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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The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”), which requires vendors of personal health records (PHR) and related entities that aren’t covered by HIPAA to provide notice for breaches of personally identifiable health data.  Since its adoption by the FTC in 2009, the Rule has been largely overshadowed by HIPAA and its implementing regulations. The FTC is now considering whether the Rule should be updated, or even pared back, to keep up with the times. The public comment period will extend until August 20, 2020. Given the patchwork of data breach laws now in place in every state, an expansion of the Rule could very well add to the already difficult task that is data breach notification analysis for companies operating in the healthcare sector. Read our <a target="_blank" href="https://www.mofo.com/resources/insights/200602-ftc-seeks-comments-health-breach-notification.html?utm_source=publication&utm_medium=email">client alert</a>.

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Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector.

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Melissa Crespo

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FTC Seeks Comments on Health Breach Notification Rule

New York Enacts Employee Monitoring Notification Law

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The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”),

FTC Seeks Comments on Health Breach Notification Rule

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-uses-EUAs-broadly-in-the-fight-against-Covid-19.html">previously reported</a>. Notably, in its <a target="_blank" href="https://www.fda.gov/media/135659/download">Policy for Diagnostic Tests for Coronavirus Disease-2019</a> (last updated May 11), FDA describes circumstances under which CLIA-certified laboratories that develop and validate tests for coronavirus can use the tests before the agency has completed review of the lab’s EUA. But this policy does not apply to at-home tests, a caveat we analyzed <a target="_blank" href="https://classdismissed.mofo.com/fda/fda-warns-against-at-home-covid-19-testing-kits/">here</a>. In March, FDA warned that it had “<a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits">not authorized any test</a>” for at-home use, noting that the public health value of expanded COVID-19 testing is predicated on testing that is “safe and accurate.” This statement halted a cadre of startups that were gearing to launch such tests, such as Carbon Health, Nurx, and Everlywell.Now, a couple of months later, FDA has signaled more openness to a variety of tests—those being (a) collected at home, (b) performed at point of care, and (c) used for asymptomatic patients. <h4>At-Home Tests</h4>A patient hoping to take a COVID-19 test from the comfort of home—and thereby minimize the need for PPE—has at least three options. The first is manufactured by LabCorp. FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection">re-issued an EUA to LabCorp</a> to permit testing of samples collected by patients using a designated kit containing nasal swabs and saline. This was the first test approved for home collection; we shared the development <a href="https://classdismissed.mofo.com/fda/covid-19-update-fda-authorizes-first-at-home-collection-kit/" target="_blank">here</a>.The second test approved for home collection is by Rutgers. Rutgers’ test is the only one authorized to <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva">use saliva samples</a> to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. This saliva-based test is <a target="_blank" href="https://www.rutgers.edu/news/fda-approves-first-home-saliva-collection-test-coronavirus">arguably less invasive</a> than the nasal swab alternative.The latest test to receive an EUA for home collection is from Everlywell—the same company that announced launch plans back in March. Everlywell’s test is first-of-its-kind in a third way: it is the first <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-standalone-home-sample-collection-kit-can-be-used">standalone at-home</a> sample collection kit. In other words, the kit can work with multiple tests at multiple labs.The points of distinction among these tests are summarized below:<table cellpadding="0" cellspacing="0" border="1"><tbody><tr><td valign="top" width="156" style="width: undefined%; height: auto;">Manufacturer</td><td valign="top" width="156" style="width: undefined%; height: auto;">Sample Type </td><td valign="top" width="160" style="width: undefined%; height: auto;">Test Type</td></tr><tr><td valign="top" width="156" style="width: undefined%; height: auto;"><a target="_blank" href="https://www.fda.gov/media/136148/download">LabCorp</a></td><td valign="top" width="156" style="width: undefined%; height: auto;">Nasal</td><td valign="top" width="160" style="width: undefined%; height: auto;">PCR Test (molecular)</td></tr><tr><td valign="top" width="156" style="width: undefined%; height: auto;"><a target="_blank" href="https://www.fda.gov/media/137773/download">Rutgers</a></td><td valign="top" width="156" style="width: undefined%; height: auto;">Saliva</td><td valign="top" width="160" style="width: undefined%; height: auto;">PCR Test (molecular)</td></tr><tr><td valign="top" width="156" style="width: undefined%; height: auto;"><a target="_blank" href="https://www.fda.gov/media/138144/download">Everlywell</a></td><td valign="top" width="156" style="width: undefined%; height: auto;">Nasal</td><td valign="top" width="160" style="width: undefined%; height: auto;">For use only withIVD Tests (molecular)</td></tr></tbody></table> All three EUAs, however, still require that the nasal or saliva sample be sent to a CLIA-certified lab for processing. The emergency authorization should not be construed as a general authorization to fully test oneself at home, without lab involvement. Furthermore, all three tests require a doctor’s order. The Everlywell kit, for example, may be used by individuals who have been screened using an online questionnaire reviewed by a healthcare provider. <h4>CLIA-Waived Tests (Point of Patient Care)</h4>In another major step, FDA has approved at least four CLIA-waived tests. This means the tests can be performed at the point of patient care. They may be relatively more straightforward or otherwise less risky than other diagnostic tests. These tests include:<ol><li><a target="_blank" href="https://www.fda.gov/media/138179/download">Quidel’s antigen test</a>;</li><li><a target="_blank" href="https://www.fda.gov/media/136522/download">Abbott’s ID NOW molecular test</a>;</li><li><a target="_blank" href="https://www.fda.gov/media/136345/download">Mesa Biotech’s molecular test</a>; and </li><li><a target="_blank" href="https://www.fda.gov/media/136316/download">Cepheid’s molecular test</a>.</li></ol>Furthermore, Quidel’s EUA is the <a href=" https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes" target="_blank">first for an antigen test</a>—a new category of tests that detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. In contrast, molecular tests for viral RNA, typically PCR tests, received FDA’s earliest stamp of approval.<h4>Tests for Asymptomatic Patients</h4>FDA has also, for the first time, finally <a target="_blank" href="https://www.fda.gov/media/138097/download">authorized a test</a> that is intended for use by individuals without symptoms. The test, manufactured by Hologic, is the first for asymptomatic patients but the second for the firm, which was <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp">among the first</a> handful of firms to receive an EUA for COVID-19.For a complete list of COVID-19 tests that have received an EUA from FDA in light of the <a target="_blank" href="https://www.fda.gov/media/135010/download">Public Health Emergency</a>, please see <a href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations">its website</a>. The Morrison & Foerster COVID-19 Task Force will continue to provide updates to consumer‑facing product manufacturers as FDA issues new guidance. Follow our <a target="_blank" href="https://lifesciences.mofo.com/">Life Sciences</a> and <a target="_blank" href="https://classdismissed.mofo.com/">Product Liability</a> blogs to stay informed.

Fertility Center Litigation

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Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

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Leading Chemical Company

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In re Air Crash Near Peixoto de Azevedo, Brazil

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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.

Erin Bosman

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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FDA Signals Flexibility with COVID-19 Tests

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

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A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 mil

FDA Signals Flexibility with COVID-19 Tests

Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID‑19 crisis, more and more countries are restricting foreign direct investment (FDI) in their domestic companies, especially in the medical and healthcare industries. These restrictions tend to target Chinese investment in particular. Japan is no exception. On April 22, 2020, the Nikkei reported that the Japanese government appears to be moving in a direction to “add advanced medicine and medical equipment businesses to the list of sectors deemed critical to national security” under the revised Foreign Exchange and Foreign Trade Act (FEFTA, or, the “Act”).Read our <a href="https://www.mofo.com/resources/insights/200522-japan-restrictions-foreign-investment.html?utm_source=publication&utm_medium=email" target="_blank">client alert</a>.

Fujifilm’s $2.3 billion acquisition of Xerox’s 25% stake in Fuji Xerox

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Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries