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 Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

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.

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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

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19.The PREP Act grants tort liability immunity to manufacturers, developers, sellers, and prescribers of certain medical countermeasures during a public health emergency. In response to the COVID-19 pandemic, the Secretary of HHS issued a PREP Act declaration last month. The Act immunizes “covered persons,” with respect to all claims for loss arising out of the use or administration of a “covered countermeasure.” But the complexity of these defined terms makes it difficult for entities to determine whether they are protected. The new guidance clarifies the countermeasures, entities, and activities that are covered by the PREP Act declaration and expands protections in a way that encourages cooperation between private parties and public health agencies.Read our Class Dismissed <a href="https://classdismissed.mofo.com/fda/hhs-guidance-broadens-prep-act-immunity-tightens-focus-on-public-private-cooperation/" target="_blank">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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Co-Chair, Litigation Department

Erin Bosman is the global co-chair of Morrison Foerster’s litigation department. Erin is also the founder and co-head of the Artificial Intelligence group and former chair of the Complex Litigation + Advisement practice 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 the Global Co-Chair of Morrison Foerster’s Litigation Department. Erin is also the founder and co-head of the Artificial Intelligence Group and former chair of the Complex Litigation + Advisement Practice 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

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to 

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation