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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In follow-up to our colleagues recent <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html">post</a> about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft <a target="_blank" href="https://www.fda.gov/media/109618/download">Guidance</a> (together the “CDS Draft Guidance”) and the MDR. While still in draft form, we note that FDA has <a target="_blank" href="https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2021-fy-2021">signaled its intent</a> to finalize the CDS Draft Guidance in 2021.<h4>Statutory Framework</h4>Under the current CDS Draft Guidance, FDA first bases its approach to CDS on criteria set forth in the 21st Century Cures Act (the “Cures Act”). Excluded from the definition of a “device” under the Cures Act are software functions that met all four of the following criteria:(1) not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern signal from a signal acquisition system;(2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);(3) not intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and(4) intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.Notably, these criteria do not include software functions intended for a patient or caregiver; rather, these criteria apply only to those software functions for “health care professionals.” Accordingly, software device manufacturers must analyze all software functions utilized by patients and caregivers carefully using the CDS Draft Guidance to determine whether FDA will either exercise its oversight focus, requiring the software to receive FDA approval as a device, or its enforcement discretion.  <h4>IMDRF Framework</h4>FDA’s CDS Draft Guidance also relies on the International Medical Device Regulators Forum (“IMDRF”) Framework for Software as a Medical Device (“SaMD”) in approaching its interpretation of the criteria from the statue that would exclude a software from the definition of a medical device. The MDR also utilized this IMDRF framework for SaMD. IMDRF focuses on two factors, which are critical to the analysis of SaMD: (1) whether the user uses the information provided by a SaMD to treat or diagnose, to drive clinical management, or to inform clinical management; and (2) whether the patient’s healthcare situation or condition is critical, serious, or non-serious.The CDS Draft Guidance utilizes the IMDRF framework, and includes a variation of the classification used under Rule 11 by the European Commission’s <a href="https://ec.europa.eu/docsroom/documents/37581" target="_blank">Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745-MDR and Regulation (EU) 2017/746-IVDR</a>, to similarly categorize different types of SaMD.<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="156" rowspan="2" style="width: undefined%; height: auto;">State of healthcare situation or condition</td><td width="468" colspan="3" style="width: undefined%; height: auto;">Significance of information provided by SaMD tohealthcare decision</td></tr><tr><td width="156" style="width: undefined%; height: auto;">Treat ordiagnose</td><td width="156" style="width: undefined%; height: auto;">Drive clinical management</td><td width="156" style="width: undefined%; height: auto;">Inform clinicalmanagement</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Critical</td><td width="156" valign="top" style="width: undefined%; height: auto;">IV</td><td width="156" valign="top" style="width: undefined%; height: auto;">III</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Serious</td><td width="156" valign="top" style="width: undefined%; height: auto;">III</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Non-serious</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td></tr></tbody></table> FDA uses the risk-categorizations described above to apply a risk-based policy to its regulation of Device CDS functions.<h4>Other Components of the CDS Draft Guidance</h4>In addition to the above framework from IMDRF, the CDS Draft Guidance also focuses on whether the intended user is a healthcare provider or a patient or caregiver and whether the user can independently review the basis for the recommendation from the software.  This focus on user-type and independent review, rooted in the Cures Act language, is a departure from the IMDRF (and the MDR’s) framework, which focuses more upon the intended use of the software and the medical conditions the software covers. As you can see in the table below, FDA has a demonstrated interest in those software functions where the intended user is a patient or caregiver, particularly when the device is informing clinical management for serious or critical healthcare situations or conditions. Similarly, when the intended user is a healthcare provider, FDA does not consider the software to be a device so long as the healthcare provider can independently review the basis for the recommendation.Combining the IMDRF Framework with FDA’s focus on the user-type and whether the user can independently review the basis for the recommendation, results in the following table:<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="249" colspan="2" valign="top" style="width: undefined%; height: auto;"> </td><td width="125" valign="top" style="width: undefined%; height: auto;">Intended User is HCP</td><td width="234" valign="top" style="width: undefined%; height: auto;">Intended User is Patient or Caregiver</td></tr><tr><td width="125" valign="top" style="width: undefined%; height: auto;">IMDRF Risk Categorization</td><td width="125" valign="top" style="width: undefined%; height: auto;">Can the User Independently Review the Basis?</td><td width="125" valign="top" style="width: undefined%; height: auto;">FDA Regulation</td><td width="234" valign="top" style="width: undefined%; height: auto;">FDA Regulation</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxCritical</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Oversight Focus</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxSerious</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Oversight Focus</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxNon-Serious</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Enforcement Discretion</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Enforcement Discretion</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr></tbody></table> <h4>Examples</h4>The CDS Draft Guidance provides a number of examples where FDA works through its framework. These examples walk through the IMDRF framework while considering the intended user and whether the user can independently review the recommendation from the SaMD.Non-Device CDSFDA considers the following software to not be a device: software that compares patient signs, symptoms, or results with available practice guidelines (institutions-based or academic/clinical society-based) to recommend condition-specific diagnostic tests, investigations, or therapy to healthcare providers. In this example, the software uses practice guidelines as the basis for the recommendation and provides such guidelines to the healthcare provider to review, such that the health care provider does not rely primarily on the software’s recommendation.Enforcement DiscretionFDA plans to utilize its enforcement discretion on software that assist a patient in identifying an over-the-counter cold or allergy medication to consider purchasing based on symptoms. In this example, the software would include appropriate warnings about products with overlapping ingredients. This software is device CDS because it is intended for a patient; however, FDA does not intend to enforce compliance because the software is intended to provide options to patients for the treatment of a non-serious situation or condition and because the patient can independently review the basis for the software’s recommendations.Oversight FocusFDA plans to focus its regulatory oversight on device CDS functions intended for patients, where the software is informing clinical management of serious or critical conditions. For example, FDA intends to regulate the following as device CDS: a software function that recommends when the parent or caregiver of pediatric patients with cystic fibrosis should take a child to the emergency room by aggregating information based on patient-specific symptoms and care guidelines. This software is device CDS because a caregiver uses the software and the software informs clinical management for a critical situation or condition, particularly because of the fragility of the target population.   <h4>Conclusion</h4>Recognizing that companies with global offerings face a complexity of issues, companies should seek to leverage similarities amongst the regulatory classification of SaMD and CDS. However, companies should simultaneously be acutely attuned to the critical differences in how those frameworks are applied by the applicable regulatory bodies. There is a need for attention to these issues, particularly with the upcoming finalization of the CDS guidance in FY2021 by FDA and the MDR coming into effect on May 26, 2021.

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

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

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In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of t

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes in the airline industry to help distressed companies. Now, with vaccine manufacturing ramping up, it makes sense that governments would intervene in the life sciences and pharmaceutical sectors as well. In our article published earlier this month on, we analyzed the <a target="_blank" href="https://lifesciences.mofo.com/topics/COVID-19-State-Intervention-in-Times-of-Vaccine-Shortages.html">legal framework for state intervention in vaccine production in Germany</a>. Since then, the German government has <a target="_blank" href="https://www.reuters.com/article/health-coronavirus-vaccine-supply-insigh/as-vaccine-nationalism-deepens-governments-pay-to-bring-production-home-idUSKBN2B40IX">increased its support </a>for local vaccine production. But what is happening across the pond in the United States?Here, too, the federal government has intervened to ramp up the vaccine supply. On March 2, 2021, President Biden announced an historic partnership between Johnson & Johnson (J&J) and Merck to increase production of J&J’s COVID-19 vaccine. While this partnership between two pharmaceutical behemoths is significant in its own right, it also made headlines for the role government played in brokering the deal. The Biden administration agreed to pay $268.8 million to upgrade two Merck production facilities and is helping Merck procure necessary equipment. Of course, this was not the first time during the Coronavirus crisis that the federal government has intervened to shape the private sector’s pandemic response.[2] Nevertheless, it is notable that President Biden is engaging the private sector at this scale and so soon into his presidency. The Biden administration’s early approach to state intervention during the COVID-19 pandemic may portend even greater involvement down the road, which would present both opportunities and risks for life sciences companies doing business in the U.S.<h4>The Statutory Framework</h4>Over 90 percent of constitutions in the world contain emergency clauses, but not the U.S. Constitution.[3] Instead, the federal government’s authority to intervene in a pandemic comes from a patchwork of statutes and regulations. At the center of this constellation is the Defense Production Act, 50 U.S.C. § 501 et seq. (DPA). The origins of the DPA trace back to the War Powers Act of 1941 and 1942, passed during WW2 to give President Roosevelt more control over the wartime economy. Congress enacted the DPA in 1950 during the Korean War and has re-authorized it ever since then—most recently in the John S. McCain National Defense Authorization Act of 2019. In short, the modern DPA authorizes the executive branch to mobilize private actors and allocate resources during moments of national crisis. The president can compel companies to prioritize orders from the government, allocate materials/resources, offer loans or loan guarantees, make purchase commitments, and authorize companies to work together. Historically, the federal government has used the DPA to procure defense contracts and respond to natural disasters. For more information about the DPA, see MoFo’s articles providing a <a target="_blank" href="https://govcon.mofo.com/coronavirus/a-summary-of-the-defense-production-act/">summary of the Defense Production Act</a> and <a target="_blank" href="https://govcon.mofo.com/coronavirus/the-defense-production-act-a-little-known-statute-that-may-soon-be-running-your-company/">three key takeaways about the DPA</a>. In addition to the DPA, the executive branch derives authority to respond to public health emergencies from several other sources. First, the National Emergencies Act, 50 U.S.C. § 1601 et seq., allows the president to declare national emergencies, which essentially unlock statutory powers that the executive branch cannot otherwise access. President Trump declared the COVID-19 pandemic a national emergency on March 13, 2020. Second, the Stafford Act, 42 U.S.C. § 5521 et seq., organizes federal emergency assistance with respect to state and local governments. Third, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, 42 U.S.C. ch. 6A § 201 et seq., allows the Food & Drug Administration (FDA) to prepare and stockpile medical countermeasures (drugs, vaccines, and devices), and streamlines the FDA’s emergency responsiveness. Fourth and most recently, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) gives the FDA a greater role in drug/vaccine supply chains. This is not an exhaustive list of emergency legislation. But when it comes to intervening in private contracting to boost vaccine production, the DPA is the most significant legislation.<h4>The Biden Administration’s Response to COVID-19</h4>On his very first day in office, President Biden passed Executive Order 13987. E.O. 13987 established the position of Coordinator of the COVID-19 Response (currently Jeffrey Zients) and organized that office in the White House. Among other responsibilities, President Biden charged the COVID-19 Response Coordinator with coordinating the government’s efforts to produce and distribute personal protective equipment, vaccines, and tests, “including through the use of the Defense Production Act[.]”[4] President Trump depended somewhat on the DPA for his early COVID-19 response, but critics, including then-candidate Biden, argued that he did not fully take advantage of the <a target="_blank" href="https://www.nytimes.com/2020/09/22/health/Covid-Trump-Defense-Production-Act.html">Act to manage the medical equipment supply chain</a>. Thus, President Biden’s early focus on the DPA signaled a shift from the prior administration.The next day, on January 21, 2021, President Biden signed Executive Order 14001, ordering the secretary of state, secretary of defense, secretary of health and human services, secretary of homeland security, and the heads of relevant agencies to review the inventory of critical pandemic response supplies and fill any shortfalls. In particular, section 2 of the E.O. directs executive officers to “take appropriate action using all available legal authorities, including the Defense Production Act, to fill those shortfalls as soon as practicable by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base.”[5] Section 3 lays out steps to address the pricing of pandemic supplies. Section 4 seeks to develop “a strategy to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats.” Section 5 provides that the federal government will communicate with Tribal governments to ensure access to the Strategic National Stockpile.The Biden administration <a target="_blank" href="https://www.politico.com/news/2021/02/05/biden-defense-production-act-coronavirus-466130">announced its first significant anti-COVID-19 measures</a> on February 5, 2021. Specifically, it announced plans to sign DPA contracts with six diagnostic companies to make at-home and point-of-care testing more widely available. It also announced that it would use the DPA to give Pfizer priority access to certain materials that are essential in vaccine manufacturing. At that time, the FDA had only approved the Pfizer and Moderna vaccines, while the J&J single-shot vaccine was still under review. The White House expected J&J to get FDA approval, but <a target="_blank" href="https://www.politico.com/news/2021/02/05/biden-defense-production-act-coronavirus-466130">under-produce in terms of quantity</a>. Of course, the Biden administration later addressed that shortfall when it facilitated the J&J-Merck partnership.<h4>Opportunities for Collaboration Among Private Actors</h4>Given President Biden’s early reliance on the DPA within the first 60 days of his presidency, it is likely that the federal government will continue to intervene in private contracting. This is exciting for life sciences companies because government purchase orders and loan guarantees can provide businesses with reliable revenue streams. Moreover, the DPA may create unique opportunities for businesses to collaborate that might not otherwise be possible. Most notably, Section 708 of the DPA provides for voluntary agreements among private parties to meet national defense requirements or needs. Section 708(j) creates a limited defense to antitrust enforcement if anticompetitive behavior was done “in the course of developing a voluntary agreement initiated by the President or a plan of action adopted under any such agreement [or] to carry out a voluntary agreement initiated by the President and approved in accordance with this section[.]” In other words, collaboration between competitors, such as J&J and Merck, does not risk antitrust enforcement when it has the president’s seal of approval. And while subsection (j) requires the president to initiate voluntary agreements, there is little antitrust risk if entities pitch these agreements to the White House. Thus, the DPA may create new opportunities for businesses during COVID-19.Yet would-be collaborators should still be wary of antitrust risks. In April 2020, MoFo antitrust lawyers published an <a target="_blank" href="https://www.corporatecomplianceinsights.com/collaboration-pricing-covid-19/">article highlighting several antitrust risks</a> specific to the COVID-19 pandemic. They warned that the Department of Justice and Federal Trade Commission will still go after anticompetitive behavior, especially behavior that seeks to take advantage of the ongoing pandemic such as price gouging, price fixing, and stockpiling/hoarding resources. The article also highlighted possible consumer protection issues related to COVID-19. For instance, consumer protection laws in many states also proscribe price gouging. And although the DPA provides a <a target="_blank" href="https://fas.org/sgp/crs/natsec/LSB10534.pdf">limited defense with respect to antitrust enforcement</a>, it is not clear that subsection (j) applies to consumer protection laws as well. Ultimately, businesses hoping to collaborate with pandemic responsiveness/vaccine production should be cautious and seek counsel.<h4>The Outlook for Late 2021 and Beyond</h4>President Biden’s intervention to ramp up vaccine production has been an unqualified success. Entering office, his goal was to provide 100 million vaccinations within his first 100 days. After reaching that target on day 59, President Biden announced a bold, new goal: 200 million vaccinations within the first 100 days. Given that there are 260 million adults living in the U.S., that is good news; experts predict that approximately <a target="_blank" href="https://www.nytimes.com/live/2021/03/25/world/covid-vaccine-coronavirus-cases">80 percent of the population, or 208 million, must be vaccinated to achieve herd immunity</a>. Altogether, the Biden administration hopes to make vaccines available to <a target="_blank" href="https://www.nytimes.com/2021/03/02/us/politics/merck-johnson-johnson-vaccine.html">every adult in the United States by May 1</a>.Yet that will not mark the end of vaccine production in the United States. First, as new variants of the coronavirus emerge over the summer, vaccinated individuals may require <a target="_blank" href="https://www.npr.org/sections/health-shots/2021/02/25/971345409/covid-19-vaccine-makers-booster-shots-aim-at-a-moving-target-coronavirus-variant.">booster shots</a> to keep up their immunity. Fortunately, Pfizer and Moderna have already started preparing to bring variant-specific third doses to clinical trial. Second, the FDA is likely to approve COVID-19 vaccines for children at some point in the future. To date, the FDA has only approved vaccines for adults. Just last week, however, Pfizer announced a <a target="_blank" href="https://www.cnbc.com/2021/03/25/covid-vaccine-pfizer-begins-trial-on-infants-and-young-kids.html">clinical trial for its COVID-19 vaccine involving healthy 6-month-old to 11-year-old children</a>. With over 70 million children living in the U.S., it is likely that demand for the COVID-19 vaccines will remain high through the end of 2021. Third, the U.S. will remain involved in vaccine production even after reaching domestic herd immunity. Soon after entering office, President Biden entered <a target="_blank" href="https://www.bbc.com/news/world-55795297">Covax</a>, a partnership with the World Health Organization to deliver COVID-19 vaccines to the developing world. Low- to middle-income countries lag behind wealthy nations in terms of vaccine procurement, and current models estimate that there will not be enough vaccines for the global population until 2023–24.What exactly does all of this mean for life sciences companies doing business in the United States? It means that, although there appears to be a light at the end of the COVID-19 tunnel, the pandemic will continue to unfold both domestically and abroad well into the future. Correspondingly, private-public partnerships and state interventions into vaccine production should persist into the future as well. Businesses that are currently fighting COVID-19 should brace themselves to continue long-term. And businesses that have not been involved with the pandemic response thus far may yet find opportunities to contribute going forward.<h4>Short-Term Authority and Long-Term Preparedness</h4>Looking beyond COVID-19 vaccine production and rollout, the DPA will also play a prominent role in general pandemic preparedness going forward. Again, E.O. 14001 sought to increase vaccine production capacity for future pandemics. On the surface, it may seem odd that the president could wield emergency powers to achieve long-term objectives. Yet the DPA actually contemplates such prophylactic measures; in fact, preparedness is one of the primary objectives of the policy.[6] Of course, life sciences companies may not be able to produce vaccines in anticipation the next deadly virus outbreak, but they can begin to replenish the national stockpile of personal protective equipment and medical devices, such as ventilators. Already, President Biden has used <a target="_blank" href="https://www.wsj.com/articles/biden-to-address-chip-shortages-supply-chain-problems-with-executive-action-11614160803">executive authority to bolster supply chains</a> for critical pharmaceutical materials. Look out for similar measures in the future.Over one year into COVID-19, even with vaccines rolling out across the country, there is still a long way to go in responding to this pandemic and preparing for the next one. And while the Biden administration is still in its infancy, it is already clear that the White House will take a hands-on approach in public health and emergency preparedness—before, during, and after crises. Healthcare and life sciences companies should prepare for—and look forward to—that new reality.[1] OECD Policy Responses to Coronavirus (COVID-19)The COVID-19 crisis and state ownership in the economy: Issues and policy considerations. The Wall Street Journal: <a target="_blank" href="https://www.wsj.com/articles/western-economies-embrace-state-intervention-emulating-asia-11604574001">Western Economies Embrace State Intervention, Emulating Asia</a>.[2] <a target="_blank" href="https://www.lawfareblog.com/understanding-trumps-invocation-defense-production-act-meat">Understanding Trump’s Invocation of the Defense Production Act for Meat</a>.[3] Harvard Law Review: States of Emergencies Part I. Oxford Academic: <a target="_blank" href="https://academic.oup.com/icon/article/16/1/101/4995561?login=true">The architecture of emergency constitutions</a>.[4] Federal Register: <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/25/2021-01759/organizing-and-mobilizing-the-united-states-government-to-provide-a-unified-and-effective-response">Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security</a>.[5] Federal Register: <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/26/2021-01865/a-sustainable-public-health-supply-chain">A Sustainable Public Health Supply Chain</a>.[6] The Stafford Act defines “emergency preparedness” to include “[m]easures to be undertaken in preparation for anticipated hazards[.]” 42 U.S.C. § 5195a(3)(A).

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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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Vaccine Production and State Intervention in the U.S.

Using Waivers to Curb COVID-19 Legal Exposure

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been co

Vaccine Production and State Intervention in the U.S.

The preceding articles of this <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">series </a>laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated before.  This episode will put the spotlight on a feature introduced to the European market of medical devices for the first time: the Unique Device Identification (“UDI”) system, also referred to as the bar-code system for medical devices.<h4>INTRODUCTION</h4>Following the lifecycle approach of the MDR, the identification system aims to enhance the effectiveness of the post-market safety-related activities. The system brings about two key obligations: device labeling and data submission requirements.  If this does not sound at all novel, it might be for other medical device markets, such as the U.S., that have had similar rules in place for quite some time.  The UDI is obtained through officially designated entities, some of which are entrusted by both EU and U.S. authorities.  The data submissions will have to be made to the European Databank on Medical Devices (“<a href="https://eudamed.eu/" target="_blank">EUDAMED</a>”), which is in the process of being set up. Submissions of UDI data to EUDAMED will be mandatory beginning November 26, 2022. However, providers of medical device software (“MDSW”) can start the process of obtaining a UDI immediately.<h4>1. UDI FORMATS</h4>The MDR requires a medical device to be labelled with a certain UDI, which allows for a clear and unambiguous identification of specific medical devices and facilitates their traceability on the market. What is visible, is called the “UDI-carrier,” which can either be an automatic identification and data capture (“AIDC”) (i.e., bar codes, smart cards, biometrics, etc.) or a human-readable interpretation (“HRI”) (a series of numeric or alphanumeric characters). All of the issuing entities, currently <a href="https://ec.europa.eu/docsroom/documents/38582?locale=en" target="_blank">GS1</a>, <a href="https://ec.europa.eu/docsroom/documents/38564?locale=en" target="_blank">HIBCC</a>, <a href="https://ec.europa.eu/docsroom/documents/38566?locale=en" target="_blank">ICCBBA</a>, and <a href="https://ec.europa.eu/docsroom/documents/38581?locale=en" target="_blank">IFA GmbH</a>, have their own algorithm to create UDIs. The format is based on guidelines (<a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_1_budi_rules_ie_en.pdf" target="_blank">here</a>) but will be specific to the issuing entity.  An example of a human-readable UDI assigned by IFA GmbH could be “(9N)1101234568(S)ABC123.”According to Article 27 of the MDR, the UDI comprises of a Device Identifier (“UDI-DI”), which is specific to a manufacturer and a device, and the Production Identifier (“UDI-PI”), which identifies the unit of device production.The UDI-DI is linked to a so-called Basic UDI-DI that connects devices with the same intended purpose, risk class, and essential design and manufacturing characteristics, identifying a certain group of devices. The Basic UDI-DI itself will not be placed on the product but has to be provided to EUDAMED.<h4>2. UDI FOR MDSW</h4>Annex VI Part C Point 6.5 of the MDR addresses the UDI assignment on MDSW specifically. Some guidance on the <a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018_5_software_en.pdf" target="_blank">UDI assignment to MDSW</a> provided by the Medical Device Coordination Group is provided <a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018_5_software_en.pdf" target="_blank">here</a>, according to which UDI-DI shall be assigned to stand-alone MDSW (available on its own and software that constitutes a device in itself) at the system level of such MDSW. If MDSW is sold on a physical medium, every level of packaging needs to display UDI in AIDC format and HRI format. Software comprising a user interface must display the UDI easily accessible in plain-text format, while software without a user interface needs to be able to transfer the UDI by API.Upon substantial changes to the MDSW, a new UDI-DI is required (Annex VI Part C Point 6.5.2 of the MDR). Guidance on changes can be found <a href="https://ec.europa.eu/docsroom/documents/40322" target="_blank">here</a>. Such new UDI-DI requirements are also triggered upon a change to Basic UDI-DI that impacts the original performance, safety, or the interpretation of data or to the name or trade name, version or model number, critical warnings or contraindications, or user interface language. Minor software revisions, such as bug fixes, usability enhancements that are not for safety purposes, security patches, or operating efficiency, shall require a new UDI-PI and not a new UDI‑DI.<h4>3. CONCLUDING REMARKS</h4>With the introduction of the UDI system, the MDR steps up the post-market transparency and levels with what seems to have become an international regulatory standard. For providers of MDSW, this means to plan for additional steps before placing their products on the market. From a regulatory perspective, it is necessary to obtain a UDI and provide data to EUDAMED, while practically a labeling concept has to be developed.Against this background, manufacturers of medical devices should bear in mind the timeline regarding the obligation of UDI assignment, which depends on the device class. High-risk devices in Class III start on May 26, 2021, followed by Class IIa and IIb devices, which are due on May 26, 2023. The low-risk devices in Class I are due on May 26, 2025. Links to previous articles in the series: <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 1 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 2 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 3 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 4 OF 6)</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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Counsel

Stephan is counsel at Morrison Foerster’s German office in Berlin. He focuses on advising major German and international clients with regard to drafting and negotiating complex technology-related agreements and on matters concerning cloud computing, software, e/m-commerce, digital media, intellectual property rights, consumer rights, electronic communication, big data and cyber security requirements.

Stephan Kreß

Stephan is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising major German and international clients with regard to drafting and negotiating complex technology-related agreements and on matters concerning cloud computing, software, e/m-commerce, digital media, intellectual property rights, consumer rights, electronic communication, big data and cyber security requirements.

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Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

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

mofolifesciences-eu

The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an o

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">part 2</a>) and the implications of the new risk classification regime (in <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html" target="_blank">part 3</a>), in this part 4 of our <a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html" target="_blank">series on Software as a Medical Device in Europe</a>, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“MDSW”) under the new <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN" target="_blank">EU Medical Device Regulation 2017/745</a> (“MDR”).<h4>INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH</h4>While the current <a target="_blank" href="https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF">EU Medical Device Directive 93/42/EEC</a> (as amended by Directive 2007/47/EC – “MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can obtain the CE marking, the MDR deploys a product life cycle-focused approach, aiming to establish responsibilities of medical device companies throughout the life cycle of the product. While not all requirements are new, to ensure conformity of the MDSW with the MDR, detailed and partly enhanced requirements concerning quality management, risk management, clinical evaluation, and technical documentation must be complied with post-market for the time the MDSW is in service.<h4>1. QUALITIY MANAGEMENTS SYSTEMS</h4>Article 10(9) of the MDR has extended the scope of the Quality Management Systems (“QMS”) required to be in place for MDSW. Key changes include:<ul><li>Document Control. More so than the MDD, the MDR requires continuous alignment and updating of the documentation with regard to available data, records, and post-market surveillance (see, e.g., Article 83(3) and Annex IX, I 2.2 (c) MDR). This will require the manufacturer to maintain a seamless system of data and information, ensuring that documents are generated and updated in a coordinated and coherent way throughout the organization.</li></ul><ul><li>Post-Market Surveillance: According to Articles 83 and 84 of the MDR, for each device, the manufacturer shall implement, maintain, document, and update a post-market surveillance system that shall be suited to actively and systematically gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire lifetime, and to draw the necessary conclusions and take preventive and corrective actions. This includes continuously updating the risk assessment and technical files of the MDSW. The post-market surveillance system shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III.</li></ul><ul><li>Periodic Safety Update Report. Manufacturers of class IIa, class IIb, and class III devices have to prepare a Periodic Safety Update Report (“PSUR”) for each device (or category or group of devices, as applicable), summarizing the results and conclusions based on the post-market surveillance data and any preventive and corrective actions taken (Article 86 of the MDR). For class IIb and class III devices, the PSUR shall be updated at least annually.</li></ul><ul><li>General Safety and Performance Requirements. The “essential requirements” under the MDD have been replaced by the “General Safety and Performance Requirements” (GSPR). GSPR for software are included in the new Section 17.2 of Annex I. According to this provision, software shall be developed and manufactured in accordance with the state of the art, taking into account the principles of development life cycle and risk management, including information security, verification, and validation. According to Article 8 of the MDR, compliance with so-called harmonized standards creates the presumption of conformity with the GSPR of Annex I. While there are over 250 harmonized standards for the MDD, there are currently no relevant harmonized standards for the MDR. Manufacturers will need to adhere to existing relevant standards (e.g., IEC 62304:2006 – Medical device software – Software life-cycle processes) but should pay close attention to any upcoming harmonized standards.</li></ul><ul><li>Supply Chain. Under the MDR, required scrutiny with regard to suppliers and outsourced processes is increased. The documentation requirements pertaining to the supply chain are stipulated in Article 25 of the MDR. While manufacturers already have responsibilities for stand-alone MDSW under the MDD, the MDR sets out specific new requirements for other economic operators like authorized representatives (Article 11 and 12), importers (Article 13), distributors (Article 14), and sterilizers and packaging (Article 22) in this regard. Manufactures have to ensure that everyone in the supply chain of its MDSW who is considered an “economic operator” under the MDR understands the key changes to quality management and has a plan in place for compliance with their specific responsibility under the MDR.</li></ul><ul><li>Document Retention. The period during which manufacturers have to store technical documentation has extended from five to 10 years after the last device has been placed on the market (Annex IX Section 7 MDR). For implants it is, and has been, 15 years.</li></ul><ul><li>Incident Reporting. The deadline for reporting serious incidents involving medical devices made available on the EU market to the competent authorities has been shortened from 30 days (for incidents not amounting to serious public health threats, death, or serious deterioration in health) under the MDD (MEDDEV 2 12-1, Section 5.1.7) to 15 days under the MDR (Article 87(3) MDR).</li></ul>Manufacturers of MDSW find a framework for QMS in <a href="https://www.iso.org/standard/59752.html" target="_blank">ISO 13485</a>, which provides a safe and easy way to prove conformity. While certification under this already-established standard will be the main path to establish QMS compliance under the MDR, manufacturers of MDSW with an existing QMS must ensure that the new and amended requirements under the MDR are covered by their existing QMS. Manufacturers should note that all QMS requirements must be met as of May 26, 2021, even if certain medical devices offered by them fall under a transition period.<h4>2. CLINICAL EVALUATIONS</h4>All manufacturers of medical devices are obligated to conduct a clinical evaluation. The MDR provides for requirements that are more precise as compared to the MDD regime, particularly regarding the post-market obligations. Clinical evaluation means a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. A sufficient amount and quality of clinical data have to underpin scientific validity, technical, and clinical performance. The Post-Market Clinical Follow-up (“PMCF”) that already existed under the MDD is now specified in more detail in Annex XIV Part B. A newly introduced requirement is the PMCF evaluation report, which shall provide analyzed findings of the PMCF. A template for the PMCF evaluation report can be found <a href="https://ec.europa.eu/docsroom/documents/40906" target="_blank">here</a>. The Medical Device Coordination Group provides guidance on relevant aspects regarding MDSW, focused on international standards (<a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_1_guidance_clinic_eva_md_software_en.pdf" target="_blank">MDCG 2020-1</a>). The MDCG 2020-1 identifies three key components that need to be taken into account when compiling clinical evidence for every MDSW:<ul><li>Scientific Validity (Valid Clinical Association). There needs to be a valid scientific association between the output of the MDSW (calculations, recommendations, etc.) based on the input and algorithms selected on the one hand and the targeted physiological state or clinical condition on the other hand. For example, if the MDSW is designed to detect a certain disease by analyzing abnormal measurement values, there needs to be a valid clinical association between the analyzed measurement values and the disease in question. The association must be well founded or clinically accepted. This component seeks to establish that the use of the MDSW is based on sound scientific principles.</li></ul><ul><li>Technical Performance (Analytical Performance). The MDSW must be able to accurately, reliably, and precisely generate the intended output from the input data. Evidence of this can be generated through verification and validation activities.</li></ul><ul><li>Clinical Performance. For those features of the MDSW that claim a specific clinical benefit, the manufacturer must demonstrate that the MDSW can achieve clinically relevant output in accordance with the intended purpose. For the validation of an MDSW’s clinical performance, the MDSW must have been tested (i) for the intended use(s) on the target population(s), (ii) under the use condition(s) and operating and use environment(s), and (iii) with all intended user group(s).</li></ul><h4>3. TECHNICAL DOCUMENTATION</h4>Requirements for the technical documentation of the MDSW are now explicitly addressed in Article 10(4) and Annexes II and III of the MDR. With regard to the technical documentation, the MDR brings about increased requirements, along with more details on how technical documentation has to be carried out and structured. The technical documentation has to be drawn up in a “clear, organized, readily searchable and unambiguous manner.” Annexes II and III of the regulation list elements to be contained, which in the pre-market phase include (i) information on device description and specification, including variants and accessories; (ii) information to be supplied by the manufacturer; (iii) design and manufacturing information; (iv) general safety and performance requirements; (v) risk-benefit analysis and risk management; and (vi) product verification and validation. As outlined above, any MDSW that is available on the market must be covered by a post-market surveillance plan according to Article 84, a post-market surveillance report according to Article 85, and a periodic safety update report according to Article 86 (PSUR) if class IIa or higher. The newly introduced PMCF evaluation report shall form part of the PSUR.<h4>CONCLUDING REMARKS</h4>The new life cycle-oriented approach under the MDR requires manufacturers of stand-alone MDSW to reassess their current quality management and documentation strategy and to set up a comprehensive process that encompasses, among other things, QMS and technical documentation post-market surveillance procedures. As it might take months to have a complying QMS in place, suppliers of MDSW need to be working on this now if they have not already done so.

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to stakeholder feedback. It is now one month later, and the FDA has yet to implement any steps outlined in its action plan, all the while approving more and more AI products. This post discusses the progress the FDA has made thus far for regulating AI/ML-based SaMDs and the concerns that remain.<h4>FDA’s Progress for Regulatory Oversight</h4>Artificial intelligence is growing rapidly in the field of healthcare. The <a target="_blank" href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device">FDA has acknowledged</a> its importance and the impact it has on health care, but has not been able to keep up with manufacturers. In April 2019, the FDA published “<a target="_blank" href="https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf">Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback</a>,” describing for the first time, clearly, the FDA’s potential approach to premarket review of AI/ML SaMDs. The potential approach involved a “Predetermined Change Control Plan” for premarket submissions including “SaMD Pre‑Specifications” (SPS) and an “Algorithm Change Protocol” (ACP) to account for the iterative nature of AI/ML-based SaMDs.In February 2020, the FDA announced a marketing authorization via the De Novo pathway for the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user">first cardiac ultrasonic software that uses AI to guide users</a>. The manufacturer used a Predetermined Change Control Plan in its application to obtain authorization.In the same month, the FDA held a public workshop on the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The FDA and the public stakeholders discussed best practices for validation of AI‑automated radiological imaging software and image acquisition devices.In September 2020, FDA launched the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence">Digital Health Center of Excellence</a> within the Center for Devices and Radiological Health. According to the FDA, the focus of the Digital Health Center of Excellence is “helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimaging digital health device oversight.”In January 2021, the FDA published “<a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan">Artificial Intelligence/Machine Learning (AI/ML)‑Based Software as a Medical Device (SaMD) Action Plan</a>,” outlining the FDA’s plans for progressing its regulatory oversight. The Action Plan identified five areas for the FDA focus: <ol><li>Tailored regulatory framework for AI/ML-based SaMDs; </li><li>Good machine learning practices (GMLPs); </li><li>Patient-centered approach incorporating transparency to users; </li><li>Regulatory science methods related to algorithm bias and robustness; and </li><li>Real-world performance (RWP).  </li></ol>The FDA stated that it will update its regulatory framework and publish a draft guidance in 2021, actively engage in efforts to harmonize GMLPs, hold public workshops on device labeling for transparency to users, develop methodology for evaluating and improving machine learning algorithms (including identifying and eliminating bias), and develop a framework for gathering and validating RWP. Although the AI/ML Action Plan is recent, the FDA has not yet taken any steps to implement any of these focus areas for policy development or clarification.<h4>The FDA’s Approval of AI/ML-Based SaMDs</h4>Since 2012, the FDA has approved over 160 medical AI/ML-based SaMDs, the majority being in 2019 and 2020. Some <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-artificial-intelligence-clearance-products/">reports</a> have found, upon investigation, that the requirements the FDA has imposed on device submission have been inconsistent. For example, some submission sponsors disclosed the amount of patient data used to validate the performance of their devices while others did not. And, according to one investigative <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-clearances-artificial-intelligence-data/">report</a>, when disclosed, the amount of data varied widely from 100 patients on one end of the spectrum to 15,000 patients on the other end. Only a handful of manufacturers reported racial makeup of the study populations and a few provided gender breakdown. This creates uncertainty as to how effective the AI/ML-based SaMDs will perform with respect to algorithmic bias. Additionally, the FDA has not made training and testing data for these approved AI/ML-based SaMDs publicly available, potentially creating a lack of trust in these technologies or, at the very least, making it difficult for purchasers of the SaMDs to make informed decisions based on similar evidence criteria. However, perhaps most importantly, the FDA has yet to figure out how to handle real-world leaning and adaptation within the regulatory framework. Although the FDA clearly aims for increased regulation and monitoring of AI/ML-based SaMDs, it has not provided a specific plan for any of the five focus areas identified in its AI/ML Action Plan. The FDA may need to act much quicker in developing consistent standards as the number of AI/ML-based SaMDs submissions to the FDA continue to increase (from two products in 2012 to 70 products in 2019). The FDA should address stakeholder concerns of data and approval process inconsistencies, lack of well-established standards, transparency, labeling challenges, trustworthiness, algorithmic biases, and RWP. ConclusionThe FDA is slowly taking steps towards its commitment to develop a regulatory framework for AI/ML-based SaMDs. For now, the FDA has not yet provided any consistent standards. Without such widely-applicable guidance, manufacturers should expect a longer application timeline and extensive discussions with the FDA—in effect creating a customized plan for data and evidence generation for each and every AI/ML SaMD. It is unpredictable at this stage what the FDA will require and ask for in these negotiations, although to some extent prior submissions and authorizations serve as a baseline for consideration. As artificial intelligence and machine learning technologies are increasing in availability and applicability, organizations and device sponsors will continue to build their own databases and define their own standards, which the FDA may be strategically waiting for.

Round Rock Research, LLC v. [Multiple Defendants]

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

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Associate

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

Jean Nguyen Ph.D.

Jean Nguyen

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FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

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

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (S

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows down deliveries due to manufacturing issues. Yet, time is of the essence when it comes to vaccine rollouts, particularly amid a surge in cases due in part to the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.Against this backdrop, it comes as no surprise that certain political voices in Germany are calling for state intervention in the vaccine manufacturing process (see, i.e., the coverage by Central German Broadcasting, in German language). However, the idea that the state could take over production of highly complex vaccines or allow third parties to manufacture their competitors’ proprietary pharmaceuticals faces factual and legal challenges. In this article, we discuss whether German law provides the necessary means for state intervention in vaccine production and what stakeholders should bear in mind.<h4>What would be the basis for state intervention in Germany?</h4>The German legislator amended the German Infection Protection Act (Infektionsschutzgesetz – “GIPA”) at a very early stage of the pandemic, among other things to allow quicker decision‑making processes that will reduce requirements for participation of the German Federal Parliament (Bundestag). It thereby authorized the German Ministry of Health (Bundesministerium für Gesundheit – the “Ministry of Health”) to autonomously[1] take “measures to ensure the supply of medicinal products, including vaccines,” in an epidemic situation of national importance (sec. 5 (2) no. 4 GIPA).The authorizations vested in the Ministry of Health are comprehensive. In the case that the German Federal Parliament declares an “epidemic situation of national importance,” the Ministry of Health can issue statutory decrees, e.g., to:<ul><li>Allow exceptions from provisions of the German Medicines Act (“GMA”) with respect to manufacturing, labeling, approval, clinical testing, use, prescribing and dispensing, import and export, and transfer and liability; </li><li>Order the securing and the use of vaccines; or</li><li>Maintain, convert, open, or close production facilities or individual operating sites of enterprises producing the abovementioned products.</li></ul>The aforementioned list in sec. 5 (2) no. 4 GIPA is exemplary and not exhaustive. Other measures are thinkable, too. In light of the extremely broad competences given to the Ministry of Health, such order could even encompass the manufacturing of vaccines by a new third‑party manufacturer to ensure continuous vaccine supply to the German population.<h4>What are the requirements for such an order?</h4>As the COVID-19 pandemic was already declared an “epidemic situation of national importance” in Germany on March 25, 2020, the only further requirement that would have to be fulfilled is that any of the listed measures would have to be proportionate to reach the purpose of ensuring the supply of the population with medicinal products as part of the maintenance of healthcare. The proportionally test involves three prongs. The question is whether the individual measure is suitable and necessary, as well as appropriate to reach this purpose.[2]The suitability for the intended purpose already faces serious doubts, as it requires that the envisaged measure can at least facilitate such purpose, i.e., accelerate the production of vaccines as part of the maintenance of healthcare. The production of vaccines is an extremely complex process that cannot simply be assigned to any new third party. From a practical point of view, the transfer of vaccine production is highly complex and by no means a fast process. In an interview with the German newspaper Rheinische Post, Dr. Hans-Georg Feldmeier, the chair of the German Pharmaceutical Industry Association (“BPI”), states in this context: “[. . . ] out‑licensing to other manufacturers, regardless of the legal implications, according to our estimations would take at least 12 months or longer for vaccines to become available from this [third-party] manufacturing.” Against this backdrop, it is indeed questionable whether Germany can reach an acceleration in overall production capacity of vaccines by trying to integrate third parties into the process.Even if the answer to this question would be yes, however, the next challenge will be to show the necessity of these measures. This may be difficult as there are likely equally effective options available to the Ministry of Health with fewer limitations of the fundamental rights of the stakeholders involved. First, when looking at the examples of Israel, the United States, and the UK, it is obvious that there are ways to carry out vaccination programs more effectively, short of direct government intervention into vaccine production. Second, it remains possible that simply undertaking higher spending for vaccine purchases now or funding of the establishment of additional production capacities would also be a viable path to resolve the problem. The EU and Germany have applied restrictive policies of vaccine purchases while others were willing to spend significantly more for early shipments (see <a target="_blank" href="https://www.bmj.com/content/372/bmj.n281">here</a>). Third, options to incentivize voluntary cooperation between vaccine developers and candidates for third-party manufacturing as a long-term plan should also be looked at and may be an alternative to unilateral government orders.Regarding the appropriateness of the described measures, it is clear that the vaccine proprietor will suffer extensive interferences with their fundamental rights (i.e., property rights) if they are ordered to enable a new third party to help with the production. For such interferences to be appropriate, the achievement of the pursued purpose of the measure must be highly likely. Yet, it is questionable whether an order by the Ministry of Health could effectively reach the purpose of swiftly ramping up production capacities by involving new third‑party manufacturers. This is because the latter will need to have access to the specific composition and formula of the vaccines. Albeit, this information is part of the dossier that must be filed with the competent authority in the marketing authorization process. This part of the dossier is subject to confidentiality requirements, the so-called data exclusivity. Whether the Ministry of Health could legally base a demand for disclosure of such information simply on sec. 5 (2) no. 4 GIPA may be doubtful. However, even if a general provision like sec. 5 (2) no. 4 GIPA the Ministry of Health could justify such a severe interference with the vaccine proprietors constitutionally protected property rights, the Ministry of Health would face additional factual hurdles. In particular, with regard to the newly developed mRNA-vaccines, specific manufacturing know-how may be required. If such manufacturing know-how was not disclosed as part of the marketing authorization application dossier (e.g., because it has never been put to writing), it is again questionable if sec. 5 (2) no. 4 GIPA will be able to justify a request for disclosure of such confidential information from the vaccine proprietor.<h4>What impact does patent protection have in this respect?</h4>In context of state intervention relating to vaccine manufacturing, patent law exemptions are often praised as salvation. And indeed, as previously <a target="_blank" href="https://www.mofo.com/resources/insights/200414-patent-exceptions-cure-covid-19.html">reported</a>, sec. 5 (5) GIPA[3] authorizes the Ministry of Health to issue administrative orders to use patented technology relating to COVID-19-relevant pharmaceuticals and medical devices. Of course, these instruments will likely be necessary means to circumvent vaccine proprietor’s patent protection relating to the general technology underlying their vaccine (e.g., a type of general mRNA‑related technology). Yet, with respect to the COVID-19 vaccine’s specific features, sec. 5 (5) GIPA orders may not be necessary, at least, if the respective patents are still in the application stage. This is because patent applications do not exclude third parties from using their relevant discoveries and until publication do not even trigger compensation claims.<h4>Will the affected party be compensated?</h4>The Ministry of Health is required to provide for a compensation to be paid to the affected party for any measure that results in expropriation or expropriation-like interference with the affected party’s rights. Such compensation is to be obtained directly from the government and not from third parties authorized by the Ministry of Health or its subordinates to produce or sell the vaccine. The Ministry of Health must lay down the type and scope of such compensation in the underlying statutory decree. Above all, however, the compensation will need to be appropriate. It will be subject to discussion what “appropriate” in this context means. As a statutory decree ordering the manufacturing of a vaccine proprietor’s product by a third party (even if not or not yet protected by patent right) is very similar to the order of a compulsory license to a pharmaceutical patent, it seems worth thinking about adapting the established case law of the German Federal Patent Court (Bundespatentgericht) on drawing upon the concept of an average license fee.  <h4>Who will be liable for damages caused by the vaccine?</h4>If third-party manufacturers operating under an order of a state authority cause harm to others, the question of liability arises. So far, no case law directly relevant to the constellation described herein exists, but it is likely that the competent German Civil Courts will assess damage claims based on the assumption that these manufacturers are so-called “administrative assistants.” In this scenario, if manufacturers cause damages following the Ministry of Health’s order, they cannot be held liable personally; instead, claims must be brought directly against the Ministry of Health (sec. 823 (1) of the German Civil Code and Article 34 of the German Basic Law).<h4>How can an order based on a sec. 5 (4)no. 4 GIPA statutory decree be challenged?</h4>Challenges against an order that is based on the Ministry of Health’s statutory decree issued in accordance with sec. 5 (2) no. 4 GIPA must be brought before the German Administrative Courts. In order to reach a suspending effect, the affected party will need to file for a specific order for interim relief as sec. 5 (4) sentence 5 GIPA provides for the immediate enforceability of any measure ordered by the Ministry of Health. Challenges of the inadequacy of compensation must be brought before the German Civil Courts.<h4>Outlook</h4>It seems as though sec. 5 (2) no. 4 GIPA can pave the way for the Ministry of Health to procure production of COVID-19 vaccines by new third-party manufacturers. However, at a closer look, the complexity and duration of the transfer of production as well as the available alternative means to accelerate the production and availability of vaccines cast serious doubts as to the likelihood and legality of such measures. Yet, as it has always been the case with state intervention, the mere existence of the possibility of a sovereign to intervene can be a persuasive means to leverage market players into increasing their capacities for delivery. If the pandemic has shown one thing so far, it is that cooperation is a key factor in successfully combating the virus and that the stakeholders in the pharma industry are principally willing to work together to deliver on their promises. Thus, it can be expected that an incentive-based strategy would likely lead to increased level of cooperation among key players and subsequently to a higher availability of vaccines while simultaneously protecting the rights of the stakeholders. Either way, now may be a good time for pharmaceutical manufacturers to hold prospective vaccine production capacities out and to brace themselves for potential negotiations and engagement in the production of vaccines, either based on a state order or on licensing deals with vaccine proprietor’s or current manufacturers of COVID-19 vaccines.    [1] Due to the impact on commerce, these statutory decrees are issued in consultation with the Federal Ministry of Health for Economic Affairs and Energy (Bundesministerium für Wirtschaft und Energie).[2] It must be noted that sec. 5 (2) no. 4 GIPA has already been used by the Ministry of Health to enact a number of administrative decrees during the pandemic, which, e.g., allow for facilitated procurement of medicinal products or order hospital pharmacies to stockpile such products for intensive medical care.[3] In conjunction with Section 13 of the German Patent Act (Patentgesetz).

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COVID-19: State Intervention in Times of Vaccine Shortages

The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availabil

COVID-19: State Intervention in Times of Vaccine Shortages

Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on <a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a> was led by <a href="https://www.mofo.com/capabilities/life-sciences-transactions-licensing.html" target="_blank">Life Sciences Transactions + Licensing</a> partner <a target="_blank" href="http://www.mofo.com/people/wolfgang-schonig.html">Wolfgang Schoenig</a> focusing on key EU Intellectual Property. Wolfgang discussed Intellectual Property Rights, GMOs, and Employee inventors’ rights in the EU sharing that "it was fun to highlight some of the starkest differences between the U.S. and EU when it comes to patentable subject matter, policies around GMO, and inventor remuneration to such a talented group of researchers and entrepreneurs."<a href="https://www.mofo.com/capabilities/patent-litigation.html" target="_blank">IP Litigation</a> partner <a href="https://www.mofo.com/people/mark-whitaker.html" target="_blank">Mark Whitaker</a> followed in session 12, providing a trade secrets overview and best practices including strategies for reviewing specific trade secrets and how to protect trade secrets overseas involving the ITC. Mark commented that "a thorough knowledge of federal, state, and international trade secrets laws, directives, and best practices is critical for inventors, entrepreneurs, and companies to adequately protect their intellectual property regardless of where they sit in the development life cycle. I hope that our session raised the participants’ awareness of these indispensable tools."This Wednesday, we’ll turn to Plant Intellectual Property Protection with <a target="_blank" href="https://www.mofo.com/people/cory-ellison.html">Cory Ellison</a>.

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Mark Whitaker is co-chair of the firm’s Intellectual Property Litigation Practice and has more than 30 years of experience crafting legal strategies in high-stakes patent and trade secret litigation.