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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

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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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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.

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of AI on intellectual property, licensing, contracts, regulatory policy, enforcement, privacy, and venture markets in life sciences.Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks, AI agents are semi-autonomous software systems capable of independently making decisions traditionally reserved for humans, performing complex sequences of tasks, and interacting dynamically with other systems with minimal human intervention. In the life sciences and medtech industries, these agents can autonomously design experiments, analyze research data, monitor clinical trials, optimize manufacturing processes, interact with patients and provide support, and even generate novel hypotheses for investigation.As the medtech industry moves toward wider adoption of AI agents as a service (AIAaaS), businesses should consider adopting a nuanced framework for their commercial contracts.1. Navigating Data Rights and UsageNow more than ever, data is central, making data ownership and usage rights a pivotal point in contract negotiations. Providers typically prefer broader access to anonymized patient data to continually enhance AI model accuracy and capabilities. Healthcare organizations and other customers, however, are typically concerned with patient privacy and compliance obligations, which may lead them to limit data usage strictly. Companies negotiating AIAaaS agreements may therefore wish to explicitly address data access parameters, permissible usage scopes, audit procedures, and specific regulatory obligations (e.g., HIPAA and GDPR compliance).Companies should consider whether particular ownership and usage rights should apply to different categories of data, such as raw input data, generated output, and analytical data related to model and AI agent performance.2. Intellectual Property ClarityIntellectual property (IP) considerations surrounding AI agents can involve complexities such as ownership of algorithms, datasets, user-driven improvements, and AI-generated outputs. Providers generally aim to retain core AI technology rights, whereas healthcare organizations and other customers may seek rights or exclusive access to specific customizations or derivative outputs. Clearly delineating ownership, permitted uses, and restrictions within agreements can help ensure a successful collaboration.3. Addressing Regulatory FrameworksAI agents in medtech operate within a multi-jurisdictional and rapidly evolving regulatory landscape. Agreements should consider the scope of regulatory obligations and which party is responsible for complying with them. For example, parties should determine whether the AI agent qualifies as a medical device under FDA or international regulations and who is responsible for its compliance. The parties should also address compliance with the EU AI Act, particularly if the AI system would be classified as “High Risk” under Article 6. And given the rapidly changing landscape, parties should build in flexibility to adapt as needed when further guidance comes.4. Managing Responsibility and Human OversightAs companies give AI agents more autonomy in clinical settings—particularly in high-risk areas like diagnostics and patient care decisions—clear delineation of the scope of oversight and responsibility for its implementation becomes crucial. The required level of human oversight can vary significantly depending on the AI system’s complexity and risk profile. Additionally, where AI agents directly interact with patients or healthcare professionals, transparency about AI involvement, clarity in operational guidelines, and mechanisms for feedback or reporting concerns can be critical. AIAaaS agreements should articulate specific oversight requirements and define roles and responsibilities.5. Liability Allocation and Third-Party ManagementThe autonomous nature of AI agents introduces unique liability considerations. Parties might consider clearly distinguishing between liability related to inherent AI system errors and liability stemming from misuse or inadequate human oversight. The parties may treat the former as an inherent business risk, potentially offset by a lower-priced service. The latter may be more reasonably allocated to a party. Contracts may also need to reflect any risk allocation requirements mandated by underlying AI model providers as flow-down requirements. Further, vendors may be more able to accept customer-imposed regulatory, quality, and cybersecurity requirements if they can pass those risks in their own AI vendor agreements.As medtech companies increasingly consider AI agents, companies may need to adjust their commercial contracting framework. Thoughtful negotiation around data ownership and usage rights, IP protections, regulatory responsibilities, human oversight, and liability allocation will be critical.

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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Tricia Matibag is an associate in the Boston office of Morrison Foerster and a member of the firm’s Technology Transactions Group.

Tricia Matibag

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AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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On Tuesday, FDA proposed a <a href="https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/front-package-nutrition-labeling" target="_blank">rule</a> that would require a front-of-pack mini nutrition label on most packaged foods by 2028. This is yet another effort by FDA to make it easier for consumers to determine which foods are “healthy” at a quick glance. Last month, FDA set a final rule on using the term “healthy” and its derivatives on food packaging, which also takes effect in 2028. And FDA is considering coming up with a symbol to indicate whether a product meets FDA’s definition of healthy.The proposed nutrition label has two requirements: (1) display the three nutrients that research shows are the leading contributors to chronic disease: saturated fat, sodium, and added sugars, and (2) interpret whether the amount of those nutrients in the product is “high,” “medium,” or “low.” Manufacturers are permitted to voluntarily include calories, as well. This front-of-pack label is meant to complement the complete nutrition facts panel on the back or side of the packaging and bring more “healthy” choices to consumers’ front of mind while shopping.<div data-reactroot=""><img class="rich-text-embed-image" alt="250117-life-sciences.jpg" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltdd6cb6a960bbd5d9/678ad1694a7803cc946bf58f/250117-life-sciences.jpg?format=auto&amp;quality=60"/></div>Comments on the proposed rule are due by May 16, 2025. We will continue to monitor and report on any updates.

Nature's Path Foods

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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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Front-of-pack, Front-of-mind

*Update: On February 24, 2025, the U.S. Department of Health and Human Services delayed the effective date for the “Healthy” Nutrient Content Claim final rule (“Final Rule”) until April 28, 2025 (previously February 25, 2025). This notice, signed by Robert F. Kennedy Jr., follows the “<a href="https://www.whitehouse.gov/presidential-actions/2025/01/regulatory-freeze-pending-review/" target="_blank">Regulatory Freeze Pending Review</a>” memorandum issued by President Trump on January 20, 2025, which orders federal agencies to consider postponing the effective date of rules that have been issued, but not yet taken effect, for 60 days. This is likely the beginning of a string of orders supporting President Trump’s Make America Healthy Again (“MAHA”) Commission. The Final Rule’s compliance date, February 25, 2028, remains unchanged. However, according to the memorandum, FDA may open a comment period for the Final Rule and, as necessary, further delay the effective date. If FDA opens a comment period and, upon review, finds that the Final Rule “raise[s] substantial questions of fact, law, or policy,” FDA would likely need to consult with the OMB Director and “take further appropriate action.” We will provide updates as new developments unfold.<hr class="divider">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 April 28, 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 in the <a href="https://www.fda.gov/media/184535/download?attachment" target="_blank">FDA’s Updated “Healthy” Claim Definition</a> and the <a href="https://www.fda.gov/media/184538/download?attachment" target="_blank">Updated Healthy Claim & What it Means for You Factsheet</a>.

What is “Healthy?” Are Fats In?

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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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Elena Klonoski