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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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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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. 

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Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure | MoFo Life Sciences

Mark D. McBriar Ph.D.

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.

Federal Court Invalidates Dosing Patent Based on Clinical Trials Disclosure

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