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

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In the wake of a December 2, 2024, ruling from the U.S. District Court for the Northern District of California that struck down...

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In the wake of a December 2, 2024, ruling from the U.S. District Court for the Northern District of California that struck down core USDA Animal and Plant Health Inspection Service (APHIS) regulations on genetically engineered (GE) organisms, the agency announced on December 19, 2024, that it will revert to its pre-2020 regulatory framework for GE organisms. Please see our <a href="https://lifesciences.mofo.com/topics/an-insecure-future-court-ruling-guts-usda-regs-on-genetically-engineered-plants" target="_self">updated blog post </a>for more information.Original post (December 6, 2024):In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024, struck down the 2020 USDA Animal and Plant Health Inspection Service (APHIS) rule codified at 7 C.F.R. § 340 regarding GE plants. The court vacated APHIS’s 2020 rule, formerly known as the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) rule, which had been adopted to streamline USDA oversight of plants developed using genetic engineering.

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group and Food + Agriculture Group.Life SciencesFor his work across the life sciences sector, Mike was named San Francisco Biotechnology Lawyer of the Year by Best Lawyers in America in 2020 and is recommended for his patent strategy and prosecution practice in LMG Life Sciences. He also led the team that was named 2022 Patent Management and Strategy Firm of the Year at the 2022 LMG Life Sciences Americas Awards.Food + AgricultureRecognized as “one of the world’s foremost plant and agriculture IP lawyers,” Mike manages a wide range of intellectual property issues related to plants and plant products. He and his team advise clients on plant and plant utility patents; licensing agreements for plant IP; litigation in U.S. state and federal court and before the International Trade Commission; and regulatory approvals from the USDA, FDA, and EPA for gene edited and genetically engineered plants.Patent Strategy + ProsecutionMike is a Legal 500 US Hall of Fame lawyer for patent prosecution and is consistently named one of the leading IP lawyers by Managing Intellectual Property, Chambers USA and Chambers Global, and IAM Patent 1000.Mike works closely with many clients to develop and manage their patent portfolios. He helps clients identify, monitor, and assess the infringement risks of third-party patents. He also assists clients in preparing both offensive and defensive patent portfolios, with a particular emphasis on drafting patent applications that will be utilized in licensing and in litigation efforts.IP Due DiligenceFor venture capitalists seeking to invest in early- and mid-stage companies, underwriters involved in IPOs, and companies seeking to acquire or merge with other companies, Mike has managed extensive IP diligence. His work includes assessment of the strengths and weaknesses of patent portfolios, evaluation of freedom to operate issues, and strategic recommendations for maximizing the value of patent portfolios going forward.Mike also works closely with the IP Litigation Group on various litigation matters including patent interferences to determine the first-to-invent and patent re-examination work and actively participates in both mediation and arbitration proceedings on behalf of clients in the life sciences and food and agriculture areas.He is a frequent lecturer and speaker. Among numerous speaking engagements, Mike is the IP instructor at the UC Davis Licensing Academy and founded Morrison Foerster’s annual Harvard Biotechnology Club Fall Patent Law Course.Mike holds a Ph.D. in plant physiology (biochemistry) and an M.S. in agronomy from the University of California, Davis; a B.S. in biology from the University of California, Berkeley; and a J.D. from Golden Gate University School of Law. He was a post-doctoral fellow in plant molecular biology at the Harvard Medical School and the Department of Molecular Biology at Massachusetts General Hospital, where he worked on the Arabidopsis genome project.

Michael Ward

Partner

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety. Bill started his career at the U.S. Environmental Protection Agency, Office of Regional Counsel in San Francisco, and he currently leads the firm’s environmental practice.Bill routinely advises clients in connection with their carbon reduction and climate-related goals and claims (including carbon neutral and net zero carbon commitments) and helps clients substantiate their claims and avoid greenwashing claims. He frequently advises clients in connection with the Federal Trade Commission’s Green Guides, state consumer protection statutes, and a broad range of sustainability and chemical disclosure laws. He defends clients in environmental and consumer class action litigation in courts throughout the country and is highly regarded for his ability to coordinate technical, legal, and communications teams to counsel clients through crises. He has tried cases in state and federal courts for a variety of complex and multidistrict litigation matters, including product liability claims and environmental and land use disputes.Bill represents the firm’s clients in nearly every aspect of environmental regulation and supports the firm’s global transactional practices in all areas of U.S. environmental law. He is also a member of the firm’s Sustainability + Corporate Responsibility Steering Committee.<h5>Environmental Litigation and Regulatory</h5>Bill has represented the firm’s clients before a broad range of environmental regulatory agencies in rulemaking proceedings, permit applications, and appeals and enforcement actions. Bill heads MoFo’s environmental due diligence teams and serves as the lead on transactional negotiations involving environmental liability risks, including significant experience in cross-border transactions.<h5>Consumer Class Action, False Advertising, and Product Liability</h5>Bill has broad experience in consumer class action and false advertising litigation, especially concerning claims of health or environmental benefits. He has also advised numerous well known life sciences, technology, and consumer product companies on consumer disclosures and warnings, including compliance with U.S. and European requirements governing product safety.<h5>More About Bill</h5>Before entering private practice, Bill clerked at the U.S. Environmental Protection Agency, Region IX Office of Regional Counsel, where he assisted in the prosecution and resolution of cases brought by the U.S. Department of Justice for violation of the Clean Air Act, Clean Water Act, and Resource Conservation and Recovery Act.Bill received his J.D. with honors from the Georgetown University Law Center and completed the Law and Public Health program sponsored by Georgetown University and the Johns Hopkins Bloomberg School of Public Health. Through this program, he earned a master’s in public health, as well as specialty certification in environmental health risk assessment from the Johns Hopkins Risk Sciences and Public Policy Institute. At Georgetown, he was an executive editor of the Georgetown International Environmental Law Journal and received the CALI Award for Excellence in International Environmental Law. In 2000, he studied law at the Universidad de Mendoza, in Mendoza, Argentina, as an international law fellow. He earned his bachelor’s degree from the University of California, Berkeley.

William Tarantino

Caressa Tsai is an associate in Morrison Foerster’s San Francisco office and a member of the firm’s Patent Strategy + Prosecution Group.Caressa’s practice focuses on life sciences and biotechnology patent drafting and prosecution.Before joining Morrison Foerster as an associate, Caressa was a summer associate and law clerk at the firm in the Two-Summer Patent Program.Caressa received her J.D. from the University of California, Berkeley, School of Law, where she was a publishing editor of the California Law Review and a senior life sciences editor for the Berkeley Technology Law Journal. She received Jurisprudence Awards for Life Sciences and Innovation Workshops I and II, the Prosser Prize for Intellectual Property Law, and the Law and Technology Certificate.Prior to law school, Caressa received her Ph.D. in biochemistry and biomedical sciences from McMaster University. Her Ph.D. research focused on exploiting host immune pathways for anti-infective drug discovery in Salmonella. She graduated with an H.B.Sc. with high distinction in biology from the University of Toronto, where her research focused on bioinformatic approaches to detect signatures of selection in intrinsically disordered proteins. Caressa has experience in research and matters relating to bacterial genomics, molecular biology, protein biochemistry, infectious diseases, immunology, and computational biology.