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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During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for public comments, which may be submitted by June 13, 2020.The draft Biosecurity Law was first brought to the Standing Committee’s review in October 2019. As a comprehensive and ambitious set of laws covering multiple areas under the overarching name “biosecurity,” the draft legislation was an attempt to address the absence of legal punishments against biotechnology misuses in China in recent years, an infamous example of which is the gene-edited babies scandal that broke out in late 2018.The Draft covers the following major areas: the establishment of a biosecurity risk prevention and control system, the prevention and control of major new or sudden infectious diseases or animal or plant epidemics, the security of biotechnology R&D and application, laboratory biosecurity, the security of human genetic resources (HGR) and biological resources, countermeasures against the threat of bioterrorism and biological weapons, the buildup of biosecurity capabilities, and the legal liability in the event of violation of relevant provisions of the Biosecurity Law. This article will summarize and analyze certain provisions in the Draft applicable to, and their potential impact on, foreign entities and individuals.The broad scope of the Draft can first be seen by the vague definition it has ascribed to “biosecurity,” which includes the following “capabilities” of the State: to effectively respond to threats from animals, plants, microorganisms, biotoxins, and other bioactive substances (collectively, “Biological Factors”) and relevant elements, to maintain stable and sound development of the biological field and a danger-free and threat-free status, and to guarantee sustainable development and security. Because of such vagueness, and because the Draft prohibits any individual and any entity from harming State biosecurity, the potential scope of violation of the Biosecurity Law appears extremely broad.Biosecurity risk prevention and control system            According to the Draft, China will implement a unified system to issue biosecurity information. The biosecurity information that is considered to be “necessary to be uniformly released” must be issued at the State level or at the local government level as necessary and authorized by the State. No unauthorized entity or individual may issue such information. This prohibition potentially covers the publication of research articles that includes biosecurity information, e.g., the sequence of a newly discovered virus with the potential to cause an epidemic.            As part of the biosecurity risk prevention and control system, China will publish and amend from time to time State directories and lists of entry and exit items related to biosecurity, which will be used by China Customs. The Draft gives Customs a wide latitude of authority related to biosecurity, which extends to inbound and outbound persons, transportation tools, containers, goods, articles, packaging materials, and the discharge of ballast water of international navigation ships. As necessary and approved by the State Council, Customs may temporarily close a port or the relevant border.Prevention and control of major new or sudden infectious diseases or animal or plant epidemics            According to the Draft, any entity or individual that finds any infectious disease or animal or plant epidemic must report it to a medical institution or a relevant professional institution or department. China will also strengthen the construction of border and port protection and control capabilities for infectious diseases and animal and plant epidemics, support international communication and cooperation, take part in international rescue and assistance as needed, and establish an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemics.Security of biotechnology R&D and application; laboratory biosecurity            The Draft includes a number of provisions governing biotechnology R&D and application. For example, the State Council will promulgate a list of important equipment and special Biological Factors involving biosecurity, any purchase or import of items on the list by any entity engaging in biotechnology R&D or application will be subject to registration, and no individual will be allowed to purchase or hold such items. The State Council will also categorize biotechnology R&D activities into high, medium or low risk categories. Foreign entities are prohibited from conducting high or medium risk biotechnology R&D activities in China.            The Draft includes a whole chapter on laboratory biosecurity, particularly with respect to laboratories of pathogenic microorganisms. The establishment of such labs is subject to approval or registration, depending on the circumstances. The establishment of such labs with foreign investment will be subject to an additional security review. If the security review determines that any pathogenic microorganism laboratory may affect public health, state security or public benefits, it may not be established. In addition, individuals will be prohibited from establishing a biosecurity laboratory.            China will classify pathogenic microorganism laboratories on four levels, based on the biosecurity protection levels. These are largely consistent with the biological safety levels established by the U.S. Centers for Disease Control and Prevention. The Draft also includes a series of provisions on the management of such laboratories, lab animals, accountability, safety and security, and emergency measures. It is worth noting that these provisions apply not only to pathogenic microorganism labs, but also to manufacturing enterprises involving pathogenic microorganism processing, and to laboratories involving other Biological Factors.Security of biological resources            The Draft has put provisions for biological resources in the same chapter as provisions for HGR, but does not provide a definition for “biological resources.” The biological resources provisions are obviously watered down compared to the HGR provisions, presumably because the legislators intend that the collection, preservation, use and outbound transportation of biological resources will be regulated by other laws and regulations. Interestingly, the only substantive provisions on biological resources in the Draft all relate to foreign entities or individuals, or alien species. For example, the acquisition or use of China’s biological resources by any overseas organization or individual or any institution established or actually controlled thereby (collectively, “Foreign Persons”), or any international scientific research collaboration using China’s biological resources, must each be approved by the relevant department according to the law. Such collaboration must ensure that the Chinese entity and its researchers are involved in a substantial part of the whole research process, and the relevant rights and interests are shared according to the law, although the Draft does not specify how exactly they should be allocated. The State Council will promulgate a directory of alien invasive species, and will strengthen the investigation, monitoring, early warning, control, evaluation and elimination of alien invasive species set out in the directory in the name of protection of biodiversity. No entity or individual may import, release or discard alien species.Security of human genetic resourcesThe Draft has included a number of provisions of China’s Administrative Regulations on Human Genetic Resources (the “Regulations”), in many instances, almost verbatim, particularly with respect to Foreign Persons. Specifically, the Biosecurity Law, according to the Draft, will prohibit Foreign Persons from collecting or preserving China HGR in China, or providing China HGR abroad. International scientific research collaboration using China HGR is permitted but must be approved by China’s Ministry of Science and Technology (MOST) in advance on a project-by-project basis. The only exception to the approval requirement is “international collaboration in clinical trials” at clinical trial institutions that do not involve the outbound transfer of China HGR materials (which has the same definition in the Draft as in the Regulations). Such clinical trial collaboration, however, must still be pre-registered with MOST and, as part of the pre-registration, the types and numbers of HGR proposed to be used and the actual proposed uses must be disclosed to MOST.The Biosecurity Law, according to the Draft, will require that the permitted international collaboration must ensure that the relevant Chinese entities and their research personnel “can take part in the research substantially in the whole process of the collaboration,” and that the relevant rights and interests resulting from the collaboration be shared in accordance with relevant laws, most likely the Regulations, which dictate that any patent rights based on scientific research results obtained in the collaboration must be jointly owned by the participating Foreign Person and Chinese entity, among other benefit-sharing provisions.Penalties for violation of the HGR provisions by Foreign Persons, according to the Draft, include injunction; confiscation of any China HGR illegally collected or preserved and of any relevant illegal income; and a fine of more than RMB 1 million but less than RMB 10 million. If the illegal income is more than RMB 1 million, the fine will be five to ten times that of the illegal income. These penalties are consistent with the ones imposed on Foreign Persons in the Regulations.The Biosecurity Law, according to the Draft, will permit the provision of, or open access to, China HGR information (which also has the same definition in the Draft as in the Regulations) to Foreign Persons, subject only to registration with MOST; provided, however, that, in the event such provision or access could endanger China’s public health, national security or public interests, MOST’s security examination will be required. This is also consistent with the Regulations.The Draft will obviously need further revisions before its final promulgation. Given the breadth of the Draft, this article does not attempt to address many other areas covered by it, some of which may seem to have more relevance to the current COVID-19 pandemic. In fact, the Regulations (and the corresponding provisions in the Draft) have already played an important role in the global battle against COVID-19. Because the certification or authorization by foreign regulatory authorities of the testing kits developed in China requires the cross-border transfer of development data, which constitutes China HGR information, the data transfer and the product development itself, which involves the use of China HGR materials, are both subject to the Regulations.The Draft’s inclusion of some of the key provisions of the Regulations related to Foreign Persons has sent a strong signal that Chinese legislators intend to codify a significant portion of the Regulations into law. The Biosecurity Law’s legislative progress undoubtedly warrants close monitoring and careful analysis.This article is not a comprehensive review of the Draft, but provides a brief summary and analysis of select provisions in the Draft that may be applicable to foreign entities or individuals. For an in-depth analysis of specific provisions or an English translation of the Draft, please contact the <a href="mailto:CCui@mofo.com?subject=MoFo%20Life%20Sciences%20blog%20post" target="_blank">author</a>. The author’s previous article on the Regulations may be accessed <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html">here</a>.

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China’s Biosecurity Law will cover Human Genetic Resources

China Patent Eligibility Update: Human Embryonic Stem Cells

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During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Bi

China’s Biosecurity Law will cover Human Genetic Resources

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.

CSPC Pharmaceutical Group Limited

ACEA Therapeutics

Kindred Biosciences

Sanuwave Health

MyChem

Special New Fruist Licensing (SNFL)

Sequlite Genomics

Arbutus Biopharma

OpenInvest

LIVEKINDLY

Adagene

Vizgen, Inc.

CareDx

Colleges and Universities

BluesphereBio

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Matt Karlyn has 23 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensi

Matt Karlyn

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FDA Establishes Clear Requirements for COVID-19 Vaccine

IR35 Update: UK Government Postpones “Off-Payroll Working” Reforms

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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 

FDA Establishes Clear Requirements for COVID-19 Vaccine

Recognizing the need for companies to quickly get products to market that might help combat the COVID-19 pandemic, the United States Patent & Trademark Office is now paving the way for shorter examination timelines for qualifying trademark applications. This could prove especially useful in battling the flood of COVID-19-related counterfeit products that have hit the marketplace since the beginning of the crisis.<a href="https://www.mofo.com/resources/insights/200629-expedited-trademark-applications-covid-19.html" target="_blank">Read our alert</a>

AK Futures LLC v. Boyd Street Distro, LLC.

The Upper Deck Company v. Panini America, Inc.

Cirba, Inc., et al. v. VMware, Inc.

 Lambda Labs, Inc. v. Lambda, Inc.

Ironhawk Technologies, Inc. v. Dropbox, Inc.

Synopsys, Inc. v. Ubiquiti Networks, Inc. et al.

One World Foods, Inc. v. Stubb’s Austin Restaurant Company LC et al.

McCormick & Company, Incorporated v. Primal Palate, LLC.

Novadaq Technologies, Inc. v. Karl Storz GmbH and Karl Storz Endoscopy America, Inc.

MI Technologies, Inc. v. Electrified Discounters, Inc.

Ubiquiti Networks, Inc. v. Kozumi USA, et al.

Airports Council International – North America (ACI-NA) Matters (Trademark Trial and Appeal Board).

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Joyce Liou is a partner in the firm’s Intellectual Property Group. Ms. Liou focuses her practice on intellectual property litigation, domestic and international trademark prosecution, copyright and tr

Joyce Liou

Joyce Liou is a partner in the firm’s Intellectual Property Group. Ms. Liou focuses her practice on intellectual property litigation, domestic and international trademark prosecution, copyright and trademark enforcement, and domain name arbitration.

Expedited Trademark Applications for COVID-19-Related Goods and Services

Recognizing the need for companies to quickly get products to market that might help combat the COVID-19 pandemic, the United States Patent & Trademark Office i

Expedited Trademark Applications for COVID-19-Related Goods and Services

FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working with online marketplaces, domain name registrars, payment processors, and social media websites to remove unproven claims from their platforms.To date, FDA has issued over 65 warning letters. In certain instances, FDA has followed those warning letters by asking DOJ to initiate formal legal proceedings against a product manufacturer. For some categories of products, FDA has used press announcements to effectively provide a generalized warning to all manufacturers in the space. Below we tabulate all of the enforcement efforts that FDA has been using to try to keep fraudulent COVID‑19 products off the market. Read our <a target="_blank" href="https://protect-us.mimecast.com/s/Aa37C9rLGjH0wv74CE_XfV?domain=www2.mofo.com">client alert</a> Follow Morrison & Foerster’s <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> and <a href="https://classdismissed.mofo.com" target="_blank">Products Liability</a> blogs to stay informed as we continue to report on FDA’s evolving role in the medical product industry.

Fertility Center Litigation

Fitbit

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

An orthopedic implant company

Julie Y. Park

How FDA Is Monitoring the COVID-19 Product Market