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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Nina Schäfer and Jin Ito contributed to this article.On November 25, 2020, the European Commission (the “Commission”) published its “<a href="https://ec.europa.eu/health/human-use/strategy_en" target="_blank">Pharmaceutical Strategy for Europe</a>” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system.  The strategy aims to achieve various goals through legislative and non-legislative actions, namely ensuring access to affordable medicines for patients and addressing unmet medical needs while supporting the competitiveness, innovation and sustainability of the EU’s pharmaceutical sector. It was accompanied by the Commission’s “Intellectual Property Action Plan” published on the same day.  Here are some notable cornerstones of the initiative (see also the <a href="https://ec.europa.eu/commission/presscorner/detail/en/fs_20_2201" target="_blank">Fact Sheet</a> published by the Commission):<ul><li>Streamline procedures and costs for regulatory approval</li><li>Achieve strategic autonomy</li><li> Fuel competition by generics and biosimilars </li><li>Facilitate R&D through efficient access to health data</li><li> Introduce a Unitary Supplementary Protection Certificate </li><li>Simplify reimbursement decisions</li></ul><h4>Regulatory Approval</h4>The Commission acknowledges that regulatory efficiency is one of the key factors to achieving the goals outlined above. To enhance regulatory efficiency, the Commission plans to:<ol><li>Evaluate procedures to explore new approaches to assessing and assembling scientific evidence regarding the safety and efficacy of medicines, e.g., create innovative and pragmatic trial designs and bring EU approval times on par with other parts of the world; </li><li>Consider how digital technology and artificial intelligence can be leveraged to support regulatory decision-making and boost efficiency; and  </li><li>Implement a regulatory framework that further advances the digital transformation of the healthcare system.</li></ol>Rightfully, the Commission emphasizes that the success of such an endeavor will largely depend on collaboration of all stakeholders involved. A study on the current situation involving authorization and monitoring of medicines for human use will be published in 2021 and shall serve as a basis for sparking the collaboration.<h4>Strategic Autonomy</h4>In light of challenges witnessed during the COVID-19 pandemic, the Commission will also pursue measures aimed at achieving greater strategic autonomy. Shortages of medicine have been a serious concern in recent years and have only worsened during the pandemic. To combat the impact the shortages have on patients, the Commission is evaluating revisions of the current legislation to potentially include stronger obligations to ensure the supply of medicines, earlier notification of shortages, enhanced transparency along the supply chain and a stronger coordination role for the European Medicines Agency (EMA).To further tackle the issue, the Commission is committed to:<ol><li>Identify precise causes and drivers for potential vulnerabilities through a structured dialogue with all actors involved; and</li><li>Encourage joint procurement by all EU Member States of critical medicines.</li></ol><h4>Generics and Biosimilars</h4>The Commission highlights the importance of generics and biosimilars when it comes to reducing costs for the healthcare system and providing accessible and affordable treatment to a large number of patients. The Commission therefore intends to support greater generics and biosimilar competition through at least two measures:<ol><li>As outlined in the “<a target="_blank" href="https://ec.europa.eu/health/human-use/strategy_en">Pharmaceutical Strategy for Europe</a>” and the “Intellectual Property Action Plan,” the Commission intends to strengthen and harmonize the so-called “Bolar Exemption.” The Bolar Exemption allows third parties to use a patented invention—for a limited time before the patent expires—for research and testing purposes to obtain market authorization, allowing for a more timely entry to market. Currently, Article 10(6) of EU Directive 2001/82/EC (as amended by EU Directive 2004/24/EC) only provides for certain minimum standards, specifically with respect to generics. Some of the EU Member States, however, adopted more permissive rules leading to a fragmented landscape. For instance, the Directive addresses only use to generate data for regulatory approval in an EU or EEA country. Germany and France, however, permit the support of regulatory approval in non-EU and non-EEA countries. In Germany, the Bolar Exemption is not limited to generics but also applies to innovative products. </li><li>In addition, the Commission plans to revisit current enforcement of EU competition rules. A <a href="https://ec.europa.eu/competition/sectors/pharmaceuticals/report2019/index.html" target="_blank">report</a> on competition enforcement in the pharmaceutical sector has shown that originator companies sometimes try to hinder the market entry or market expansion of cheaper generics and biosimilars (e.g., so-called “pay-for-delay,” i.e., originator companies paying generics companies a share of their profits for a delayed entry to market). The Commission indicated that such behaviors may come under stricter competition law scrutiny.</li></ol><h4>Access to Health Data</h4>The Commission acknowledges that the limited options to use health data for R&D are detrimental to both patients and the industry. To enable industry and regulators to access such health data from across the EU, the Commission plans to take the following steps:<ol><li>Adopt a legislative proposal for a European Health Data Space by the fourth quarter of 2021; and</li><li>Establish an interoperable data access infrastructure, to be completed in 2025, which will improve the cross-border analysis of health data, while also protecting individuals’ rights to privacy and data protection.</li></ol>The planned legislation on the European Health Data Space is in line with the European Data Strategy of the Commission from February 2020. The data strategy is aimed at the creation of a single data market for the EU and the establishment of European Data Spaces in strategic sectors and domains of public interest. One of these is the health sector.In addition to these measures, the Commission intends to:<ol><li>Revise the pharmaceutical legislation to adapt to innovative products, scientific developments (e.g., genomics or personalized medicine) and technological change (e.g., data analytics and digital tools); and </li><li>Support projects that combine the use of high performance computing and artificial intelligence with EU health data to develop pharmaceutical innovations.</li></ol><h4>Unitary Supplementary Protection Certificate</h4>In its Intellectual Property Action Plan, the Commission also looks at the protection of the fruits of pharmaceutical research and development. There the Commission revealed its plans to potentially overhaul the system for Supplementary Protection Certificates (SPCs).SPCs are granted for patented medicinal and plant protection products and offer an additional period of IP protection to counter-balance their often lengthy clinical trials and market authorization processes. They are currently regulated under Regulation (EC) No. 469/2009.A <a href="https://ec.europa.eu/docsroom/documents/43847" target="_blank">study</a> evaluating the current SPC system showed that its efficiency is suffering from its fragmented implementation across EU Member States, leading to high costs and administrative burdens on applicants, hampering innovation and ultimately harming the patients. It also found the system lacking in transparency, with no EU-wide information system and published information oftentimes not being comprehensive, up-to-date or available in foreign languages. To address these pitfalls, the Commission indicated the possibility of a unified grant mechanism and/or the creation of a unitary SPC title by the first quarter of 2022.In the same vein, the Commission also stresses the importance of a unitary patent system and called on EU Member States to ensure its rapid rollout. Information on recent developments regarding the unitary patent system can be found <a href="https://www.unified-patent-court.org/" target="_blank">here</a>.<h4>Reimbursement</h4>There are still differences in access to new medicines and therapies among EU Member States. Since companies are not obligated to offer their products in every EU Member State, different pricing and reimbursement policies are often the deciding factor why products reach some markets and not others. The Commission thus wants to work towards enabling EU Member States to make better and more consistent reimbursement decisions. Key issues identified by the Commission are:<ol><li>Lack of transparency, especially regarding R&D costs, which play an important role when determining the reimbursement price;</li><li>Lack of consensus on cost principles among EU Member States; and</li><li>Lack of uniform principles to evaluate the efficacy of health technologies.</li></ol>To address these issues, the Commission aims to assemble and lead a group of national pricing and reimbursement authorities and healthcare payers to share information among themselves on pricing, payment and procurement policies. Furthermore, the Commission will engage with EU Member States in implementing non-legislative measures designed to increase transparency, such as the introduction of guidelines on costing methods for determining R&D costs. With respect to the evaluation of the efficacy of health technologies, the Commission already issued a <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52018PC0051" target="_blank">proposal </a>in 2018 that is intended to help standardize the health technology assessment process in the EU. It is expected to be adopted in 2021.<h4>Outlook</h4>The pharmaceutical strategy was <a href="https://www.consilium.europa.eu/en/meetings/epsco/2020/12/02/" target="_blank">discussed</a> on a political level at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council Meeting on December 2, 2020. The Ministers expressed their overall support for the strategy and stated that they hoped the Member States would be fully involved in all future discussions and actions related to the implementation of the strategy.The first proposals will be implemented in the coming months, with a revision of the legislation on rare diseases and children being one of the first. The Commission states on its <a href="https://ec.europa.eu/health/human-use/strategy_en" target="_blank">website</a> that the implementation of the strategy will span the mandate of this Commission and will notably see a proposal for revision of pharmaceutical legislation in 2022.We will post further updates as the implementation of the Commission’s pharmaceutical strategy for Europe progresses.

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.

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The European Commission’s New Pharmaceutical Strategy for Europe

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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Nina Schäfer and Jin Ito contributed to this article.
On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy fo

The European Commission’s New Pharmaceutical Strategy for Europe

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and is indicated for use in individuals 16 years of age and older.The official authorization follows <a target="_blank" href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement#event-information">Thursday’s meeting</a> of FDA’s Vaccines and Related Biological Products Advisory Committee to review and discuss information about the vaccine. The external advisory panel voted to recommend that FDA grant authorization, agreeing that the benefits of the vaccine outweigh its risks for use. While it did not ultimately have to follow the Committee’s recommendation, FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19">officially did so</a> on Friday.<h4>Emergency Use Authorization</h4>An EUA grants FDA “authorization,” which is not the same as FDA “approval.” Vaccines are typically approved though a biologics license application, which can require years of clinical testing and back-and-forth with regulatory authorities. FDA uses this pathway to ensure that products meet a certain standard of safety and effectiveness. The EUA application and review are an abbreviated authorization process that only requires a showing that the product’s benefits outweigh its risks.EUAs have already issued for a variety of products like test kits, face masks, ventilators, and other drugs and devices used during the COVID-19 pandemic. Although the EUA process is not new, this is the first time that FDA is authorizing a vaccine product through the expedited EUA pathway. Drug and biologic products pose greater risks than diagnostics and PPE, and require clinical data to evaluate safety and effectiveness. While authorization was granted for the vaccine, a recurring issue in Thursday’s committee meeting was the additional information and data FDA may want from Pfizer as the vaccine moves from authorization to full approval through a BLA.<h4>The First of Its Kind</h4>In addition to being the first vaccine to be granted EUA, the Pfizer/BioNTech vaccine is also the first mRNA vaccine ever to be made available for mass inoculation. Unlike most vaccines, which use weakened or inactivated pathogens to trigger an immune response in the recipient, the Pfizer/BioNTech COVID-19 vaccine contains temporary genetic material (mRNA) that codes for the spike protein found on the surface of the novel coronavirus. Once the vaccine is administered, cells in the recipient’s body take up the mRNA and temporarily produce and display this same spike protein on their surfaces until the mRNA is degraded. The body’s immune system recognizes the spike protein as foreign and starts making antibodies. Thus, if the vaccine recipient were exposed to the coronavirus in future, the body would already know how to mount the appropriate immune response before the recipient developed symptoms.Though this is the first time an mRNA vaccine has been authorized for use on the general public, FDA has emphasized that these vaccines will be held to the same <a target="_blank" href="https://www.fda.gov/media/139638/download">standards</a> of safety and efficacy as any other type of vaccine. To that end, in the <a target="_blank" href="https://www.fda.gov/media/144245/download">briefing</a> document provided ahead of the December 10 meeting, VRBPAC reported an extensive body of data relating to Pfizer/BioNTech’s ongoing phase-3 randomized, double-blinded, and placebo-controlled trial of the vaccine in approximately 44,000 participants. These data played a key role in informing the committee’s decision to recommend authorization of the vaccine.<h4>Risk-Benefit Analysis</h4>There was significant discussion in Thursday’s Advisory Committee meeting around potentially contraindicated populations in light of two adverse events in vaccine recipients with known allergies to medications. It appears that FDA has worked with Pfizer to draft suitable warning language and contraindications for that population. The CDC stated on a conference call Sunday that people with a history of severe allergic reactions can still take the Pfizer/BioNTech vaccine, but recommends that they discuss the risks of doing so with a doctor and be monitored for 30 minutes following administration.The Committee also focused on the indicated age group for the vaccine. Younger populations are known to contract COVID-19 at lower rates and to not experience symptoms as severely as other groups, limiting the benefit of approving the vaccine for those groups. FDA ultimately authorized the vaccine for use by people aged 16 years and older. Since the authorization, CDC’s Advisory Committee on Immunization Practices (ACIP) has also recommended the vaccine for use in this population.<h4>Distribution Roadmap</h4>Although the vaccine has been authorized for use in the U.S., safety monitoring is an ongoing concern. FDA has, in the case of hydroxychloroquine, revoked an EUA following serious adverse events and questionable efficacy data. As a condition of authorization, Pfizer must report serious adverse events associated with the vaccine to the Vaccine Adverse Event Reporting System.The vaccine will likely be distributed according to <a target="_blank" href="https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm?s_cid=mm6949e1_w">CDC’s guidance</a> that health care personnel and long-term care facility residents be vaccinated in the initial phase. While not included in the initial phase, ACIP also identified older individuals and those with underlying medical conditions as potential future priority groups. To prepare for the vaccine rollout, CDC has compiled <a target="_blank" href="https://www.cdc.gov/vaccines/covid-19/index.html">clinical information</a> and <a target="_blank" href="https://www.cdc.gov/vaccines/ed/index.html">training resources</a> and recommended that all health care personnel administering vaccines receive comprehensive competency-based training on vaccine policies and procedures.VRBPAC will hold another <a target="_blank" href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement">meeting this week</a> to discuss the EUA application for a second COVID-19 vaccine submitted by Moderna, Inc. Stay up-to-date with the latest legal and regulatory COVID-19 developments at MoFo’s <a target="_blank" href="https://lifesciences.mofo.com/">Life Sciences</a> blog.

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FDA Authorizes First COVID-19 Vaccine

Using Waivers to Curb COVID-19 Legal Exposure

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccin

FDA Authorizes First COVID-19 Vaccine

Session 2 of the GSAS Harvard Biotech Club and Morrison & Foerster course on <a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a> was led by <a target="_blank" href="https://www.mofo.com/capabilities/technology-transactions.html">Transactions and Licensing</a> partner Matt Karlyn and focused on how to navigate commercial life sciences transactions and licensing issues in a COVID-19 and post-COVID-19 world.Matt discussed three key aspects, the commercial aspects of AI and COVID-19, the critical aspects of cloud transactions, and the collaborations in a COVID-19 world. Maryam attended the session and shared that "The MoFo course offers an innovative and novel approach for acquiring the knowledge that is essential to successfully form or run a start-up. Several crucial topics are covered during the sessions including IP due diligence, licensing and patentability issues. The course also includes some of the top challenges in the industry transactions including the role of artificial intelligence in a COVID-19 world where you get to stay abreast of the latest developments in the health-care industry."<a target="_blank" href="https://www.mofo.com/capabilities/emerging-companies-venture-capital.html">Emerging Companies + Venture Capital</a> partner Jim Krenn followed in session 3 providing current and future entrepreneurs with the fundamentals of raising angel investments including the deal process, the different deal structures, and the general solicitation and equity crowdfunding. Jim commented that "angel investments are often the first type of outside capital that companies raise. We hope that by walking prospective entrepreneurs through the process, most common structures, key terms and related considerations around these investments, they can be better prepared to raise funds from angel investors to position their companies for future success."This week, we’ll turn to MoFo partner and head of our <a target="_blank" href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">FDA Regulatory + Life Sciences Compliance</a> practice Bethany Hills to lead session 4 on COVID-19: FDA and Compliance Issues with Testing, Vaccines, and Therapies.

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Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

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.

Michael Ward

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Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments

GSAS Harvard Biotech Club and Morrison & Foerster’s Patent Course Off to a Roaring Start!

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Session 2 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Transactions a

Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast series, we discuss the science, regulatory framework, and commercial transaction considerations of a COVID-19 therapy. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with:<ul><li>Janet Xiao, patent partner and head of our China Life Sciences Group: What are the main differences between vaccines and therapeutics? How does COVID-19 infect our bodies? What types of COVID-19 treatments are currently being considered?</li><li>Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What is FDA’s overall drug approval process? Are there any FDA programs that would facilitate accelerated development of a therapy? How does the FDA regulate off-label, or unapproved drugs?</li><li>Rufus Pichler, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and Technology Transactions practice: What kinds of partnerships and collaboration efforts are you seeing? How about the repurposing of approved drugs? Are there specific legal issues that companies developing therapeutics should be aware of? Are there any particular challenges associated with manufacturing capacity?</li></ul><div><h4 style="box-sizing: inherit;margin-top: 0.2rem;margin-right: 0px;margin-bottom: 0.5rem;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;color: rgb(94, 95, 97);font-family: Oswald, sans-serif;line-height: 1.4;text-rendering: optimizelegibility;font-size: 1.4375rem;font-variant-numeric: normal;font-variant-east-asian: normal;text-transform: uppercase;hyphens: none;overflow-wrap: normal;"><a style="box-sizing: inherit;background-color: transparent;color: rgb(0, 120, 160);line-height: inherit;text-decoration-line: none;outline-color: initial;outline-style: initial;outline-width: 0px;cursor: pointer;" target="_blank" href="https://www.mofo.com/resources/video-audio/201123-life-sciencess-primer-covid-19-podcast-episode-4.html">LISTEN TO THE PODCAST</a></h4></div>

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Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceu

Janet Xiao Ph.D.

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world.

Janet Xiao

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Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations

Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing

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Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast seri

Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations

On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting a nasal swab and placing it in a vial, which is then placed into a battery-operated test unit that provides results in 30 minutes or less. The test can also be conducted at the point of care, in patient care settings operating under a CLIA Certificate of Waiver, with nasal swab samples self‑collected by individuals 14 and older, or with nasal swab samples collected by a healthcare provider for individuals aged 13 and under. While most rapid tests authorized by FDA so far have been direct antigen tests, Lucira’s test is a molecular test utilizing real-time loop mediated amplification reaction (LAMP) technology. Molecular tests typically provide more accurate results, and Lucira’s validation studies showed a positive percent agreement (PPA) of 94%, and a negative percent agreement (NPA) of 98%. The test is expected to cost about $50, but news reports highlight that the test will not be broadly available until the spring. The test has other limitations as well. The test has not been validated for use with patients without signs and symptoms of COVID-19 infection, and, therefore, the intended use is limited to individuals who are suspected of having COVID-19 by their healthcare provider. Perhaps most significantly, the test is still prescription only, meaning it must be ordered by a healthcare provider or other authorized prescriber. Although FDA has stated on the weekly Town Halls that when a test is designated for use in a non-laboratory environment by FDA, public health reporting is not legally required, and we suspect that FDA is hesitant to authorize a true over‑the-counter test for COVID-19 due to the important public health goals served by reporting obligations. Because Lucira’s test is by prescription only, prescribing providers can follow up with patients to obtain their results and then report to public health authorities. This appears to be an area of concern for FDA, as Lucira’s Letter of Authorization includes, as a condition of authorization: “You must develop a mobile phone application or website to further facilitate results reporting by both the healthcare provider and the individual using your product, and submit to FDA such application or website within 4 months of the date of this letter.” Additionally, the Fact Sheet for Healthcare Providers states, “When prescribing the Lucira COVID-19 All-In-One Test Kit for at home use, please encourage patients to share test results with you as their healthcare provider by using the photo guide on the bottom of the panel of the test kit box.” FDA has encouraged developers of at-home COVID-19 tests to consider developing mobile apps connected to the test that automatically report results to public health authorities, and perhaps once that technology is available, a true over-the-counter test will be authorized.FDA’s authorization of Lucira’s All-In-One Test Kit is certainly a step in the right direction, but there is still more to be done in the development of at-home COVID-19 tests to increase the availability and accessibility of testing nationwide. We look forward to continuing to monitor new developments in this rapidly evolving space.