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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What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

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Yesterday, FDA released the <a href="https://public-inspection.federalregister.gov/2024-29957.pdf" target="_blank">final rule</a> that updates the definition for “healthy” nutrient content claims. In an update that may be long overdue, manufacturers who use the term “healthy” (or derivative terms: “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) on a covered food product label must follow the rule’s limits on saturated fat, sodium, and added sugars. This is a change from the original limitations on “health” claims, which limited saturated fat, sodium, total fat, and dietary cholesterol, but not added sugar. While health trends continue to evolve, the new rule aims to better assist consumers in choosing healthy foods while shopping. While there is still not a universal symbol or icon that consumers can use to identify healthy food choices, covered food products now must contain a certain amount of food from at least one recommended food group included in the Dietary Guidelines for Americans (vegetables, fruits, dairy, protein foods, and whole grains). The rule exempts raw fruits and vegetables, as well as individual foods or mixed products that are made of at least one of the foods encouraged by the Dietary Guidelines, with no other added ingredients except water. Some foods that previously qualified to use the term “healthy” no longer do.Manufacturers may choose to use the new “healthy” claim standards starting on February 25, 2025, but compliance isn’t required until 2028.  We look forward to providing a deeper analysis in our next update, including how this final rule may impact companies who operate under a “health-halo.” For additional information, the final rule and the FDA Fact Sheet can be found <a href="https://public-inspection.federalregister.gov/2024-29957.pdf" target="_blank">here</a> and <a href="https://www.fda.gov/media/184538/download?attachment" target="_blank">here</a>.

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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

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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Lauren N. Margolies is an associate in the Litigation Department of Morrison Foerster’s New York Office.

Lauren Margolies

Lauren N. Margolies

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Regulatory Analyst

Brandy Guarda is a regulatory analyst supporting the FDA + Healthcare Regulatory and Compliance practice in Morrison Foerster’s Washington, D.C. office. Brandy predominantly focuses on researching and tracking FDA and interagency regulatory guidance, proposed and final rules, legislation, and enforcement actions.

Brandy A. Guarda

Brandy Guarda

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What is “Healthy?” Are Fats In?

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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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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

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. 

Seagen Inc. v. Daiichi Sankyo Co. Ltd. et al. (AAA Arbitration, Eastern District of Texas, District of Delaware, and Patent Trial and Appeal Board)

Evolve BioSystems, Inc. v. Abbott Laboratories (Northern District of Illinois)

Driscoll’s, Inc. v. California Berry Cultivars, LLC (Eastern District of California)

Bayer CropScience LP v. Tenfold Tech., LLC (Eastern District of Texas)

The Regents of the University of California v. California Berry Cultivars, L.L.C. et al.  (California Superior Court and Northern District of California)

Arch Development Corp. v. Genentech, Inc. (Northern District of Illinois, Patent Trial and Appeal Board, and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. (Northern District of California and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. and ImmunoGen, Inc. (Patent Trial and Appeal Board and Federal Circuit)

Focal Therapeutics, Inc. v. Senorx, Inc. (Patent Trial and Appeal Board)

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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. 

The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v. University of Massachusetts, PGR2023-00014.) The PTAB found UMass’s claims directed to methods of treating vitiligo with a functionally defined genus of compounds failed to meet enablement and written description requirements. Enablement of genus claims was addressed by the Supreme Court in last year’s Amgen case. (See Amgen v. Sanofi, 598 U.S. 594). Importantly, this PTAB decision demonstrates that method claims are not insulated from the Amgen ruling, stating that “the specification must provide some guidance regarding structure for a recited element of the claim.”Forte Biosciences, Inc. (“Forte”) challenged the patentability of claims 1–5 on enablement, written description, and obviousness grounds.Claim 1 is illustrative of the challenged claims and is shown below.<ol><li>A method of treating a subject who has a vitiligo lesion, the method comprising: identifying a subject in need of treatment; and administering a therapeutically effective amount of an inhibitor of IL-15 or the IL-15 receptor to the subject.</li></ol>The PTAB found the challenged claims unpatentable for lack of enablement and written description under 35 U.S.C. § 112(a). The PTAB did not reach the obviousness challenge.The PTAB’s Post-Amgen Enablement AnalysisIn deciding whether the challenged claims are enabled under 35 U.S.C. § 112(a), the PTAB applied the Amgen court’s analysis regarding genus claims encompassing entire classes of functionally defined compounds and considered the Wands factors to determine whether undue experimentation is required to make and use the claimed invention. Amgen v. Sanofi, 598 U.S. 594.The Amgen court held that, “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Amgen, at 610. Essentially, “[t]he more one claims, the more one must enable.” Id. This concept of quid pro quo is at the heart of the U.S. patent system.The PTAB determined that the inhibitors claimed in the UMass’s patent are even broader than the genus of antibodies at issue in Amgen, as neither the specification nor the claims of the UMass’s patent provide any structural requirement for the claimed inhibitors. Forte Biosciences, at 30. For instance, claim 2 of the UMass’s patent states that inhibitors can be small molecules, antibodies, peptides, or nucleic acids, none of which share any common structural features. Id. at 30–31. Due to the complicated and unpredictable nature of IL-15/IL-15R inhibition, the PTAB rejected UMass’s argument that IL-15/IL-15R inhibitors and their mechanisms were well known in the art and held that a skilled person would have to engage in extensive experimentation to identify and test each compound covered by the claim scope to determine whether the compound works.Furthermore, the PTAB also rejected UMass’s argument that the challenged claims are directed towards methods of treatment for vitiligo instead of the inhibitors for IL-15 or IL-15R themselves, thereby avoiding the “how to make” requirement for the inhibitors. The PTAB held that, if a challenged claim recites a functionally defined genus of compounds, as is the case with UMass’s method of treatment claims, “the specification must provide some guidance regarding structure for a recited element of the claim[.]” Id. at 37. This is to prevent a skilled person from having to engage in extensive trial and error to determine which compound falls within the claim scope. Id. Consequently, the PTAB found the challenged claims were unpatentable due to lack of enablement.The PTAB’s Written Description Analysis of Genus ClaimsThe PTAB agreed with Forte’s characterization that the challenged claims were directed broadly to methods of treating vitiligo by administering an inhibitor of IL-15 or IL-15R in a therapeutically effective amount, while UMass’s patent only disclosed a single working example, i.e., ChMBC7, which is an antibody inhibitor targeting a mouse protein, IL-2R β/IL-15R β.Furthermore, the PTAB rejected UMass’s argument that, because the challenged claims are method claims and not composition of matter claims, the written description inquiry should only consider whether the patentee possessed the claimed methods of administering a therapeutically effective amount of an inhibitor to treat vitiligo, rather than whether the patentee possessed the entire genus of the claimed inhibitors. Forte Biosciences, at 16–17. The PTAB emphasized that, regardless of whether a claim is for a compound itself or a method involving the compound, the patentee must provide a description detailed enough to differentiate infringing compounds or methods from non-infringing ones. Id. at 16. Thus, the PTAB found UMass’s contention unpersuasive.Additionally, the PTAB agreed with Forte that UMass’s patent lacked descriptive support for the challenged claims because the evidence showed: (1) that not all IL-15 or IL-15R inhibitors are therapeutically effective; (2) that the specification does not disclose structural features of the IL-15 or IL-15R inhibitors necessary or sufficient to perform the claimed methods; (3) a lack of information to allow a skilled artisan to understand or determine whether an inhibitor actually meets the functional requirement in the challenged claims; and (4) unpredictability across the breadth of the claimed genera (e.g., small molecules, peptides, antibodies, or nucleic acids).In sum, the PTAB found that the challenged claims are directed to methods using a wide range of different types of compounds that are not part of a known or readily identifiable class, do not target the same biological pathway, do not have any common structural features, and do not always function as inhibitors. Hence, the PTAB held that UMass’s patent did not disclose a representative number of species or a sufficient correlation between structure and function to demonstrate possession of the claimed methods of treatment using a functionally defined genus of compounds.TakeawaysThis recent PTAB decision underscores the importance of enablement and written description considerations for functionally defined genera recited in method claims under Amgen. The broad nature of claims containing functionally defined genera inherently increases the difficulty of meeting the enablement requirement across the full scope of the claims. Similarly, the written description requirement mandates that claims must be supported by what is described in the specification. Therefore, practitioners may strategically consider the inclusion of functional limitations in method claims and contemplate multiple backup positions with varied claim scope in view of the enablement and written description requirements.