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 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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As chair of the biotechnology group and a member of the firm’s food and agriculture steering committee, Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of life science and agriculture. Meghan is passionate about working with cutting edge technologies at the frontier or science that impacts human health and global food security. She has significant experience in diverse technologies including antibodies, cell and gene therapies, diagnostics, and gene edited plants. Meghan manages a cross-technology team to service clients developing technology at the interface of life science and AI.Meghan represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities. She 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.Meghan is a thought leader on intellectual property issues facing pharmaceutical, biotechnology, and agriculture companies and is sought after to speak at events and publish on these issues. Meghan has written numerous articles on the topics of patents vs. trade secrets, subject matter edibility, written description and enablement in life sciences. Meghan is editor of the MoFo Life Sciences Blog, where she directs content.Prior to law school, Meghan earned her PhD in biological chemistry based at the University of California, Los Angeles. Meghan’s Ph.D. work focused on analysis of protein-protein and protein-DNA interactions of site-specific recombinases. 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.

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Wolfgang Schoenig 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.

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On 4 December 2025, the Council of the European Union and the European Parliament reached a provisional agreement on a comprehensive framework for New Genomic Techniques (NGTs). The deal modernises EU agrifood rules and positions NGTs as a cornerstone for competitiveness, sustainability, and climate-resilient agriculture.How We Got Here – A Compressed OverviewSince 2023, the EU Commission has sought to update genetically modified organism (GMO) legislation to account for precision-breeding methods such as targeted mutagenesis and cisgenesis (insertion of DNA from related species, i.e., insertions that could have occurred via natural breeding techniques). The proposal introduced Category 1 (NGT-1) plants and Category 2 (NGT-2) plants.NGT-1 plants are equivalent to conventional plants. This means they could also occur naturally or be generated through conventional breeding techniques, and includes progeny obtained by conventional breeding of such NGT plants.NGT-2 plants are all other NGT plants (i.e., NGT plants that are not Category 1 plants). These are more complex or “less natural-equivalent” modifications than NGT-1 plants.Progress stalled in 2024 when Parliament pushed for an extensive patent ban, which was an approach many Member States opposed. Only in March 2025 did the Council secure a negotiating mandate by replacing the proposed patent ban with stronger transparency requirements. This opened the door to trilogue negotiations and ultimately to the current compromise.For more details regarding the Commission’s proposal, the exact NGT definitions and the previously proposed patent ban, please read our <a href="https://www.mofo.com/resources/insights/250425-april-2025-update-on-regulation" target="_self">client alert</a>.What Has Been Provisionally Agreed Upon?The provisional agreement retains the principles of the Commission’s proposal from March 2025. According to this, neither NGT-1 plants nor their non-seed products will generally need to be labelled, though seeds and other reproductive material will require labelling. National authorities must verify that a plant qualifies as Category 1, but once granted, offspring do not require repeated verification.Notably, traits conferring herbicide tolerance or the production of a known insecticidal substance cannot be classed as Category 1, but instead must be treated under the stricter Category 2 rules.NGT-2 plants will remain subject to the existing GMO legislation, including mandatory safety assessments, authorisation procedures, traceability, and product labelling.Member States may prohibit cultivation of NGT-2 plants in their territory. In addition, Member States may take optional coexistence measures to prevent the unintended presence of NGT-2 plants.Transparency Prevails Over BansContrary to earlier proposals, the new agreement does also not include a patent ban. Rather, transparency requirements will be created. When seeking registration of a Category 1 NGT product, companies or breeders must disclose all existing or pending patents, and this information must be included in a publicly accessible database. In addition, a patenting expert group will be created, and the Commission will publish a study one year after the entry into force of the regulation on the effects of patents on innovation of NGT plants, seed availability, and competitiveness of the plant breeding sector.What Happens Next?Formal adoption by the Council and Parliament is still required. National implementation, patent-impact findings, and public acceptance will determine how far the new rules encourage innovation and uptake.For breeders, researchers, and agtech companies, the agreement offers long-awaited regulatory clarity and an opportunity to accelerate development of climate-resilient, resource-efficient crops.Sources:European Council, <a href="https://www.consilium.europa.eu/en/press/press-releases/2025/12/04/new-genomic-techniques-council-and-parliament-strike-deal-to-boost-the-competitiveness-and-sustainability-of-our-food-systems/" target="_blank">New genomic techniques: Council and Parliament strike deal to boost the competitiveness and sustainability of our food systems | Consilium</a>Morrison Foerster, Client Alert, <a href="https://www.mofo.com/resources/insights/250425-april-2025-update-on-regulation" target="_blank">April 2025 Update on Regulation of New Genomic Techniques in the EU | Morrison Foerster</a>Euroseeds, <a href="https://euroseeds.eu/news/europes-seed-sector-welcomes-the-end-of-trilogue-negotiations-on-new-genomic-techniques/" target="_blank">Europe’s seed sector welcomes the end of trilogue negotiations on New Genomic Techniques | Euroseeds</a>Agrarheute, <a href="https://www.agrarheute.com/politik/durchbruch-fuer-neue-zuechtungstechniken-diese-regeln-vereinbart-637962" target="_blank">EU lässt moderne Gentechnik zu – so erkennen Landwirte das Saatgut | agrarheute.com</a>Tagesschau, <a href="https://www.tagesschau.de/wirtschaft/verbraucher/gentechnik-eu-einigung-lockerung-100.html" target="_blank">EU einigt sich auf Lockerungen für gentechnisch veränderte Lebensmittel | tagesschau.de</a>Special thanks to Darius Schulz, Research Assistant of MoFo’s Technology Transactions group, for authoring this article.

Europe’s New Genomic Techniques: Patent Ban Off the Table

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Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.
Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technolo

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Wolfgang Schoenig advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Read the <a href="https://www.mofo.com/resources/insights/251215-biosecure-act" target="_blank">Japanese version</a>. The BIOSECURE Act has returned in the 2025 legislative session in a new form as part of the Senate-passed version of the National Defense Authorization Act.<a href="#_ftn1">[1]</a> The BIOSECURE Act (the “BIOSECURE Act” or the “Act”) was first introduced in the 2023–2024 legislative session, but ultimately did not pass despite bipartisan support, due to concerns from key legislators and significant opposition from the U.S. biopharma industry. Newly reintroduced as an amendment to the National Defense Authorization Act (NDAA), a piece of legislation that Congress has consistently passed every year for decades, and with key changes to address concerns that prevented its passage last session, its future enactment is looking much more likely.The proposed legislation would prohibit any U.S. Executive Agency (including the four agencies that make up 98% of federal medical supply purchases: the Department of Health and Human Services, the Department of Defense, the Department of Veterans Affairs, and the Department of Homeland Security)<a href="#_ftn2">[2]</a> from procuring or obtaining “biotechnology equipment or services” that are produced or provided by certain Chinese pharmaceutical and biotech companies that are controlled by or operated under the direction of a foreign adversary government and pose national security risks to the U.S. (“Biotechnology Companies of Concern”). The Act would also prohibit federal agencies from contracting with, and providing federal funding to, entities that use “biotechnological equipment or services” of a Biotechnology Company of Concern to perform a U.S. government contract.If passed, the BIOSECURE Act will have significant implications for pharmaceutical companies that both (A) have significant U.S. government contracts and/or receive significant U.S. federal government funding and (B) are dependent on Biotechnology Companies of Concern to manufacture (or to support the manufacturing processes of) their pharmaceutical products (e.g., through the outsourcing of manufacturing processes to such companies).Legislative HistoryBelow is a brief summary of the legislative history of the BIOSECURE Act, to date:<ul><li>December 20, 2023 – Senate introduces the initial version of the Act (S. 3558).</li><li>January 25, 2024 – House introduces its version of the Act (H.R. 7085).</li><li>May 10, 2024 – The House Committee on Oversight and Accountability holds a markup session and amends the Act, after which the Act is advanced (under a new bill number, H.R. 8333) for a full House vote. At this point, the wording of the House and Senate versions became nearly identical.</li><li>September 9, 2024 – House passes H.R. 8333.</li><li>December 2024 – 118th Congress ends without either version of the BIOSECURE Act passing.</li><li>July 31, 2025 – Senator Bill Hagerty proposes an amendment to the NDAA that contains most of the same provisions and requirements as the BIOSECURE Act.</li><li>October 9, 2025 – Senate passes its version of the NDAA, which includes the BIOSECURE Act. The House version of the NDAA passed in September and did not include a corresponding BIOSECURE Act, leaving the reconciliation process standing between the BIOSECURE Act and enactment.</li></ul>BIOSECURE Act SummaryExcept for certain restrictions on the use of federal funding (see item C, below), the BIOSECURE Act does not impose restrictions on pharmaceutical companies directly. Instead, the Act restricts “U.S. Executive Agencies” from taking certain specified actions (i.e., contracting or funding) that implicate companies designated Biotechnology Companies of Concern, as well as their subsidiaries, parents, affiliates, and successors.Specifically, the bill makes the following prohibitions: <ul><li>A U.S. Executive Agency may not procure or obtain biotechnology equipment or services produced or provided by a Biotechnology Company of Concern.</li><li>A U.S. Executive Agency may not enter into a contract (or extend or renew any contract) with an entity that, while not itself a Biotechnology Company of Concern, in performing such contract with the U.S. Executive Agency, (i) “uses” biotechnology equipment or services produced or provided by a Biotechnology Company of Concern, or (ii) enters into a contract that such entity knows, or has reason to believe, will require the use of biotechnology equipment or services produced or provided by a Biotechnology Company of Concern.</li><li>A U.S. Executive Agency may not obligate or expend loan or grant funds, and a loan and grant recipient is prohibited from using loan or granting funds, to (i) procure or obtain any biotechnology equipment or service from a Biotechnology Company of Concern, or (ii) enter into a contract with an entity described in item B, above.</li></ul>Key Differences Between 2024 and 2025 VersionsWhile most provisions remain the same between the 2024 and 2025 versions of the Act, there are a few key differences.<ul><li>Removal of Named Biotechnology Companies of Concern. Unlike both the former House and Senate versions of the BIOSECURE Act, the 2025 version does not explicitly list any Biotechnology Companies of Concern. In the 2024 versions of the BIOSECURE Act, the BGI Group, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics (named only in the 2024 House version) were specifically named as Biotechnology Companies of Concern. However, their inclusion was a principal reason the BIOSECURE Act did not pass last session, as some members of Congress expressed concerns that these companies’ due process rights were being violated.<a href="#_ftn3">[3]</a></li><li>New Process for Naming Biotechnology Companies of Concern. The 2025 BIOSECURE Act includes a new pathway for Biotechnology Companies of Concern to be named. Now, the definition includes entities identified on the Department of Defense’s annual list of Chinese military companies operating in the United States (commonly referred to as the “1260H List”). This is in addition to the option for the Office of Management and Budget (OMB) to name new Biotechnology Companies of Concern, as found in both the 2024 and 2025 versions.</li><li>New Due Process Protections for Named Companies. Entities that have been identified as Biotechnology Companies of Concern by OMB now have the right to submit information and arguments in opposition to their designation within 90 days, and the Act now requires that, where practicable, the government include mitigation steps that the entity might undertake to prevent the designation.</li><li>Exception for Medical Countermeasures During Public Health Emergencies. The 2025 version of the BIOSECURE Act adds an exception for countermeasures, medical products, related supplies, and ancillary medical supplies during declared public health emergencies.</li><li>Removal of Certain Technologies from Definition of Biotechnology Equipment or Service.The 2024 versions specifically included mass spectrometry technologies and polymerase chain reaction machines in the definition of Biotechnology Equipment or Service, but these mentions have been omitted in the 2025 version. Their inclusion was a major point of concern for industry when facing the 2024 version of the Act.</li></ul>Consequences of BIOSECURE Act Passage for Biotech CompaniesOne key implication of the BIOSECURE Act for affected companies is that the use of equipment or services of a Biotechnology Company of Concern—e.g., outsourcing the manufacturing of a drug substance or active pharmaceutical ingredients (API) used in a pharmaceutical product—may result in such products becoming ineligible for sales to U.S. Executive Agencies (for example, a supply contract to veterans’ hospitals or to the U.S. Department of Defense).Another implication of the Act for pharmaceutical companies is that if such companies use or plan to use U.S. federal grants to subsidize drug research and development, they will need to take measures to ensure that funded projects are designed to avoid paying federal funds to Biotechnology Companies of Concern. Pharmaceutical companies seeking post facto reimbursement of expenses should also be prepared to attest, in their funding applications, that the expenditures for which funding is being sought did not involve payments to Biotechnology Companies of Concern.Next StepsWhile passage of the BIOSECURE Act is likely, it is not yet guaranteed. Both chambers need to pass the NDAA in identical form before a final version can be sent to the U.S. president for final approval. To reconcile differences between the two versions, (1) the House or Senate can adopt the other chamber’s version of the bill, or (2) the chambers can appoint a formal conference committee to negotiate a compromised version.Given the likelihood of enactment, companies that receive or expect to receive significant revenue from sales of pharmaceutical products to U.S. Executive Agencies should therefore (i) review the manufacturing processes for their products, especially any outsourcing of manufacturing of their pharmaceutical products, (ii) assess whether the manufacturing processes of any pharmaceutical products that are (or expected to be) the subject of government contracts utilize equipment or services of a Biotechnology Company of Concern (or a company at risk of later being designated a Biotechnology Company of Concern), and (iii) consider modifying manufacturing processes to eliminate dependencies on such companies.This kind of review will be especially important for contractors that are already included on the Department of Defense’s 1260H List. While there is a grandfather period of five years for contracts already entered into with entities identified by OMB, this grace period does not exist for those on the 1260H List. Instead, these prohibitions will go into effect 60 days after the Federal Acquisition Regulation is revised regarding these companies.For pharmaceutical and biotech companies that are currently reliant on Biotechnology Companies of Concern, transitioning away from these companies could be challenging. Transferring manufacturing operations from one contract development and manufacturing organization (CDMO) to another takes time and resources. Depending on how the manufacturing process is affected, pharmaceutical companies may be required to file an amendment to their drug approvals and seek prior regulatory approval before commercializing products manufactured by the new CDMO. This is especially complicated because any changes to the manufacturing process of an FDA-approved drug must be reported to the FDA. Also, depending on the facts and circumstances of what is changing and the likelihood of an adverse effect to the identity, strength, quality, purity, or potency of a drug product, a pharmaceutical company may be required to file an amendment to its NDA and obtain prior approval to commercialize products produced using the new manufacturing process.It is also likely that the BIOSECURE Act will more adversely impact small biopharmaceutical companies than large ones. Large pharmaceutical companies often (i) own their own manufacturing facilities and are therefore not dependent or are less dependent on CDMOs to support manufacturing and (ii) have more resources to facilitate a change in CDMO (changing CDMOs can be a complex and intensive process).<a href="#_ftn4">[4]</a> Larger companies are also more likely to work with multiple manufacturing partners and therefore find it easier to shift manufacturing to an alternative CDMO. Smaller pharmaceutical companies, on the other hand, are often more dependent on outsourcing services of CDMOs and may also have few resources to change CDMOs, if their current CDMO is designated a Biotechnology Company of Concern.___________________________________<a href="#_ftnref1">[1]</a> S. Amend. 3236 to S. 2296, 119th Cong. (2025).<a href="#_ftnref2">[2]</a> Health Industry Distributors Association, 2023 United States Federal Procurement Market Report (2023), <a href="https://www.hida.org/distribution/news/press-releases/2023/federal-spending-medical-supplies-8-billion.aspx" target="_blank">https://www.hida.org/distribution/news/press-releases/2023/federal-spending-medical-supplies-8-billion.aspx</a>.<a href="#_ftnref3">[3]</a> Josh Abbott, “BIOSECURE Act passes through US House,” BioProcess International (Sept. 11, 2024), <a href="https://www.bioprocessintl.com/regulations/biosecure-act-passes-through-us-house" target="_blank">https://www.bioprocessintl.com/regulations/biosecure-act-passes-through-us-house</a>; Fraiser Kansteiner, “After BIOSECURE Act passes in House, targeted Chinese companies say they’re ‘deeply’ concerned” (Sep. 10, 2024), <a href="https://www.fiercepharma.com/pharma/china-focused-biosecure-act-passes-house-heres-what-targeted-companies-are-saying" target="_blank">https://www.fiercepharma.com/pharma/china-focused-biosecure-act-passes-house-heres-what-targeted-companies-are-saying</a>; Steven T. Dennis and Roxana Tiron, “Biosecure Act Out of Key Defense Bill in Win for Chinese Biotech,” Bloomberg (Dec. 7, 2024), <a href="https://www.bloomberg.com/news/articles/2024-12-08/biosecure-act-out-of-key-defense-bill-in-win-for-chinese-biotech" target="_blank">https://www.bloomberg.com/news/articles/2024-12-08/biosecure-act-out-of-key-defense-bill-in-win-for-chinese-biotech</a>.<a href="#_ftnref4">[4]</a> Miranda McLaren, “A quick guide to transferring a commercial drug product to a new fill-finish CDMO,” Pharmaceutical Technology (Sept. 4, 2024), <a href="https://www.pharmaceutical-technology.com/sponsored/a-quick-guide-to-transferring-a-commercial-drug-product-to-a-new-fill-finish-cdmo/#:~:text=Fill%20finish%20is%20a%20pivotal%20phase%20in%20drug,out%20the%20journey%20from%20onboarding%20to%20batch%20release" target="_blank">https://www.pharmaceutical-technology.com/sponsored/a-quick-guide-to-transferring-a-commercial-drug-product-to-a-new-fill-finish-cdmo/#:~:text=Fill%20finish%20is%20a%20pivotal%20phase%20in%20drug,out%20the%20journey%20from%20onboarding%20to%20batch%20release</a>.

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

Associate

Atiq Chowdhury is an associate in the FDA + Healthcare Regulatory and Compliance practice, where he advises FDA-regulated companies on a wide range of regulatory, enforcement, and compliance matters. 

Atiq Chowdhury

Lindy Pittman

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China Patent Eligibility Update: Human Embryonic Stem Cells

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It’s Baaack… The BIOSECURE Act Passes Senate

On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods that, in the EU, are collectively termed “new genomic techniques” (NGTs). This agreement came after months of political deadlock and allows new formal negotiations with the European Parliament to begin. It marks a pivotal step forward in advancing the legislative proposal adopted by the European Commission on July 5, 2023 (Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625; 2023 Proposal), which aims to create new regulations tailored to plants produced using NGTs (NGT Regulation) in order to adapt the EU regulatory landscape to better fit the technological developments of recent decades in the field of plant breeding. Thus, the March 2025 agreement sets the stage for further negotiations, bringing the EU closer to finalization and implementation of the NGT Regulation.Read our <a href="https://www.mofo.com/resources/insights/250425-april-2025-update-on-regulation" target="_blank">client alert</a>.

April 2025 Update on Regulation of New Genomic Techniques in the EU

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FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this.On December 17, 2024, Congress presented a short-term funding bill that, if passed, would prevent a partial government shut down and fund the government through March 14, 2025.[1] On top of additional spending for disaster relief, the draft funding bill includes a more than 500-page health care package with a short section that may raise the eyebrows of everyone working at life sciences and pharmaceutical companies. Specifically, Section 904, which outlines amendments to 35 U.S. § 271(e) and would impose a limit on the number of patents that can be asserted in litigation over approval of biosimilars under Section of 351(k)[2] of the Public Health Service Act. The proposed legislation would restrict innovators in the biologics space (referred to herein as “reference product sponsors”) to asserting “not more than 20 patents” in litigation against applicants for approval of a biosimilar under Section of 351(k) of the Public Health Service Act (referred to herein as “subsection (k) applicants”).[3] There is some complexity around the “20-patent limit” under the proposed amendments, and this article explains which patents would be covered under that limit, which would not be covered, and how the limit may be modified by the courts.Covered PatentsThe patents covered under the new 20-patent limit must satisfy each of the following criteria:<ul><li>Claim the biological product or a method or product used in the manufacture of the biological product;</li><li>Be disclosed by the reference product sponsor to the subsection (k) applicant as a patent the reference product sponsor believes covers making, using, offering to sell, or importing into the United States the biological product;[4] and</li><li>Have an actual filing date of more than four years after the date the reference product is approved or include a claim to a method of manufacturing process that is not used by the reference product sponsor.</li></ul>Notably, patents directed to a method for using the product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use,[5] would not be included in the 20-patent limit.Increases to the LimitThe proposed statutory language outlines the ways a court can increase the number of patents that the reference product sponsor can assert against the subsection (k) applicant.If a request to increase is made without undue delay, and if the interests of justice require or good cause is shown, the court:<ul><li>Shall increase the number of patents that the reference product sponsor can assert if the subsection (k) applicant fails to provide enough information in the subsection (k) application to enable the reference product sponsor to form a reasonable belief as to if an infringement claim could reasonably be asserted, and</li><li>May increase the number of patents that the reference product sponsor can assert: if there is a material change in the product or subsection (k) application, if the patent would have issued ahead of the effective date of the biosimilar application approval but for patent office delay, or for other reasons deemed to be good cause by the court.</li></ul>The limit is also not imposed if the subsection (k) applicant has not completed all necessary disclosures related to patents covering the biological product. The necessary actions are described under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of § 351(l) of the Public Health Service Act and are intended to ensure both parties exchange necessary information regarding the subsection (k) biological product, patents covering the biological product, and potential infringement of the patents.ImplicationsAs drafted, the amendments to 35 U.S. § 271(e) would limit the number of patents that innovators of biologics will be able to assert in infringement suits against biosimilar applicants. The impact of this legislation would be felt most directly by life sciences companies with large patent portfolios for their approved biologics. The 20-patent limit would be a relief for biosimilar applicants, who sometimes face upwards of that number of patents at least in the initial stages of litigation before that number is whittled down. However, the law’s impact would be blunted by the substantial limitations on which patents are subject to the restrictions. First, only patents filed after approval of the product will likely be subject to the limit. Second, courts are given wide discretion to increase the limits beyond 20 patents. Accordingly, even if this change to 35 U.S. § 271(e) is enacted via this bill or some other future bill, life sciences companies should not be deterred from pursuing additional patent protection for biological products based on this legislation.<blockquote>While there remains uncertainty regarding the ultimate fate of this bill, there is unlikely to be serious debate about these patent-related provisions before passage. The deadline for Congress to enact a funding bill to avoid a government shutdown is Friday, December 20, 2024, at midnight. </blockquote>[1] <a href="https://www.congress.gov/bill/118th-congress/house-bill/10445" target="_blank">H.R. 10445 - 118th Congress (2023-2024): Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 | Congress.gov | Library of Congress</a>.[2] <a href="https://www.law.cornell.edu/uscode/text/42/262" target="_blank">42 U.S. Code § 262 - Regulation of biological products | U.S. Code | US Law | LII / Legal Information Institute</a>.[3] Section 904(a)(2) (emphasis added).[4] Patents described in paragraph (3)(A) of § 351(l) of the Public Health Service Act, including newly issued or licensed patents under paragraph (7) of § 351(l).[] Section (B)(i) of the amendment to 35 U.S. § 271(e) provides that covered patents include those “that claim the biological product … (or a use of that product) or a method or product used in the manufacture of such biological product.” (emphasis added). Despite this reference to “or use of that product,” section (E)(ii) explicitly states that the provisions of the law “shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.”

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Briana’s practice focuses on patent preparation, prosecution, and counseling in the areas of biotechnology, pharmaceuticals, and artificial intelligence.

Briana Erin Mittleman Ph.D.

Briana Mittleman

Clinical Stage Pharmaceutical Company

Aurinia Pharmaceuticals 

Seagen

Frontier Medicines

Cerus 

General Catalyst 

Frazier Life Sciences

Abingworth 

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Dr. Lisa Silverman’s practice focuses on patent portfolio management and strategic patent counseling in the areas of life sciences, pharmaceuticals, and chemistry. 

Lisa N. Silverman Ph.D.

Lisa Silverman

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

On September 12, 2024, Morrison Foerster, in collaboration with Bayer Co.Lab, hosted a pivotal panel discussion under the title “MoForum Charting the Biotech Startup Journey” at Morrison Foerster’s Berlin office.The event provided an in-depth exploration of the biotech startup ecosystem, particularly focusing on the journey from foundation and early-stage funding to growth, scaling, and successful exits. The event was a tremendous success, drawing attention to the vibrant biotech scene in Berlin and Germany and providing valuable insights into the challenges and opportunities faced by startups in this dynamic sector.Wolfgang Schönig, a partner at Morrison Foerster specializing in Life Sciences Transactions and Licensing, led through the evening. He was joined by an esteemed panel of industry leaders, including Ruth Shah (Head of Bayer Co.Lab Berlin), Anela Vukoja (Principal at Apollo Health Ventures), Elisa Kieback (Co-founder and CTO of T-knife Therapeutics), Stefanie Urlinger (Chief Scientific Officer of Cimeio Therapeutics), Nikita Sharma (Principal at Versant Ventures), and Jan‑Philipp Kruse (Senior Director at Lilly Ventures).Key Takeaways from the Panels DiscussionThe panel discussion was segregated into four different chapters curated along the lifecycle of a Biotech company. The topics covered in the discussion and key take aways include:<ul><li>Chapter 1: Foundation and Early-stage Funding The discussion highlighted the critical role of technology transfer and the need for streamlined processes to facilitate the transition from academic research to commercial ventures. Panelists emphasized the importance of public funding in setting attractive incentives for private investments. Key takeaways included the need for academia to be measured by tech transfer impact and the importance of creating good data to attract private investments.</li><li>Chapter 2: Growth and Scaling Insights from this session underscored the necessity of shifting from an academic to a commercial mindset for successful growth and scaling. The panelists discussed the challenges of attracting growth funding and the strategic importance of establishing a U.S. presence to attract more risk-tolerant investors. Critical aspects covered included the need to professionalize processes, particularly regarding quality and compliance, and the importance of having a clear focus and a lean operational model.</li><li>Chapter 3: Partnering and Internationalization This segment of the discussion focused on the significance of forming partnerships with Big Pharma and the advantages of operating across multiple biotech hubs, including the United States and Germany. The panelists shared their experiences and strategies for successful international expansion. Key points included the benefits of different ecosystems and the importance of new ways to collaborate.</li><li>Chapter 4: Achieving Successful Exits The final chapter dealt with exit strategies, highlighting various scenarios and the importance of aligning these with the goals of stakeholders. The discussion provided insights into managing stakeholder relationships throughout the exit process to ensure the continuation of innovation. The panelists discussed the different opinions on exit scenarios and the critical milestone of bringing innovation forward.</li></ul>ConclusionThe MoForum on Charting the Biotech Startup Journey offered invaluable insights and fostered discussions that underscored the collaborative spirit necessary to drive innovation in the biotech sector. Morrison Foerster and Bayer Co.Lab are proud to have facilitated this engaging and informative event.Watch this spot for further information on the German and Berlin Biotech scene.<div><img class="rich-text-embed-image" alt="Panelist group 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltdf181cb90a577444/66e9d0b98dc03a91091b5170/Panelists-life-sciences-blog.jpg?format=auto&amp;quality=60"/></div><div><img class="rich-text-embed-image" alt="Group photo 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blte90deeae9321508c/66e9d2f4a924ba3445df2574/panel-discussion-life-sciences.jpg?format=auto&amp;quality=60"/></div><div><img class="rich-text-embed-image" alt="Terrace photo" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc4e0b9d4966489b2/66e9d2dd44a1ad887c36a4c1/crowd-terrace-life-sciences.jpg?format=auto&amp;quality=60"/></div>

MoForum: Bayer Co.Lab Edition – Charting the Biotech Startup Journey

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

Alpine Immune Sciences

Karen Potter

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