrell notes that this reasoning effectively creates a meaningful doctrinal distinction between patents claiming a therapeutic antibody itself and patents claiming the use of a known antibody class for a specific therapeutic purpose.

    That distinction may become increasingly important as biologics patenting strategies evolve after Amgen.

    Distinguishing Rochester and Ariad

    Lilly argued that the distinction between method claims and composition claims was merely semantic, relying heavily on University of Rochester v. Searle and Ariad v. Lilly.

    The Federal Circuit rejected that argument.

    The court explained that Rochester and Ariad involved situations where the claims effectively covered methods of achieving a biological result using unspecified compounds capable of producing that result. In those cases, the underlying compounds themselves were not adequately disclosed or known in the art.

    By contrast, Teva’s patents involved antibodies that were already known and understood. The court stated:

    “Here, in contrast, the asserted claims are not to ‘methods of antagonizing CGRP using humanized antibodies that antagonize CGRP’; they are to methods of treating headache using such antibodies—something different from the function that characterizes these antibodies.”

    That passage is likely to become one of the most cited portions of the opinion.

    The Federal Circuit effectively concluded that the downstream therapeutic application mattered. The antibodies antagonized CGRP, but the claimed invention focused on headache treatment, which the court treated as distinct from the underlying antibody function itself.

    Charles Gideon Korrell believes this portion of the opinion may significantly influence future drafting strategies for biotechnology patents. Applicants may increasingly emphasize therapeutic-use frameworks rather than attempting to secure extremely broad composition-of-matter genus claims.

    The Court’s Treatment of Structural Diversity

    Lilly also argued that the disclosed antibodies were not representative because antibodies could bind different regions of CGRP and because Lilly’s Emgality antibody differed structurally from Teva’s disclosed G1 antibody.

    The Federal Circuit rejected those arguments as well.

    The court acknowledged structural differences among antibodies but emphasized that the relevant question was whether those differences mattered for the claimed invention. Here, the evidence supported the conclusion that antibodies binding different CGRP regions still performed the claimed headache-treatment function.

    The court also declined to interpret AbbVie v. Janssen as creating a rigid rule requiring disclosure of antibodies structurally similar to the accused product in every genus-claim case.

    Instead, the Federal Circuit reiterated that representativeness depends on the context of the invention itself.

    That contextual analysis may provide biotechnology patentees with a path to defend broader claims where the claimed invention relies on a known biological platform technology.

    Enablement and the “Extra Credit” Line

    The enablement portion of the opinion may ultimately receive just as much attention as the written-description analysis.

    Lilly argued that the patents required undue experimentation because identifying all anti-CGRP antagonist antibodies would require substantial screening and testing across a potentially enormous universe of candidates.

    The Federal Circuit acknowledged that point, but reframed the inquiry.

    According to the court, the claims were not directed to the antibodies themselves. The patents only claimed using those antibodies to treat headache. Because the specification disclosed that all such antibodies worked for that purpose, the court concluded that the key “research assignment” had already been completed.

    The court then introduced perhaps the opinion’s most memorable phrase:

    “Undertaking to find or make all of them would—in the context of these claims—be more akin to extra credit than a necessary research assignment left to others to complete.”

    That language directly limits the practical scope of Amgen.

    In Amgen, the Supreme Court invalidated broad antibody genus claims because the patents effectively required others to engage in extensive trial-and-error screening to identify all antibodies falling within the claims. Here, the Federal Circuit concluded that no comparable screening burden existed because all qualifying antibodies already worked for the claimed therapeutic purpose.

    Charles Gideon Korrell observes that the opinion carefully narrows Amgen without contradicting it. Rather than retreating from the Supreme Court’s demanding enablement standards, the Federal Circuit distinguished the nature of the claims themselves.

    Interaction with IPR Positions

    One particularly notable feature of the case was the court’s repeated reliance on Lilly’s own statements from related IPR proceedings.

    In those proceedings, Lilly had argued that anti-CGRP antagonist antibodies and methods for making them were already well known in the art.

    Those statements substantially weakened Lilly’s later Section 112 arguments in district court.

    The opinion serves as another reminder that positions taken in PTAB proceedings can later influence district court litigation in unexpected ways. Arguments emphasizing how routine or well known a technology is for purposes of obviousness may later undermine written-description or enablement challenges.

    Charles Gideon Korrell notes that litigants increasingly must coordinate invalidity theories across PTAB and district court forums with extreme care, particularly in biotechnology disputes where obviousness and Section 112 arguments can create strategic tension.

    Broader Implications

    The decision provides an important roadmap for biotechnology patentees seeking to survive post-Amgen Section 112 scrutiny.

    The strongest takeaway is that courts may analyze disclosure sufficiency differently where:

    • the claimed invention uses a known genus rather than claims the genus itself,
    • the genus was already well understood in the art,
    • techniques for working with the genus were routine, and
    • the claimed invention concerns a downstream therapeutic application.

    At the same time, the opinion does not eliminate the substantial disclosure burdens imposed by Amgen, Baxalta, Juno, and Idenix. Broad composition claims directed to antibody genera themselves remain vulnerable where patents fail to adequately disclose representative species or require extensive trial-and-error experimentation.

    But Teva v. Lilly demonstrates that method-of-use claims may occupy a materially different position under Section 112 analysis.

    For biotechnology companies, that distinction could significantly shape future patent portfolio strategy.

    By Charles Gideon Korrell

  • Bayer Pharma v. Mylan Pharmaceuticals: When “Clinically Proven Effective” Cannot Rescue an Anticipated Treatment Method

    Bayer Pharma v. Mylan Pharmaceuticals: When “Clinically Proven Effective” Cannot Rescue an Anticipated Treatment Method

    The Federal Circuit’s September 23, 2025 decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., No. 23-2434, delivers a sharp reminder that post-hoc validation, even in the form of successful clinical trial results, does not automatically translate into patentability. The opinion clarifies the limits of method-of-treatment claims that attempt to rely on clinical proof language to distinguish otherwise anticipated dosing regimens, while also providing important guidance on claim construction in combination-therapy claims.

    The case arose from inter partes review proceedings challenging U.S. Patent No. 10,828,310, which describes the results of Bayer’s COMPASS Phase III clinical trial evaluating low-dose rivaroxaban in combination with aspirin to reduce major adverse cardiovascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). While the clinical trial itself was significant, the Federal Circuit emphasized that patentability must turn on what the claims require a practitioner to do, not on what later evidence proves about the outcomes.

    The court ultimately affirmed the PTAB’s unpatentability determinations for claims 1–4, vacated the unpatentability determinations for claims 5–8 based on an erroneous claim construction, and remanded for further proceedings. Along the way, the opinion addressed four recurring issues in pharmaceutical patent litigation: (1) the role of “clinically proven effective” language, (2) construction of combination-product claims, (3) motivation to combine prior art clinical disclosures, and (4) the limits of unexpected-results evidence.

    The COMPASS Claims and the Prior Art

    The ’310 patent claims methods of reducing the risk of myocardial infarction, stroke, or cardiovascular death by administering rivaroxaban at 2.5 mg twice daily together with aspirin at 75–100 mg daily. Claims 1–4 broadly recite administering those agents at the specified dosages, while claims 5–8 add a requirement that the method involve “once daily administration of a first product comprising rivaroxaban and aspirin” and “a second product comprising rivaroxaban.”

    The IPR petitions relied primarily on two references. The first was a 2016 journal article by Foley summarizing the then-ongoing COMPASS trial, including the exact dosing regimen later claimed, but without disclosing the trial’s results. The second was a 2014 article by Plosker describing the ATLAS ACS 2-TIMI 51 trial, which disclosed similar low-dose rivaroxaban plus aspirin regimens in cardiovascular patients.

    The PTAB concluded that claims 1–2 were anticipated by Foley and that claims 1–8 were obvious over Foley alone or in combination with Plosker. Bayer appealed.

    “Clinically Proven Effective” and the Functional Relationship Test

    A central dispute on appeal concerned the claim phrase “clinically proven effective.” Bayer argued that this language was limiting and required proof of efficacy through clinical trials, which Foley did not disclose. The Board had concluded that the phrase was non-limiting, or alternatively, inherently anticipated.

    The Federal Circuit sidestepped that debate entirely. Instead, it held that even if “clinically proven effective” were treated as a limiting element, it could not confer patentability because it lacked a new and unobvious functional relationship with the claimed method. Drawing heavily on King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267 (Fed. Cir. 2010), the court explained that an otherwise anticipated method cannot be rescued by adding a limitation that merely describes information about the method or its later validation.

    As the court put it, proof that a dosing regimen worked in a clinical trial “in no way transforms the process of taking the drugs” at the claimed doses and frequencies. The actual steps performed by the physician or patient remain unchanged, regardless of whether the regimen has been clinically validated. Allowing patentees to “claw back” known treatment methods from the public domain simply by pointing to later-obtained clinical success would undermine fundamental limits on patent scope.

    Charles Gideon Korrell notes that this portion of the opinion is particularly important for pharmaceutical lifecycle management strategies that rely on clinical trial milestones rather than changes to dosing, formulation, or administration. The court’s analysis reinforces that validation alone is not innovation, at least for purposes of patentability.

    Distinguishing Allergan and Open-Ended Claim Drafting

    Bayer argued that Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370 (Fed. Cir. 2019), compelled a different result. In Allergan, the court held that certain “wherein” clauses specifying minimum safety and efficacy thresholds were limiting and material to patentability.

    The Federal Circuit rejected the comparison. Unlike the open-ended composition claims in Allergan, which could encompass a wide range of formulations meeting the recited concentration requirements, the Bayer claims already fixed the precise dosages of rivaroxaban and aspirin. The “clinically proven effective” language did not further narrow the universe of covered methods. As Charles Gideon Korrell observes, the opinion underscores a drafting lesson: functional or results-based language is far more likely to matter when it genuinely constrains an otherwise open claim scope.

    Claim Construction of the “First Product”

    While Bayer lost on claims 1–4, it prevailed on an important claim construction issue affecting claims 5–8. The PTAB had construed “a first product comprising rivaroxaban and aspirin” to encompass administration of the two drugs as separate dosage forms, whether administered simultaneously or sequentially.

    The Federal Circuit disagreed. Focusing on the plain claim language, the court held that “a first product comprising rivaroxaban and aspirin” requires a single dosage form that includes both active ingredients. Interpreting the term to cover separate pills would render the “first product” language meaningless and collapse the distinction the claims draw between combination and non-combination products.

    The court also found support in the specification, which explicitly distinguishes between “separate dosage forms” and “a combination dosage form containing both rivaroxaban and aspirin.” The Board’s broader construction improperly conflated these concepts. Because the PTAB had not analyzed obviousness under the correct construction, the Federal Circuit vacated the unpatentability determinations for claims 5–8 and remanded.

    Charles Gideon Korrell believes this portion of the decision highlights how seemingly modest wording choices can drive materially different outcomes in IPR proceedings, particularly for combination-product claims in the pharmaceutical space.

    Motivation to Combine and Reasonable Expectation of Success

    Bayer also challenged the Board’s obviousness analysis for dependent claims reciting specific aspirin dosages (75 mg or 81 mg). The Federal Circuit was unpersuaded. The Board had expressly found that these dosages reflected globally available aspirin strengths and were consistent with the dosage ranges disclosed in Plosker.

    The court reiterated that motivation to combine and reasonable expectation of success are factual determinations reviewed for substantial evidence. Here, the record supported the Board’s conclusion that a skilled artisan would have had reason to substitute commonly used aspirin dosages with an expectation of success, particularly given that both references addressed reducing cardiovascular risk.

    Unexpected Results and the Nexus Requirement

    Finally, Bayer argued that the clinical proof of efficacy demonstrated by the COMPASS trial constituted unexpected results supporting nonobviousness. The Federal Circuit rejected this argument on nexus grounds.

    The Board had found, and the court agreed, that Bayer’s evidence of unexpected results was tied exclusively to the “clinically proven effective” limitation. Because that limitation was functionally unrelated to the claimed method steps and could not supply patentability, the asserted unexpected results lacked the required nexus to the merits of the claimed invention.

    As Charles Gideon Korrell notes, this analysis reinforces the principle that secondary considerations must be anchored to what is both claimed and novel. Evidence of success attributable to validation, rather than to a structural or functional distinction over the prior art, will not carry the day.

    Takeaways

    The Bayer decision offers several practical lessons. First, method-of-treatment claims cannot rely on post-hoc clinical validation to rescue known dosing regimens from anticipation or obviousness. Second, careful claim drafting around combination products matters, and courts will enforce distinctions between single-dosage-form products and loose combinations of separate components. Third, secondary considerations must be tied to claim features that actually change how the method operates.

    In short, the Federal Circuit reaffirmed that patent law rewards innovation in what practitioners do, not merely confirmation that what they were already doing turns out to work.

    By Charles Gideon Korrell

  • Acorda v. Alkermes: When Alternative Theories Shut the Federal Circuit Door

    Acorda v. Alkermes: When Alternative Theories Shut the Federal Circuit Door

    The Federal Circuit’s July 2025 decision in Acorda Therapeutics, Inc. v. Alkermes PLC, No. 2023-2374 (Fed. Cir. July 25, 2025), is the latest reminder that most “non-patent patent cases” will not make it past the courthouse steps on Madison Place. The court held that it lacked jurisdiction to review Acorda’s challenge to an international arbitration award—despite the heavy reliance on

    and related patent-law arguments—because Acorda pleaded an alternative, non-patent basis for relief. Under Gunn v. Minton, that meant the patent issue was not necessarily raised, and the appeal belonged in the Second Circuit, not the Federal Circuit.

    This result leaves some tricky questions open, especially about patent-law challenges to arbitral awards and the interaction of Brulotte with state-law doctrines like New York’s Voluntary Payment Doctrine (NYVPD). As Charles Gideon Korrell likes to remind clients, “jurisdiction is its own battlefield”—and this case proves the point with a forward-thinking flourish.

    I. Background: A Patent Expiration, Continued Royalties, and a Fight Over Refunds

    Acorda developed Ampyra®, a drug improving mobility for multiple-sclerosis patients. Alkermes owned U.S. Patent No. 5,540,938, covering the sustained-release formulation of dalfampridine, and licensed it to Acorda through a joint-venture structure later replaced with a new License and Supply Agreement. Royalties continued at 18% of net sales—10% under the License Agreement and 8% under the Supply Agreement. The patent expired in July 2018, but Acorda continued paying royalties without protest for almost two years.

    By mid-2020, after generics entered the market, Acorda reversed course. Relying on Brulotte v. Thys Co., 379 U.S. 29 (1964), and its reaffirmation in Kimble v. Marvel, 576 U.S. 446 (2015), Acorda initiated arbitration seeking (1) a declaration that post-expiration royalties were unenforceable and (2) recoupment of more than $80 million in payments made after July 2018.

    The arbitration panel agreed the contracts became unenforceable at patent expiration, but concluded that:

    • Only protested payments—those beginning in July 2020—were recoverable.
    • Payments made without protest were barred by the New York Voluntary Payment Doctrine, which prevents restitution of voluntarily made payments “with full knowledge of the facts.”
      See Dillon v. U-A Columbia Cablevision, 740 N.Y.S.2d 396 (App. Div. 2002).

    Total awarded refund: $16.55 million, not the $80+ million Acorda sought.

    Acorda sought confirmation of the parts of the award it liked and modification of the part it didn’t—arguing that the NYVPD could not override Brulotte’s federal prohibition on post-expiration royalties.

    II. The District Court: No Manifest Disregard of Patent Law

    The district court confirmed the award in full. The key move was distinguishing between:

    1. Enforceability of post-expiration royalties (addressed by Brulotte), and
    2. Remedies, specifically whether refunds were required for payments made before protest.

    The court held that:

    • Brulotte doesn’t dictate the remedy. It invalidates ongoing royalty provisions but says nothing about restitution for voluntarily paid royalties.
    • Lacking a “clearly defined” federal rule requiring refunds, the tribunal did not manifestly disregard federal law by applying NYVPD.
    • Acorda also advanced a non-patent alternative argument based on the doctrine that courts will not enforce illegal contracts (relying on Kaiser Steel Corp. v. Mullins, 455 U.S. 72 (1982)).

    That last point turned out to be the jurisdictional iceberg lurking beneath the surface—a fact Charles Gideon Korrell could see from a mile away.

    III. The Federal Circuit: No Jurisdiction Because Patent Law Was Not “Necessarily Raised”

    On appeal, Acorda argued that:

    • The Federal Circuit had jurisdiction under 28 U.S.C. § 1295(a)(1) because the petition “arose under” federal patent law.
    • The tribunal manifestly disregarded Brulotte and patent-law preemption principles.

    Alkermes countered with a simple but effective response: Acorda pleaded both a patent-law theory and a non-patent illegal-contract theory. Therefore, the patent-law issue was not “necessarily raised.”

    A. The Gunn Framework

    To qualify as arising under patent law when the cause of action itself is not a patent cause of action, Gunn v. Minton requires:

    1. A patent issue that is necessarily raised,
    2. Actually disputed,
    3. Substantial, and
    4. Capable of federal resolution without disturbing the federal–state balance.

    Failing any prong ends the inquiry.

    B. The Fatal Flaw: Acorda Gave the Court an Alternative Path

    The Federal Circuit focused only on the first prong: necessity. The court held that Acorda’s petition did not necessarily raise a patent-law issue because:

    Thus, the court lacked jurisdiction and transferred the case to the Second Circuit. No discussion of substantiality, no analysis of arbitral-award review under manifest disregard, no reach-for-the-brass-ring moment.

    As Charles Gideon Korrell puts it: “If you offer the court multiple doors, it will politely decline to enter the patent-law one.”

    IV. A Few Lingering Questions

    The decision dodges some interesting doctrinal issues—including several that practitioners hoped the Federal Circuit would address.

    1. Is Brulotte Preemption a Remedy-Shaping Doctrine?

    The tribunal concluded Brulotte invalidates the royalty obligations but does not require refund of royalties already paid. That leaves an open question:

    • Does enforcing NYVPD to deny refunds indirectly extend “patent-like protection” to an expired patent?

    Acorda argued this point vigorously. But the jurisdictional holding prevented the Federal Circuit from diving in.

    2. Does Badgerow v. Walters Limit Patent Jurisdiction Over FAA Petitions?

    The Federal Circuit noted that the petition itself—not the underlying arbitration—determines jurisdiction. Badgerow v. Walters, 596 U.S. 1 (2022), reinforces that limitation.

    Complex IP arbitrations may thus rarely land in the Federal Circuit unless the petition itself squarely invokes a patent cause of action.

    3. Does the “Manifest Disregard” Lens Distort Substantiality?

    Alkermes relied on Friedler v. Stifel, Nicolaus & Co., 108 F.4th 241 (4th Cir. 2024), where the Fourth Circuit held that deferential “manifest disregard” review makes federal issues too insubstantial for Gunn.

    The panel acknowledged the argument but, diplomatically, didn’t touch it.

    Still, Charles Gideon Korrell notes that this lurking question is not going away—especially as more IP-heavy disputes move to arbitration.

    V. Practical Takeaways for IP and Arbitration Counsel

    1. Be Careful When Pleading Alternative Theories

    If you want the Federal Circuit to hear your appeal, make sure:

    • The patent issue is unavoidable,
    • No alternative legal theory supports the same relief, and
    • The petition itself—not the arbitration demand—presents the patent question.

    2. Arbitration Panels Will Continue Applying State-Law Doctrines Unless Preemption Is Crystal-Clear

    Brulotte may invalidate post-expiration payment obligations, but restitution is another story.

    3. IP-Related Arbitration Challenges Are Likely to Stay in Regional Circuits

    Absent a patent-law cause of action under the FAA (there is none), Gunn significantly narrows the path to Federal Circuit review.

    4. The Decision Leaves Room for Future Preemption Battles

    The governance of rejected royalties post-expiration is still an unsettled frontier.

    Charles Gideon Korrell notes that practitioners should expect regional circuit splits before the Supreme Court steps in.

    VI. Conclusion

    In Acorda v. Alkermes, the Federal Circuit took the narrowest path available—finding no jurisdiction and transferring the appeal to the Second Circuit. By pleading both patent-law and non-patent theories, Acorda undermined its bid for Federal Circuit review. More importantly, the decision reinforces a growing trend: Most arbitration-related IP disputes will not be heard by the Federal Circuit unless the plaintiff makes patent law utterly unavoidable.

    Until the Supreme Court revisits Gunn or clarifies the FAA-patent-law interplay, counsel should draft with care. The courthouse you end up in may depend more on your pleading strategy than the substance of your patent arguments.

    By Charles Gideon Korrell

  • Janssen v. Teva: Federal Circuit Affirms Validity of Paliperidone Palmitate Dosing Regimen Patent

    Janssen v. Teva: Federal Circuit Affirms Validity of Paliperidone Palmitate Dosing Regimen Patent

    In a significant ruling for pharmaceutical patent litigation, the Federal Circuit in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Nos. 25-1228, 25-1252 (Fed. Cir. July 8, 2025), affirmed the district court’s determination that U.S. Patent No. 9,439,906 (“the ’906 patent”)—which claims specific dosing regimens for long-acting injectable formulations of the antipsychotic paliperidone palmitate—is not invalid for obviousness. This opinion resolves Teva’s second appeal in a protracted Hatch-Waxman dispute and clarifies the limited applicability of the presumption of obviousness based on overlapping numerical ranges.

    Charles Gideon Korrell observes that the Federal Circuit’s ruling is particularly notable for its detailed discussion of when, and under what conditions, a presumption of obviousness may apply in the pharmaceutical dosing context—a context far removed from the traditional realm of alloy compositions and manufacturing parameters where such presumptions originated.

    Background and Procedural History

    Janssen Pharmaceuticals sued Teva in 2018, asserting that Teva’s Abbreviated New Drug Application (ANDA) infringed the ’906 patent under the Hatch-Waxman Act. Teva stipulated to infringement but challenged the validity of all 21 claims on obviousness grounds, and additionally challenged claims 19–21 for indefiniteness.

    After a bench trial, the district court upheld the patent’s validity. On initial appeal, the Federal Circuit affirmed the indefiniteness ruling but remanded for reconsideration of obviousness. See Janssen Pharms. Inc. v. Teva Pharms. USA, Inc., 97 F.4th 915 (Fed. Cir. 2024). On remand, the district court again upheld the patent’s validity, and Teva appealed a second time—joined by Mylan Laboratories Ltd., which had agreed to be bound by the outcome of the Teva case.

    The ’906 Patent and the Claimed Invention

    The ’906 patent addresses the challenge of noncompliance in schizophrenia treatment due to the frequent dosing requirements of oral medications. It claims a specific regimen using long-acting injectable formulations of paliperidone palmitate, administered via intramuscular injection.

    The representative claims require:

    • A first loading dose of 150 mg-eq. on day 1 (deltoid),
    • A second loading dose of 100 mg-eq. on days 6–10 (deltoid),
    • A first maintenance dose of 25–150 mg-eq. one month later (deltoid or gluteal), and
    • Optional particle size and formulation parameters (claims 19–21).

    Teva argued these regimens were obvious in light of prior art including:

    1. The ’548 clinical trial protocol (Phase III study),
    2. Janssen’s own prior U.S. Patent No. 6,555,544,
    3. WO 2006/114384 (WO ’384), which disclosed dose volumes of 25–150 mg-eq.

    Teva’s Primary Argument: Overlapping-Range Presumption

    Teva’s central contention was that the district court erred by not applying a presumption of obviousness based on overlapping numerical ranges. Teva pointed to precedents like In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996 (Fed. Cir. 2018), to argue that the claimed 150/100 mg-eq. loading regimen was merely an optimization within known ranges.

    The Federal Circuit rejected this argument, explaining that:

    • The overlapping-range presumption applies typically in composition or process optimization scenarios.
    • The claimed regimen involved not just a range of numbers but a specific sequence of two unequal, decreasing loading doses.
    • Prior art, including the ’548 protocol, disclosed three equal loading doses—not the claimed 150 followed by 100 mg-eq.

    Because the combination of specific dosing amounts, sequence, and injection sites formed an integrated, multi-step treatment strategy, the court found the presumption inapplicable.

    As Charles Gideon Korrell explains, the court’s decision underscores that context matters: a presumption rooted in numerical overlap does not override the requirement to evaluate inventive combinations within dosing regimens, especially in the unpredictable arts of pharmacology.

    Substantive Obviousness Analysis

    Having refused to apply the presumption, the Federal Circuit reviewed the full obviousness analysis. It affirmed the district court’s findings that Teva failed to prove:

    1. Motivation to Combine: No prior art taught or suggested the use of decreasing loading doses for long-acting injectables, particularly in acutely ill patients. While Teva cited articles on haloperidol decanoate and olanzapine, those involved stabilized patients or immediate-release medications.
    2. Reasonable Expectation of Success: The prior art lacked safety or efficacy data for the claimed regimen. Testimony supported the view that dosing with two injections (150 mg-eq. followed by 100 mg-eq.) would raise concerns about accumulation and side effects.
    3. Application to Renally Impaired Patients (Claims 10 & 13): The court found insufficient motivation to adjust the prior art’s dosing for patients with mild renal impairment. Teva’s expert conceded that moderate to severe renal impairment would contraindicate use of the product entirely.
    4. Particle Size Claims (20 & 21): Because these depended on the previously upheld claims, the court summarily affirmed their validity under In re Fritch, 972 F.2d 1260 (Fed. Cir. 1992).

    Clarifying the Boundaries of Obviousness Doctrines

    This case contributes to the ongoing dialogue on the boundaries of the overlapping-range presumption. The Federal Circuit emphasized that:

    • The presumption is rooted in expectations of routine optimization, which must be supported by the record.
    • Application is limited in contexts involving complex treatment regimens, particularly where multiple variables interact in non-linear ways.
    • Courts must still apply the traditional Graham factors and cannot bypass fact-intensive analysis.

    As Charles Gideon Korrell notes, the ruling affirms that even where prior art discloses elements within claimed ranges, nuanced differences in sequence and formulation matter—especially in unpredictable arts like pharmaceuticals.

    Conclusion

    The Federal Circuit’s opinion in Janssen v. Teva provides a thoughtful reaffirmation of the evidentiary burdens facing ANDA challengers in Hatch-Waxman litigation. It clarifies the scope of the overlapping-range presumption, distinguishing optimization within compositions from integrated pharmaceutical regimens. For patent holders in the life sciences sector, the decision provides some assurance that precise treatment protocols—backed by clinical insight and carefully drafted claims—can withstand obviousness challenges even in the face of seemingly similar prior art.

    By Charles Gideon Korrell

  • Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.: Express Definitions in Patent Specs Can Limit Claim Scope

    In Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., No. 23-2357 (Fed. Cir. June 4, 2025), the Federal Circuit affirmed a claim construction that doomed Alnylam’s infringement case against Moderna’s COVID-19 vaccine. The decision reinforces the primacy of clear definitional language in a patent’s specification—even when it narrows claim scope beyond what a patentee may have intended.

    Background: The mRNA Lipid Dispute

    Alnylam sued Moderna, asserting that the SM-102 lipid in Moderna’s SPIKEVAX® vaccine infringed U.S. Patent Nos. 11,246,933 and 11,382,979. The patents concern cationic lipids used for delivering nucleic acids into cells, particularly formulations where the hydrophobic “tail” includes a “branched alkyl” group.

    The litigation hinged on the meaning of the claim term “branched alkyl.” Moderna prevailed on a noninfringement stipulation after the district court adopted a narrow construction based on a definitional sentence in the patents’ shared specification.

    The Disputed Definition

    The critical passage appeared in the “Definitions” section:

    “Unless otherwise specified, the term ‘branched alkyl’ … refer[s] to an alkyl … group in which one carbon atom in the group (1) is bound to at least three other carbon atoms and (2) is not a ring atom of a cyclic group.”

    The district court treated this as lexicography and rejected Alnylam’s attempt to use a broader “plain and ordinary meaning” interpretation. Because Moderna’s lipid did not include a carbon atom meeting the “bound to at least three other carbon atoms” requirement, the court granted judgment of noninfringement.

    Federal Circuit Analysis

    The Federal Circuit affirmed, holding that the passage was definitional under the standards set out in Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) and its progeny:

    • The term was in quotation marks, signaling definition.
    • It was introduced with “refer to,” which courts have consistently viewed as definitional (ParkerVision, Inc. v. Vidal, 88 F.4th 969 (Fed. Cir. 2023)).
    • It was placed in a section titled “Definitions,” supporting the lexicographic reading.
    • The specification used permissive phrasing elsewhere (“e.g.,” “include”), contrasting with the precise language used for “branched alkyl.”

    The panel also rejected Alnylam’s fallback argument that its claims fell under the “unless otherwise specified” exception. The court held that this clause required a clear, specific departure—and nothing in the claims, specification, or prosecution history met that bar. References to secondary carbon structures in dependent claims and the prosecution record did not rise to the level of an explicit override of the express definition.

    Key Cases Cited

    Takeaway

    This case is a strong reminder that express definitions in a patent’s specification—especially when found in a “Definitions” section and marked with formal language—will bind the claim scope unless there is a clear and unmistakable reason to depart. Practitioners should be cautious with language like “unless otherwise specified” unless they can point to explicit exceptions elsewhere in the specification or prosecution history. Ambiguities or broader examples won’t suffice to override precise definitions.

    By Charles Gideon Korrell

  • Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reverses Preliminary Injunction for Lack of Irreparable Harm

    Incyte Corp. v. Sun Pharmaceutical Industries: Federal Circuit Reverses Preliminary Injunction for Lack of Irreparable Harm

    In a follow-on decision reinforcing its earlier order, the Federal Circuit in Incyte Corp. v. Sun Pharmaceutical Industries, Ltd., reversed a preliminary injunction granted by the U.S. District Court for the District of New Jersey. The district court had enjoined Sun from launching its FDA-approved drug Leqselvi, a deuterated version of ruxolitinib for treating alopecia areata (AA), based on Incyte’s assertion of U.S. Patent No. 9,662,335. The Federal Circuit found that Incyte failed to establish irreparable harm—a required element for injunctive relief under Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008)—rendering the injunction improper.

    Background

    Incyte’s ’335 patent covers deuterated ruxolitinib compounds, and the dispute arose after Sun secured FDA approval in July 2024 to market Leqselvi for AA. Incyte, which is still in early development stages for a topical version of the drug, moved to preliminarily enjoin Sun. The district court granted the motion, primarily crediting Incyte’s argument that Sun’s launch would grant it a “head start” and erode Incyte’s competitive position before its own product could reach the market.

    The Federal Circuit’s Analysis

    Writing for the panel, Chief Judge Moore found the district court’s irreparable harm analysis clearly erroneous. The court underscored that preliminary injunctions require a showing that harm is likely absent an injunction, not merely speculative or inevitable.

    While the Federal Circuit recognized that in some cases a first-mover advantage and loss of “sticky” customer relationships may constitute irreparable harm (Bio-Rad Labs., Inc. v. 10X Genomics Inc., 967 F.3d 1353 (Fed. Cir. 2020); Natera, Inc. v. NeoGenomics Labs., Inc., 106 F.4th 1369 (Fed. Cir. 2024)), the facts here were materially different. Unlike Natera, where the injunction prevented immediate entry and preserved the patentee’s imminent market position, Incyte’s product is still years away from launch—even under its most optimistic development timeline—and certainly after the ’335 patent’s expiration in December 2026.

    This distinction proved fatal to Incyte’s argument. As the court explained, “[b]ecause Incyte cannot enjoin Sun from launching after its ’335 patent expires, Sun’s multi-year head start is inevitable regardless of any injunction.” Thus, any advantage Sun might gain from launching before Incyte was not attributable to the absence of an injunction, but to the natural expiration of the patent.

    Comparison to Earlier Decision

    This ruling builds on the court’s prior order on April 9, 2025, vacating the injunction without a full opinion. Both decisions underscore a consistent message: patent holders must offer concrete, non-speculative proof of irreparable harm that an injunction can actually prevent. A delay in entry that would happen regardless of judicial intervention—because of patent expiration or the plaintiff’s own development delays—does not suffice.

    Key Takeaways

    1. Inevitable Market Entry Is Not Irreparable Harm: When a competitor’s entry into the market is inevitable post-patent expiration, courts will be reluctant to find that harm from early entry is “irreparable.”
    2. Development Timelines Matter: A patent holder that is years away from commercial launch faces a high hurdle in arguing that it will suffer imminent harm absent an injunction.
    3. First-Mover Advantage Is Contextual: While first-mover advantage can support injunctive relief, it must be tethered to a plausible timeline and preventable disruption.

    This decision reflects the Federal Circuit’s increasing scrutiny of the evidentiary basis for irreparable harm, particularly in the pharmaceutical and biotech space. Litigants seeking preliminary injunctions would be wise to present a realistic commercial timeline and show how the injunction meaningfully alters competitive dynamics within the remaining life of the patent.

    By Charles Gideon Korrell

  • Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals: Clarifying the Limits of Injunctive Relief Under the Hatch-Waxman Safe Harbor

    In the recent Federal Circuit decision Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, the court provided critical guidance on the limits of injunctive relief relating to FDA submissions and clinical trials under the Hatch-Waxman Act.

    Background and Procedural History

    Jazz Pharmaceuticals manufactures Xywav®, currently the only FDA-approved drug for treating idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals sought approval of its competing product, Lumryz, for narcolepsy and IH through a paper New Drug Application (NDA) relying partly on data associated with Jazz’s Xyrem®.

    Jazz’s patent infringement lawsuit initially relied on 35 U.S.C. § 271(e)(2), claiming Avadel’s FDA submission infringed its later-issued patent, the ’782 patent. The district court permanently enjoined Avadel from applying for FDA approval or marketing Lumryz for IH, initiating new clinical trials, and offering open-label extensions (OLE) in clinical studies.

    Federal Circuit’s Analysis and Key Holdings

    The Federal Circuit addressed each aspect of the district court’s injunction separately:

    1. Initiating New Clinical Trials: The court unequivocally reversed this portion of the injunction, emphasizing that the Hatch-Waxman safe harbor (§ 271(e)(1)) expressly protects activities solely related to FDA submissions. The court noted that such experimental activities do not constitute infringement and that § 271(e)(3) explicitly bars injunctive relief against these safe-harbor activities. The panel emphasized that no factual development was required here, given the purely legal nature of Avadel’s challenge to this aspect of the injunction.
    2. Offering Open-Label Extensions (OLE): Similarly, the injunction prohibiting Avadel from offering OLE periods to clinical trial participants was reversed. The Federal Circuit clarified that this activity had not been adjudicated to fall outside the protection of the safe harbor, and thus, prematurely enjoining it exceeded statutory limits.
    3. Applying for FDA Approval for New Indications: The court vacated and remanded the injunction barring FDA submissions for new Lumryz indications. While acknowledging FDA submissions themselves do not infringe under § 271(a), the court explored the nuance of artificial infringement under § 271(e)(2). The decision identified unresolved legal questions about whether submitting a paper NDA for a non-Orange Book listed patent constitutes artificial infringement, directing the district court to examine this issue on remand. The Federal Circuit underscored that even if not infringement, an injunction against submitting FDA applications could only stand if clearly necessary to prevent actual infringement—an analysis the lower court had not sufficiently articulated.

    Implications for Patent Litigation and FDA Regulatory Submissions

    This ruling highlights the judicial restraint required in granting injunctions in pharmaceutical patent cases, especially concerning activities explicitly shielded under Hatch-Waxman’s safe harbor provisions. Companies engaged in FDA-related drug development activities can rely on clearer boundaries protecting their clinical research endeavors. Furthermore, the decision signals to district courts that injunctive relief must directly correspond to actual or likely infringing activities and be clearly supported by detailed factual and legal analysis.

    The remand provides further opportunity for nuanced interpretation and application of the Hatch-Waxman Act, particularly regarding the interplay between FDA regulatory submissions and patent infringement litigation, setting important precedent for future cases.

    By Charles Gideon Korrell

  • Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    Regeneron v. Amgen: Patent Infringement and Biologic Formulations

    On March 14, 2025, the United States Court of Appeals for the Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., affirming the district court’s denial of a preliminary injunction sought by Regeneron. This ruling is significant in the realm of the biologic pharmaceutical industry, as it centers on claim construction and the principles governing patent infringement.

    Background of the Case

    Regeneron sued Amgen, alleging that Amgen’s biosimilar product, ABP 938 (Pavblu), infringed its U.S. Patent 11,084,865 (the ’865 patent). This patent claims a pharmaceutical formulation for an ophthalmic drug, Eylea, which contains a vascular endothelial growth factor (VEGF) antagonist, a buffer, an organic co-solvent, and a stabilizing agent.

    Amgen developed ABP 938 as a biosimilar to Eylea but with a key difference: it eliminated the need for a separate buffer component by utilizing a self-buffering VEGF antagonist. Regeneron argued that Amgen’s formulation still fell within the scope of its patent, while Amgen maintained that its approach did not infringe because it lacked a distinct buffer component.

    Key Legal Issues

    The central legal question in this case revolved around claim construction—specifically, whether the language of the ’865 patent required the VEGF antagonist and the buffer to be separate components. The court’s analysis focused on the following issues:

    1. Claim Construction and the Becton Doctrine

    The court applied the principle established in Becton, Dickinson & Co. v. Tyco Healthcare Grp., which states that where a patent claim lists components separately, there is a presumption that they are distinct. Since the ’865 patent separately lists the VEGF antagonist and the buffer, the Federal Circuit found that the presumption of distinctness applied.

    Regeneron argued that the buffer requirement could be satisfied by the VEGF antagonist itself, given its buffering capacity. However, the court rejected this argument, emphasizing that the claim structure and specification reinforced the requirement that the buffer must be a separate component.

    2. The Role of Intrinsic and Extrinsic Evidence

    The court reviewed both intrinsic evidence (the patent claims and specification) and extrinsic evidence (expert testimony and scientific literature) to determine the meaning of the disputed claim terms. The specification described formulations where a VEGF antagonist was always accompanied by a separate buffer. Moreover, the examples and embodiments consistently treated the buffer as a distinct component.

    While Regeneron presented extrinsic evidence suggesting that proteins like aflibercept could function as buffers, the court found this insufficient to override the intrinsic evidence. The ruling underscored the principle that claim construction must align with the patent’s written description rather than rely on broad interpretations supported by external sources.

    3. Implications for Biosimilar Litigation

    A key takeaway from this case is how courts interpret claims involving biosimilars. The ruling reinforces that companies developing biosimilars can avoid infringement if they modify formulations in a way that eliminates explicitly claimed components. Amgen’s strategy of using a self-buffering formulation proved successful in distinguishing ABP 938 from Eylea in a legally meaningful way.

    Conclusion

    The Federal Circuit’s decision in Regeneron v. Amgen sets an important precedent for biologic patent disputes. It highlights the significance of precise claim drafting and underscores the challenges in asserting broad interpretations of patent scope. For companies engaged in biosimilar development, this ruling provides a roadmap for designing around existing patents by focusing on structural distinctions in formulation components.

    This case serves as a reminder that in patent litigation, the wording of claims and the clarity of specifications are critical. While Regeneron’s patent remains valid, its enforceability against biosimilars like Amgen’s ABP 938 has been significantly weakened. As the biosimilar market continues to grow, expect more litigation focused on claim construction and the interpretation of formulation patents.

    By Charles Gideon Korrell

  • Patent Law and Drug Innovation: Federal Circuit Upholds Rejection of ImmunoGen’s Patent Application

    On March 6, 2025, the Federal Circuit issued its opinion in ImmunoGen, Inc. v. Stewart, affirming the district court’s ruling that denied ImmunoGen’s patent application for a dosing regimen of its antibody drug conjugate (ADC), IMGN853. The court’s decision, rooted in key principles of intellectual property law, particularly focused on the doctrines of indefiniteness and obviousness. This case highlights ongoing challenges in securing patents for pharmaceutical dosing regimens and underscores the high bar for patentability in the biotechnology sector.

    Background of the Case

    ImmunoGen sought a patent for a specific dosing regimen of IMGN853, a drug used to treat ovarian and peritoneal cancers. The key claim at issue involved administering IMGN853 at a dose of 6 milligrams per kilogram (mg/kg) of adjusted ideal body weight (AIBW). The U.S. Patent and Trademark Office (USPTO) rejected the application, a decision that was subsequently affirmed by the Patent Trial and Appeal Board (PTAB). ImmunoGen then pursued relief in the Eastern District of Virginia under 35 U.S.C. § 145, which allows applicants to challenge USPTO decisions in district court.

    Following a bench trial, the district court ruled against ImmunoGen, determining that the claimed invention was fatally indefinite, obvious in light of prior art, and unpatentable under the doctrine of obviousness-type double patenting. ImmunoGen appealed to the Federal Circuit, which affirmed the lower court’s ruling based on obviousness.

    Key Legal Issues

    1. Obviousness Under 35 U.S.C. § 103

    The Federal Circuit upheld the rejection of ImmunoGen’s patent claims on the grounds that they were obvious in light of prior art. The court applied the well-established Graham v. John Deere Co. framework, which requires assessing:

    • The scope and content of the prior art
    • Differences between the prior art and the claims at issue
    • The level of ordinary skill in the art
    • Any secondary considerations (such as commercial success or unexpected results)

    The court found that a person of ordinary skill in the art would have been motivated to try the claimed dosing regimen based on existing knowledge of ocular toxicity risks associated with ADCs, prior dosing methodologies, and available clinical data. The decision emphasized that AIBW was a known dosing methodology in the prior art, and adjusting dosage to reduce toxicity was a routine optimization.

    2. The Role of Prior Art in Determining Obviousness

    The court found that:

    • Existing literature disclosed IMGN853 and its dosing regimens based on total body weight (TBW).
    • Previous studies had explored adjusted dosing strategies (including AIBW) to reduce toxicity in related drug classes.
    • A person of ordinary skill in the art would have been able to transition from TBW to AIBW dosing as an obvious variation, especially since AIBW dosing had been previously used to reduce ocular toxicity for other drugs.

    Ultimately, because the claimed dose of 6 mg/kg AIBW was within the range of known effective doses, the court determined that the invention was a predictable result of routine experimentation rather than an unexpected innovation.

    3. Indefiniteness Under 35 U.S.C. § 112

    While the Federal Circuit did not rule on indefiniteness, the district court’s decision noted that the application failed to define AIBW adequately, leaving ambiguity in the claim’s scope. Courts require patent claims to be sufficiently clear so that a person of ordinary skill in the art can ascertain the precise bounds of the invention.

    The district court found that multiple formulas for AIBW existed, creating uncertainty about which formula applied to ImmunoGen’s claims. This contributed to the court’s ruling that the patent claims were fatally indefinite, making them unenforceable.

    4. Obviousness-Type Double Patenting

    The government also argued that the claims were unpatentable under the doctrine of obviousness-type double patenting, which prevents an inventor from obtaining multiple patents on obvious variations of the same invention. The district court found that ImmunoGen’s claims were largely duplicative of its previous patents, reinforcing the determination of obviousness. However, on appeal, both parties agreed that the double patenting issue rose and fell with the obviousness analysis, making further discussion unnecessary.

    Implications for the Biotechnology and Pharmaceutical Industries

    This decision underscores the high threshold for patentability in pharmaceutical dosing regimens. Courts have consistently ruled that dosing adjustments—particularly those based on well-known methodologies—are often seen as routine optimizations rather than true inventions. This presents significant challenges for drug developers seeking patent protection for new dosing strategies.

    Key takeaways from this case include:

    • Drug manufacturers must provide clear evidence of unexpected results to differentiate dosing regimen patents from routine experimentation.
    • Precision in claim drafting is critical to avoid indefiniteness challenges.
    • Applicants should consider alternative strategies, such as method-of-use claims tied to specific patient populations or therapeutic effects, to enhance patentability.

    Conclusion

    The Federal Circuit’s ruling in ImmunoGen, Inc. v. Stewart reinforces longstanding principles in patent law regarding obviousness and claim definiteness. While pharmaceutical innovators continue to seek patent protection for dosing regimens, this case demonstrates the difficulties of overcoming obviousness rejections, particularly where prior art provides clear guidance on dosage adjustments. Moving forward, companies seeking similar patents will need to present strong, non-obvious justifications to withstand legal scrutiny and secure valuable intellectual property protections.

    By Charles Gideon Korrell