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U.S. Regulatory Requirements for Gene Edited Plants

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Join Morrison Foerster and University of Minnesota Technology Commercialization and Center for Precision Plant Genomics for a webinar exploring the overlapping roles of USDA, FDA, and EPA in the regulation of gene edited plants.

Join Morrison Foerster and University of Minnesota Technology Commercialization and Center for Precision Plant Genomics for a webinar exploring the overlapping roles of USDA, FDA, and EPA in the regulation of gene edited plants.Gene editing has the potential to revolutionize agriculture and food production, but innovators in this sector must navigate a complex regulatory landscape to successfully commercialize a product. In the United States, gene edited plants are regulated under a coordinated framework governed by USDA, FDA, and EPA, and it is critical that scientists, entrepreneurs, and investors in this sector have an understanding of the role each agency plays. In this program, MoFo’s leading patent, FDA, and EPA lawyers will provide an overview of how these agencies intersect and important recent regulatory developments.Topics of discussion include:<ul><li>How USDA, FDA, and EPA work together to regulate gene edited plants and foods produced therefrom</li><li>Strategic considerations for addressing USDA’s SECURE rule</li><li>Developments in regulations addressed at the recent USDA-BRS Stakeholder Meeting in December 2022﻿</li></ul>Speakers:<div><ul><li>​​​​Michael Ward, Ph.D., Partner & Chair, Plant Intellectual Property, Life Sciences, and Patent Groups; Co-chair, IP and Food + Agriculture Groups, Morrison Foerster</li><li>Stacy Cline Amin, Partner & Chair, FDA + Healthcare Regulatory and Compliance Group, Morrison Foerster, former FDA Chief Counsel and Deputy General Counsel of the Department of Health and Human Services</li><li>Brigid Bondoc, Partner, FDA + Healthcare Regulatory and Compliance Group, Morrison Foerster</li><li>Bill Tarantino, Partner, EPA Regulatory Strategist, Morrison Foerster</li></ul></div><hr>

U.S. Regulatory Requirements for Gene Edited Plants

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.As co-chair of the Patent Group, Mike manages a team that includes 80+ Ph.D.s and 100+ attorneys and others with advanced scientific degrees in life sciences and related engineering disciplines. From small molecules and antibodies to gene editing, artificial intelligence, and machine learning, MoFo has deep experience protecting some of the most important innovations in the life sciences and food and agriculture sectors.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

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.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

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 ESG + Sustainability 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.

U.S. Regulatory Requirements for Gene Edited Plants

16 Feb 2023 12:00 PM - 1:30 PM CST