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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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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In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses the issues, among other topics, with:<ul><li>James Mullen, partner, founder, and head of MoFo’s Antibody Patent Group, and head of the San Diego Patent Group: What exactly is COVID-19 and why does it spread so quickly? Where did the name for the coronavirus originate? How does COVID-19 compare to the flu? What kinds of tests are available, and what can they tell us? What causes test-result delays?</li></ul><ul><li>Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What types of COVID-19 tests are there on the market? How do Emergency Use Authorizations (EUAs) work to lower the barrier for products to make it to market? How many EUAs has MoFo secured for its clients, and how long did they take?</li></ul><ul><li>Matt Karlyn, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s Technology Transactions practice: The many pharma, biotech, and tech companies collaborating to test, treat, and track COVID-19 are joining forces faster than usual. When cloud based technologies are involved, MoFo often starts with assessing the criticality of the service and the sensitivity of the data that will be used, stored, or processed. What contingencies do supply agreements need to address? If the collaborations don’t achieve their strategic objectives, what happens to the data?</li></ul><ul><li>Kristen Mathews, partner in MoFo’s Global Privacy + Data Security practice: Can employers require employees to take COVID-19 tests? How must they protect the test results and how do U.S. Equal Employment Opportunity Commission guidelines and state laws apply?</li></ul><h4><a target="_blank" href="https://www.mofo.com/resources/video-audio/201006-life-sciences-primer-on-covid-19-episode-1.html">Listen to the podcast</a></h4>

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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

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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.

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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.

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

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

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In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each 

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act immunity in the COVID-19 setting have emphasized that the protection applies to those who actually use medical countermeasures, not where injuries arise from parties not using countermeasures. By extension, these cases establish that certain negligence claims may escape the scope of PREP Act immunity and can be properly heard in state court—even if those claims are related to COVID-19.Each of the cases described below was brought against healthcare facilities that allegedly failed to take appropriate COVID-19 prevention measures like social distancing, disinfecting, and using adequate personal protective equipment. The actions were originally filed in state court and the defendants removed them to federal court, claiming that the PREP Act preempts state law claims and presents a federal question. The district courts weighed in to determine whether the PREP Act applied and preempted the state law claims.<h4>Estate of Maglioli</h4>In Estate of Maglioli, plaintiffs brought wrongful death and medical malpractice claims based on the defendants’ failure to implement proper COVID-19 prevention measures. Estate of Maglioli v. Andover Subacute Rehab. Center, 2020 WL 4671091 (D.N.J. 2020). No product liability claims were asserted. The issue before the court was plaintiffs’ motion to remand the case back to a New Jersey state court after defendants removed it to federal court.The defendants argued that the PREP Act preempted this action because the claims originated and arose from the allocation, use, distribution, procurement, and administration of various covered countermeasures in responding to COVID-19: namely, the decision not to use those countermeasures. But plaintiffs asserted that the claims did not fall within the scope of the Act because they simply related to medical negligence, and were not directed to the defendants’ role in manufacturing, distributing, administering, or using the covered countermeasures.The court remanded the case, holding that the PREP Act was “designed to protect those who employ countermeasures, not those who decline to employ them.” Id. at *9. In addition, many of the allegedly negligent acts related to measures like social distancing, quarantining, and lockdowns, which are not covered countermeasures at all. Id. at *10. The court clarified that it was not deciding whether or not the defendants were entitled to a PREP Act defense. Instead, the ruling was limited to the narrow issue that the Act “does not so occupy the field as to squeeze out state court jurisdiction over what are state-law claims of negligence and require an exclusive federal forum.” Id. at *11. “[T]he Act still leaves room for ordinary claims of negligent or substandard care.” Id. at *9.<h4>Big Blue Healthcare</h4>Twelve similar lawsuits alleging negligence claims were filed against defendant care facilities Big Blue Healthcare, Inc. et al. in Kansas. See, e.g., Lutz v. Big Blue Healthcare, Inc., 2020 WL 4815100 (D. Kansas 2020). Just as in Estate of Maglioli, the plaintiffs alleged that the defendant care centers negligently failed to provide COVID-19 protections, and the issue before the court was whether to remand the cases back to state court after defendants removed them to a federal forum.The court declined to apply the PREP Act to plaintiffs’ claims because they were not causally connected or related to the administration or use of a covered countermeasure. Id. at *5. Defendants argued that the PREP Act applied to plaintiffs’ claims because the Act applied to the use of covered countermeasures for other individuals elsewhere in the facilities. But these arguments were rejected because the Act requires a causal connection: the PREP Act “addresses the administration or use of covered countermeasures. There is simply no room to read it as equally applicable to the non-administration or non-use of covered countermeasures.” Id. at *8.<h4>Takeaways</h4>These cases should not be interpreted as significantly limiting the scope of PREP Act protection. The findings are consistent with the policy rationale behind the PREP Act, which is to protect entities that affirmatively distribute and manufacture products to treat and prevent COVID‑19, not to protect those that fail to do so. Courts have reached similar conclusions applying the PREP Act in other settings. See, e.g., Casabianca v. Mt. Sinai Med. Ctr., 2014 WL 10413521 (N.Y. Sup. 2014) (holding that the PREP Act does not apply to defendant hospital’s failure to administer the H1N1 vaccine to a patient).Although these cases affirm the ability of plaintiffs to sue healthcare facilities in state courts over ordinary negligence claims, they do not present new liability exposure for manufacturers or distributors of covered countermeasure products or erode any of the PREP Act immunity protections we have previously written about. For more updates on the PREP Act and COVID‑19 legal issues, visit MoFo’s <a href="https://classdismissed.mofo.com/" target="_blank">Class Dismissed</a> and <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> blogs.

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Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice 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 the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

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Julie Y. Park

First Decisions Limit PREP Act Immunity in Coronavirus Context