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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Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

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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 Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements:  a new Digital Health Center of Excellence and an update on its Software Precertification Program.  Manufacturers developing mobile medical devices, software as a medical device (SaMD), artificial intelligence (AI), and wearables when used as a medical device may want to become involved with new center and/or keep the components of the Software Precertification Program in mind.Digital Health Center of ExcellenceThe FDA recently created the Digital Health Center of Excellence, a group of digital health experts assigned with providing technical advice to help accelerate access to safe and effective digital tools.  The new center aims to connect and build partnerships among stakeholders by accelerating digital health advancements, sharing knowledge, and innovating regulatory approaches.  The center is currently in Phase 1, where the focus is on raising awareness and engaging stakeholders.  Phase 2, set to begin at the end of the year, will focus on building partnerships.Update on Software Precertification ProgramThe FDA also released an update on its Software Precertification (“Pre-Cert”) Program.  The goal of the Pre-Cert pilot is to develop a streamlined premarket review process for SaMDs, reducing unnecessary regulatory burden for both the medical device manufacturers and the FDA.  SaMDs range from apps on smartphones to computer-aided detection software.  With the Pre-Cert Program, the FDA first examines the medical software manufacturer rather than the medical device.  The companies that meet the criteria through the Pre-Cert process can seek a streamlined review of SaMD products. Essential Components in the Software Pre-Cert ProgramThe Pre-Cert pilot project implements the Total Product Lifecycle Approach (TPLC), which the update outlined.  Four essential components are designed to reflect the total lifecycle of a product: (1) Excellence Appraisal – The FDA uses five main criteria (patient safety, project quality, clinical responsibility, cybersecurity responsibility, and proactive culture) to determine whether the medical software manufacturer demonstrates a robust culture of quality and organizational excellence.(2) Review Determination – The medical software manufacturer itself would be allowed to determine the regulatory pathway for its own products.  Low-risk software products could be placed on the market with a simplified notification procedure.(3) Streamlined Review – The FDA will develop a special approach to determine the scope of information to be provided by the medical software manufacturer when filing the initial submission.(4) Real-World Approach – The medical software manufacturer shall collect and analyze information related to the actual performance of the software placed on the market to determine safety concerns and risks.Although the development of the Software Pre-Cert Program involves nine (out of over 100) selected companies, it is still early in its development stage.  Additionally, the FDA may face major regulatory hurdles as it will need to ask Congress for the legislative authority to proceed. We will continue to monitor the efficacy of the Digital Health Center of Excellence and the trajectory of the Pre-Cert Program and update this post with any new developments. Subscribe to our blog to never miss a post from MoFo Life Sciences, and keep up with the latest legal and industry insights, news, and events by signing up at <a target="_blank" href="https://www.mofo.com/resources">Morrison & Foerster’s Resource Center</a>.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Of Counsel

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

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Recent Digital Health-Related FDA Announcements

Recent Digital Health-Related FDA Announcements

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The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements:  a new Digi

MoFo & GSAS Harvard Biotech Club’s new course, “<a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a>,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The<a target="_blank" href="https://www.linkedin.com/company/harvard-biotech-club/"> Harvard Biotech Club</a> is a student organization that seeks to bridge the gap between industry and academia. MoFo partners Anita Choi, Andrew Boyd, and Fredo Silva kicked off the course with the first class, “Corporate Due Diligence for Investors and Start-Ups.”Anushree Gulvady who is participating in the course noted that "the MoFo course comes straight from a team of exceptional lawyers and has been immensely informative & enjoyable. As a scientist, I have benefitted a lot from this deep dive into the fundamentals of IP, including patentability, infringement, and due diligence analyses- all integral to biotech start-ups.” Andrew Boyd observed that “it was fantastic to see the level of interest and engagement of the students and be able to share some insights on how our global corporate and IP teams work together to identify and solve diligence issues we see on M&A and investment deals.” Fredo Silva commented that, “until it first happens to them, many companies never really consider the level of scrutiny that comes with the business, technical and legal due diligence in a significant financing raise. By helping prospective entrepreneurs understand how diligence works, we hope they can better operate their business at the early stages to ensure a smooth diligence process later.”Anita Choi added that “IP due diligence often plays a critical role in technology transactions. But the scope of diligence may vary depending on the deal and circumstances. We appreciate the opportunity to share our insights and thoughts on the diligence process. We draw from our group’s extensive experience in helping investors mitigate potential IP risks in their deals, as well as companies navigating the diligence process to get the investment needed to take their company to the next stage of growth.”Upcoming sessions will include classes on “Commercial Life Sciences Transactions and Licensing Issues in a COVID-19 and post-COVID-19 World”; “Raising Angel Investment”; “FDA and Compliance Issues with Testing, Vaccines and Therapies”; “Considerations for ANDA and BPCIA Litigation”; and “The PCT Application Process and International Patent Prosecution.”<a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Learn more about the course</a>.

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Managing Partner, London

Andrew Boyd is an M&A partner based in the London office. He specializes in advising on strategic cross-border mergers and acquisitions, private equity and joint venture transactions with particular e