Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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USPTO Fee Changes for 2025

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The <a href="https://www.congress.gov/118/bills/s150/BILLS-118s150es.pdf" target="_blank">Affordable Prescriptions for Patients Act (APPA) of 2023</a> unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would revise certain provisions of 35 U.S.C. § 271(e) to limit the number of patents a drug manufacturer can assert in a patent infringement lawsuit against biosimilars and generics companies. Specifically, the revisions to § 271(e) state that a drug manufacturer may assert no more than 20 patents in an infringement action and that no more than 10 of the 20 patents shall have been newly issued or licensed to the drug manufacturer, as defined by section 351(l)(1)7(A) of the Public Health Service (PHS) Act.The limit on the number of patents that can be asserted may be increased (i) if the drug manufacturer makes a request without undue delay and (ii) if the interest of justice so requires or for good cause shown. Good cause will be established if the biosimilars or generics drug company fails to provide information that would enable a drug manufacturer to form a reasonable belief that a claim of infringement could reasonably be asserted. Good cause may be established if there is a material change to the biological product or process with respect to the biological product by the biosimilars or generics company, if there is a delay by the USPTO in issuing the patent of the drug manufacturer, or for another reason the court deems appropriate.More recently, companion bill H.R. 9070, titled Affordable Prescriptions for Patients Act (APPA) of 2024, was introduced to the House on July 18, 2024 by U.S. Representatives Darrell Issa (R-Calif.) and Hank Johnson (D-Ga.).Whether the bill passes the House of Representatives remains to be seen. Should the bill pass, the impact on biosimilar litigation is hard to predict. While there have been cases in which more than 20 patents are asserted, including litigations regarding Humira, in other litigations the patents at issue have not exceeded 20.Subscribe to the MoFo Life Sciences blog to stay up to date on legislative changes affecting biotechnology and pharmaceutical companies.

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

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Associate

Dr. Paige Chandler focuses her practice on patent drafting and prosecution and IP due diligence, with an emphasis on biomedical physiology.

Paige N. Chandler Ph.D.

Paige Chandler

Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes.

Matthew Chivvis

Matthew A. Chivvis

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Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

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The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. 

On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in <a href="https://www.bing.com/ck/a?!&&p=5fe7fbcfa8dbe8bdJmltdHM9MTcyMzU5MzYwMCZpZ3VpZD0wOTdiNTBhYS0wMTY4LTY2MDYtMjJhYi00NGU3MDBkMjY3NmQmaW5zaWQ9NTE5Nw&ptn=3&ver=2&hsh=3&fclid=097b50aa-0168-6606-22ab-44e700d2676d&psq=Allergan+USA%2c+Inc.+v.+MSN+Laboratories+Private+Ltd.%2c+No.+24-1061+(Fed.+Cir.+2024)&u=a1aHR0cHM6Ly9jYWZjLnVzY291cnRzLmdvdi9vcGluaW9ucy1vcmRlcnMvMjQtMTA2MS5PUElOSU9OLjgtMTMtMjAyNF8yMzY2MDc0LnBkZg&ntb=1">Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024)</a> clarifying the scope of obviousness-type double patenting (ODP) in the aftermath of its In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023) decision last year.In a potentially significant win for patentees, the Federal Circuit in Allergan held that “a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.” This represented a reversal of the district court’s determination that claim 40 of the ’356 patent at issue was invalid under the doctrine of ODP over claim 33 of the ’011 patent and claim 5 of the ’709 patent. The relationship among these patents is depicted in the following figure from the decision. The first filed ’356 patent has a longer patent term due to grant of patent term adjustment (PTA) due to delays caused by the U.S. Patent and Trademark Office (USPTO) during prosecution.  <div data-reactroot=""><img class="rich-text-embed-image" alt="Expiration graphic" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc446430cde1004b1/66be59411257f55a24b40b44/expiration-without-pta.jpg?format=auto&amp;quality=60"/></div>The district court considered the “first-filed, first-issued” distinction of the ’356 patent at issue to be “immaterial” and, instead, focused only on the patent expiration dates for its ODP analysis based on its reading of In re Cellect, which held that “ODP for a patent that has received PTA, regardless [of] whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added.”The Federal Circuit, however, noted that the district court’s reading of In re Cellect was incorrect since the holding of In re Cellect “answered a different question than that at issue here.” The Federal Circuit explained that “[In re] Cellect does not address, let alone resolve, any variation of the question presented here—namely, under what circumstances can a claim properly serve as an ODP reference—and therefore has little to say on the precise issue before us.” Rather, the Federal Circuit noted that its holding in In re Cellect “is only controlling in this case to the extent that it requires us to consider, in our ODP analysis, the ’356 patent’s June 24, 2026 expiration date (i.e., the expiration date after the addition of PTA), not the March 24, 2025 expiration date that it would have shared with the ’011 and ’709 reference patents in the absence of a PTA award.” The Federal Circuit further explained that its holding “is the only conclusion consistent with the purpose of the ODP doctrine, which is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.”The Federal Circuit clarified that “the fact that the ’356 patent expires later is of no consequence here because it is not a ‘second, later expiring patent for the same invention” and that “[a]s the first-filed, first-issued patent in its family, [the ’356 patent] is the patent that sets the maximum period of exclusivity for the claimed subject matter and any patentably indistinct variants.”This decision clarifies the scope of the doctrine of ODP following last year’s In re Cellect decision by establishing that the filing and issuance dates of a patent are relevant to an ODP analysis. This decision also clarifies that applicants are entitled to PTA caused by delays of the USPTO during prosecution of a first-filed patent application, no matter when the first patent issues or how long the PTA extends the life of the patent. This decision is important because, as recognized by the Federal Circuit, a first-filed application often requires “greater time and effort by the applicant and examiner alike” and, thus, is often awarded PTA; whereas, a later-filed continuing application “proceeds much more efficiently through prosecution” and, thus, is more likely to receive little or no award of PTA. Accordingly, this decision removes the risk of invalidation by ODP over a later-filed, later-issued, earlier-expiring reference claim having a common priority date.

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Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

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Federal Circuit Clarifies Scope of Obviousness-type Double Patenting in Allergan Usa V. Msn Laboratories

On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action. This follows from a string of other recent Notices where the USPTO is seeking public input on other areas of patent law, including a recent Notice of Proposed Rulemaking on Terminal Disclaimer practice.The USPTO explained that the current experimental use exception is a common law exception that was created to prevent punishing someone who infringes a patent “merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the [invention] to produce its desired effects.” This led to the availability of the experimental use exception based on whether the alleged infringement involved profit-making or other commercial purposes. The USPTO describes the current state of the experimental use exception as being a “very narrow and strictly limited experimental use defense.”The USPTO’s request for public input on the “narrow” experimental use exception appears to stem, at least in part, from divergent views of the exception and its narrow breadth. The USPTO explains that some argue that “a narrow exception enhances innovation by rewarding innovators with robust patent rights, while others noted that restricting researcher access to patented technologies would impede innovation.”This is not the first time there has been discussion of codifying the common law experimental use exception. Unsuccessful attempts at enacting legislation to codify the exception occurred in Acts proposed in 1990 and again in 2002. This stands in contrast to many foreign jurisdictions where statutory experimental use exceptions have been enacted, including jurisdictions where life sciences research and development are robust. This includes European countries, such as Germany, the UK, France, Spain, Italy, Switzerland, and the Netherlands, Asian countries, such as Japan and China, and countries across the Americas, such as Canada and many Latin America jurisdictions, including Brazil.A limited type of experimental use exception has, however, been codified in the U.S. in the Hatch-Waxman Act as 35 U.S.C. § 271(e), which is commonly referred to as the “safe harbor” exception rather than the experimental use exception. Section 271(e) provides that making, using, offering to sell, or selling certain patented inventions “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products” shall not be considered an act of infringement. This “safe harbor” provision allows, for instance, a company to perform the testing required to obtain regulatory approval of a generic drug product without having to first wait for the patents covering the drug product to expire, thereby accelerating the timeline by which generic drug products can reach the market. Although certain acts can be shielded from liability for patent infringement under the § 271(e) exception where there is regulatory intent, the scope of the exception is ever evolving.The USPTO will be accepting public comments over the next 90 days relating to the experimental use exception.While the USPTO welcomes comments on any issues relating to the experimental use exception and its potential codification, they are particularly seeking out comments relating to the following issues:<ol><li>Please explain how the current state of U.S. experimental use exception jurisprudence impacts investment and/or research and development in any field of technology, including, but not limited to: (a) quantum computing; (b) artificial intelligence; (c) other computer-related inventions; (d) agriculture; (e) life sciences (including prescription drugs and medical devices); and (f) climate-mitigation technologies.</li><li>Do you believe there are any technologies that are negatively affected by the current state of experimental use exception jurisprudence in the United States? If yes, please identify which technologies and explain how you believe they are affected.</li><li>Please explain what impact, if any, a statutory experimental use exception would have on the innovation and commercialization of new technologies, including with respect to: (a) research and development; (b) ability to obtain funding; (c) investment strategy; (d) licensing of patents and patent applications; (e) product development; (f) sales, including downstream and upstream sales; (g) competition; and (h) patent enforcement and litigation.</li><li>Has the current state of experimental use exception jurisprudence impacted decisions you have made with respect to filing, purchasing, licensing, selling, or maintaining patent applications and patents in the United States? If yes, please explain how.</li><li>Please explain whether you believe the United States should adopt a statutory experimental use exception. In doing so, please identify your reasons, including by providing evidence and data to support your views.</li><li>Please explain how a statutory experimental use exception, if any, should be defined. Please include specific limitations and restrictions you believe would be needed to ensure that patent rights are preserved.</li><li>Please identify public policy reasons in support of maintaining the status quo or changing the experimental use exception in the United States.</li><li>Please provide any additional recommendations on how best to enhance and facilitate experimental research on patented inventions in the United States.</li></ol>

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On June 28, 2024, the United States Patent and Trademark Office (USPTO) issued a Notice requesting public comments on the current state of the common law experimental use exception to patent infringement and whether Congress should consider codifying the experimental use exception through legislative action.

USPTO Seeks Input on Experimental Use Exception to Patent Infringement and Possible Legislative Action

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. Disclosure of a protocol summary of the human clinical trial to the National Institutes of Health (“NIH”) is federally mandated.[1] The NIH, in turn, must report information about the study publicly on <a href="https://clinicaltrials.gov/" target="_blank">ClinicalTrials.gov</a>.[2] The Federal Food, Drug, and Cosmetic Act labels failing to timely submit clinical study information to the NIH as a “prohibited act” that carries criminal and potential civil liability.[3]Innovators may face challenges when attempting to comply with these government-mandated disclosure requirements and with the rules and regulations of U.S. patent law. For example, the mandated ClinicalTrials.gov disclosures are published and publicly accessible. The America Invents Act (“AIA”) 35 U.S.C. § 102(b)(1) provides a one-year grace period after a first inventor-originated disclosure of an invention within which the inventor or assignee may file a patent application that disqualifies the disclosure as prior art.[4] However, most clinical studies take much longer than a year to complete,[5] and as such, postings on ClinicalTrials.gov frequently fall outside of the one-year grace period time frame. Not only may clinical trial disclosures be considered during prosecution, but challengers have also relied on such disclosures as art during litigation and in post-grant proceedings, including inter partes reviews (“IPRs”) before the Patent Trial and Appeal Board (“PTAB”).A recent decision from the United States Court of Appeals for the Federal Circuit demonstrates just that. On April 11, 2024, the Federal Circuit issued a precedential decision in Salix Pharms., Ltd. v. Norwich Pharms. Inc.,[6] affirming the United States District Court for the District of Delaware’s final judgment[7] that several pharmaceutical method of treatment claims for rifaximin are invalid as obvious over a clinical study protocol published on ClinicalTrials.gov in combination with another reference. Rifaximin is the active ingredient in the commercial product Xifaxan® owned by Salix Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc., Bausch Health Ireland Ltd., and Alfasigma S.P.A. (collectively, “Salix”).BackgroundRifaximin has been widely used as an antibiotic for decades.  The U.S. Food and Drug Administration (“FDA”) approved 200 mg tablets of Xifaxan® in 2004 for the treatment of travelers’ diarrhea, 550 mg tablets of Xifaxan® in 2010 for hepatic encephalopathy (“HE”), and 550 mg tablets of Xifaxan® in 2015 for irritable bowel syndrome with diarrhea (“IBS-D”).[8]Norwich Pharmaceuticals Inc. (“Norwich”) submitted an Abbreviated New Drug Application (“ANDA”) to the FDA in 2019 for approval to market a generic 550 mg tablet version of Xifaxan® for reducing HE recurrence.United States District Court for the District of DelawareSalix sued Norwich for infringement of twenty-six patents covering Salix’s Xifaxan® 550 mg tablets that were narrowed to the following three groups prior to trial:<ul><li>Group 1:  U.S. Patents 8,624,573; 9,421,195; and 10,335,397, directed to methods of treating HE (“the HE patents”);</li><li>Group 2:  U.S. Patents 8,309,569 (“U.S. Pat. No. ’569”) and 10,765,667 (“U.S. Pat. No. ’667”), directed to methods of treating IBS-D by administering 550 mg rifaximin three times a day (1,650 mg/day) for 14 days (“the IBS-D patents”); and</li><li>Group 3:  U.S. Patents 7,612,199 and 7,902,206, directed to rifaximin form β (“the polymorph patents”).</li></ul>Norwich countered that the asserted patents were invalid as obvious.This article focuses on the IBS-D patents, of which the challenged IBS-D claims include claim 2 of U.S. Pat. No. ’569[9] and claim 3 of U.S. Pat. No. ’667.[10]Following a bench trial, the district court held that the challenged IBS-D claims were obvious over: (1) a trial protocol published on ClinicalTrials.gov (“the Protocol”)[11] in combination with (2) a scientific journal article (“Pimentel”).[12]The Protocol outlined a Phase II clinical trial to evaluate the dose-response relationship of placebo administered for 28 days and rifaximin administered at various doses for a period of 14 days,[13] including “twice-daily doses of 550 mg (1,100 mg/day) and 1,100 mg (2,200 mg/day) for 14 and 28 days for the treatment of IBS[-]D.”[14] The Protocol also included the outcome measures of providing adequate relief of symptoms and evaluating a durability of response over a 12-week post-treatment period.[15] However, the Protocol does not disclose the 1,650 mg/day dose, thrice-daily dosing of the challenged IBS-D claims, or any outcome measures.Pimentel discloses administration of 400 mg of rifaximin three times daily (i.e., 1,200 mg/day total) to treat IBS patients aged 18-65,[16] and explains that the “optimal dosage of rifaximin may, in fact, be higher than that used in our study.”[17] <table><tbody><tr><td> </td><td>Total amount of rifaximin</td><td>Condition</td><td>Subject</td><td>Time period</td></tr><tr><td>Claim 2 of U.S. Pat. No. ’569 </td><td>1,650 mg (administered as 550 mg three times per day)</td><td>IBS-D</td><td> </td><td>14 days</td></tr><tr><td>Claim 3 of U.S. Pat. No. ’667</td><td>1,650 mg (administered as 550 mg three times per day)</td><td>IBS-D</td><td>Subject is 65 years of age or older</td><td>14 days</td></tr><tr><td>The Protocol</td><td>1,100 mg (administered as 550 mg two times per day) 2,200 mg (administered as 1,100 mg two times per day)</td><td>IBS-D</td><td> </td><td>14 days and 28 days</td></tr><tr><td>Pimentel</td><td>1,200 mg (administered as 400 mg three times per day)</td><td>IBS</td><td>Subject is 18-65 years of age</td><td>10 days</td></tr></tbody></table>The court held that the challenged IBS-D claims were obvious over the Protocol in combination with Pimentel. In coming to this conclusion, the court explained that “Pimentel [] reported sustained improvement in IBS symptoms for patients aged 18-65 for at least 10 weeks on a 400 mg TID [times a day], 10-day regimen [and the] Protocol included no upper age limit, a 14-day dosing regimen of 550 to 2200 mg per day, and the treatment of patients with IBS-D in particular.”[18] Rifaximin had been shown to be effective in treating IBS in Pimentel and IBS-D in the Protocol.  The court found that a person having ordinary skill in the art would have had the motivation to select an optimal dosing regimen from within the known range,[19] because “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation.”[20]Salix appealed.United States Court of Appeals for the Federal Circuit<h5>Majority</h5>Salix did not dispute the district court’s finding that the combination of the Protocol and Pimentel “disclose all limitations of the IBS-D claims.”[21]  Instead, Salix argued that even if the asserted combination of references effectively disclosed the claimed 1,650 mg/day dosage, there was insufficient evidence to support a finding of a reasonable expectation of success in using that particular dosage amount.  According to Salix, “the highest prior art dosage amount that could have been supported with a reasonable expectation of success was the 1,200 mg/day dose evaluated by Pimentel.”[22]In being “hesitant to conclude as a general matter that the disclosure of a Phase II clinical trial plan, standing alone, provides an expectation of success sufficient to render obvious a dosage that was not included within the planned clinical trial,”[23] the Federal Circuit explained that the Protocol was not asserted alone—it was asserted in combination with Pimentel.The Federal Circuit has previously held that where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious, provided there is also a reasonable expectation of success.[24]  Further, conclusive proof of efficacy is not required to show a reasonable expectation of success, but at least some degree of predictability is required.[25]According to the Federal Circuit, a person having ordinary skill in the art “would have looked to both [Protocol and Pimentel], considered their limits, and had a reasonable expectation of success as to the efficacy of 550 mg TID dosing,”[26] and there would have been a reasonable expectation of success in administering higher doses of rifaximin without an intolerable increase in negative side effects.The Federal Circuit majority affirmed the district court’s decision, noting that disclosure of a clinical trial plan is likely insufficient alone to render obvious a dosage that was not included within the planned clinical trial, absent a showing of a reasonable expectation of success. However, a clinical trial plan, combined with another prior art reference, may tip the scale into a finding of obviousness if the additional reference demonstrates a reasonable expectation of success regarding the claimed dosage.<h5>References</h5>[1] See U.S. Public Law 110-85 (FDA Amendments Act of 2007 (“FDAAA”), Title VIII, Section 801) (which expanded the legal registration requirement for sponsors responsible for clinical trials of FDA-regulated drugs and biologics to register their studies to ClinicalTrials.gov).[2] ClinicalTrials.gov is a registry of clinical trials managed by the United States National Library of Medicine at the NIH. [3] See 21 U.S.C. § 331(jj), 21 U.S.C. § 333(a)(1), and 21 U.S.C. § 333(f)(3)(A)&(B).  See also FDA, Civil Monetary Penalties Relating to ClinicalTrials.gov DataBank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (Aug. 20, 2020), perma.cc/SV5N-3JUF.[4] See 35 U.S.C. § 102(b)(1).[5] See FDA, Step 3: Clinical Research (Jan. 4, 2018), perma.cc/23ZD-H6FN.[6] Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024).[7] See Salix Pharms., Ltd. v. Norwich Pharms., Inc., No. 20-cv-430, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (“Decision”).[8] See Decision, 2022 WL 3225381, at *1.[9] Claim 2 of U.S. Pat. No. ’569 is a dependent claim that includes two elements:  (1) administering 1650 mg/day of rifaximin for 14 days to a subject in need thereof, where the 1650 mg is administered as 550 mg three times per day; and (2) after stopping rifaximin, achieving a durability of response that comprises about 12 weeks of adequate relief of symptoms.[10] Claim 3 of U.S. Pat. No. ’667 is a dependent claim that includes three elements:  (1) administering 550 mg of rifaximin three times a day for 14 days; (2) to treat one or more symptoms of IBS, where the IBS is IBS-D; and (3) in a subject 65 years of age or older.[11] See ClinicalTrials.gov, History of Changes for Study: NCT00269412, Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Different Doses of Rifaximin Administered BID either Two or Four Weeks in the Treatment of Patients with Diarrhea-Associated Irritable Bowel Syndrome (December 22, 2005).[12] See M. Pimentel et al., The Effect of a Nonabsorbed Oral Antibiotic (Rifaximin) on the Symptoms of the Irritable Bowel Syndrome, 145 Ann. Intern. Med. 557 (2006).[13] See the Protocol.[14] See Salix Pharms., Ltd., 2024 WL 1561195, at *6.[15] See Decision, 2022 WL 3225381, at *19.[16] See id. at *18–19.[17] See Salix Pharms., Ltd., 2024 WL 1561195, at *6.  See also Decision, 2022 WL 3225381, at *20.[18] See Decision, 2022 WL 3225381, at *19.[19] See id.[20] See id. at *20 (quoting In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012)).[21] See Decision, 2022 WL 3225381, at *17.[22] See Salix Pharms., Ltd., 2024 WL 1561195, at *7.[23] See id. at *7–8.[24] See In re Merck & Co., Inc., 800 F.2d 1091 (Fed. Cir. 1986).[25] See Almirall, LLC v. Amneal Pharms. LLC, 28 F.4th 265, 275 (Fed. Cir. 2022) (“A finding of a reasonable expectation of success does not require absolute predictability of success.”).[26] See Salix Pharms., Ltd., 2024 WL 1561195, at *8.

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Of Counsel

Mark D. McBriar focuses his practice on patent drafting and prosecution, IP due diligence, freedom to operate, patentability evaluations, re-examinations, and litigation support. Dr. McBriar works wit

Mark D. McBriar Ph.D.

Mark McBriar

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As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in their overall patent strategy. 

Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure

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On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the Inflation Reduction Act (IRA).[1]  The Negotiation Program is an unprecedented program intended to lower the cost of healthcare for millions of Americans by requiring that manufacturers of the top ten highest cost prescription drugs covered by Medicare engage in a negotiation process to determine a “maximum fair price” (MFP).  

Medicare Drug Price Negotiation Program Final Guidance

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the cases and compare the lawsuits.The ProgramAs we previously <a href="https://lifesciences.mofo.com/topics/cms-reveals-new-details-on-medicare-drug-price-negotiation-program#_ftn2">covered</a>, the drug price negotiation requirements were enacted as part of the IRA, which authorizes the Centers for Medicare and Medicaid Services (CMS) to engage in price negotiations with drug manufacturers for certain high-cost, single-source Medicare Part B or Part D drugs. CMS will select the 10 and 15 highest-ranked Part D drugs for rolling out negotiated prices in 2026 and 2027, respectively. To ensure compliance with the negotiation process, the IRA applies an excise tax on each sale of the drug during a period of non-compliance, including drugs sold to purchasers other than Medicare and Medicaid.Some of the Program’s first, major deadlines are fast approaching. CMS recently <a href="https://www.cms.gov/newsroom/press-releases/cms-releases-revised-guidance-historic-medicare-drug-price-negotiation-program" target="_blank">confirmed</a> that by September 1, 2023, the agency will publish a list of 10 Medicare Part D drugs for negotiation. By October 1, 2023, manufacturers of the selected drugs must sign an agreement with CMS to conduct negotiations.The LawsuitsCurrently, six complaints have been filed against the U.S. Department of Health and Human Services (HHS), which oversees CMS. The primary plaintiff and location of each suit are listed below:<ol><li>Merck & Co., Inc. (Merck): Filed June 6, 2023, in Washington, D.C.<a href="https://www.courtlistener.com/docket/67478203/1/merck-co-inc-v-becerra/" target="_blank"> Merck v. Becerra et al., D.D.C., No. 1:23-cv-01615</a></li><li>U.S. Chamber of Commerce (Chamber): Filed June 9, 2023, in Columbus, OH<a href="https://www.uschamber.com/assets/documents/Complaint-Dayton-Area-Chamber-of-Commerce-v.-Becerra-S.D.-Ohio.pdf" target="_blank"> Dayton Area Chamber of Com. et al. v. Becerra et al., S.D. Ohio, No. 3:23-cv-00156</a></li><li>Bristol Myers Squibb (Bristol): Filed June 16, 2023, in Trenton, NJ<a href="https://www.courtlistener.com/docket/67508656/1/bristol-myers-squibb-company-v-becerra/" target="_blank"> Bristol Myers Squibb Co. v. Becerra et al., D.N.J., No. 3:23-cv-03335</a></li><li>Pharma. Research and Manufacturers of America (PhRMA): Filed June 21, 2023, in Austin, TX<a href="https://www.courtlistener.com/docket/67515442/1/1/national-infusion-center-association-v-xavier-becerra/" target="_blank"> Nat’l Infusion Ctr. Ass’n v. Becerra et al., W.D. Tex., No: 23-cv-00707</a></li><li>Astellas Pharma (Astellas): Filed July 14, 2023, in Chicago, IL<a href="https://litigationtracker.law.georgetown.edu/wp-content/uploads/2023/07/Astellas_20230714_COMPLAINT.pdf" target="_blank"> Astellas Pharma US, Inc., v. Dep’t of Health and Hum. Services et al., N.D. Ill., No: 23-cv-04578</a></li><li>Johnson & Johnson (J&J): Filed July 18, 2023, in Trenton, NJ Janssen Pharmaceuticals, Inc. v. Becerra et al., D.N.J., No: 23-cv-03818</li></ol>Factual AllegationsTwo factual allegations are most common among the plaintiffs: 1) that drug price negotiation will not provide a genuine opportunity to negotiate, and 2) that the excise taxes operate as a coercive penalty.The Chamber complaint argues that there is no genuine opportunity to negotiate by pointing out that there is no judicial or administrative review of prices, government offers are capped via statute and have no minimum, and materials used in the negotiation are limited. The Chamber complaint also preempts the government’s likely counter, that manufacturers could voluntarily withdraw from Medicare and Medicaid to avoid the Program altogether. The Chamber points out that Medicare and Medicaid programs dominate the market, respectively accounting for 21% and 17% of <a href="https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet#:~:text=Historical%20NHE,%202021:&amp;text=Medicare%20spending%20grew%208.4%25%20to,28%20percent%20of%20total%20NHE." target="_blank">national health spending</a>. Therefore, manufacturers cannot afford to withdraw drugs from those programs to avoid the price setting.The Merck complaint provides an example supporting the argument that enormous excise taxes constitute a penalty. Merck states that excise taxes escalate daily from 186% to 1900% of a drug’s daily revenues, and estimates that refusal to negotiate for even just the one drug cited in their complaint would incur tens of millions of dollars in penalties on the first day. The penalties would purportedly escalate to hundreds of millions of dollars per day thereafter.Legal ArgumentsThe legal arguments detailing why the Program is unconstitutional are varied, but overlap across complaints. The most common argument is that the Program violates the First Amendment by forcing companies to state that they “agree voluntarily” to the government’s offer. Across all the complaints, seven legal arguments in total challenge the constitutionality of the Program. A summary of each argument and the associated litigants are below.<ol><li>Fifth Amendment – Unlawful Taking: Under the Program, the government is taking products and giving them to third parties through arbitrary, forced sales. Plaintiffs: Merck, Bristol, Astellas, and J&J</li><li>Fifth Amendment – Due Process: There is no procedural or legal recourse under the Program, prices are prejudiced against manufacturers, and negotiations are concealed from the public. Thus, there is significant risk of “erroneous depravation” under Supreme Court legal standards. Plaintiffs: Chamber, PhRMA, and Astellas</li><li>First Amendment – Compelled Speech: The Program forces companies to publicly state that they voluntarily “agree” to a price, when it is actually a forced negotiation. Plaintiffs: Merck, Chamber, Bristol, Astellas, and J&J</li><li>Eighth Amendment – Excessive Fines: The “excise taxes” imposed by the Program are not taxes intended to discourage the use of a product, but rather are penalties intended to punish manufacturers for refusing to agree to negotiate or agree to the maximum fair price. Plaintiffs: Chamber and PhRMA</li><li>Const. Article 1 – Separation of Powers: The Program violates constitutional nondelegation principles through Congress’s impermissible delegation of broad, unconstrained authority to HHS to set prices without any meaningful constraints. Plaintiffs: Chamber and PhRMA</li><li>Const. Article 1 – Enumerated Powers: Congress does not have the power to authorize the Program’s excise tax because it operates as a penalty. Plaintiffs: Chamber</li><li>First and Fifth Amendment – Unconstitutional Condition: The government cannot condition participation in Medicare and Medicaid upon compliance with the Program and subsequent relinquishment of its constitutional speech and property rights. Litigant: J&J</li></ol>Recent MotionsOn July 11, 2023, Merck filed a <a href="https://litigationtracker.law.georgetown.edu/wp-content/uploads/2023/06/Merck_20230711_MOTION-for-Summary-Judgment.pdf" target="_blank">motion for summary judgment</a> seeking declaratory and injunctive relief, reasserting allegations that the Program “is tantamount to extortion” and further expounding arguments that the Program violates the Fifth Amendment as an illegal taking and the First Amendment as compelled speech. The motion also more fully develops a response to the government’s argument that participating in Medicare and Medicaid is voluntary. Specifically, it argues that the Program is not analogous to receipt of federal funds with “conditions,” especially since a manufacturer cannot realistically terminate participation in Medicare or Medicaid in time to avoid potential excise taxes. Merck points out that it would have needed to give CMS notice by January 31, 2022, in order to properly extricate its products before the upcoming October 1, 2023, deadline.On July 12, 2023, the Chamber filed a <a href="https://aboutblaw.com/9f5" target="_blank">motion for a preliminary injunction</a>, asking the court to enjoin HHS from implementing the Program. The Chamber’s motion focuses on the Due Process argument, stating that when the government sets prices, it must afford parties procedural safeguards to ensure just and reasonable prices and a fair return on investment, as directly addressed by Sixth Circuit precedent. The Chamber finally asserts that manufacturers will be irreparably harmed by costs associated with compliance and disclosure, separate from the even greater costs associated with government-mandated prices.Key Takeaways<ul><li>Litigation challenging the Program will likely grow more active as CMS deadlines approach in the Fall, with resultant court decisions potentially impacting the pharmaceutical and healthcare industry more broadly.</li><li>The courts’ decisions will inform the legal strategy of other litigants seeking to challenge the Program, and likely indicate which arguments present the most viable challenge.</li><li>Unless a court is willing to take action before October, the first phase of the Program will go into effect, and affected manufacturers will need to collect necessary data for submission to CMS.</li><li>With lawsuits filed in five district courts in five circuits, plaintiffs are clearly trying to diversify their chances for an injunction. It remains to be seen whether this strategy will increase the likelihood that the Supreme Court will take the case and whether the Supreme Court would decide in favor of the pharmaceutical industry.</li></ul>The Morrison Foerster team will continue to monitor this litigation for developments and is actively advising clients on how it may impact their business.

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Joe Palmore co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Chambers USA describes him as “an outstanding oral advocate,” who is “calm, focused, effective and doesn’t back down,” and has “complete command of the facts.” Joe “writes great briefs” (Chambers USA), with one client recounting that “the Court mirrored the language he thoughtfully chose in its ultimate order” (Legal 500).

Joseph R. Palmore

Joseph R. Palmore is co-chair of the firm's Appellate and Supreme Court Practice Group and Managing Partner for the Washington, D.C. office. Before joining Morrison Foerster, Joe was an Assistant to the Solicitor General at the United States Department of Justice and the Deputy General Counsel of the Federal Communications Commission (FCC).

Joseph Palmore

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the cases and compare the lawsuits.

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole.<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> The Supreme Court emphasized “the need for caution in granting a patent based on the combination of elements found in the prior art”<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> and discussed circumstances in which a patent might be determined to be obvious. An objective analysis for determining obviousness includes considering: (1) the scope and content of the prior art, (2) the differences between the prior art and the claims at issue, (3) the level of ordinary skill in the field of art, (4) and any objective indicia of non-obviousness.<a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> Objective evidence of non-obviousness, or “secondary considerations,” includes evidence of commercial success, long-felt but unsolved needs, failure of others, and unexpected results.<a href="#_ftn4" target="_self" id="_ftnref4">[4]</a>Pharmaceutical composition claims and method of treatment claims may often face obviousness rejections and validity challenges involving arguments that a claim feature (e.g., pharmacokinetic parameters or an effect of a therapeutic combination) is inherent. To establish inherency in an obviousness analysis, “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.”<a href="#_ftn5" target="_self" id="_ftnref5">[5]</a> In general, the burden to establish inherency in the obviousness context is high.A prima facie case of obviousness for methods using a combination of known chemical compounds can be overcome if the combination yields unexpected results, such as a synergistic effect.<a href="#_ftn6" target="_self" id="_ftnref6">[6]</a> The precedential decision of In re Couvaras<a href="#_ftn7" target="_self" id="_ftnref7">[7]</a> contains cautions on the importance of distinguishing between unexpected results obtained with a combination of two known pharmaceuticals as opposed to an unexpected mechanism of action – if a claim merely recites a mechanism of action in a known use of a known compound (or a combination of compounds), the claim limitation is likely inherent and cannot be used to overcome a prima facie case of obviousness, even if the mechanism of action is previously unappreciated or surprising.BackgroundInventor John Couvaras filed a patent application for combatting hypertension, with claims directed to methods of increasing the release of prostacyclin in blood vessels by co-administering two antihypertensive agents: (1) a gamma-aminobutyric acid-a (GABA-a) agonist and (2) an angiotensin II receptor blocker (ARB).<a href="#_ftn8" target="_self" id="_ftnref8">[8]</a> During prosecution of the application, Couvaras conceded that GABA-a agonists and ARBs “have been known as essential hypertension treatments for many, many decades.”<a href="#_ftn9" target="_self" id="_ftnref9">[9]</a> The examiner not only agreed, but also found that the results of the compounds’ administration (i.e., increasing prostacyclin release, activating uninhibited GABA-a receptors, and smooth muscle relaxation) were not patentable because they naturally flowed from the administration of known antihypertensive agents.<a href="#_ftn10" target="_self" id="_ftnref10">[10]</a>Patent Trial and Appeal Board (“Board”)Couvaras appealed to the Board, arguing that the mechanism of action recited in the claims, e.g., increasing prostacyclin release, was an unexpected result sufficient to overcome the prima facie case, and thus patentable. Unpersuaded, the Board affirmed the rejection, holding that the claimed result of increasing prostacyclin release was inherent in the obvious administration of the two known antihypertension agents.<a href="#_ftn11" target="_self" id="_ftnref11">[11]</a> In particular, the Board found that the increase in prostacyclin release was “simply a recitation of an inherent, but unknown, property of an otherwise obvious formulation” and that “identifying an inherent result of the combination of GABA and ARB compounds does not constitute a patentable invention unless there is also a showing that the newly discovered inherent result also provides an unexpected benefit.”<a href="#_ftn12" target="_self" id="_ftnref12">[12]</a>Federal CircuitCouvaras appealed to the Federal Circuit, in part arguing that because the increased prostacyclin release was unexpected it cannot be dismissed as having no patentable weight due to inherency, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017).<a href="#_ftn13" target="_self" id="_ftnref13">[13]</a> In rejecting Couvaras’ argument, the Federal Circuit noted that Honeywell “held that ‘unexpected properties may cause what may appear to be an obvious composition to be nonobvious,’ not that the unexpected mechanisms of action must be found to make the known use of known compounds nonobvious.”<a href="#_ftn14" target="_self" id="_ftnref14">[14]</a>After addressing representative independent claim 11, the Federal Circuit noted that the dependent claims included limitations “drawn to dosing amounts and time-release formulations”<a href="#_ftn15" target="_self" id="_ftnref15">[15]</a> and that all of the claims stand or fall based on the analysis provided.<a href="#_ftn16" target="_self" id="_ftnref16">[16]</a>The court further found that Couvaras attempted to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents – “the two antihypertension agents exert the same ultimate result as the two separate compounds were known to effect: a decrease in blood pressure.”<a href="#_ftn17" target="_self" id="_ftnref17">[17]</a> In quoting another Federal Circuit case, the court explained that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”<a href="#_ftn18" target="_self" id="_ftnref18">[18]</a> Thus, even if the mechanisms of action are unexpected, they are still results that naturally flow from the administration of a mixture of compounds, and therefore, are inherent. Unfortunately, Couvaras did not show any benefit of the combination or that the ultimate result from administering the combination is different from that of individually administering the antihypertension agents. In the absence of such an unexpected benefit or result, the mere recitation of a mechanism of action is insufficient to overcome a prima facie case of obviousness.In re Couvaras is informative in that it emphasizes the importance of secondary considerations (e.g., unexpected results) in overcoming prima facie cases of obviousness, particularly in combination therapy cases where individual pharmaceutical active ingredients have known effects that can be related to the claimed effect.Practical Tips for ProsecutionWhen addressing a prima facie case of obviousness, the arguments should be focused on actual unexpected therapeutic results.<a href="#_ftn19" target="_self" id="_ftnref19">[19]</a> Practitioners should consider adding claim limitations that recite the therapeutic result, as the Court noted that Couvaras’ success in establishing unexpected results relied on the demonstration that “the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages.”<a href="#_ftn20" target="_self" id="_ftnref20">[20]</a> This would be consistent with case law where the result of a combination of known compounds is sufficiently surprising, such as when the combination results in an unexpected synergy.<a href="#_ftn21" target="_self" id="_ftnref21">[21]</a>Further, practitioners should keep in mind that “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art”<a href="#_ftn22" target="_self" id="_ftnref22">[22]</a> and a direct or indirect comparison is permissible.<a href="#_ftn23" target="_self" id="_ftnref23">[23]</a> Further, in order to establish unexpected results for an invention, the unexpected results must be commensurate in scope with the claims.<a href="#_ftn24" target="_self" id="_ftnref24">[24]</a>  Arguments associated with an unappreciated mechanism of action may be useful if they are tied to an unexpected ultimate effect (which may, but does not need to be, recited in a claim), otherwise the mere recitation of the mechanism of action in the claim may be discounted as inherent. The additional limitation of the mechanism of action may also make it more difficult to prove infringement. As a result, practitioners should consider avoiding mechanism of action limitations in at least the independent claims and instead focus on establishing the benefits of the claimed subject matter.References<a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> See MPEP §§ 2111-2116.01.<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007).<a href="#_ftnref3" target="_self" id="_ftn3">[3] </a>Graham v. John Deere, 383 U.S. 1, 17-18 (1966).<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> See MPEP § 2141(II).<a href="#_ftnref5" target="_self" id="_ftn5">[5]</a> PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1195-96 (Fed. Cir. 2014).<a href="#_ftnref6" target="_self" id="_ftn6">[6]</a> Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014).<a href="#_ftnref7" target="_self" id="_ftn7">[7]</a> In re Couvaras, No. 2022-1489, 2023 WL 3984753 (Fed. Cir. June 14, 2023).<a href="#_ftnref8" target="_self" id="_ftn8">[8]</a> See In re Couvaras, 2023 WL 3984753, at *1.<a href="#_ftnref9" target="_self" id="_ftn9">[9]</a> See id., at *3 (quoting J.A. at 998).<a href="#_ftnref10" target="_self" id="_ftn10">[10]</a> See id. (quoting J.A. at 1011-18).<a href="#_ftnref11" target="_self" id="_ftn11">[11]</a> In re: John L. Couvaras, No. 2022-001037, 2021 WL 6124743, at *3-4 and *7 (P.T.A.B. Dec. 24, 2021) (“Decision”).<a href="#_ftnref12" target="_self" id="_ftn12">[12]</a> See Decision, at *14.<a href="#_ftnref13" target="_self" id="_ftn13">[13]</a> See In re Couvaras, 2023 WL 3984753, at *8 (citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017).<a href="#_ftnref14" target="_self" id="_ftn14">[14]</a> See id. (citing Honeywell International Inc., 865 F.3d at 1355).<a href="#_ftnref15" target="_self" id="_ftn15">[15]</a> See In re Couvaras, 2023 WL 3984753, at *3 (quoting J.A. at 982-87).<a href="#_ftnref16" target="_self" id="_ftn16">[16]</a> See id.<a href="#_ftnref17" target="_self" id="_ftn17">[17]</a> See id., at *8.<a href="#_ftnref18" target="_self" id="_ftn18">[18]</a> See id. (quoting In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012)). See also In re Huai-Hung Kao, 639 F.3d 1057, 1070-71 (Fed. Cir. 2011).<a href="#_ftnref19" target="_self" id="_ftn19">[19]</a> Application of Gershon, 372 F.2d 535, 537 (C.C.P.A. 1967) (explaining that “[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected beneficial results are evidence of unobviousness thereof”).<a href="#_ftnref20" target="_self" id="_ftn20">[20]</a> See In re Couvaras, 2023 WL 3984753, at *9.<a href="#_ftnref21" target="_self" id="_ftn21">[21]</a> See Sanofi-Aventis Deutschland GmbH, 748 F.3d at 1354.<a href="#_ftnref22" target="_self" id="_ftn22">[22] </a>In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).<a href="#_ftnref23" target="_self" id="_ftn23">[23] </a>In re Payne, 606 F.2d 303, 316 (C.C.P.A. 1979). See also In re Merchant, 575 F.2d 865, 869 (C.C.P.A. 1978) and In re Blondel, 499 F.2d 1311, 1317 (C.C.P.A. 1974).<a href="#_ftnref24" target="_self" id="_ftn24">[24] </a>In re Clemens, 622 F.2d 1029, 1035 (C.C.P.A. 1980).

Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action