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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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

Anita Choi has decades of experience providing strategic advice to companies and investors in the <a href="/capabilities/life-sciences-healthcare" target="_self" dir="ltr">Life Sciences</a> and <a href="/capabilities/food-agriculture" target="_self">Food + Agriculture</a> industries. She has helped start-up companies build IP portfolios around their core technologies, and counseled them on issues related to patents versus trade secrets. She has worked with larger, more established companies to manage global patent portfolios in a way that integrates IP with their business models. Combining her legal and business expertise enables her to navigate complex challenges that require complex solutions hence why she is so often called upon by clients to help with assessing, building and strengthening patent portfolios.  She has also counseled investors in IP due diligence, identifying critical issues that may affect valuation and risk assessment in deals.Anita is part of the <a href="/life-sciences-healthcare-leadership" target="_self">Life Sciences + Healthcare Leadership Team</a>, as well as the Food + Agriculture Leadership Team within the firm. She co-leads the firm’s Chemistry Subgroup within the patent practice, which covers both the Pharmaceuticals and Materials sector within the chemistry space. She also co-leads the firm’s Food + Agriculture patent practice. Anita’s clients praise her ability to quickly gain a deep understanding of their technology and business, which allows her to think critically, creatively and practically in patent portfolio management.Anita is recognized as a key lawyer by The Legal 500 US for patent prosecution. She received her J.D. from the University of Pennsylvania Law School where she graduated magna cum laude with a degree in Chemistry and was named to the Order of the Coif. During law school, Anita also completed her M.B.A. at the Wharton School of Business.Anita is co-editor of our <a href="https://lifesciences.mofo.com/" target="_blank" dir="ltr">MoFo Life Sciences Blog</a>.Life SciencesAnita gained a solid technical background across disciplines during her time studying at the California Institute of Technology (CalTech), where she received her Bachelor of Science with honors. She spent several years working at Pfizer, developing small molecule compounds for use in oncology therapies. She has performed research at CalTech involving unnatural amino acids, and at MIT involving fluorescent zinc sensors, both for use in developing neuroscience applications.Anita has counseled clients in a wide variety of life science technologies, including small-molecule pharmaceuticals, cannabinoids, nutraceuticals, pharmaceutical and cosmetic uses, pharmaceutical formulations, medical devices, diagnostics, and digital health.Food and AgTechAnita has advised businesses in developing IP strategies for soil and crop technologies, sustainable farming, alternative protein sources, fermentation technologies, extraction technologies, new categories of food and beverage products, and food packaging.The breadth of technologies that Anita works with also enables her to provide IP advice at the intersection of multiple technical disciplines. For example, Anita’s practice is also well positioned at the convergence of data analytics in the Life Sciences and Agriculture industries.ChemistryAnita also has technical expertise in chemistry outside of Life Sciences, such as in the Materials space, including Cleantech. She has developed IP strategies for biobased materials, polymer chemistry, composite materials, catalyst-based technologies, industrial processing, batteries, and carbon capture technologies.IP Due DiligenceAnita is skillful with investor-side and company-side patent due diligence. She supports many of the firm’s corporate deals, advising on ownership and patent portfolio risks and conducting patentability and freedom-to-operate assessments. She also supports her own clients undergoing IP due diligence by investors.IP Litigation SupportAnita also works closely with the IP Litigation Group to formulate strategies for infringement contentions, validity/invalidity contentions, and claim construction positions. She actively supports the patent litigators in pre-litigation diligence matters to evaluate the strength of patents and patent portfolios.Pro BonoAnita has an active pro bono practice and has been awarded the State Bar of California's Wiley W. Manuel Award for Pro Bono Legal Services for many consecutive years. She regularly represents families seeking legal guardianship. She also assists numerous non-profit organizations in developing and securing patent protection for their core technologies.

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Anita Choi’s practice focuses on patent prosecution, portfolio management, IP due diligence, and IP litigation support. Her clients range from early-stage start-up enterprises to established domestic and international companies. She is well-versed in building and managing worldwide patent portfolios across many sectors and technologies, including small-molecule pharmaceuticals, medical devices, diagnostics, industrial chemicals and advanced materials, food and agtech.

Anita Choi

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.

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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.

Stacy Cline Amin

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Matthew Chivvis, life sciences IP litigation partner in Morrison & Foerster’s San Francisco office led session 5 of our course on Legal Topics for Scientists, E

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Considerations for ANDA and BPCIA Litigation

Considerations for ANDA and BPCIA Litigation | MoFo Life Sciences

Matthew A. Chivvis

Michael Ward Ph.D.

<a href="https://www.mofo.com/people/matthew-chivvis.html" target="_blank">Matthew Chivvis</a>, life sciences <a href="https://www.mofo.com/capabilities/patent-litigation.html" target="_blank">IP litigation</a> partner in Morrison & Foerster’s San Francisco office led session 5 of our course on <a target="_blank" href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a>. Matthew discussed the Hatch-Waxman and Biologics Price Competition and Innovation Act for generics and biosimilars. As part of his discussion, he addressed exclusivities and how litigation is initiated under each act.We will kick off 2021 with <a href="https://www.mofo.com/people/james-mullen.html" target="_blank">James Mullen</a>, <a href="https://www.mofo.com/capabilities/patent-counseling-prosecution.html" target="_blank">patent</a> partner, teaching the session 6 this Wednesday January 6 on the PCT application process and international patent prosecution.We are wishing you all a Happy and Healthy New Year.

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Considerations for ANDA and BPCIA Litigation

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