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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USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

Subject Matter Eligibility of AI Medical Treatments

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

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FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul Patel - Director of CDRH Digital Health Center of Excellence, Zachary Henderson - Head of Legal at Levels Health, and Diane Johnson - Senior Director of Strategic Regulatory, MD&D at Johnson & Johnson.  Shelby Buettner, Principal Legal Counsel at Medtronic, moderated the panel discussion.Below are three key takeaways from the panel discussion:<ol><li>Intentionality of Functionality. This is a key concept in the development of digital health products. Panelists discussed the importance of intentionality in creating and developing products in the digital health space, and the need to understand how the inclusion of or change to some functionalities may impact the level of regulatory oversight. Bakul Patel, Director of the Digital Health Center of Excellence, emphasized the importance of breaking down and parsing out the different functionalities of a digital health software product, especially in communications with FDA, to effectively evaluate if and how the product may fall within FDA’s regulatory purview. </li><li>Early Communications. Panelists discussed how much information should be provided to FDA in early communications and what level of detail is actually helpful in early stages. Bakul Patel noted that manufacturers should strike a balance, providing more than just an idea but not too much information. Ideally, FDA would like companies to read the applicable FDA guidance and come to FDA with specific questions about how the guidance applies to them.</li><li>Development of Guidances. FDA has announced its intention to publish guidance on marketing submission recommendations for change control plans for AI/ML device software function in 2022. In addition, FDA’s final report on the <a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program">Digital Health Software Precertification Pilot Program</a> is expected to be published soon outlining key learnings from the pilot. Examples in FDA guidance have great utility and FDA is continuing to figure out ways to craft helpful examples that provide enough detail without losing applicability across various stakeholders. FDA recognizes the usefulness of examples in guidance documents and notes that interactions with and feedback from industry stakeholders will be essential in continuing to provide detailed and meaningful guidance and examples for industry.</li></ol>Morrison & Foerster’s Stacy Cline Amin served on the planning committee for this conference. For questions on any of the topics discussed, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

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Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

Recent Digital Health-Related FDA Announcements

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FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was 

Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

United States

Digital Health

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference.  Stacy Cline Amin, who served on the conference planning committee, moderated a panel discussion on congressional perspectives and considerations in the digital health space. Bethany Hills participated on a panel discussion on evolutions in telehealth regulation and reimbursement, with a focus on recent developments in 2021. Below are key topics and takeaways discussed during the panels.<h4>Congressional Perspectives in Digital Health</h4>This panel featured senior staff from both of the FDA’s committees of jurisdiction, the Senate Health Committee and the Senate Finance Committee, the House Energy & Commerce Committee, as well as senior staff who led the negotiations for the 21st Century Cures Act.<ol><li>At the time the 21st Century Cures Act was drafted and negotiated, Congress had in mind smart watches and similar digital health technology that is far less complicated than the realities of the technology today.  The advancements and increased technological complexity have brought a slew of intricate questions about when and how FDA regulation should come into play and whether Congress should provide more clarity for the industry.  For example, how should clinical decision support be defined, and at what point should it be subjected to FDA regulatory review or approval?    </li><li>In the artificial intelligence and machine learning (AI/ML) space, panelists discussed the challenges of regulating technology that is continuously changing and the potential incompatibility of AI/ML technologies with existing regulatory frameworks, such as change protocols.  Panelists emphasized the importance of having patients and providers at the table in these ongoing discussions and ensuring that Congressional stakeholders and constituents can understand the technology and mechanics in order to make meaningful decisions. </li><li>Congress is considering these issues as part of the Medical Device User Fee Amendments. Panelists encouraged industry stakeholders and constituents to provide comments and insights to Congressional representatives and staff as these discussion continue.</li></ol><h4>Telehealth 2021:  Regulatory and Reimbursement Developments</h4><ol><li>As we begin to approach the end of the pandemic, the waivers and exemptions extended during the public health emergency have begun to be withdrawn.  Without action from Congress, most Medicare beneficiaries of telehealth will lose access to the majority of telehealth services available during the pandemic.  While many stakeholders are advocating for permanent changes to law regarding telehealth access, a simple extension of the current wavier period is more likely as a near-term action.  Of note, the Centers for Medicare and Medicaid Services (CMS) has already expanded its definition of telehealth services to include audio-only services for mental health services.  </li><li>CMS has created carve-outs for services that may not be defined exactly as telehealth services, but that are supportive of and integrated with telehealth, such as remote physiologic and therapeutic monitoring.  Changes to the RPM and RTM codes and guidelines indicate a certain degree of desired flexibility, but also come with additional questions and areas of ambiguity.  </li><li>Digital health companies are taking advantage of the health insurance adoption of telehealth, maximizing the benefit of telehealth and its potential to lower costs while enhancing patient care.  However, there are a number of challenging issues going forward, particularly with digital-first health insurance offerings and direct-to-consumer (DTC) telehealth products that incorporate insurance‑like features.  In addition, many states issued waivers permitting clinicians to practice across state borders without licensure during the pandemic.  As state-level licensure waivers are winding down, this poses challenges for digital health providers in constructing and maintaining viable provider networks for insurance and DTC markets.</li></ol>For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.

Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. 


Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

MedTech

This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), identified <a href="https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles?utm_medium=email&utm_source=govdelivery&utm_source=STAT+Newsletters&utm_campaign=6a098880a8-health_tech_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-6a098880a8-153551262" target="_blank">10 guiding principles</a> to inform the development of Good Machine Learning Practice (GMLP) and promote safe and effective medical devices that use artificial intelligence and machine learning (AI/ML).  The guiding principles “identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP,” including creation of educational tools and resources, international harmonization, and consensus standards.<img alt="Good Machine Learning" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt4bac1f9a18159f5f/6273178d4d9f89297129022f/211101-good-machine.jpg?format=auto&quality=60" type="asset" sys-style-type="download">The guiding principles reflect some of the focus topics articulated in FDA’s <a href="https://lifesciences.mofo.com/topics/five-key-takeaways-from-FDAs-transparency-of-AIML-enabled-medical-devices-virtual-workshop.html" target="_blank">Transparency of AI/ML-Enabled Medical Devices Virtual Workshop</a>.  For example, the guiding principles recommend that “users are provided clear, essential information,” emphasizing the importance of providing clear, contextually relevant information about the device to the intended audience.  The principles also include requirements that “testing demonstrates device performance during clinically relevant conditions,” and “deployed models are monitored for performance and re-training risks are managed.”FDA welcomes feedback through the public docket at Regulations.gov (<a href="https://www.regulations.gov/docket/FDA-2019-N-1185" target="_blank">FDA-2019-N-1185</a>) and may be contacted directly at <a href="mailto:Digitalhealth@fda.hhs.gov" target="_blank">Digitalhealth@fda.hhs.gov</a>.  Health Canada and the UK’s MHRA may be contacted directly at <a href="mailto:mddpolicy-politiquesdim@hc-sc.gc.ca" target="_blank">mddpolicy-politiquesdim@hc-sc.gc.ca</a> and <a href="mailto:software@mhra.gov.uk" target="_blank">software@mhra.gov.uk</a> respectively.For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html" target="_blank">FDA Regulatory + Compliance</a> practice.

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FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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This week the U.S. Food and Drug Administration (FDA), along with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MH

FDA and International Counterparts Release Best Practices for Machine Learning in Medical Device Development

Regulatory

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening standard for written description and enablement of genus claims for biologic inventions, leading some legal scholars to proclaim the “death of the genus claim.”[1] While we think reports of the death of genus claims are a bit premature, such claims are becoming more and more challenging to obtain during prosecution and to enforce in litigation. In particular, antibody claims that do not recite CDR sequences raise the specter of being subject to written description and/or enablement challenges. Likewise, functional language, while potentially helpful to distinguish claims from prior art, is becoming increasingly problematic. The following are several practice tips for protecting biologic innovations in view of the current trends.<h4>Practice Tips</h4><ul><li>To borrow an analogy the courts have returned to repeatedly, if a genus is a plot of land, the disclosed species and guidance regarding subgenera should cover as much of the terrain as possible.[2] It is important to build subdivisions into your property and include layers of subgenera that reduce the size of the plot (and total number of species). In the current climate, providing as many representative species as possible is more important than ever.</li><li>When considering the level of disclosure to include in an application, keep in mind that the test for written description is the same whether a claim element is essential or auxiliary to the invention. Add language to the description and layers of backup positions for elements that represent emerging technologies or less predictable fields.</li><li>Functional limitations “raise the bar” for enablement and written description. Carefully consider the necessity of each functional limitation in the claims. It is essential to provide support for all functional elements of the claims and build in appropriate backup positions and crystal-clear roadmaps for identifying species that meet the functional limitations. Whenever possible, structural motifs common to the members of a genus or subgenus should be identified to support a structure-function correlation.</li><li>Despite increasing challenges for written descriptions and enablement of a functionally defined genus, functional limitations remain an important component of patent strategy for antibodies and related technologies, including in jurisdictions such as Europe and Japan. Patent applications should include support for multiple layers of claim scope, including claiming antibodies by epitope.</li></ul>Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of biologics.  [1] Karshtedt, Dmitry, Lumley, Mark A., and Seymore, Sean B., The Death of the Genus Claim (Aug. 5, 2020), Harvard Journal of Law & Technology (available at <a target="_blank" href="https://ssrn.com/abstract=3668014">https://ssrn.com/abstract=3668014</a>).[2] Amgen Inc. v. Sanofi, 987 F.3d 1080, 1084 (Fed. Cir. 2021), citing AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299-300 (Fed. Cir. 2014).

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. 

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Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

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Traversing Higher Hurdles for Functional Limitations Under Section 112

mofolifesciences-litigation

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions 

Traversing Higher Hurdles for Functional Limitations Under Section 112

Intellectual Property

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices.  The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers.Below are five key takeaways from the workshop:<ol><li>Cultivating user awareness for both patients and healthcare providers will be a key area of focus for AI/ML-enabled device manufacturers and regulators going forward.  In presentations and panel discussions, many panelists expressed concern as to whether healthcare providers would understand the limitations of AI/ML devices and be able to properly interpret and use the data in administering care.</li><li>Transparency and effective communication of AI/ML medical device labeling will be important to consider for all user types.  Panelists discussed the idea of a nutrition facts label approach to AI/ML device labeling, using the analogy of food labeling to describe the balance of information and detail needed to enable users to make informed decisions.</li><li>Bias and systemic discrimination remain persistent issues in the AI/ML space.  FDA and various industry stakeholders expressed commitment to ensuring that the data used to train AI/ML models are diverse and accurately reflect the patient population in which the technology will be used.  Use of synthetic or artificial datasets to close the data gap and ensure devices are trained using ethnically diverse datasets has been a particularly relevant discussion.</li><li>Inequality, from both a patient and a manufacturer perspective, was a key topic of conversation during the workshop.  Panelists discussed the potential for inequitable access to AI/ML devices across different patient populations, as well as the potential for unequal access to data amongst manufacturers in the industry.</li><li>Transparency surrounding tracking and reporting of device error or malfunctions will be an important topic of discussion as AI/ML-enabled devices are made available.  Panelists discussed the potential for two-way communication between manufacturers and users, and FDA’s role in promoting such transparency.</li></ol>The recording of the webcast, transcript, and presentation slides will be posted on the Workshop webpage within the next few weeks.  FDA will continue to receive and review comments and questions regarding transparency of AI/ML-enabled medical devices online on the public docket.  Comments may be submitted on <a href="https://www.regulations.gov/" target="_blank">regulations.gov</a> (Docket No. FDA-2019-N-1185) until November 15, 2021.For questions on any of the topics discussed at this meeting, please contact the authors or a member of MoFo’s <a target="_blank" href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html">FDA Regulatory + Compliance</a> practice.

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning 

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

Healthcare

On September 30, 2021, the U.S. Food and Drug Administration (FDA) <a target="_blank" href="https://www.federalregister.gov/documents/2021/09/30/2021-21324/interpreting-sameness-of-gene-therapy-products-under-the-orphan-drug-regulations-guidance-for">announced</a> final guidance titled “<a target="_blank" href="https://www.fda.gov/media/134731/download">Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations</a>.”  The guidance finalizes the January 2020 draft guidance and provides FDA’s current perspective on certain criteria that help determine sameness of human gene therapy products for orphan drug designation and exclusivity purposes.  In the Federal Register notice announcing the final guidance, FDA noted that it received comments on the draft guidance that “generally supported the approach described in the guidance.”  FDA considered these comments and requests for additional clarification when finalizing the guidance, “adding clarification and examples, as feasible.”<h4>Background</h4>The Orphan Drug Act (ODA) seeks to incentivize the development of drugs for rare diseases, defined in the ODA as those affecting fewer than 200,000 people in the United States.  The incentives include a 25% tax credit on applicable research and development expenditures, waived user fees when submitting applications to FDA, and the potential for a seven-year period of orphan drug exclusivity for the approved indication.  Manufacturers must request and be granted designation before they are eligible for any incentives. When FDA grants marketing approval for a designated orphan drug for a use or indication within the designation disease or condition, FDA will determine if the drug is eligible for orphan drug exclusivity.  Orphan drug exclusivity is product and indication specific, meaning FDA cannot approve a drug containing the same active moiety for the same intended use or indication during the period of marketing exclusivity. FDA uses different criteria in determining sameness for macromolecule and small molecule drugs [1]. The FDA defines “same drug” for macromolecule drugs as “a drug that contains the same principal molecular structural features (but not necessarily all of the same structural features) and is intended for the same use as a previously approved drug, except that, if the subsequent drug can be shown to be clinically superior, it will not be considered to be the same drug." [2]If a sponsor requests orphan drug designation for a drug that is the same as a drug already approved for the same use or indication, the sponsor must provide a plausible hypothesis that its drug is clinically superior to the already approved drug.  Designation as clinically superior is based on greater efficacy, safety, or a major contribution to patient care.  In order to receive the seven-year market exclusivity, a sponsor must demonstrate that its product is actually clinically superior.<h4>Interpreting Sameness of Gene Therapy Products</h4>Human gene therapy products may qualify for orphan drug designation if they are intended for the treatment of a rare disease or condition and the sponsor sufficiently establishes a basis for expecting the drug to be effective in treating the rare disease.  The existing regulations do not describe how the “same drug” definition applies specifically to gene therapy products for orphan drug designation and exclusivity.  Mirroring the January 2020 draft guidance, FDA’s final guidance provides some insight into the current interpretation of how the “sameness” criteria applies to gene therapies.Assuming that two gene therapy products are intended for the same use or indication, FDA will consider the “principal molecular structural features” of the gene therapy products when determining “sameness.”  In the final guidance, FDA states its intention to generally “consider certain key features such as transgenes and vectors used in gene therapy products to be ‘principal molecular structural features’ under this regulation.”  However, FDA does not intend to classify two gene therapy products as different based solely on minor differences in the transgenes and/or vectors, and will determine whether differences are minor differences on a case-by-case basis.For two gene therapy products intended for the same use or indication, if the products express different transgenes, FDA generally intends to consider them to be different drugs because they will not contain the same principal molecular structural features.  This would be the case regardless of whether the two gene therapy products at issue have or use the same vector.  FDA also intends to consider vectors from a different viral group to be different for purposes of determining “sameness.”  Additionally, FDA clarified in the final guidance that it will consider two gene therapy products from the same viral group to be different “when the differences between the vectors impact factors such as tropism, immune response avoidance, or potential insertional mutagenesis.”  FDA intends to determine whether variants of a vector from the same viral group are the same or different on a case-by-case basis.In a case where two gene therapy products express the same transgene and have/use the same vector, FDA may also consider additional features of the final product when determining “sameness,” such as regulatory elements (e.g., promoters or enhancers).  In these instances, FDA generally intends to determine “sameness” of gene therapy products on a case-by-case basis.[1] 21 CFR 316.3(b)(14).[2] 21 CFR 316.3(b)(14)(ii).

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

The EU General Court’s Ruling on Pay for Delay

mofolifesciences-pharma

On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orp

FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products

Rare Disease

Pharma

Cell + Gene Therapy

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated <a target="_blank" href="https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf">report</a> to the White House Competition Counsel regarding a “Comprehensive Plan for Addressing High Drug Prices.” The HHS Report—issued in response to President Biden’s <a target="_blank" href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/">Executive Order on Promoting Competition in the American Economy</a>—contains a range of approaches for effecting reforms aimed at reducing the price of prescription drugs. Among these proposed reforms are administrative actions that will be undertaken by the Food and Drug Administration to “address potential barriers to biosimilar and generic drug development and market entry to spur competition so that consumers can access the medicines they need at affordable prices.” HHS Report at 19.For both the biosimilar and generic drug marketing pathways, HHS emphasized the importance of labeling carve-outs—so-called “skinny” labels—under 21 U.S.C § 355(j)(2)(A)(viii) as a way to “decrease[] costs to patients and to the federal government, including reducing spending on Medicare and Medicaid.” HHS Report at 21. HHS’s emphasis appears driven in part by a recent case before the Federal Circuit, GlaxoSmithKline v. Teva Pharmaceuticals USA, Inc., addressing patent-infringement liability for generic drug manufacturers that employ skinny labeling practices. 976 F.3d 1347 (Fed. Cir. 2020), aff’d in part and vacated in part, 7 F.4th 1320 (Fed. Cir. 2021); HHS Report at 21 (“Recent litigation has raised some questions about the practice of carving out patent-protected indications for generic drugs, which may discourage the use of carve-outs and thus delay the approval of some generic drugs.”).The patent at issue in GlaxoSmithKline covered the use of Coreg® (carvedilol) to treat congestive heart failure. Teva’s label for its generic carvedilol product omitted this patented indication when FDA first approved it but retained indications for two other approved uses: treatment of post-MI LVD (left ventricular dysfunction following post-myocardial infarction) and hypertension. During this time, however, Teva also marketed carvedilol as therapeutically equivalent to Coreg®, and there was evidence that post-MI LVD patients were also being treated with carvedilol for congestive heart failure. Beginning in 2011, Teva maintained the carve-out but added language elsewhere in the carvedilol label stating that it could be used to treat congestive heart failure. The jury found Teva liable for induced infringement, but the district court granted Teva judgment as a matter of law reversing the verdict. GSK appealed, and, last year, the Federal Circuit reversed the district court’s judgment, holding that the jury’s finding of induced infringement was supported by substantial evidence. GlaxoSmithKline, 976 F.3d 1347 (Fed. Cir. 2020). Teva subsequently requested rehearing, but the same three-judge panel <a target="_blank" href="http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1976.OPINION.8-5-2021_1814836.pdf">affirmed </a>its prior judgment on August 5, 2021, again holding that substantial evidence supported the jury’s verdict that Teva was liable for inducing infringement.[1]The panel reiterated that its decision was limited to the particular factual circumstances presented. The panel emphasized, for example, that “GSK presented evidence that doctors read and consider labels, that Teva’s marketing materials guided doctors to the label and to its website promoting the patented use, that Teva issued press releases encouraging doctors to prescribe carvedilol for the patented use, that Teva’s own employees expected doctors to prescribe carvedilol during the partial label period for the patented uses, and expert testimony that Teva’s actions encouraged doctors to do so.” 7 F.4th at 1338. But the decision raised concerns among generic manufacturers that skinny labeling would not sufficiently shield them from liability and appears to have piqued HHS’s interest. In fact, Teva filed a <a target="_blank" href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltfbd4dcd9d59ab6e0/627317894d9f89297129022b/1429000-1429343-petition.pdf">petition</a> for en banc rehearing on October 7, 2021, in which it urged the full court to reject the panel’s decision because it would “throw inducement doctrine into disarray” and have a “seismic” effect on skinny-label cases.Given how recently GlaxoSmithKline was decided and the uncertainty about how the court will rule en banc, the scope of its impact on skinny labeling practices remains to be seen. The handful of opinions citing it so far have not expanded its application. See Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 503 F. Supp. 3d 156, 2020 U.S. Dist. LEXIS 223968 (D. Del. Nov. 30, 2020) (jury could reasonably infer lack of intent to induce infringement from “removal of field restrictions from [generic] labelling”); Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 2021 U.S. Dist. LEXIS 54618 (D. Minn. Mar. 23, 2021) (distinguishing GlaxoSmithKline in finding insufficient evidence of intent to induce infringement by generic manufacturer); United Food & Commer. Workers Local 1776 v. Takeda Pharm. Co., 2021 U.S. App. LEXIS 25572 (2d. Cir. Aug. 25, 2021) (citing GlaxoSmithKline solely for general proposition that a generic manufacturer may carve out patented uses). Nevertheless, and although the Court observed that “the FDA is not the arbiter of patent infringement issues,” the HHS Report concludes that HHS is “committed to taking steps as appropriate to ensure these critical [skinny label] practices remain available for generic drugs and biosimilars.”Check back to the <a target="_blank" href="https://lifesciences.mofo.com/">MoFo Life Sciences Blog</a> for updates on any specific actions HHS and/or FDA take to address skinny labeling. [1] Teva requested en banc rehearing, but the Federal Circuit interpreted its request as seeking panel rehearing. For a quick overview of this procedural quirk, see this <a target="_blank" href="https://federalcircuitry.mofo.com/topics/Know-Your-En-Banc-Petition-ProcessHow-An-En-Banc-Petition-In-GlaxoSmithKline-v-Teva-Led-To-A-New-Panel-Argument-Without-Apparent-En-Banc-Action.html">recent post </a>from MoFo’s Federal Circuitry blog.

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Fitz Collings is an IP litigator who puts science first to develop innovative litigation strategies for life sciences and technology companies.
Fitz counsels some of the largest pharmaceutical, biotec

Fitz B. Collings

Fitz Collings

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report

Skinny Labels Back in Focus after HHS Report on Addressing Drug Prices

Litigation

As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a <a target="_blank" href="https://www.ftc.gov/system/files/documents/public_statements/1596364/statement_of_the_commission_on_breaches_by_health_apps_and_other_connected_devices.pdf">Policy Statement</a> that emphasizes its commitment to ensuring the protection of sensitive information collected by these apps and devices. On September 15, 2021, the FTC issued its “Statement on the Commission of Breaches by Health Apps and Other Connected Devices,” which offers guidance on the FTC’s Health Breach Notification Rule (the “Rule”), including guidance as to the Rule’s scope, and makes clear that the FTC intends to bring actions to enforce the Rule consistent with the Policy Statement.Read our <a target="_blank" href="https://www.mofo.com/resources/insights/210929-health-breach-notification-rule-enforcement.html">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.