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Legal Considerations in Commercializing Gene-Edited Plants: IP Protection, Licensing, Regulatory, and Compliance Issues

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Over 130 attendees worldwide attended our two-day seminar on Legal Considerations in Commercializing Gene-Edited Plants where we took attendees through a real world hypothetical explaining the use of gene editing in plant breeding. We covered the science behind gene-editing technology as well as the related IP, licensing, regulatory and compliance issues.

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Over 130 attendees worldwide attended our two-day seminar on Legal Considerations in Commercializing Gene-Edited Plants where we took attendees through a real world hypothetical explaining the use of gene editing in plant breeding. We covered the science behind gene-editing technology as well as the related IP, licensing, regulatory and compliance issues.Gene editing has the potential to revolutionize agriculture and food production. However, to be successful, innovators need to address the challenges of IP protection and licensing as well as regulatory hurdles in order to successfully commercialize a product. Day one of this two-part webinar took attendees through a real world hypothetical that explained the use of gene editing in agriculture and we discussed freedom-to-operate and licensing issues for edited plants. On day two, we took a deep dive into the IP protection for edited plants and commercialization requirements for edited plants and food products through a discussion of CRISPR licenses, FDA, USDA, and EPA regulatory approvals and other commercialization issues.Day 1: Tuesday, June 8, 12:00 – 1:00 p.m. PDT<ul dir="ltr"><li>Michael Ward, global head of Morrison & Foerster’s Life Sciences Practice Group, head of our Patent Practice Group, co-chair of our Intellectual Property Practice Group and co-chair of our global AgTech + Food Industry practice</li><li>Stephen Dellaporta, founder of Verinomics, a genomics and computational biology company serving the agriculture sector</li><li>Otis Littlefield, Senior Of Counsel, Patent, San Francisco</li><li dir="ltr">Matt Karlyn, Partner, Life Sciences Transactions + Licensing, Boston</li><li>Wolfgang Schoenig, Partner, Life Sciences Transactions + Licensing, Berlin</li></ul><iframe src="https://www.youtube-nocookie.com/embed/clkBadFlqu0?rel=0" title="Legal Considerations in Commercializing Gene-Edited Plants: Day 1" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="1" title="iframe"></iframe>Day 2: Wednesday, June 9, 12:00 – 1:00 p.m. PDT<ul><li>Michael Ward, global head of Morrison & Foerster’s Life Sciences Practice Group, head of our Patent Practice Group, co-chair of our Intellectual Property Practice Group and co-chair of our global AgTech + Food Industry practice</li><li>William Tarantino, Partner, Environmental Litigation + Regulatory, San Francisco</li><li>Wolfgang Schoenig, Partner, Life Sciences Transactions + Licensing, Berlin</li><li>Bethany Hills, Partner, FDA Regulatory + Life Sciences Compliance, New York</li></ul><iframe src="https://www.youtube-nocookie.com/embed/-gfYcSbE370?rel=0" title="Legal Considerations in Commercializing Gene Edited Plants: Day 2" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="1" title="iframe"></iframe>Supplemental materials can also be found on our life sciences <a href="https://lifesciences.mofo.com/" target="_blank">blog</a> and <a href="/capabilities/food-agriculture.html">Food + Ag capabilities</a>.<hr>

Berkeley Center for Law & Technology and Morrison & Foerster LLP

Legal Considerations in Commercializing Gene-Edited Plants: IP Protection, Licensing, Regulatory, and Compliance Issues

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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>

Wolfgang Schönig

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

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

Matt Karlyn has 25 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensing, and technology transactions. His clients range from Fortune 100 companies to start-ups, and he regularly advises companies on matters involving IP commercialization, complex collaboration transactions, licensing initiatives, subscription-based economics, and business transactions related to the procurement, development, commercialization, and use of technology and life sciences products. He has also worked with a number of clients on corporate transactions including mergers and acquisitions, as well as private equity and venture capital financing.Matt is ranked Band 1 by Chambers USA for Intellectual Property: Licensing in Massachusetts. Clients in Chambers describe Matt as: “accessible and engaged, and he is really focused on getting the right answer for us."<h4>Life Sciences</h4>Life sciences clients, including pharmaceutical, medical device, and healthcare companies, rely on Matt for his breadth of knowledge in licensing, collaboration, and commercialization strategies across a wide range of transactions designed to strengthen operations and maximize value. Matt’s clients come from sectors across the global economy and include emerging companies, privately held companies, and many of the world’s biggest brands.Matt has broad experience with commercial transactions and agreements in the life sciences space, including:<ul><li>Intellectual property and technology licenses</li><li>Collaboration and development transactions</li><li>Commercialization agreements</li><li>Supply and manufacturing transactions</li></ul><h4>Technology</h4>Matt regularly advises on the use of technology in business, pricing strategies, and market terms across a wide variety of technology transactions that benefit clients both large and small. He has extensive experience negotiating a wide range of transactions, including:<ul><li>Enterprise resource planning and customer relationship management licensing and implementation transactions</li><li>Cloud-based transactions including software-as-a-services, platform-as-a-service, and infrastructure-as-a-service.</li><li>Software licensing</li><li>Supply chain and procurement deals</li></ul>Additionally, Matt has worked on many of the largest outsourcing transactions in the United States, representing numerous Fortune 100 companies on information technology, business process, finance and accounting, facilities services, and other outsourcing transactions.Matt is a frequent author and speaker on topics pertaining to drafting and negotiating commercial technology, outsourcing, and licensing transactions. He has published over 25 articles (including chapters in two books), given over 175 presentations on licensing, technology, outsourcing, and data security, and is the co-author of A Guide to IT Contracting: Checklists, Tools, and Techniques.Matt is currently co-chair of the Legal and Regulatory policy group at the Massachusetts Biotechnology Council. He served as chair of the New England Chapter of the International Association of Outsourcing Professionals, and served for five years on the board of directors of Julie’s Family Learning Program, a wellness program for mothers and children in South Boston. Matt has also been elected as a Fellow of the American Bar Foundation.

Legal Considerations in Commercializing Gene-Edited Plants: IP Protection, Licensing, Regulatory, and Compliance Issues

08 Jun 2021 - 09 Jun 2021