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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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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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

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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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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

On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.Specifically, the USPTO proposes amending the patent rules “to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which the terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which: (1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 in a Federal court in a civil action or at the USPTO, and all appeal rights have been exhausted; or (2) a statutory disclaimer of a claim is filed after any challenge based on 35 U.S.C. 102 or 103 to that claim has been made.”The USPTO explains that this new requirement “solves the current problem of requiring a competitor to invalidate multiple patents tied by terminal disclaimers in order to have freedom to operate” and, thus, “has the likely advantages of reducing litigation and administrative proceeding costs and increasing predictability….”Although the proposed rule characterizes this as a “voluntary agreement” regarding enforceability of the patent, there is little that is voluntary about this proposed requirement. In essence, the proposed rule change would impose the requirement that in order to obviate a nonstatutory double patenting rejection, the disclaimant would need to agree that its patent would only be enforceable if it is not tied (and has never been tied) to any patent having a claim that was invalidated under 35 U.S.C. § 102 or § 103 for anticipation or obviousness, respectively. This means if a challenger is successful in invalidating “any” claim in a challenged patent under § 102 or § 103, then any other patents “tied” to that challenged patent by one or more terminal disclaimers would be unenforceable. Notably, the validity of the other patents would not be affected, as only their enforceability is affected by the voluntary agreement included in the terminal disclaimers. However, what is the point of obtaining a valid patent that you cannot enforce?This reflects a major change in current practice as it exists today where invalidation of one patent by a challenger does not affect the patent holder’s ability to enforce its other patents against the same (or a different) challenger, even if they are tied together by terminal disclaimers.Among the many concerns with this proposed rule is that once a terminal disclaimer is filed in an application it cannot be withdrawn after the patent is issued. The finality of such an action coupled with the effect of this proposed rule would result in applicants being forced into a “voluntary agreement” that may restrict their ability to enforce their own patents many years down the road.The USPTO will be accepting comments over the next 60 days relating to this proposed rule change.These proposed rule changes also coincide with the USPTO’s proposed changes in its fees, which include increasing the cost of filing a terminal disclaimer. Currently, the USPTO charges $170 to file a terminal disclaimer regardless of when it is filed. Under the proposed fee changes, this fee would be increased to $200 if the terminal disclaimer is filed prior to the first action on the merits, and would be further increased to $500 to $1,400 if filed after the first action, depending on the stage of prosecution. The judicially created doctrine of obviousness-type double patenting was created in an effort to prevent the unjustified extension of patent term, with the “solution” to this concern being the terminal disclaimer. The USPTO’s recently proposed fee changes that tie significantly increased filing fees for terminal disclaimers to the particular timing of their submission—coupled with today’s proposed rulemaking that would render patents tied together by terminal disclaimers unenforceable—is incongruous with the purpose behind this judicially created doctrine.

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On May 10, 2024, the USPTO issued a Notice of Proposed Rulemaking that proposes major changes to terminal disclaimer practice that could greatly affect both patent prosecution and patent litigation strategies.

USPTO Considers Changing Terminal Disclaimer Practice to Require Agreement Regarding Enforceability

MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now <a href="https://soundcloud.com/user-496742723/03-27-lifescience-podcast01-v1" target="_blank">available</a>. The podcast features interviews with legal experts who share insights and advice you just might need when your life sciences are on the line.The special guest for Episode 1 was Jim Krenn, a MoFo partner whose practice is focused on major corporate transactions for emerging and established companies in the life sciences. Jim, Nate, and Kate discuss strategies to maximize and protect the value of trade secrets, how investing in compliance early pays dividends as companies mature, and where companies may face government scrutiny on the journey from startup to public company.Trade secrets play a central role in raising capital, selling a company, and going public, and the rise of cyber breaches and sophisticated intellectual property theft has pushed investors to look closely at how trade secrets are safeguarded. Jim maps out strategies for maximizing the value of trade secrets at key stages and discusses with Nate and Kate how to protect a critical asset for many life sciences companies.Early-stage companies often focus on development and growth, but an appropriate compliance function is important to control present and future downside risk. Jim explains the decision dynamics at play, and Kate discusses how increased scrutiny on life sciences companies makes good compliance a winning value proposition.Outside scrutiny on company systems peaks when the time comes to take a company public or consider a merger or acquisition. Interested parties pore over compliance functions at this stage, particularly in the highly regulated life sciences industry. Nate and Kate discuss corresponding risks for company insiders.

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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. 

Nathaniel Mendell

Nathaniel R. Mendell

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Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. 

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

FDA REGULATORY ISSUES[1]The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare services models, startups and established companies alike are positioning themselves to take advantage of the growing market for technologies and products that enable non-lab-based diagnostics capable of being purchased without a prescription and conducted entirely at home.[2] MoFo’s FDA Regulatory team has described the top three issues developers of these tests should consider.<ol><li>Understand Your Regulatory Obligations</li></ol>Companies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations. FDA has authority to regulate in vitro diagnostics (IVDs) for end-to-end use at home (such as pregnancy tests or COVID rapid tests) under both the Federal Food, Drug, and Cosmetics Act (FDCA) and the Public Health Service Act.[3] This regulatory authority extends throughout the product lifecycle, from premarket clinical studies to post-market obligations like adverse event reporting and manufacturing controls.a. OTCs Are Not LDTsFDA has issued a significant rulemaking proposal to regulate “laboratory developed tests” (LDTs), a category that FDA has not actively regulated in the past, citing a policy of “enforcement discretion.” [4] The proposed changes to FDA’s regulations do not specifically define LDTs, but the proposed rule would add language to the regulatory definition of IVD to clarify that laboratories may be deemed manufacturers of IVDs and thus subject to regulation.However, FDA’s rulemaking around LDTs would not apply to OTC tests. In the past and in the preamble to the proposed rule, FDA defines LDTs as tests that are “designed, manufactured and used within a single laboratory.”[5] When FDA uses the term “OTC,” it means a test for which the end user collects a specimen at home and performs the test at home. Although there is often thought to be some overlap between tests that use “self-collected” specimens[6] and LDTs, OTC tests, by definition, cannot be LDTs and have never been the subject of FDA’s enforcement discretion.b. Premarket ReviewFor IVDs sold OTC, premarket review is required because FDA generally considers these tests, as a category, to be moderate-risk or high-risk.[7] This means that FDA will likely require a de novo review for a test that has no legally marketed predicate. If there are already similar tests on the market, it may be possible to obtain clearance through the generally less-burdensome 510(k) process.[8] Companies undergoing premarket review for an OTC test should plan to complete a user-comprehension test and/or usability study, as well as prepare for FDA to review the product’s accuracy, reliability, clinical validity, and claims.A de novo request will include a description of the “probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended.”[9] For OTC devices, risks might include “misinterpretation or over-reliance on device output,” which might be addressed through human factors and usability engineering testing under simulated conditions of use, and risk mitigation measures, including appropriate information within labeling.[10]c. Post-market ObligationsEven after regulatory clearance or approval has been granted, a cleared or approved product and its manufacturer are subject to extensive regulatory requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, and promotion for the product.Companies launching a new diagnostic product, as well as companies converting a lab-based test to an at-home test, should carefully consider labeling. The label must contain adequate information so that a lay user can select the device as an appropriate match for their condition, understand how to use the device, correctly interpret the results, and appropriately manage their condition—all without assistance from a healthcare provider.[11] Such information includes the test’s intended use, recommended procedures from specimen collection to results, test limitations, specific performance characteristics, and list of interfering substances.[12]Any advertising or promotion of the product should strictly adhere to the FDA-cleared indication, and any claims made about the safety or efficacy of the product should be consistent with any FDA-cleared or approved labeling. This is an area where many companies have struggled and faced not only enforcement actions from FDA but also civil and criminal enforcement for false claims made to government healthcare programs.Device manufacturers are required to follow FDA’s Quality System Regulation (QSR), a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing, and shipping of their marketed products. FDA enforces QSR and other requirements through periodic announced and unannounced inspections of manufacturing facilities.Medical Device Reporting (MDR) is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters, including manufacturers, device user facilities, and importers, must submit to FDA certain types of reports for adverse events and product problems about medical devices.<ol start="2" class=""><li class="">Talk to FDA Early and Often or Face the Consequences</li></ol>Companies considering launching an at-home diagnostic test should consult with FDA early and often. Proactive communication generally limits unexpected regulatory hurdles, clarifies the regulatory costs associated with bringing a test to market, and may help prevent regulatory tangles. Using tools like the pre-submission process to ask clarifying questions of the relevant review division prior to making a submission can save valuable time and avoid wasting resources on studies that will not satisfy FDA’s requirements.When test companies do not comply with their regulatory obligations, FDA has a number of enforcement tools that it can employ. Failure to comply with the regulatory requirements of the FDA may cause a company to be subject to administrative or judicially imposed sanctions, including restrictions on the products, manufacturers, or manufacturing process; adverse inspectional observations (Form 483), warning letters, or untitled letters; civil or criminal penalties or fines; injunctions; product seizures, detentions, or import bans; voluntary or mandatory product recalls and publicity requirements; suspension or withdrawal of regulatory clearances or approvals; total or partial suspension of production; imposition of restrictions on operations, including costly new manufacturing requirements; refusal to clear or approve pending applications or premarket notifications; and import and export restrictions.<ol start="3" class=""><li class="">Keep COVID-19 Lessons in Mind</li></ol>As noted above, the COVID-19 pandemic marked a turning point in consumer demand for at-home diagnostics and more widespread dissemination of information about how FDA thinks about this category diagnostics, but did not necessarily make it easier to bring an OTC diagnostic test to market. Recognizing this shift in the IVD market, FDA has now created a <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm" target="_blank">searchable database</a> for approved OTC diagnostic tests, linking would-be test developers to more readily available details about FDA’s review of those tests. FDA also issued guidance documents, templates, and summary review documents to aid the development of rapid antigen tests that shared learnings from the COVID-19 experience, highlighting the issues that were a focus of FDA oversight.[13]Companies looking to bring at-home diagnostics to market can learn from FDA’s regulation of COVID rapid tests by not underestimating the data requirements. During the pandemic, FDA required OTC COVID rapid test manufacturers to meet high accuracy standards, as well as conduct separate usability studies.[14] After rapid tests were slow to come to market, the agency’s approval process was criticized as too stringent.[15] While FDA has vocally supported increasing at-home diagnostic testing, the same high standards that applied to COVID rapid tests continue to be used for all OTC diagnostic tests. By fully understanding and planning to meet stringent standards, companies can be better prepared for the premarket review process.[1] This is the third in a series of three articles addressing the licensing and regulatory considerations for at-home diagnostic companies. The first article focuses on issues in structuring customer agreements and can be found [<a href="/topics/fda-regulatory-considerations?_gl=1*17zsyv4*_ga*MjA0NTYxMDg1Ny4xNzA3MzI0ODE3*_ga_3HVRG7GH76*MTcxMTY1OTY5MC44MS4wLjE3MTE2NTk3ODUuMC4wLjA." target="_self">here</a>]. The second focuses on issues in structuring manufacturer, supplier, and vendor agreements and can be found [<a href="/topics/at-home-diagnostics-articles-non-lab-diagnostics-supply-manufacturing-and-distribution-agreements" target="_self">here</a>].[2] Some diagnostic tests are marketed “direct-to-consumer,” but the consumer is not able to perform the entire test because the self-collected specimen must be analyzed by a laboratory. This article deals exclusively with tests that can be performed end-to-end by the consumer. We note, however, that FDA has recently issued a rulemaking proposing to regulate laboratory developed tests (LDTs), a category that FDA claims has long been subject to enforcement discretion. That proposal clearly distinguishes between tests performed by the consumer at home from LDTs, noting that OTCs have never been the subject of FDA’s enforcement discretion.[3] 21 C.F.R. § 809.3(a).[4] FDA, Proposed Rule: Medical Devices; Laboratory Developed Tests, 88 Fed. Reg. 68006 (Oct. 3, 2023).[5] FDA, Draft Guidance for Industry, FDA, and Clinical Laboratories: Framework for Regulatory Oversight of LDTs (Oct. 2014).[6] This article deals exclusively with tests that can be performed end-to-end by the consumer. We note that some diagnostic tests that use self-collected specimens are marketed as “direct-to-consumer” (DTC) tests. This category is outside the scope of this article because the consumer is not able to perform the entire test, i.e., the sample must be analyzed by a laboratory.[7] Direct-to-Consumer Tests, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests" target="_blank">https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests</a> (last visited October 9, 2023).[8] For a diagnostic test to be cleared for its intended use, FDA must find that the product is substantially equivalent to a legally marketed predicate device. See 21 U.S.C. §§ 360c(i) & (f)(1); see also FDA, Guidance for Industry and FDA: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (July 2014).[9] FDA Website, Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers, <a href="https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers" target="_blank">https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers</a>.[10] Id.[11] Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers" target="_blank">https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers</a> (last visited October 9, 2023).[12] In Vitro Diagnostic Device Labeling Requirements, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/device-labeling/in-vitro-diagnostic-device-labeling-requirements" target="_blank">https://www.fda.gov/medical-devices/device-labeling/in-vitro-diagnostic-device-labeling-requirements</a> (last visited October 9, 2023).[13] See, e.g., FDA, Molecular and Antigen Home Use Test Template, <a href="https://www.fda.gov/media/140615/download" target="_blank">https://www.fda.gov/media/140615/download</a>; FDA, In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2, <a href="https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2" target="_blank">https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2</a>.[14] William Rinehart, Improving the FDA: Lessons Learned from COVID-19 Rapid Tests 9 (Center for Growth and Opportunity at Utah State University 2023).[15] Id. at 8–11.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Matthew Ferry

Non-Lab Diagnostics: FDA Regulatory Considerations