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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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.

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What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

USPTO Fee Changes for 2025

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

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After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released <a target="_blank" href="https://home.treasury.gov/news/press-releases/sm779">proposed regulations</a> to implement the Foreign Investment Risk Review Modernization Act (FIRRMA). These proposed regulations follow an initial round of FIRRMA-implementing regulations issued in October 2018, which most notably included the Committee on Foreign Investment in the United States (CFIUS) critical technologies pilot program imposing mandatory CFIUS filing requirements on certain foreign investments in U.S. technology and life sciences companies.The draft regulations propose long-awaited answers to questions about how Treasury and the other CFIUS member agencies will conduct national security reviews of foreign investment under the “modernized” FIRRMA construct, and would amend and restate in entirety the existing rules at Part 800 of the Treasury Regulations. As with the October 2018 regulations, the new proposed rules include changes that will fundamentally alter how foreign investors and U.S. businesses approach mergers and acquisitions, equity investments, and real estate transactions going forward. In other ways, the new rules formalize practices that CFIUS has adopted over time to address the current national security and international trade policy environment.This piece — highlighting some of the key takeaways from the sweeping proposal — is the first in a series of four client alerts. The next three will address in more detail the proposed regulations’ treatment of: (1) real estate transactions; (2) transactions involving U.S. businesses relating to critical technologies, critical infrastructure, and sensitive personal data; and (3) the type and composition of foreign investors.

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Senior Advisor, National Security

Joseph Benkert is a senior advisor  in Morrison & Foerster’s National Security practice group. He advises  clients on critical national security matters pertaining to the Committee on  Foreign Investm

Joseph Benkert

Joseph A. Benkert

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Charles Capito is a partner in both Morrison Foerster’s National Security and Government Contracts + Public Procurement practices.
In the National Security space, he has significant experience couns

Charles L. Capito

Charles Capito

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Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

China’s new administrative regulations on human genetic resources as applied to foreign persons

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After more than a year of anticipation, the U.S. Department of the Treasury (“Treasury”) has released proposed regulations to implement the Foreign Investment R

Foreign Investment 2020: Key Takeaways from the “Modernized” CFIUS Regulations

Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Bethany discusses that the pharmaceutical sector has been one of the more robust areas where private partnerships with artificial intelligence-based technology companies have developed. She covers that many of these partnerships focus on drug design, but some also focus on drug discovery, or aspects of clinical trial or management. Bethany goes on to discuss that these partnerships are emerging in the absence of clear legal and regulatory frameworks.Read more in PHARMAnetwork Magazine, beginning on <a href="https://www.pharmanetwork.digital/html5/reader/production/default.aspx?pubname=&edid=5cc61e07-6c20-4323-99b1-77b38b939490" target="_blank">page 54</a>.

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Artificial Intelligence and Pharma

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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Bethany Hills authored an article for PHARMAnetwork, covering how the pharmaceutical industry has been adopting artificial intelligence and machine learning. Be

Artificial Intelligence and Pharma

In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapies are discovered and produced. Indeed, it is possible for AI to provide insights into disease and treatment that could not have been identified by one or a group of human brains. Translating the union of AI with life sciences technologies into patentable inventions within the framework of the current U.S. patent system, however, is not necessarily a straightforward task. Fortunately, the U.S. Patent and Trademark Office (USPTO) is working diligently to provide guidelines for practitioners to make the path to patentability less uncertain.On August 27, the USPTO published a <a href="https://www.federalregister.gov/documents/2019/08/27/2019-18443/request-for-comments-on-patenting-artificial-intelligence-inventions" target="_blank">Notice </a>in the Federal Register requesting information from the public on AI patent-related issues, including feedback on questions pertaining to the intersection of AI and patent law. The life sciences community is likely to provide unique commentary on these and other questions as the strategic application of AI continues to drive innovation in this sector. Input from the life sciences community is certain to aid the USPTO in developing guidance that will provide a more predictable path to navigate patenting of AI technologies.

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Of Counsel

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. 

Anna Yuan

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

Karen G Potter Ph.D.

Karen Potter

AI Patent Policy – Calling all Life Sciences Practitioners

In the life sciences, artificial intelligence (AI) may be facilitating a sea change in how diseases are diagnosed, prognosed, and treated, and even how therapie

AI Patent Policy – Calling all Life Sciences Practitioners

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human Genetic Resources Administration.This article is not a comprehensive review of the Regulations, but rather focuses on those provisions in the Regulations that govern conducts related to “foreign organizations and individuals, as well as their established or actually controlled institutions” (collectively, the “Foreign Persons”). For a detailed analysis or an English translation of the Regulations, please contact the <a target="_blank" href="mailto:CCui@mofo.com?subject=MoFo%20Life%20Sciences%20blog%20post">author</a>.The Regulations prohibit Foreign Persons from collecting or preserving China HGR in China, or providing China HGR abroad. The Regulations do permit Foreign Persons’ limited use of China HGR “to carry out scientific research activities,” which must be conducted through collaboration with Chinese scientific research institutions, higher education institutions, medical institutions, or enterprises (collectively, the “Chinese Entities”). Such activities must be approved by China’s Ministry of Science and Technology (“MOST”), and the application for approval must be filed jointly by the Foreign Person and the relevant Chinese Entity. The only exception to the approval requirement is “international collaboration in clinical trials” that do not involve the outbound transfer of China HGR materials such as organs, tissues, or cells comprising the human genome, genes, or other genetic substances (collectively, “China HGR Materials”). Such clinical trial collaboration, however, must still be pre-registered with MOST.The Regulations require that the permitted international collaboration ensure that “the Chinese Entities can take part in the research substantially in the whole process for the duration of the collaboration” and have full access to and complete copies of “all records, data and other information in the research process.”The outbound transfer of China HGR Materials in permitted international collaborations must be on an as-needed basis and subject to MOST’s prior approval, which is required for the customs procedures.The Regulations dictate that any patent rights based on scientific research results obtained in the permitted international collaboration must be jointly owned by the participating Foreign Person and Chinese Entity. Ownership and use rights of other scientific and technological achievements arising from the collaboration may be contractually agreed upon by the parties. Notably, the Regulations do not dictate the ownership of HGR information, i.e., the data and other information materials generated from the utilization of China HGR Materials (collectively, “China HGR Information”), arising from the international collaboration, but simply provide, without further clarification, that it can be used by both collaborating parties.Penalties for violation of the Regulations by Foreign Persons include injunction; confiscation of any China HGR illegally collected or preserved and of any relevant illegal income; and  a fine of more than RMB 1 million but less than RMB 10 million. If the illegal income is more than RMB 1 million, the fine will be five to ten times that of the illegal income.The Regulations do permit the provision of or open access to China HGR Information to Foreign Persons, subject only to registration with MOST. In the event such provision or access could endanger China’s public health, national security or public interests, MOST’s security examination will be required. This may provide an easier route for Foreign Persons to gain access to China HGR Information (but not China HGR Materials), because apparently no international collaboration is required for such access.China’s next steps in regulating China HGR will likely focus on legislation related to the clinical application of new technologies in biomedicine, in part as a response to the gene-edited babies scandal that broke out in late 2018.

China’s new administrative regulations on human genetic resources as applied to foreign persons

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into

In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public.The Court of Justice of the European Union (“CJEU”) ruled in its decision of June 28, 2019 (<a href="http://curia.europa.eu/juris/document/document.jsf?docid=215581&text=&doclang=EN&part=1&occ=first&mode=LST&pageIndex=0&cid=1772522">Case T-377/18</a>), that a pharmaceutical company cannot invoke the exceptions of <a target="_blank" href="http://www.europarl.europa.eu/RegData/PDF/r1049_en.pdf">Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents</a> (the “Regulation”) to prohibit public access to a periodic benefit-risk evaluation report submitted in the context of a marketing authorization of a medicinal product.  The exceptions to the Regulation for protection of court proceedings or commercial interests must be interpreted and applied strictly, as such exceptions derogate from the Regulation’s objective of ensuring the widest possible access to documents.Background to the DisputeIn the context of a communication of the Food and Drug Administration (FDA, United States) concerning the safety of a medicinal product and a drop in the share price followed by a lawsuit filed by shareholders in the U.S. against the pharmaceutical company manufacturing the medicinal product (the “DeSmet lawsuit,” a so-called stock drop lawsuit), a law firm requested access to several documents from the European Medicines Agency (“EMA”) relating to the marketing authorization of the medicinal product in question.  Despite the fact that the pharmaceutical company proposed redactions of specific sections of the report relating to the safety of the medicinal product with regard to the disclosure request, EMA decided to disclose the report without the proposed redactions.  The pharmaceutical company challenged EMA’s decision.Decision of the CJEUThe CJEU approved EMA’s decision to grant access to documents submitted in the context of a marketing authorization of the medicinal product, and found that the exceptions of the Regulation did not apply in this case. Exception to publication applies to documents relating to court proceedings (second indent of Art. 4(2) of the Regulation)The CJEU ruled that this exception only applies to documents drawn up in the context of specific pending court proceedings (e.g., pleadings in pending court proceedings) or, exceptionally, documents that contain legal positions that subsequently become the subject of such proceedings and whose disclosure would be likely to compromise the defense of the documents’ author in the context of such proceedings.  However, the contested report is a scientific document that was submitted to EMA in the context of an administrative procedure (in order to establish whether the risk-benefit balance remained unchanged), and not a document that met the conditions set forth by the CJEU. (N.B.: The term “court proceedings” also covers non-European court proceedings.)The exception to publication for protection of court proceedings is necessary to ensure observance of the principles of equality of arms.  Contrary to the claimant’s opinion, disclosure of the report would not lead to circumvention of the protections conferred by U.S. legislation in proceedings relating to preliminary investigation.  The main purpose of that legislation is characterized by the intention to limit abusive class actions, given that such actions have a negative impact on the U.S. capital markets.  Accordingly, that legislation is not concerned with the protection of court proceedings as interpreted by the EU courts and, consequently, does not affect the principle of equality of arms.Exception to publication applies to documents where disclosure undermines the protection of commercial interests (first indent of Art. 4(2) of the Regulation)The CJEU ruled that pharmaceutical companies have to show that the requested documents contain commercially sensitive information, e.g., with regard to commercial strategies of the undertakings involved or to their customer relations or where that document contains information particular to that undertaking that reveals its expertise.  Arguments such as a greater financial investment in the context of the court proceedings pending in the U.S. or the scientific nature of the complex, detailed, or specialized report are not sufficient to constitute a ground for non-disclosure.Key TakeawaysTo invoke the exception of “court proceedings,” the document must be drawn up in the context of specific court proceedings or contain internal positions of a legal nature. To invoke the exception of “commercial interest” successfully, pharmaceutical companies have to show that the requested documents contain sensitive commercial information.  The mere fact that a document concerns an interest protected by an exception is not sufficient to justify the application of that exception.  Furthermore, the risk of such interest being undermined by disclosure of the document must be reasonably foreseeable and must not be purely hypothetical. Otherwise, these exceptions do not apply and disclosure of the documents cannot be prohibited.Note that other EU Regulations, such as the Trade Secrets Directive, in particular its rules for preservation of confidentiality of trade secrets in the course of legal proceedings, do not affect the rules on public access to documents or on the transparency obligations set forth in the Regulation (<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016L0943&from=EN">recital 11 of the Trade Secrets Directive</a>).

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing a

Confidentiality of Documents: Only if Related to Court Proceedings or Commercial Interests

In response to the opinion of European Data Protection Board (EDPB), the European Commission has issued its <a href="https://ec.europa.eu/health/sites/health/files/files/documents/qa_clinicaltrials_gdpr_en.pdf" target="_blank">Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A)</a>. The non-binding Q&A offers some additional clarifications for data processing within clinical trials. However, the Q&A also falls short in other respects. In particular, it omits some core issues, deferring to national data protection authorities instead.Key takeawaysThe Q&A aligns with the opinion that he EDPB issued on the Q&A ahead of its publication on:<ul class="li-margin"><li>The legal justification within clinical trials and deterrent on using consent – Under the GDPR, the processing of personal data must be tied to one of the legal justifications/derogations (for sensitive data such as health data) listed in the GDPR. One of those justifications/derogations is consent, but there are also others, such as public interest or scientific research. In parallel, EU clinical trial rules generally require that clinical trial participants provide their informed consent to participate in a clinical trial. The Q&A confirms that consent under the GDPR (protecting privacy) should be distinguished from clinical trialinformed consent (protecting ethics), and that consent is generally not the appropriate justification under the GDPR. <ul class="li-margin"><li>This is the case in particular, given the potential imbalance of power between participants and clinical trial investigators (so that consent would not be freely given) and because if a participant withdraws consent, personal data collected prior to the withdrawal may have to be deleted, which can lead to a host of issues, and threaten the quality and credibility of the clinical trial.</li><li>As a result, the Q&A recommends other legal justifications than consent, which it allocates depending on some core activities identified within clinical trials, namely “reliability and safety purposes” and “research activities” as the EDPB had suggested (see the table below). As we identified in our previous alert, while clarifying the absence of the need for consent under the GDPR is helpful, it can also cause tension where local privacy laws prescribe consent for reliance on scientific research, as in Ireland or the Netherlands.</li></ul></li></ul><ul class="li-margin"><li>Secondary use – The Q&A also confirms the existence of a “presumption of compatibility” under the GDPR for further scientific research outside the study protocol. Within clinical trials, a “protocol” must be drafted to describe the clinical trial objectives among other details. Those objectives are then built into clinical trial documentation that is provided to the participants. That said, clinical trials may last several years and discoveries may prompt the need for research beyond the protocol. Under clinical trial rules, such prolonged use is allowed (CTR Art. 28.2) under certain conditions. The question therefore arises as to whether such prolonged use is also possible under the GDPR without having to obtain a new legal justification (or whether, conversely, a separate justification is required, which may require taking additional steps, such as re-notice/re-consent with individuals). The EDPB confirms that it is possible to rely on the initial justification for the scientific research also for the prolonged use. It should be noted, however, that secondary use is a complex issue under the GDPR, and that the EDPB already announced, in its opinion, that it will devote further attention and guidance to it in the future. There will, therefore, be additional considerations to look out for in the future.</li></ul>

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Managing Partner, Brussels

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Brussels office, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management. 

With more than a decade of experience, Mr. van der Wolk helps clients develop privacy strategies for digital transformations, industrial IoT, telematics, Big Data, commercial and marketing programs, a

Alex van der Wolk

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Brussels office, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management.

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European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR

New York Enacts Employee Monitoring Notification Law

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In response to the opinion of European Data Protection Board (EDPB) (see our alert), the European Commission has issued its Question and Answers on the interpla

European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published 20 years of reports submitted through the ASR Program that had not previously been disclosed to the public, leaving manufacturers with potentially massive amounts of data to sort through regarding their products.Background of the ASR ProgramCreated in 1997, the ASR Program was designed to give FDA more time to review and act on “new safety signals and less understood risks” by relieving FDA of the obligation to review well-known and well-understood adverse events. Under the ASR Program, manufacturers could request an exemption from the burden of submitting individual reports and instead submit quarterly summary reports for common adverse events. Since the ASR program’s inception, FDA has granted 108 exemptions for specific, well-known adverse events associated with medical devices, such as adverse events those described in the labeling of the device.FDA Ends ASR Program to Increase TransparencyThe ASR Program caused some concern among the public because very few of the reports submitted to the FDA through this program were accessible to the public. In 2017, FDA took steps to make the ASR program more transparent by requiring manufacturers to submit dual reports. Along with their ASR reports, FDA asked manufacturers to submit a “companion” MDR that would be available to the public through the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database holds mandatory reports (submitted by manufacturers, importers, and device user facilities) and voluntary reports (submitted by healthcare professionals, patients, and consumers) that the entire public can access. In 2018, FDA also began to slowly phase out the ASR Program when it launched the Voluntary Malfunction Summary Reporting (VMSR) Program.The VMSR Program was also designed to reduce FDA’s monitoring burden. Under the VMSR Program, manufacturers of specific medical devices can report certain malfunctions on a quarterly basis in a summary format rather than through individual reports. When FDA ended the ASR Program, only 13 companies still had VMSR exemptions. These included manufacturers of dental implants, implantable cardiac defibrillators, and pacemaker electrodes. In an effort to increase transparency regarding safety of medical devices, FDA decided to end the ASR Program and release 20 years of reports that were filed under the ASR Program.Further Steps Taken by FDA to Improve TransparencyFDA has also been working to make the MAUDE system more user-friendly and to modernize the Medical Device Programs Information Technology Systems. Since 2012, FDA has been working on the National Evaluation System for health Technology (NEST). This active surveillance system uses real-world data to quickly find and address safety signals once devices are on the market. NEST is designed as a counterpart to the MDR Program, with the intent of removing the human error that can come through reports. These actions demonstrate FDA’s commitment to making records more transparent and giving the public a more open view into its regulatory activities.ImplicationsMedical device manufacturers should monitor FDA’s push for transparency and the potential impact transparency may have on their businesses. With the release of 20 years’ worth of ASR Program data, 6 million previously undisclosed adverse event reports are open now to public scrutiny. Morrison & Foerster’s new FDA practice and our product liability lawyers can help you assess the potential impact of these reports on your company. [1] Shuren, Dr. Jeffery E. “Statement on agency’s efforts to increase transparency in medical device reporting.” U.S. Food & Drug Administration, 21 June 2019, <a href="https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting" target="_blank">https://www.fda.gov/news-events/press-announcements/statement-agencys-efforts-increase-transparency-medical-device-reporting</a>