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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The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) address

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Digital Health in 2019 | MoFo Life Sciences

The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes from the 21st Century Cures Act, which went into effect at the end of 2016.Artificial Intelligence in Digital HealthIn April, FDA proposed a foundational framework for regulating the emerging field of AI/ML in software as a medical device (SaMD) applications. This framework is in response to the unique regulatory challenges presented by AI/ML-based devices.  While a device has traditionally required additional regulatory approval if its behavior changes after its initial approval, changing behavior is generally the goal of an AI/ML-based device. AI/ML-based devices promise to continuously improve throughout the device’s lifetime, often yielding more accurate results than existing methodologies. The continuously learning aspect of AI/ML necessitates a rethinking of how FDA approaches regulating such devices.FDA’s proposed framework outlines scenarios where changes to an AI/ML-based SaMD may not require additional approval after an initial premarket approval. In the proposal, FDA conceptualizes AI/ML-based SaMD along two main axes. First, FDA proposes to evaluate AI/ML-based SaMD on risk according to the International Medical Device Regulators Forum (IMDRF) framework. On one end, a device may be considered high-risk if it is used to treat or diagnose a critical condition. On the other end, a device may be considered low-risk if it is used to simply inform clinical management of a non-serious condition. Second, FDA proposes to evaluate AI/ML-based SaMD on where it falls along the “locked” to “continuously learning” spectrum. Although FDA has already approved a number of AI/ML-based devices (and continues to do so at an increasing pace), these devices generally use “locked” algorithms that provide the same result each time the same input is provided. Under the current regulatory framework, device manufacturers can perform additional training on approved devices and submit algorithm updates for additional approval.Under the new framework, FDA proposes a total product lifecycle approach where the agency “will assess the culture of quality and organizational excellence of a particular company.” For premarket submissions, FDA intends to assess whether organizations exercise good machine-learning practices and whether organizations have sufficient risk management controls to continually manage patients throughout the product lifecycle. A key feature of the framework is the introduction of a predetermined change control plan to cover anticipated changes to AI/ML-based SaMD. If proposed changes fall within the scope of the agreed-upon change control plan, the changes may be documented and implemented without further regulatory submissions. If proposed changes fall outside the scope of the plan but do not lead to a new intended use, FDA may conduct a “focused review” of the proposed changes. Under this framework, only proposed changes that fall outside the plan and lead to a new intended use may require a full, new premarket submission. FDA solicited feedback on its proposed framework, and comments were generally positive. The industry welcomed FDA’s efforts to provide clarity in this fast-moving space. Many comments requested that FDA provide clear and specific guidance (with detailed examples) on what FDA considers good machine-learning and risk management practices. Many comments also requested robust transparency requirements to ensure the continued clinical reliability of AI/ML-based SaMD. Although this framework focuses on SaMD, AI/ML has also grown significantly in adjacent spaces, such as drug development.  In 2019, FDA approved an accelerating number of AI/ML submissions. One such example is an algorithm that identifies instances of breast cancer using machine learning on mammogram images from CureMetrix. Another example is a Biovitals Analytics Engine, which uses machine learning to identify correlations between vital signs and daily activities for patients suffering chronic conditions. Canon Medical also received FDA clearance for using machine learning to reduce noise and increase spatial resolution in CT scan image reconstruction. FDA will likely continue to monitor AI/ML applications in a variety of medical contexts.  However, whether FDA currently possesses sufficient authority to implement its proposed AI framework, or will instead require additional legislative authorization, is not clear.Digital Health Innovation Action PlanFDA’s AI regulatory proposal is part of a larger push to stay abreast of technology innovation in the digital space. In 2017, FDA unveiled a Digital Health Innovation Action Plan with three major prongs: (1) implementing new legislation through updated guidance, (2) implementing a pre-certification program for digital products, and (3) adding additional digital expertise to FDA staff. On the first prong, FDA implemented several legislative changes from the 21st Century Cures Act (Cures Act) in September 2019. These changes took the form of a finalized Mobile Medical Applications guidance, a finalized Off-the-Shelf Software in Medical Devices guidance, a finalized Medical Device Data Systems guidance, a finalized General Wellness guidance, and a second-draft Clinical Decision Support (CDS) guidance. The finalized guidances generally implemented categories of software that FDA no longer considers a medical device—and therefore no longer plans to regulate—under the Cures Act.The second-draft CDS guidance follows a first-draft CDS guidance issued in December 2017. Both guidances set out to categorize devices that do not meet the definition set forth in the Cures Act, devices that do meet the definition but will be subject to enforcement discretion, and devices over which FDA intends to exercise regulatory oversight. Compared to the first CDS guidance, the second CDS guidance adopts the IMDRF framework for a risk-based approach to device regulation. The second CDS guidance also extended the scope of CDS to include Patient Decision Support devices, which previously fell under their own, separate guidance. Given the extent of the changes from the first-draft guidance to the second-draft guidance, FDA may still take a while before it finalizes its CDS guidance to comply with the Cures Act.On the second prong, the pre-certification program continues to move slowly. FDA introduced the pilot pre-certification program in 2017 with the goal of streamlining the regulatory approval pathway. Under the program, FDA would validate software design, software maintenance, and quality standards at the company level, rather than at the device level. Although the pilot launched in 2017 with nine companies, the pilot is still running with the same nine companies (perhaps progressing at a slower rate than initially contemplated). One major impediment has been congressional discomfort with the program. Congress has issued two letters to FDA requesting legal justification for the pilot and the eventual full-fledged program, as well as implementation details to assure that public safety will not be compromised. On the third prong, FDA has stated that it intends to hire software engineers, health scientists, and clinicians to bolster its expertise and response times. However, it’s not clear how successful FDA has been in strengthening its ranks. When asked in April if the agency was equipped to handle a total product lifecycle approach to regulation, the agency declined to comment.On the cybersecurity front, FDA continues to drag its feet and has not finalized a draft guidance issued in 2018. FDA does list a cybersecurity draft guidance as a CDRH priority target for 2020, but the cybersecurity draft guidance was also listed as a priority target for 2019 and never materialized.

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