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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This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations:

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FDA Issues Final Transition Guidances for COVID-19 Devices | MoFo Life Sciences

Brigid DeCoursey Bondoc

This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1) <a href="https://www.fda.gov/media/155038/download" target="_blank">Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a> (the “Enforcement Policy Transition Guidance”) and 2) <a href="https://www.fda.gov/media/155039/download" target="_blank">Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)</a> (the “EUA Transition Guidance”), both dated March 27, 2023. These final guidance documents finalize the corresponding draft guidances issued on December 23, 2021, and both set out a 180-day transition period.Enforcement Policy Transition GuidanceThe 180-day transition period under the Enforcement Policy Transition Guidance will start on the “implementation date,” which will be May 11, 2023, unless the PHE declaration is renewed another time contrary to the <a href="https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf" target="_blank">Administration’s current plan</a>. The Enforcement Policy Transition Guidance applies to devices that fall under 15 FDA COVID-19 enforcement policies, where FDA has indicated that it does not intend to object to certain modifications or distribution of certain devices in the following categories:<ol><li>remote digital pathology devices;</li><li>imaging systems;</li><li>non-invasive fetal and maternal monitoring devices;</li><li>telethermographic systems;</li><li>digital health devices for treating psychiatric disorders;</li><li>extracorporeal membrane oxygenation and cardiopulmonary bypass devices;</li><li>remote ophthalmic assessment and monitoring devices;</li><li>infusion pumps and accessories;</li><li>face shields, surgical masks, and respirators;</li><li>gowns, other apparel, and gloves;</li><li>sterilizers, disinfectant devices, and air purifiers;</li><li>ventilators and accessories and other respiratory devices;</li><li>FDA-cleared molecular influenza and RSV tests;</li><li>coagulation systems; and</li><li>viral transport media.</li></ol>These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023.The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after the implementation date—expected to be from May 11 to August 8, 2023); Phase 2 (the second 90 days after the implementation date—expected to be from August 9 to November 6, 2023); and Phase 3 (180 days after the implementation date—expected to begin on November 7, 2023). In the Enforcement Policy Transition Guidance, FDA provides phase‑by‑phase compliance guidance for manufacturers of a device that falls under any of the FDA COVID-19 enforcement policies mentioned above. It is important to note that some of the guidance applies to manufacturers regardless of whether they intend to continue distribution of the device after a certain phase. For example, manufacturers should send a notification of intent to FDA regardless of whether they intend to continue distribution of their device after Phase 2.EUA Transition GuidanceThe 180-day transition period under the EUA Transition Guidance, on the other hand, will start when the corresponding EUA declaration terminates (the “EUA termination date”). The EUA Transition Guidance applies to devices that are authorized under any of the EUA declarations related to COVID-19 such as the <a href="https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency" target="_blank">EUA declaration for COVID-19 in vitro diagnostics</a> (the “EUA devices”). As FDA explains in the guidance, an EUA declaration is not dependent on the PHE declaration, which means that the 180-day transition period for the EUA devices may start well after the PHE declaration expires, that is, possibly well after May 11, 2023.The EUA Transition Guidance requests manufacturers of the EUA devices that FDA deems to be “reusable life-supporting or life-sustaining” to submit a letter of intent to FDA as soon as possible, regardless of their intent to continue distribution of the device after the EUA termination date. Note that this request is effective as of March 27, 2023, and manufacturers should not wait until the transition period or the EUA termination date to submit the intent letter. Section A of the guidance provides the details including the product codes relevant to this request and the information to include in the letter.The EUA Transition Guidance also provides recommendations and policies for manufacturers seeking a full marketing authorization for a device related to any of their EUA devices. The guidance indicates that FDA does not intend to object to continued distribution of the EUA device after the EUA termination date, if (i) the manufacturer submits a marketing submission for a candidate device that is the same as, derivative of, or next generation of the EUA device, (ii) FDA formally accepts the marketing submission before the EUA termination date, and (iii) FDA has not taken a final action on the marketing submission. Since FDA’s formal acceptance of the marketing submission could be delayed due to various reasons, including administrative incompleteness of the submission, manufacturers are advised to submit well before the EUA termination date.FlexibilitiesNotably, both guidance documents indicate FDA’s willingness to be flexible in certain areas. For example, the guidance documents indicate that real-world data from the actual use of the device during the COVID-19 pandemic may be included in the marketing submission. Both guidance documents also recommend manufacturers to engage with FDA early in the transition period to discuss extenuating circumstances such as an ongoing clinical study that makes it difficult to meet certain deadlines provided in the guidance. Further, both guidance documents acknowledge that there may be unique quality system compliance considerations for certain manufacturers and suggest requesting an exemption or variance from a device quality system requirement within the first 90 days of each transition period.Finalization of these guidances does not necessarily mean that the COVID-19 EUA declarations will be terminated soon or that FDA will soon cease accepting and reviewing new EUA requests. At the same time, however, it certainly gets us closer to such transitions. This is an important development, and manufacturers who have distributed devices under an EUA or under one of these enforcement discretion policies during the pandemic should seek the advice of counsel to ensure compliance with the transition.

FDA Issues Final Transition Guidances for COVID-19 Devices

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