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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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

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

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Because No One is Immune to the Law

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On June 30, 2020, the U.S. Food and Drug Administration released its much anticipated guidance on the licensure of COVID-19 (SARS-CoV-2) vaccines. According to 

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FDA Establishes Clear Requirements for COVID-19 Vaccine

FDA Establishes Clear Requirements for COVID-19 Vaccine | MoFo Life Sciences

Matt Karlyn

On June 30, 2020, the U.S. Food and Drug Administration released its much anticipated <a target="_blank" href="https://www.fda.gov/media/139638/download">guidance</a> on the licensure of COVID-19 (SARS-CoV-2) vaccines. According to the <a target="_blank" href="https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html">New York Times</a>, there are currently over 145 COVID-19 vaccines in development across the globe with 20 in human trials. There are several different types of COVID-19 vaccines in development, including genetic vaccines (based on RNA/DNA fragments from the coronavirus to provide an immune response), viral vector vaccines (inserting coronavirus genes using an adenovirus), protein-based vaccines (using a protein fragment from the coronavirus as the antigen to produce an immune response), and whole virus vaccines (using attenuated virus).To support COVID-19 vaccine development efforts, the U.S. Government launched Operation Warp Speed (OWS) in May 2020 with the goal of having substantial quantities of a safe and effective vaccine available for Americans by January 2021, through government assistance to accelerate development, manufacturing, and distribution of a COVID-19 vaccine. Under the OWS program, Congress has designated over $6.5 billion for countermeasure development through the Biomedical Advanced Research and Development Authority (BARDA), along with $3 billion for National Institutes of Health (NIH) research. On June 16th, the <a target="_blank" href="https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html">HHS announced</a> that the OWS program has reportedly narrowed down its list from 14 vaccine candidates to about seven candidates. Thus far, the OWS program has awarded the following grants for vaccine development: (i) $456 million to Johnson & Johnson’s candidate vaccine, with Phase 1 clinical trials set to begin this summer; (ii) up to $483 million to Moderna’s candidate vaccine, which received a fast-track designation from the FDA, expecting to start Phase 3 clinical testing in July 2020; and (iii) up to $1.2 billion to AstraZeneca’s candidate vaccine being co-developed with the University of Oxford with an agreement to make available at least 300 million doses of the vaccine for the United States, with the first doses delivered as early as October 2020 and Phase 3 clinical testing beginning this summer with approximately 30,000 volunteers in the United States.The FDA’s recent COVID-19 vaccine guidance describes current recommendations regarding the data needed to facilitate clinical development and licensure of vaccines to prevent COVID-19. Specifically, the FDA provided key considerations for (i) Chemistry, Manufacturing, and Controls (CMC), (ii) nonclinical data, (iii) clinical trials, (iv) post-licensure safety evaluation, (v) diagnostic and serological assays, and (vi) additional considerations. The FDA did not create a special accelerated pathway or designation for COVID-19 vaccines – the usual FDA Biologics License Application (BLA) framework rules still apply including Fast Track designation. However, the FDA is still willing to accept an Emergency Use Application (EUA) for a COVID-19 vaccine, but would effectively require the same safety and efficacy clinical data along with quality and purity manufacturing data as a BLA. In the guidance, the FDA explicitly stated that “for a vaccine for which there is adequate manufacturing information, issuance of a EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or FDA has completed its formal review of the biologics license application.” Moreover, the FDA clarified that all current good laboratory, clinical, and manufacturing practices fully apply throughout the vaccine development process.The FDA has made it clear that there are no surrogate endpoints that can reasonably predict the clinical benefit of a COVID-19 vaccine, and thus, vaccine developers should pursue traditional approval via direct evidence of vaccine safety and efficacy in protecting humans from SARS-CoV-2 infection and/or clinical disease. The FDA requires that the primary efficacy endpoint estimate for a placebo-controlled efficacy trial should be at least 50% based on scientifically acceptable biostatistics standards set forth in the FDA guidance. For reference, in December 2019, the FDA approved the live Ebola vaccine, <a target="_blank" href="https://www.fda.gov/media/134227/download">Ervebo</a>, which demonstrated a point estimate of vaccine efficacy of 100% (95% CI: 63.5% to 100%) in 3,537 subjects ≥ 18 years of age. On the other hand, during the 2019-2020 flu season, the <a target="_blank" href="https://www.cdc.gov/flu/vaccines-work/2019-2020.html">influenza vaccine</a> efficacy rate was 22-45% depending on the virus strain and age group demographics. The scientific challenge in developing a first generation vaccine in the midst of a global pandemic is striking the right balance between maximizing efficacy while reducing safety concerns from immunological or inflammatory side effects. The 50% minimum efficacy threshold may represent the FDA’s position that it will tolerate lower efficacy, while requiring greater safety given the prevalence of COVID-19 in the United States. From a safety perspective, vaccine developers are advised to collect and evaluate at least preliminary clinical safety and immunogenicity data for each dose level and age group (e.g., younger versus older adults) to support progression of clinical development to include larger numbers (e.g., hundreds) of participants and participants at higher risk of severe COVID-19. Based on the recent guidance, the FDA requires two specific sets of safety data in addition to standard requirements of immunogenicity and other safety studies. The first data set consists of studies to address the risk for vaccine-associated enhanced respiratory disease (ERD). Specifically, the FDA has recommended the use of predictive animal models to assess the likelihood of ERD, including post-vaccination challenge studies where the animal is introduced to the COVID-19 virus after receiving the vaccine to correlate how viral exposure might affect humans after receiving the vaccine, along with non-clinical studies evaluating protection and/or histopathological markers of vaccine-associated ERD following SARS-CoV-2 challenge. The second set of preliminary data that the FDA has requested include assessments of neutralizing vs. total antibody responses along with polarization data of T-helper cells types 1 and 2 to better understand the type and patterns of immune response that SARS-CoV-2 induces.Another key issue with developing, scaling, and marketing a COVID-19 vaccine is quality, purity, and stability of the vaccine product during the manufacturing and distribution process. The FDA is encouraging leveraging established and validated vaccine development platforms, which benefits the pharmaceutical companies that have previously developed and commercialized a vaccine. First-time vaccine developers should work closely with their contract manufacturers or consider collaborating with other organizations that have a validated vaccine manufacturing infrastructure. Vaccine developers are also advised and encouraged to communicate early with the Office of Vaccines Research and Review (OVRR) to discuss the type and extent of CMC information needed for development and licensure of their COVID-19 vaccine. Details of the manufacturing process must be provided in a BLA to market a COVID-19 vaccine. Accordingly, vaccine developers should submit data and information identifying critical process parameters, critical quality attributes, batch records, defined hold times, and the in-process testing scheme, along with establishing specifications for each critical parameter. Validation data from the manufacture of platform-related products may provide useful supportive information, particularly in the identification of critical parameters. Prior to approving the BLA, the FDA typically performs an onsite inspection of manufacturing facilities. However, in view of the COVID-19 pandemic, the<a target="_blank" href="https://www.fda.gov/media/139638/download"> FDA stated</a> that it will use “additional tools, where available, to determine the need for an on-site inspection and to support the application assessment, such as reviewing a firm’s previous compliance history, and requesting records in advance of or in lieu of on-site inspections or voluntarily from facilities and sites.” Thus, vaccine developers should also anticipate additional documentation requests from the FDA in lieu of the on-site inspection. Please follow Morrison & Foerster’s <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> blog to stay informed as we continue to report on FDA’s evolving role in the medical product industry.

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