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Gene Editing: Opportunities and Implications Across the Food and Ag Value Chain

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The panel will be moderated and jointly led by leaders from McKinsey & Co. and Morrison & Foerster, who will share their respective perspectives on the opportunities gene editing creates in an evolving technological and regulatory landscape worldwide. 

The panel will be moderated and jointly led by leaders from McKinsey & Co. and Morrison & Foerster, who will share their respective perspectives on the opportunities gene editing creates in an evolving technological and regulatory landscape worldwide. The panelists will address key questions relating to:<ul><li>What is possible through gene editing? How does it differ from traditional GMO tech?</li><li>What is the outlook for gene editing in Europe and China?</li><li>What is the regulatory landscape in the US?</li></ul><h4>Moderators:</h4><ul><li>Josh Katz - Partner, McKinsey & Company</li><li>Michael Ward - Partner, Morrison & Foerster</li></ul><h4>Panelists:</h4><ul><li>Stacy Amin - Partner, Morrison & Foerster</li><li>Tom Brennan - Associate Partner, McKinsey & Company</li><li>Shane Bryan - Associate Partner, McKinsey & Company</li><li>Wolfgang Schönig - Partner, Morrison & Foerster</li><li>William (Bill) Tarantino - Partner, Morrison & Foerster</li></ul><hr>

McKinsey & Company and Morrison & Foerster

Gene Editing: Opportunities and Implications Across the Food and Ag Value Chain

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Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.His subjects of focus include research and development collaborations, complex licensing agreements, technology transactions, 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/" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4>Representative Experience</h4><h5>Representative Transactional Matters</h5><ul><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Provide commercial and IP advice to startups and established companies in the area of digital health, IoT (5G), and other industry 4.0 or data-driven business models.</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)—medical devices, and 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>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><h5>Representative Contentious IP Matters</h5><ul><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>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><li>Advise on border seizure measures and trade fair disputes in the areas of household appliances, cosmetics, and sanitary installations, as well as anti-counterfeiting strategies.</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 Digitalwirtschaft, High-Tech, Life Sciences und Pharmaindustrie.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen, Technologie-Transaktionen, 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>Referenzen</h4><h5>Vertragsgestaltung</h5><ul><li>Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen.</li></ul><ul><li>Beratung von etablierten Unternehmen und Start-ups zu kommerziellen und IP-rechtlichen Fragestellungen im Bereich Digital Health, IoT (5G) und anderen Industrie 4.0 Sektoren.</li><li>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>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>Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht.</li></ul><h5>IP-Streitigkeiten</h5><ul><li>Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US Streitigkeiten.</li></ul><ul><li>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><li>Prozessführung im Markenrecht, Urheberrecht und Wettbewerbsrecht, darunter insbesondere eine hochvolumige Markenstreitigkeit für eine deutsche Bank sowie ein hochkarätiger neun Länder umfassender grenzüberschreitender Markenstreit eine bekannte pharmazeutische Marke betreffend.</li><li>Beratung zu Grenzbeschlagnahmemaßnahmen und Messestreitigkeiten in den Bereichen Haushaltsgeräte, Kosmetik und Sanitär sowie Entwicklung von Strategien zu Anti-Counterfeiting.</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 hazardous substances, mass torts, and consumer product safety. Bill is highly regarded for his ability to coordinate technical, legal, and communications teams to counsel clients through crises. He has coordinated FDA and CPSC-led recalls of various products, and has served as national coordinating counsel for litigation related to those recalls. He has argued motions and tried cases in state and federal courts for a variety of complex and multidistrict litigation matters, including product liability claims and environmental disputes.Bill is recommended by Legal 500 US (2011–2018) in product liability and mass tort defense and is described as “an experienced counsel who is an excellent leader and has great knowledge of the law.” For the past seven years, San Francisco magazine has recognized Bill in its “Super Lawyers” list for his work in environmental and consumer litigation. In 2014, he was chosen as the exclusive recipient of the Client Choice Award for Environmental Law in California and as a Rising Star in Environmental Law by Law360.<h5>More About Bill</h5>Bill has also 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. Bill has represented the firm’s clients in all aspects of environmental regulation and has represented companies before 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.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 hazardous waste and water quality laws.Bill received his J.D. from the Georgetown University Law Center with honors 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 F. Tarantino

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.As head 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.Recognized 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.Mike 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. For 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.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. His representative clients include:<ul><li>The California Table Grape Commission</li><li>Inari</li><li>Verinomics</li><li>Amycel</li><li>Driscoll’s</li><li>Terviva</li><li>Dole Fresh Foods</li></ul>For 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.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.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.

Michael Ward

Chair of Life Sciences + Healthcare

Stacy Cline Amin leads the FDA + Healthcare Regulatory and Compliance practice within the firm’s Global Life Sciences + Healthcare Group and provides strategic regulatory and business advice to companies in the life sciences, healthcare, and technology industries. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), and held senior positions within the White House Counsel’s Office and health committees in both the House and Senate. With her depth of experience across government agencies, she provides clients with an insider’s perspective on regulatory and compliance issues, enforcement actions, and litigation challenges.As chief counsel of the FDA, Stacy led an office of approximately 170 counselors and litigators and navigated difficult regulatory issues and litigation challenges across the agency’s entire portfolio. During her last year of service, Stacy played a critical role in nearly every aspect of FDA’s COVID-19 pandemic response effort, including record numbers of emergency use authorizations, guidances, and compliance actions. Most notably, she served as a key leader of the team responsible for issuing the first two COVID-19 vaccine authorizations.During her tenure, she served as a trusted strategist and advisor to several FDA Commissioners, including former Commissioner Scott Gottlieb, the FDA Center Directors and Deputy Commissioners, and the HHS Secretary. She worked closely with the leadership of the agency to resolve challenging legal and regulatory issues, including in the areas of human gene therapy and regenerative medicine, in vitro diagnostics, medical device safety and innovation, digital health, animal and plant biotech, food safety, compounding, opioids, and e-cigarettes. She advised on legal issues related to all aspects of the medical product life cycle and worked with Center leadership to resolve novel or challenging issues that arose during product review. She also oversaw the agency’s significant civil and criminal enforcement actions, in coordination with the Department of Justice, and advised on all of the agency’s novel or significant compliance activities.For more than a decade, Stacy’s work has often focused on the intersection of health, life sciences, and technology. At FDA, she advised on the creation and launch of the Digital Health Center of Excellence and oversaw the development of regulations and policy in all areas of digital health, including software as a medical device, artificial intelligence and machine learning, medical device interoperability, and cybersecurity. While serving in Congress, Stacy led multiple bipartisan investigations of digital health, health IT, and cybersecurity issues that resulted in an influential oversight report, a series of six bipartisan hearings, and significant provisions of the 21st Century Cures Act of 2016 and the Cybersecurity Act of 2015.Previously, Stacy served in the White House Counsel’s Office as Senior Associate Counsel to the President, where she advised on matters involving the FDA and Centers for Medicare and Medicaid Services, the Federal Trade Commission, and the Federal Communications Commission.Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. She frequently advised on FDA, insurance market, and health IT matters and led significant oversight investigations. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013.Earlier in her career, Ms. Amin served as an associate at two leading Washington, D.C. law firms, where she advised multinational financial services industry clients and startup organizations.She graduated cum laude from Harvard Law School and summa cum laude from the George Washington University in philosophy and clerked for the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit.

Gene Editing: Opportunities and Implications Across the Food and Ag Value Chain

28 Sep 2021 3:00 PM - 4:00 PM EDT

Moderators:

Panelists: