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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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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Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

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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.AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must also comply with a constantly evolving data privacy, security, and AI regulatory landscape. In this blog post, we consider how several key data privacy, security, and AI principles impact the use of AI in life sciences.Notice and ChoiceUnder U.S. and foreign data privacy laws, companies are required to inform consumers about how they collect, use, and process consumers’ personal data such as health data. Through its enforcement actions, the FTC has made clear that companies must provide consumers with notice and obtain their consent before acquiring their sensitive information, which includes health data. Under U.S. state consumer privacy laws as well as the <a href="https://gdpr-info.eu/art-9-gdpr/" target="_blank">EU General Data Protection Regulation (GDPR)</a>, companies must obtain express consent before collecting a consumer’s health data. Certain U.S. state laws, such as <a href="https://app.leg.wa.gov/RCW/default.aspx?cite=19.373&full=true" target="_blank">Washington’s My Health My Data Act</a>, also require businesses to post an additional, dedicated consumer health data <a href="https://app.leg.wa.gov/RCW/default.aspx?cite=19.373.020" target="_blank">privacy notice</a>, and to obtain consumer consent for uses and disclosures of health data that aren’t necessary to provide the product or service required by the consumer. Note, however, that health data subject to the <a href="https://www.law.cornell.edu/wex/health_insurance_portability_and_accountability_act_(hipaa)" target="_blank">Health Insurance Portability and Accountability Act (HIPAA)</a> is exempt from these U.S. state laws and subject to federal privacy and security requirements.The use of AI in the healthcare context may also trigger additional notice and choice requirements. For example, companies in the healthcare space that use automated decision making to determine whether a consumer should be offered healthcare services must offer consumers the right to opt out from the company’s use of the automated decision-making activity under the <a href="https://gdpr-info.eu/art-22-gdpr/" target="_blank">GDPR</a> and forthcoming <a href="https://cppa.ca.gov/regulations/ccpa_updates.html" target="_blank">regulations</a> in California. To the extent that U.S. state privacy laws apply, the use of AI in the healthcare space may also trigger the right to opt out of profiling.TransparencyCompanies that use AI chatbots to communicate with consumers about their healthcare, such as chatbots that assist users in diagnosing their symptoms, are also subject to transparency requirements. Specifically, under laws such as <a href="https://le.utah.gov/~2024/bills/static/SB0149.html" target="_blank">Utah’s AI Policy Act</a>, companies must disclose that the consumer is chatting with AI and not a human. Similar requirements under the <a href="https://artificialintelligenceact.eu/article/50/" target="_blank">EU AI Act</a> and <a href="https://leg.colorado.gov/sites/default/files/2024a_205_signed.pdf" target="_blank">Colorado AI Act</a> will take effect in the coming year.Explainability and Bias MitigationConsumers affected by the decision of an AI system must be provided with an explanation of how the decision was reached. The FTC <a href="https://www.ftc.gov/policy/advocacy-research/tech-at-ftc/2025/01/ai-risk-consumer-harm" target="_blank">advises</a> companies to take necessary steps to prevent harm before and after deploying AI models, including taking preventative measures to detect and deter AI-related impersonation and fraud.<a href="#_ftn1" target="_self">[1]</a> The <a href="https://leg.colorado.gov/sites/default/files/2024a_205_signed.pdf" target="_blank">Colorado AI Act</a> requires deployers of high-risk AI systems that make a decision adverse to the consumer—such as systems that determine whether to grant an individual preventative care—to provide the consumer with a statement disclosing the reasons for the decision, the degree to which AI contributed to the decision, the type of data processed by the AI in making the decision, and an opportunity to appeal the decision. If technically feasible, the appeal must also allow for human review.Similarly, companies must take steps to reduce bias in their AI-based decision making. Large language models, for example, can perpetuate biases in the medical system such as race-based equations to determine organ capacity. While completely eradicating biases may be impossible, both the <a href="https://leg.colorado.gov/sites/default/files/2024a_205_signed.pdf" target="_blank">Colorado AI Act</a> and <a href="https://artificialintelligenceact.eu/article/11/" target="_blank">EU AI Act</a> require developers of high-risk AI systems to publish a public statement explaining how they manage known or reasonably foreseeable risks of algorithmic discrimination associated with the development of such systems. Under the EU AI Act, AI systems subject to the EU Medical Devices Regulation, such as those that diagnose illness, are considered high-risk even if a human doctor makes the final decision. Such systems are required to comply with the EU AI Act’s high-risk system <a href="https://artificialintelligenceact.eu/article/16/" target="_blank">requirements</a> including the development of a risk management system and implementation of transparency and human oversight requirements.Individual RightsUnder the Colorado AI Act, deployers of a high-risk AI system that makes a consequential decision concerning a consumer must provide the consumer with the right to opt out of the processing of their personal data for these purposes. In addition, under state consumer privacy laws in the United States and the GDPR in Europe, consumers must be offered the ability to access, correct, and delete their personal data, including their health data. However, when a company uses health data to train an AI model or as input to an AI model, the data cannot be “deleted” from the model in response to a consumer’s request. Companies that use AI models to process such information must find alternative ways to comply with consumers’ deletion requests, such as to suppress the data in the model or anonymize it, which is typically considered a form of deletion under applicable privacy laws.Data SecurityIn both the United States and Europe, the unauthorized disclosure of health data triggers requirements to notify affected individuals and regulators. To protect against such incidents, companies must comply with applicable security requirements. For example, in the United States, companies regulated by the <a href="https://www.hhs.gov/hipaa/for-professionals/security/index.html" target="_blank">HIPAA Security Rule</a>, such as healthcare providers that engage in HIPAA-covered transactions, must implement administrative, physical, and technical safeguards to protect electronic protected health information. Under the <a href="https://gdpr.eu/article-32-security-of-processing/" target="_blank">GDPR</a>, companies must implement appropriate technical and organizational measures to protect personal data.The use of AI to process health data also triggers novel data security risks, such as adversarial attacks on AI systems to tamper with the model or steal sensitive data from it. To address these concerns, companies should consider complying with AI-specific risk mitigation standards, such as the <a href="https://www.nist.gov/itl/ai-risk-management-framework" target="_blank">NIST AI Risk Management Framework</a>.EnforcementU.S. and EU regulators actively enforce violations of data privacy and security requirements in connection with sensitive data, and we expect to see increased enforcement of AI in the coming years. The FTC, for example, has initiated enforcement actions against companies that share consumer health data with third parties, and the U.S. Department of Health and Human Services has investigated complaints alleging the impermissible use and disclosure of, and lack of measures to safeguard, HIPAA protected health information. European data protection authorities have imposed fines on healthcare facilities for the collection of health data without notice and the lack of appropriate technical and organizational measures to protect personal data from unauthorized access.TakeawaysTo effectively leverage AI in the life sciences sphere while remaining compliant with relevant AI requirements and data privacy and security principles, companies should take the following steps:<ul><li>Develop a risk management program that spans the lifecycle of an AI system and that reduces biases in the system’s decision making, maintains human oversight and accountability, and ensures robust data security controls;</li><li>Minimize the amount and sensitivity of health data ingested into AI systems;</li><li>Provide consumers with the option to contest an AI-produced adverse decision and inform consumers about steps taken to reduce bias in AI;</li><li>Determine how to comply with consumers’ personal data requests, including requests to delete personal data from AI models; and</li><li>Take appropriate steps to secure personal data in AI models against unauthorized disclosure, such as adversarial training to reduce the risk of adversarial attacks and strict access controls to prevent model theft.</li></ul><a href="https://wordhtml.com/#_ftnref1">[1]</a> As relevant to medical device companies, the U.S. FDA and UK MHRA have jointly <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles" target="_blank">identified</a> guiding principles for good machine learning practice.

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Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector.

Melissa M. Crespo

Melissa Crespo

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Marijn Storm specializes on the intersection of law and technology, with a focus on cutting-edge technologies, such as (generative) artificial intelligence (AI) and large language models, ethical tech, and biometrics. 

Marijn Storm

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Marian Waldmann Agarwal is a partner in the Privacy + Data Security Group at Morrison Foerster. She also co-leads the firm’s Artificial Intelligence Group and is a member of the global Environmental, Social, and Governance (ESG) Steering Committee.

Marian Waldmann Agarwal

Marian A. Waldmann Agarwal

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Joshua R. Fattal is an associate in Morrison Foerster’s Privacy + Data Security Group. He advises clients across industries on data protection best practices, product development, complex national and international regulatory compliance, transaction diligence, incident preparedness and response, and emerging topics, such as the use of artificial intelligence (AI).

Joshua R. Fattal

Joshua Fattal

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Katherine Wang

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Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral arguments in The Regents of the University of California v. Broad Institute, Inc., No. 22-1653, were more than a year ago, and the decision just came down on Monday, May 12, 2025. But the decision was not the final word. The Federal Circuit vacated and remanded, sending the case back the U.S. Patent Office to try again at resolving which party was the first to invent a single guide CRISPR-Cas system for eukaryotic gene editing. This interference is one of several ongoing disputes related to the technology.Read the <a href="https://www.mofo.com/resources/insights/250513-federal-circuit-vacates-and-remands" target="_blank">full client alert</a>.

 Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

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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

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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