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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As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern.  Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating psychiatric disorders in its Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (“the Guidance”).As the Guidance states, “[i]n the context of the COVID-19 public health emergency, the use of digital health technologies … may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine.”  The Guidance makes clear that it applies specifically to computerized behavior technology and other digital health therapeutic devices for psychiatric disorders, along with low-risk general wellness and digital health products for mental health or psychiatric conditions.  The purpose of the Guidance is to improve the availability of devices used to treat psychiatric conditions remotely without the need for patients to visit healthcare facilities, allowing patients and mental health professionals to avoid in-person contacts.The Agency temporarily waived four requirements related to: (1) submissions of a 501(k) premarket notification; (2) 21 CFR 806 corrections and removals; (3) 21 CFR Part 807 registrations and listings; and (4) 21 CFR Part 830 and 21 CFR 801.20 unique device identification (UDI).  Also subject to the exclusion are prospective clinical data requirements for computerized behavioral therapy devices for psychiatric disorders.The Guidance also applies to software products that provide wellness recommendations for patients with mental health conditions.  One example includes digital health tools that promote and/or track choices to reduce risk of certain psychiatric conditions.  However, as the Guidance reiterates, certain software functions are not regulated as devices (e.g., software used for video conferencing, general wellness software functions related to sleep, and functions or reminders to promote social distancing practices).  Additionally, digital therapeutics for treating a specific condition, such as substance abuse, would not be exempted under these waivers.Lastly, the Guidance added labeling recommendations to make clear which products have received clearance and which have not.  For example, a computerized behavioral therapy device should include user instructions specifically telling the patient to contact a physician before using the device.In sum, the Guidance appears to be addressing the mental health needs arising from the pandemic by temporarily waiving requirements for certain digital health devices.

Round Rock Research, LLC v. [Multiple Defendants]

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

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Mental Health during COVID-19: FDA Waivers for Digital Health Devices

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As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern.  Last we

Mental Health during COVID-19: FDA Waivers for Digital Health Devices

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel coronavirus (SARS-CoV-2). On the basis of the February 4, 2020 HHS determination, FDA began exercising its Emergency Use Authorization (EUA) powers.An EUA is a tool that allows FDA to facilitate availability and unapproved uses of “medical countermeasures” needed to prepare for and respond to chemical, biological, radiological, and nuclear threat agents. In the context of SARS-CoV-2, the EUA authority allows FDA to authorize the use of unapproved medical products or unapproved uses of approved products to detect and prevent the spread of SARS-CoV-2.EUAs help address emergencies by lowering the barriers for bringing products to market. Throughout the years there have been several amendments to the legal basis for FDA’s EUA authority; section 564 of the FD&C was amended by the Project Bioshield Act of 2004, which was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017. In January 2017, FDA issued its current EUA <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities" target="_blank">guidance</a>, which lays out when FDA can exercise EUA authority and the process for requesting an EUA.Under the 2017 guidance, medical products may be considered for an EUA if FDA determines that the product “may be effective” to prevent, diagnose, or treat serious or life-threatening disease or conditions caused by chemical, biological, radiological, and nuclear threat agents identified in the HHS Secretary’s declaration of a public health emergency. Notably, the EUA standard (“may be effective”) is lower than the “effectiveness” standard that FDA requires for product approvals. Further, a product may be considered for an EUA if FDA determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat life-threatening disease or conditions, outweigh the known and potential risks of the product. In making the determination of whether to grant an EUA, FDA will look at the totality of the scientific evidence related to the product. One important factor in FDA’s determination to grant an EUA for a given product is the availability of alternatives, which includes an examination of the adequacy of supply.When submitting an EUA, FDA recommends including any available relevant scientific evidence related to the product. To date, FDA has issued EUAs for the following types of products in response to SARS-CoV-2: in vitro diagnostic products, personal protective equipment and decontamination systems, ventilators and “other medical devices,” and therapeutics. A list of all current EUAs is available on FDA’s <a href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ventilators" target="_blank">website</a>.In Vitro Diagnostics EUAsOn February 29, 2020, FDA issued <a href="https://www.fda.gov/media/135659/download" target="_blank">guidance</a> on Diagnostic Tests for Coronavirus, which was updated on March 16, 2020. This guidance provides the requirements for SARS-CoV-2 testing and the process for FDA to issue EUAs for individual tests.Under the EUA guidance, laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high-complexity tests may seek an EUA to develop and perform diagnostic tests to detect SARS-CoV-2. Notably, according to current FDA policy, the laboratory developed tests (LDTs) for detecting SARS-CoV-2 can be validated in a CLIA laboratory and used immediately, so long as the appropriate EUA is submitted to FDA within 15 business days.Further, under the Diagnostic Test EUA guidance, commercial manufacturers may seek an EUA to develop and distribute diagnostic tests to detect SARS-CoV-2 to clinical laboratories or to healthcare workers for point-of-care testing. Notably, however, this policy does not apply to at-home testing. As with LDTs, under current FDA policy, the commercial manufacturer developed tests can be validated by the manufacturer and distributed immediately, so long as the appropriate EUA is submitted to FDA within 15 business days.Finally, in the same guidance, FDA issued a policy explaining that FDA does not intend to object when developers of serological tests market or use their tests without prior FDA review where: (1) the tests are validated by the developer to determine that they are accurate and reliable, (2) notification of the developer’s validation is provided to FDA, and (3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. Therefore, when serological tests are conducted within the limited purposes outline by FDA, an EUA is not required.As of April 21, 2020, FDA has issued 42 EUAs to test kit manufacturers and commercial laboratories, including the <a href="https://www.mofo.com/resources/news/200327-fda-emergency-gci-genomics.html" target="_blank">EUA Morrison & Foerster obtained for client BGI Genomics Co. Ltd</a>, as well as 17 EUAs to LDTs. Templates for these EUA submissions are available online:<ul><li>“Accelerated” Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template (updated March 6, 2020)</li><li><a href="https://www.fda.gov/media/135900/download" target="_blank">Test Kit Manufacturer: EUA Template (updated March 12, 2020)</a></li></ul>Personal Protective Equipment EUAsOn March 2, 2020, the HHS Secretary stated that current circumstances justify the authorization of emergency use of personal respiratory protective devices during the SARS-CoV-2 pandemic. Under this declaration, FDA has authorized the use of NIOSH-approved respirators; imported, non-NIOSH-approved respirators; non-NIOSH-approved respirators manufactured in China; face shields; and non-surgical facemasks.On March 2, 2020, FDA <a href="https://www.fda.gov/media/135763/download" target="_blank">authorized</a> the use of all NIOSH-approved respirators for use in healthcare settings during the SARS-CoV-2 emergency. The authorization is specifically for HCPs and does not permit use of the authorized respirators by the general public. The authorization covers the use of:<ol><li>Non-powered air-purifying particulate filtering facepiece respirators (FFRs or “respirators”) and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH and listed on the NIOSH Certified Equipment List for non-powered air-purifying respirators with particulate protection;</li><li>Other powered air-purifying respirators (PAPRs) approved by NIOSH and included on the NIOSH Certified Equipment List for PAPRs with particulate protection;</li><li>FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, are not damaged, and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles; and</li><li>Any authorized respirator under (1) or (3) above that has been decontaminated based on the terms and conditions of the authorized decontamination systems.</li></ol>FDA updated its authorization on March 28, 2020 to include respirators decontaminated by authorized decontamination systems and to no longer require manufacturers of NIOSH-approved FFRs and strategic stockpilers to submit requests for authorization of their products to FDA. Instead, all manufacturers are authorized under the EUA, and they may contact FDA to withdraw some or all of their authorized model numbers from the EUA.On March 24, 2020, FDA <a href="https://www.fda.gov/media/136403/download" target="_blank">authorized</a> the use of non-NIOSH-approved disposable FFRs by HCPs that either meet the performance standards of foreign jurisdictions or have marketing authorization in either Europe, Australia, Canada, or Japan. In contrast to the March 2, 2020 authorization for NIOSH-approved FFRs, this authorization is limited to the manufacturers listed in <a href="https://www.fda.gov/media/136731/download" target="_blank">Exhibit 1</a>, and manufacturers must send a request to FDA by email of their intent to import non-NIOSH-approved respirators. As of April 21, 2020, Exhibit 1 includes 5 authorized respirator models.The March 24, 2020 authorization excluded non-NIOSH-approved FFRs manufactured in China; however, on April 3, 2020, FDA <a href="https://www.fda.gov/media/136664/download" target="_blank">authorized</a> the use of imported disposable FFRs manufactured in China that are not NIOSH-approved, and for which data exists that supports the respirators’ authenticity. Again, manufacturers must request to be added to <a href="https://www.fda.gov/media/136663/download" target="_blank">Appendix A</a>, which lists the authorized respirators. As of April 21, 2020, Exhibit A includes 87 authorized respirator models.FDA has also authorized the use of <a href="https://www.fda.gov/media/136842/download" target="_blank">face shields</a> by HCPs and the use of <a href="https://www.fda.gov/media/137121/download" target="_blank">non-surgical facemasks</a> by both HCPs and the general public. Manufacturers of face shields and non-surgical facemasks covered by the authorizations do not need to contact FDA to request inclusion, but they must comply with the requirements of the authorization.Ventilators and Other Medical Device EUAsOn March 24, 2020, the HHS Secretary declared that circumstances justify the authorization of emergency use of medical devices, including alternative products used as medical devices due to shortages during the SARS-CoV-2 outbreak. Under this declaration, FDA has authorized the use of ventilators and ventilator accessories; devices for decontaminating and reprocessing other devices; extracorporeal blood purification devices; and others.On March 24, 2020, FDA <a href="https://www.fda.gov/media/136423/download" target="_blank">authorized</a> the emergency use of ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. Products authorized under this EUA are added to <a href="https://www.fda.gov/media/136528/download" target="_blank">Appendix B</a> upon submission and review of a request from a sponsor as described in the Scope of Authorization included in the Letter of Authorization. As of April 21, 2020, FDA has added 33 ventilators, 3 ventilator tubing connectors, and 2 ventilator accessories to Appendix B.On March 28, 2020, FDA <a href="https://www.fda.gov/media/136529/download" target="_blank">authorized</a> the use of the Battelle Decontamination System as the first system for decontaminating compatible N95 or N95-equivalent respirators for reuse by healthcare personnel. As of April 21, 2020, FDA has authorized the use of a total of 4 respirator decontamination systems.As of April 21, 2020, FDA has authorized the use of 3 extracorporeal blood purification devices. FDA has authorized these devices based on the conclusion that they may effectively remove pro-inflammatory cytokines from the plasma to provide clinical benefit.As of April 21, 2020, FDA has also authorized the use of:<ul><li><a href="https://www.fda.gov/media/136894/download" target="_blank">B. Braun Medical, Inc.’s infusion pumps</a> for use in tracheal delivery of continuous nebulized medications into nebulizers to treat patients with SARS-CoV-2 and to decrease the exposure of HCP to such patients;</li><li><a href="https://www.fda.gov/media/136934/download" target="_blank">Synapse Biomedical, Inc.’s diaphragmatic pacing stimulator system</a> to assist in weaning patients off of ventilators in order to reduce the risks of prolonged mechanical ventilation and increase the availability of ventilators; and</li><li><a href="https://www.fda.gov/media/136989/download" target="_blank">Lungpacer Medical USA, Inc.’s diaphragm pacing therapy system</a> also to assist weaning patients off ventilators.</li></ul>Therapeutics EUAsOn March 27, 2020, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the SARS-CoV-2 pandemic. On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the <a href="https://www.phe.gov/about/sns/Pages/default.aspx" target="_blank">Strategic National Stockpile</a> (SNS) to be distributed and used on select SARS-CoV-2 patients. As of April 21, 2020, FDA has only issued this 1 therapeutics EUA.Post-pandemic ImplicationsWhen the February 4, 2020 EUA declaration is terminated, any EUAs issued based on that declaration will no longer remain in effect. The HHS Secretary’s EUA declaration will terminate if SARS-CoV-2 circumstances cease or if the product for which the EUA was issued is no longer unapproved for the sought use. Before an EUA declaration terminates, the Secretary of HHS must provide advance notice to allow for the disposition of unapproved products and of labeling related to an unapproved use of an approved product. Although products like test kits may no longer be in existence because they were used already, products like ventilators may need to be recalled and destroyed. However, companies should consider the possibility of re-marketing products such as ventilators for approved uses.PREP ActBringing products to the market in this post-market regulatory scheme may increase litigation risks. In response to these increased risks, and as we <a href="https://classdismissed.mofo.com/product-liability/prep-act-declaration-emboldens-drug-and-device-industry-to-innovate-in-the-face-of-a-growing-crisis/" target="_blank">previously reported</a>, on March 17, 2020, the Secretary of HHS issued a <a href="https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures" target="_blank">declaration</a> pursuant to the Public Readiness and Emergency Preparedness (PREP) Act granting tort immunity to entities involved in creating and distributing “covered countermeasures” that address the current pandemic. 85 FR 15198. <a href="https://classdismissed.mofo.com/fda/hhs-guidance-broadens-prep-act-immunity-tightens-focus-on-public-private-cooperation/" target="_blank">HHS issued an advisory opinion on April 14</a> to clarify the scope of the PREP Act declaration.This declaration covers “any claim of loss caused by, arising out of, relating to, or resulting from” “covered countermeasures” for SARS-CoV-2. The term “covered countermeasures” is defined as any “qualified pandemic or epidemic product,” or a “security countermeasure,” or a drug, biological product, or device authorized for investigational or emergency use. Following amendment by the CARES Act, the PREP Act now also includes certain respirators as covered countermeasures. This declaration applies to “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.” The declaration covers manufacturing, testing, development, and distribution from February 4, 2020 to (1) October 1, 2024 or (2) when the emergency declaration ends, whichever comes first.Under the declaration, companies with SARS-CoV-2-related EUAs should qualify for protection. The declaration defines “qualified persons” as: “(a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction . . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; and (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act” (emphasis added). However, immunity does not apply to serious physical injury proximately caused by willful misconduct and claims that do not arise directly from the development and distribution of a covered countermeasure. Immunity is also not available for claims where the U.S. has no jurisdiction.Companies looking to understand their tort immunity protections under the PREP Act should consult legal counsel.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

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Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

FDA Uses EUAs Broadly In The Fight Against Covid-19

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmet

FDA Uses EUAs Broadly In The Fight Against Covid-19

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward.  The Act includes many provisions addressing specific needs that have come to light during the COVID-19 pandemic, but some of these provisions have important impacts on the drug and device industry well beyond the current pandemic.  The CARES Act, unsurprisingly, also contains provisions unrelated to the COVID-19 pandemic but that have potentially significant impacts on life science and medical device companies.This summary blog post outlines some of the key provisions in the CARES Act that may be of interest to Morrison & Foerster’s life science and medical device clients.  In the coming months, Morrison & Foerster will track these issues and provide more comprehensive updates on the practical application and any intended (or unintended) consequences of these new legal requirements. <h4>Provisions to meet the needs of COVID-19 and future pandemics</h4>The CARES Act includes a number of provisions impacting different financial aspects of healthcare related to COVID-19.  For example, it authorizes the allocation of $1.32 billion for fiscal year 2020 for the detection of the virus that causes COVID-19 (SARS-CoV-2) or the prevention, diagnosis, and treatment of COVID-19.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3211</a>.)  It also requires insurers to cover diagnostic tests and qualifying preventative services for COVID-19.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3201–3203</a>.)  These changes should help increase the availability of and maintain a fair pricing scheme for such tests and services.  But note that any healthcare or laboratory provider offering COVID-19 diagnostic tests is required to disclose the cash price of the test on the provider’s public website during the emergency period.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3202</a>.)The severe respiratory issues caused by COVID-19 in some patients has led to a shortage of ventilators.  The CARES Act adds certain respiratory devices to the existing list of covered countermeasures for use during public health emergencies.  As a result, manufacturers and distributors that meet the statutory requirements will not be liable for issues arising from the use of covered respiratory devices during a public health emergency.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3103</a>.)  This, in conjunction with the <a target="_blank" href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ventilators">FDA EUA process for ventilators</a>, is expected to help with this critical supply need during the pandemic.  Please see our related blog post <a target="_blank" href="https://classdismissed.mofo.com/fda/fda-inspires-modifications-and-quick-authorizations-for-ventilators/">FDA Inspires Modifications And Quick Authorizations For Ventilators</a>.Another means for tackling the COVID-19 pandemic is through expedited review of both relevant abbreviated new drug applications (ANDAs) and supplements to NDAs/ANDAs, and expedited inspections or re-inspections of establishments, if such action could help prevent or mitigate a drug shortage.  (See Section 3111.)  Prior to the CARES Act, expedited reviews and inspections were optional, but the Act now requires the FDA to carry out such expedited procedures.  This change applies not only to current shortages related to COVID-19, but to all potential drug shortages going forward. A unique issue arising from the risk of infection during the COVID-19 pandemic is the widespread need for remote access to healthcare.  The Public Health Services Act previously acknowledged the need for improved telephone-based healthcare (telehealth) systems.  The CARES Act reauthorizes and extends telehealth network and telehealth resource center grant programs.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3212</a>.)  The Act also increases access to telehealth services by, for example, increasing private insurance and Medicare coverage during emergency periods.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3701, 3703–3706</a>.)  However, it is important to note that the federal changes to telehealth regulatory requirements do not fully address the myriad of state law requirements addressing the practice of telemedicine and the licensing requirements needed to permit telemedicine practice.  Thus, we are tracking each state’s emergency response and telemedicine regulatory changes. <h4>Heightened reporting requirements for medical devices, drugs, and active pharmaceutical ingredients</h4>Both medical device and drug manufacturers are now subject to immediate, new, or heightened reporting and risk management requirements.  Importantly, these new requirements for the first time also apply to medical devices critical to human health going forward. Manufacturers of life-saving drugs were already required to notify relevant authorities, including the FDA, of any discontinuation or interruption of the manufacture of a life-saving drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, and the reasons for such discontinuance or interruption.  The CARES Act expands the reporting requirements to include “any such drug that is critical to the public health during a public health emergency” and the active pharmaceutical ingredient(s) of such life-saving drugs.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3112</a>.) Manufacturers of life-saving drugs, their active pharmaceutical ingredients, and any associated medical device included with a drug for its preparation or administration are also now required to develop a redundancy risk management plan identifying and evaluating risks to the supply of the drug for each establishment in which the drug or active pharmaceutical ingredient is manufactured.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3112</a>.)The CARES Act also imposes new reporting requirements regarding discontinuances or interruptions in the production of medical devices that are critical to public health during or in advance of a public health emergency.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3121</a>.)  Any discontinuances or interruptions must be reported 6 months in advance or as soon as practicable.  In the immediate term, these requirements most obviously apply to ventilators (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3103</a>), but they will also apply to any medical devices critical to public health in future public health emergencies.<h4>Regulatory changes to market entry for over-the-counter drugs, unrelated to COVID-19</h4>The CARES Act implements a new administrative order process that replaces the existing over‑the-counter (OTC) drug monograph process.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3851–3853</a>.)  The OTC reform legislation has been pending for some time and, as part of political negotiations, is now embedded and enacted through the CARES Act.The marketability of category I–III drugs under the new system will depend on the current monograph status of the drug (proposed, tentative final monograph (TFM), or final) and the generally recognized as safe and effective (GRASE) category. Category I ingredients in a final monograph or tentative final monograph (TFM) would generally be considered GRASE and eligible for continued OTC marketing under the new process.  Category III ingredients subject to a TFM, and Category I ingredients subject to an advanced notice of proposed rulemaking (ANPRM), can continue to be marketed without an approved new drug application (NDA), unless otherwise directed by an Administrative Order.  Category II and other OTC ingredients that were already determined as not GRASE must file NDAs and will be required to leave the market within 180 days unless approved.Further, Category I and III ingredients can only be marketed in a dosage form that has been used to a material extent and for a material time prior to enactment of the CARES Act.  Only a “minor change” (i.e., one that does not change the safety, effectiveness, or material absorption of, or exposure to, the ingredient) to a dosage form is allowed.The new provisions convert existing final monographs and TFMs, and disallowed OTC ingredients, to final Administrative Orders.  The FDA may now also make GRASE decisions for OTC drugs using the existing GRASE standard and issue Administrative Orders.  The Act requires the FDA to develop further guidance on these processes.Any OTC drug currently on the market that fails to meet the new requirements or is not subject to an FDA Administrative Order will be deemed a “new drug” subject to the FDA’s new drug approval process.To promote innovation, the CARES Act provides for a new 18-month market exclusivity process for certain OTC drugs that contain an active ingredient not previously used or provides for a change in the conditions of use of a drug for which new human data studies were conducted.  The Government Accountability Office (GAO) will evaluate the new process within four years, including, among other things, the impact on FDA resources, consumer access, OTC drug prices, and sunscreens.Finally, to fund this new Administrative Order process, the CARES Act authorizes the FDA to collect user fees from the OTC drug industry, with payments starting in July of 2020.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3861–3862</a>.)

CARES Act of 2020: Guide for Drug and Device Companies

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate 

CARES Act of 2020:  Guide for Drug and Device Companies

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators.Read our Class Dismissed <a target="_blank" href="https://classdismissed.mofo.com/fda/fda-inspires-modifications-and-quick-authorizations-for-ventilators/">blog post</a>.

Fertility Center Litigation

MicroPort

Leading Healthcare, Pharmaceutical, and Medical Device Company

Lethal Injection Matters – Major Pharmaceutical Company

Pain Pump Matters – Large Pharmaceutical Company

Major Technology Company

Leading Chemical Company

Security Device Company

In re Air Crash Near Peixoto de Azevedo, Brazil

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Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin M. Bosman

Erin Bosman is chair of MoFo’s Class Actions and Mass Torts Practice Group and is a founder and co-head of the Artificial Intelligence Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.

Erin Bosman

FDA Inspires Modifications and Quick Authorizations for Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Adm

FDA Inspires Modifications and Quick Authorizations for Ventilators

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical device companies to increase production of existing products currently in short supply, and to develop new innovative COVID-19 therapies and treatments by limiting tort liability for the goods.Read our Class Dismissed <a target="_blank" href="https://classdismissed.mofo.com/product-liability/prep-act-declaration-emboldens-drug-and-device-industry-to-innovate-in-the-face-of-a-growing-crisis/">blog post.</a>

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Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

OFCCP Issues National Interest Exemption for New Coronavirus Relief Contracts

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COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vacci

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health emergency. The Guidance contains policies regarding (i) laboratories’ development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers’ development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.First, regarding laboratory tests, the Guidance provides two policies: one eventually requires an EUA submission and the other does not. Under the first prong, FDA has indicated that it will not object to a laboratory’s use of SARS-CoV-2 diagnostic tests (i) that occurs after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the laboratory is certified and meets certain regulatory requirements under Clinical Laboratory Improvement Amendments (CLIA). However, if FDA, upon review of the EUA request, identifies a significant problem that cannot be addressed in a timely manner, the laboratory may have to stop using the test and issue test reports indicating that prior tests may be unreliable.Under the second prong, each state may authorize laboratories within its territory to develop and use SARS-CoV-2 diagnostic tests without notifying FDA of test validation and without engaging in the EUA process.Second, FDA has indicated that it will not object to a commercial manufacturer’s distribution of SARS-CoV-2 diagnostic kits (i) after validation and notification to the agency, (ii) for a reasonable time (about 15 business days), (iii) while preparing an EUA request, (iv) provided that the manufacturer posts instructions for use and data regarding performance of the kit on its website. However, it should be noted that the manufacturer may have to suspend distribution and recall its products if, upon review of the EUA request, FDA identifies a significant problem that cannot be addressed in a timely manner.Third, acknowledging the relative simplicity of serological tests, FDA has indicated that it will not object to a laboratory’s use, and a commercial manufacturer’s distribution of serological tests or kits for SARS-CoV-2 that occur after validation and notification to the agency, provided that certain information listed in section IV(D) of the Guidance is included in the test report (e.g., that the test is not FDA-reviewed).Lastly, it may be worth noting some general points. First, the policies in the Guidance do not apply to at-home testing. Second, where validation is required, FDA recommends the minimum testing described in section V of the Guidance. Finally, FDA recommends including a general statement in the test report that FDA review is pending, whenever that is the case.In sum, the policies set out in the Guidance allow laboratories and commercial manufacturers, under certain conditions, to start using or distributing diagnostic tests or kits for the novel coronavirus prior to or even without an EUA. In addition to the EUA process which is already an expedited authorization process, the new policies will further accelerate distribution and use of the tests.

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FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

After Striking Deal with the President, the House of Representatives Passes Federal Relief Bill, the Families First Coronavirus Response Act

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On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of t

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

The Biomedical Advanced Research and Development Authority (<a href="https://www.medicalcountermeasures.gov/" target="_blank">BARDA</a>), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies seeking to develop products designed to diagnose, prevent or treat coronavirus infections.<a href="https://govcon.mofo.com/health-care/u-s-government-announces-new-federal-funding-opportunities-related-to-covid-19/?utm_source=publications&utm_medium=email" target="_self">Read the full article on our Government Contracts Insights Blog.</a>