Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the Catalog has been revised in 12 years.The amendment of the Catalog as related to certain high-tech industries has attracted much media attention, particularly to the restriction on the export of drone technologies, certain information-processing technologies for artificial intelligence interactive interface and individualized information push services based on data analysis, and technologies related to password security and information defense and countermeasures. This article, however, will focus on the revisions related to the Life Sciences industry, after a brief introduction to China’s technology export regulations.Technology export from China is governed by China’s Technology Import and Export Regulations (TIER). The scope of technology export regulated by TIER is very broad, and includes all acts of technology transfer from within China to outside China, whether by way of trade, investment, or economic and technological cooperation. Specifically, TIER regulates outbound assignments of patents and patent applications, patent licenses, transfers of technological secrets, provision of technological services, and other forms of outbound cross-border technology transfers. TIER categorizes technology exports into three categories: technologies that may be “freely” exported (the “Free Technologies”), technologies the export of which is restricted (the “Restricted Technologies”), and technologies the export of which is prohibited (the “Prohibited Technologies”). The Catalog, jointly promulgated by MOFCOM and MOST, includes the lists of the Restricted Technologies and the Prohibited Technologies. Under TIER, export of the Prohibited Technologies is prohibited, export of the Restricted Technologies is subject to MOFCOM’s prior approval, and the regulatory requirement for the export of the Free Technologies is the after-the-fact registration of the relevant technology export contract, which shall become effective according to its own terms and not conditioned on the registration.MOFCOM’s approval of export of the Restricted Technologies is generally a two-step process before provincial-level branches of MOFCOM (“Local Commerce”). After it receives an application for approval of the export of a Restricted Technology, Local Commerce will conduct a review of the Restricted Technology together with other applicable governmental agencies, e.g., the local branch of China Intellectual Property Administration, the local branch of MOST, the Ministry of Agriculture and Rural Affairs, or the National Forestry and Grassland Administration, depending on the nature of the Restricted Technology. Such review may take up to 30 business days before an approval or disapproval decision can be made. The approval is not the final approval of the technology export, but will be a Provisional License for Technology Export (the “Provisional License”). The technology export applicant may not engage in any substantive negotiation of the technology export or sign any technology export contract until after the issuance of the Provisional License. After the technology export contract is signed, the applicant must apply for the final Technology Export License by submitting to Local Commerce the Provisional License, a copy of the technology export contract, a list of the Restricted Technologies to be exported under the contract, and documents evidencing the legal status of the contracting parties. Local Commerce will conduct an authenticity review of the technology export contract, and will make a decision on whether to approve the technology export within 15 business days after receiving the required documents. The approval decision will be in the form of a Technology Export License. It is worth noting that, regardless of any effective date set forth in a technology export contract, with respect to any Restricted Technology, the contract is effective only upon the issuance of the Technology Export License.As a result of the adjustment of the Catalog, the following Life Sciences-related technologies (categorized into different industries) have been deleted from the Catalog, meaning that their export is no longer prohibited or restricted but will only be subject to after-the-fact registration of the relevant technology export contract:<ul><li>Medicine manufacturing industry <ul><li>Caffeine manufacturing technology using chemical synthesis or semisynthesis</li><li>Riboflavin (VB2) manufacturing techniques</li><li>Chemical synthetic or semisynthetic drug manufacturing technology</li><li>Biotechnology for the manufacturing of penicillin, streptomycin, cephalosporin C, or aureomycin</li><li>Thrombin-like snake venom single-component preparation techniques</li><li>Natural medicine manufacturing technology</li><li>Preparation and processing technologies for functional polymer materials with biological activities</li></ul></li><li>Professional device manufacturing industry <ul><li>Enzyme-labeled monoclonal antibody preparation technology</li></ul></li></ul>The following Life Sciences-related technologies (categorized into different industries) have been added to the Catalog as Restricted Technologies, meaning that their export will be subject to the approval process described earlier in this article:<ul><li>Agriculture <ul><li>Crop (including forage grass) seed resources and their propagation technology, particularly those on the Catalog for the Classification of Crop Seed Resources for Export</li><li>Artificial propagation technology for agricultural wild plants, particularly those listed in the Catalog of Wild Plants Subject to Special State Protection and the Convention on International Trade in Endangered Species of Wild Fauna and Flora</li><li>Genetic engineering (genes and vectors) <ul><li>Newly discovered plant male sterile genes, restoration genes and vectors</li><li>Newly discovered disease- or pest-resistant genes and vectors</li><li>Newly discovered stress-resistant genes and vectors</li><li>Newly discovered quality genes and vectors</li><li>Newly discovered yield-related genes and vectors</li><li>Other newly discovered important genes and vectors</li><li>Unique gene manipulation technology</li></ul></li></ul></li><li>Medicine manufacturing industry <ul><li>All bacterial and viral strains that are obtained using genetic engineering and can be industrially produced, and their culturing technology (this has been an expansion from a limited number of strains specifically identified in the previous version of the Catalog)</li><li>Inactivated vaccine for enterovirus 71 (EV71)</li><li>Rotavirus oral live vaccine</li><li>Viral strains for EV71 vaccine</li><li>Viral strains for CA16 vaccine</li><li>Core techniques and technology for pentavalent and hexavalent rotavirus vaccine production</li><li>Polysaccharide-protein binding technology</li><li>Medical diagnostic devices and equipment manufacturing technology (including domestically made next-generation gene analyzers and third-generation single-molecule sequencers)</li></ul></li></ul>When responding to questions from the press, MOFCOM suggested that the latest amendment to the Catalog was intended to simplify the Catalog. This intention was not clearly reflected in the revisions related to the Life Sciences industry, however. As summarized above, MOFCOM seems to have added an equal or greater number of technologies related to the Life Sciences industry to the Catalog compared to the number deleted. Some of the newly added Restricted Technologies, such as “newly discovered important [plant] genes and vectors,” “bacterial and viral strains obtained using genetic engineering and which can be industrially produced,” and “medical diagnostic devices and equipment manufacturing technology,” appear to have been very broadly defined. MOFCOM also announced that it will further simplify the Catalog in the near future, and whether there will be more deletions from than additions to the Catalog of Life Sciences-related technologies in the next round of amendment to the Catalog remains to be seen.Corresponding to the export Catalog, China also has a Catalog of Technologies the Import of Which is Prohibited or Restricted. MOFCOM further announced that it will significantly simplify that catalog in the near future. For more information on China’s technology import regulations, please refer to the author’s article <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltab5f0746dbcea5cc/627317778e09542a15b7deef/191200-crossing-borders.pdf" target="_blank">here</a>.

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China Technology Export Update: Amendment of The Export Technology Catalog

China Patent Eligibility Update: Human Embryonic Stem Cells

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On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s 

China Technology Export Update: Amendment of The Export Technology Catalog

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights.At the outset, it is important to recognize that the patent term of a biologic product is distinct from the FDA’s regulatory market exclusivity period for the same product; these two public policies are governed by entirely separate laws and regulations. Patent term and the FDA’s exclusivity programs run concurrently and in parallel. As such, pediatric exclusivities (or other FDA exclusivities) do not formally extend the term of any patent rights. However, both of these legal frameworks have the same effect of extending the biologic product’s market monopoly and preventing competitors from introducing biosimilar products into the marketplace. In the event that certain patents rights are invalidated prior to the expiration of the full patent term, FDA exclusivities provide an additional safeguard against competitors seeking to enter the market. Thus, Sponsors should consider using both patent rights and FDA exclusivities to recoup research and development investments.Biologics are eligible to participate in the FDA’s pediatric exclusivity program.[i] Under Section 351 of the Public Health Service Act, in order to receive six months of pediatric exclusivity in addition to the 12-year exclusivity period granted under the Biologics Price Competition and Innovation Act,[ii] the FDA must issue a Written Request for the Sponsor to conduct specific pediatric studies for a given biological product.[iii] The Sponsor may choose (but is not required) to conduct the pediatric studies outlined in the Written Request, at its own expense, in exchange for an additional six months of exclusivity for its biological product. The exclusivity grant is based on whether the applicant complied with the terms of the Written Request and is not conditioned on approval of a pediatric indication.[iv] Any unauthorized deviation from the Written Request may result in non-compliance and can jeopardize the Sponsor’s ability to earn pediatric exclusivity. The FDA maintains discretion over issuing Written Requests for pediatric studies, and thereby controls the Sponsor’s ability to obtain multiple pediatric exclusivities. The FDA may issue multiple Written Requests, which are each eligible for an additional six-month exclusivity period, provided that the Sponsor appropriately complies with each Written Request.[v] Examples of previous Written Requests for biologics can be found on the FDA’s <a target="_blank" href="https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request">List of Determinations Including Written Request</a> web page (see, e.g., ipilimumab and tocilizumab). It appears that the FDA has not yet issued multiple Written Requests for a single biologic. In fact, it appears rare for the FDA to issue multiple Written Requests for the same drug. In a previous Guidance, the FDA explained that a Sponsor of a new drug under Section 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) may submit a detailed proposal to the FDA for a Written Request, which is equally applicable to the holder of an approved Biologics License Application under Section 351 of the Public Health Service Act.[vi] The proposal for a Written Request should substantially follow the template that the FDA has previously used for a Written Request (see, e.g., <a target="_blank" href="https://www.fda.gov/media/106997/download">ipilimumab</a> and <a target="_blank" href="https://www.fda.gov/media/115367/download">tocilizumab</a>). The proposal should contain sufficient information to execute the studies such as the objective of the study, trial design, number and kinds of patients and other relevant patient characteristics, inclusion and exclusion criteria for the study, drug dosing for the treatment arm, statistical information for analyzing the results, and other pertinent information.[vii] The FDA will then evaluate the proposal and decide whether to issue a formal Written Request based on the information submitted. In addition, the FDA maintains a <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">FAQ web page</a> dedicated to qualifying for pediatric exclusivity under Section 505A of the FDCA. To qualify for pediatric exclusivity, the pediatric studies conducted to satisfy the requirements of the Pediatric Research Equity Act (PREA) must also satisfy all of the requirements for pediatric exclusivity under Section 505A of the FDCA.[viii]Fulfilling the Written Request for pediatric exclusivity is separate from meeting the Sponsor’s PREA obligations or any other requirements to perform phase 4 post-market surveillance studies.[ix] PREA requires that all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients, unless this requirement is waived, deferred, or inapplicable.[x] In terms of scope, PREA is more limited and requires a pediatric assessment of those indications included in the pending biologics license application (BLA), which addresses the safety and effectiveness of the claimed indications with respect to the drug or biological product. The FDA’s authority to issue a Written Request for pediatric exclusivity extends to the use of an active moiety for all indications that occur in the pediatric population, regardless of whether the indications have been previously approved in adults or approval for those indications is being sought in adults.[xi] The FDA has previously advised that an applicant seeking to qualify for pediatric exclusivity should obtain a Written Request for studies from FDA before submitting the pediatric studies to satisfy PREA.[xii]  [i] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Notice that under § 262(m)(1), the rules for submitting pediatric studies are the same for both drugs and biologics under § 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) (codified as 21 U.S.C. § 355a). More precisely, § 262(m)(1) carves out the exclusivity benefits in §§ 505A (b)-(c) for drugs, which are then re-inserted as §§ 262(m)(2)-(3) as applicable to biologics given the different exclusivity periods.[ii] See 42 U.S.C. § 262(k). [iii] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Under both §§ 262(m)(2) and m(3), the Secretary makes a written request to the applicant to perform additional pediatric studies, and the applicant accepts that request (at its own expense), the applicant is rewarded another six months of exclusivity. Note that under 21 U.S.C § 355a(h) (carried over into 42 U.S.C. § 262(m)(1) for biologics), pediatric exclusivity shall only be granted for a study or studies that are the subject of a Written Request from the FDA and prior to nine months from expiration.[iv] See <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently</a>.[v] See Guidance for Industry, Qualifying for Pediatric Exclusivity Under Section 505(A) of the Federal Food, Drug, and Cosmetic Act (June 1998, revised Sept. 1999). [vi] See id. (listing specific requirements for a Proposed Pediatric Study Request).[vii] See id.[viii] See Sections 505A(d) and 505A(h) of the FDCA (codified as 21 U.S.C. §§ 355a(d) and (h), respectively).[ix] See Section 505B of the FDCA (codified as 21 U.S.C. § 355c). PREA also authorized the FDA to waive the required assessments when the drug or biological product (1) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients and (2) is not likely to be used in a substantial number of pediatric patients.[x] See id.[xi] See Section 505A(a) of the FDCA, codified as 21 U.S.C. § 355a(b)(1).[xii] <a target="_blank" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-comply-pediatric-research-equity-act">See Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (Sept. 2005)</a>.

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Pediatric Exclusivity for Biologics

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The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distincti

Pediatric Exclusivity for Biologics

The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as methods of treatment that include a diagnostic step have recently been deemed to be patent-eligible subject matter. In its recent decision in Illumina v. Ariosa, the Federal Circuit confirmed that another category of claims – methods of preparation – are patent- eligible, providing a new opportunity to cast diagnostic method claims in a patent-eligible light. The Court’s decision offers promise for patent applicants pursuing patent protection for COVID-19 and other diagnostic methods.<a target="_blank" href="https://www.mofo.com/resources/insights/200812-casting-new-light.html?utm_source=publication&utm_medium=email">Read our alert</a>

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

Karen G Potter Ph.D.

Karen Potter

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisi

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic Resources Regulations (the “Regulations”) and its draft Biosecurity Law, and sends a strong signal that China’s legislature is determined to strengthen the penalties and punishments for the protection of China’s biosecurity. The Draft has been published for public comments, which may be submitted by August 16, 2020.China’s current Criminal Law includes a number of crimes for violation of other laws and aimed for the prevention and control of infectious diseases and bioterrorism, e.g., certain crimes in violation of China’s Law on Prevention and Treatment of Infectious Diseases and causing the spread of, or a serious risk of spreading, a Category A infectious disease determined by that law, crimes for causing the spread of bacterial or viral agents for infectious diseases resulting in serious consequences, and crimes for violating health and quarantine regulations at the national border. The current Criminal Law also includes a number of crimes aimed at the prevention and control of biological invasions and for biological resource conservation, e.g., crimes for violation of certain national regulations on animal and plant epidemic prevention and quarantine. The current Criminal Law, however, lacks provisions on misuse of biotechnology, illegal use of human genetic resources (HGR), and other acts resulting in the destruction of ecological environment or biological resources. This is in part due to the slow legislation in other areas of law, because the Criminal Law, in the context of biosecurity, rather than defining crimes from scratch, typically provides for penalties and punishments against serious violations of other laws or regulations. The legislative progress in China’s Biosecurity Law provides the motivation for speeding up the corresponding legislative update to China’s Criminal Law.The Draft proposed to add the following provisions to the crimes in connection with the collection and supply of blood and the production and supply of blood products:Any person committing any of the following acts, in violation of relevant State regulations and endangering public health or social public interest, shall be sentenced to, in cases of serious circumstances, not more than 3 years of fixed-term imprisonment or criminal detention or control, and/or a fine, and, in cases of especially serious circumstances, imprisonment of not less than 3 years but not more than 7 years, and a fine: (i) illegally collecting China’s human genetic resources; (ii) illegally transporting, mailing or carrying China’s human genetic resources materials abroad; and (iii) supplying or providing open access to China’s human genetic resources information to foreign organizations or individuals or institutions established or actually controlled thereby.Although proposed to be added to the existing provisions related to blood and blood products, the new provisions related to HGR have far broader implications than curbing mishandling of blood products. Human genetic resources, as defined in the Regulations and the draft Biosecurity Law, include not only HGR materials, of which blood is but one example, but also the data and other information generated from the utilization of those materials, which is broad enough to cover medical images and laboratory test results. Both the Regulations and the draft Biosecurity Law, which is intended to codify significant portions of the Regulations, prohibit foreign organizations and individuals and institutions established or actually controlled thereby (collectively, “Foreign Persons”) from collecting or preserving China’s HGR within China, or providing China’s HGR abroad. Therefore, Foreign Persons are subject to the punishments provided for in items (i) and (ii) of the newly proposed HGR-related Criminal Law provisions.The Draft also includes punishments of up to seven years of imprisonment and a fine against the implant of genetically edited embryos or cloned embryos into humans or animals in violation of relevant State regulations, as crimes of illegal medical practice. This is an obvious countermeasure taken by the legislators in light of the gene-edited babies scandal that broke out in China in 2018.The inclusion of HGR-related crimes in the Draft is hardly surprising. Both the Regulations and the draft Biosecurity Law state that any violation thereof that constitutes a crime shall be prosecuted according to the law, and in the absence of the corresponding crimes in the Criminal Law, those provisions have so far been toothless when it comes to HGR. Foreign Persons should pay special attention to the Criminal Law’s legislative progress, because in addition to the economic consequences that they may have to bear for violating the Regulations and the Biosecurity Law, they may face criminal prosecution for the same violations in the event the circumstances are serious, which the courts in China will have considerable discretion to determine when imposing sentences.For a summary and analysis of the Regulations, please refer to this <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html" target="_blank">author’s article</a>, and for a summary and analysis of select provisions of the draft Biosecurity Law, please refer to this <a href="https://lifesciences.mofo.com/topics/Chinas-Biosecurity-Law-will-cover-Human-Genetic-Resources.html" target="_blank">author’s article</a>.

China to Criminalize Human Genetic Resources Violations

On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for r

China to Criminalize Human Genetic Resources Violations

During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for public comments, which may be submitted by June 13, 2020.The draft Biosecurity Law was first brought to the Standing Committee’s review in October 2019. As a comprehensive and ambitious set of laws covering multiple areas under the overarching name “biosecurity,” the draft legislation was an attempt to address the absence of legal punishments against biotechnology misuses in China in recent years, an infamous example of which is the gene-edited babies scandal that broke out in late 2018.The Draft covers the following major areas: the establishment of a biosecurity risk prevention and control system, the prevention and control of major new or sudden infectious diseases or animal or plant epidemics, the security of biotechnology R&D and application, laboratory biosecurity, the security of human genetic resources (HGR) and biological resources, countermeasures against the threat of bioterrorism and biological weapons, the buildup of biosecurity capabilities, and the legal liability in the event of violation of relevant provisions of the Biosecurity Law. This article will summarize and analyze certain provisions in the Draft applicable to, and their potential impact on, foreign entities and individuals.The broad scope of the Draft can first be seen by the vague definition it has ascribed to “biosecurity,” which includes the following “capabilities” of the State: to effectively respond to threats from animals, plants, microorganisms, biotoxins, and other bioactive substances (collectively, “Biological Factors”) and relevant elements, to maintain stable and sound development of the biological field and a danger-free and threat-free status, and to guarantee sustainable development and security. Because of such vagueness, and because the Draft prohibits any individual and any entity from harming State biosecurity, the potential scope of violation of the Biosecurity Law appears extremely broad.Biosecurity risk prevention and control system            According to the Draft, China will implement a unified system to issue biosecurity information. The biosecurity information that is considered to be “necessary to be uniformly released” must be issued at the State level or at the local government level as necessary and authorized by the State. No unauthorized entity or individual may issue such information. This prohibition potentially covers the publication of research articles that includes biosecurity information, e.g., the sequence of a newly discovered virus with the potential to cause an epidemic.            As part of the biosecurity risk prevention and control system, China will publish and amend from time to time State directories and lists of entry and exit items related to biosecurity, which will be used by China Customs. The Draft gives Customs a wide latitude of authority related to biosecurity, which extends to inbound and outbound persons, transportation tools, containers, goods, articles, packaging materials, and the discharge of ballast water of international navigation ships. As necessary and approved by the State Council, Customs may temporarily close a port or the relevant border.Prevention and control of major new or sudden infectious diseases or animal or plant epidemics            According to the Draft, any entity or individual that finds any infectious disease or animal or plant epidemic must report it to a medical institution or a relevant professional institution or department. China will also strengthen the construction of border and port protection and control capabilities for infectious diseases and animal and plant epidemics, support international communication and cooperation, take part in international rescue and assistance as needed, and establish an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemics.Security of biotechnology R&D and application; laboratory biosecurity            The Draft includes a number of provisions governing biotechnology R&D and application. For example, the State Council will promulgate a list of important equipment and special Biological Factors involving biosecurity, any purchase or import of items on the list by any entity engaging in biotechnology R&D or application will be subject to registration, and no individual will be allowed to purchase or hold such items. The State Council will also categorize biotechnology R&D activities into high, medium or low risk categories. Foreign entities are prohibited from conducting high or medium risk biotechnology R&D activities in China.            The Draft includes a whole chapter on laboratory biosecurity, particularly with respect to laboratories of pathogenic microorganisms. The establishment of such labs is subject to approval or registration, depending on the circumstances. The establishment of such labs with foreign investment will be subject to an additional security review. If the security review determines that any pathogenic microorganism laboratory may affect public health, state security or public benefits, it may not be established. In addition, individuals will be prohibited from establishing a biosecurity laboratory.            China will classify pathogenic microorganism laboratories on four levels, based on the biosecurity protection levels. These are largely consistent with the biological safety levels established by the U.S. Centers for Disease Control and Prevention. The Draft also includes a series of provisions on the management of such laboratories, lab animals, accountability, safety and security, and emergency measures. It is worth noting that these provisions apply not only to pathogenic microorganism labs, but also to manufacturing enterprises involving pathogenic microorganism processing, and to laboratories involving other Biological Factors.Security of biological resources            The Draft has put provisions for biological resources in the same chapter as provisions for HGR, but does not provide a definition for “biological resources.” The biological resources provisions are obviously watered down compared to the HGR provisions, presumably because the legislators intend that the collection, preservation, use and outbound transportation of biological resources will be regulated by other laws and regulations. Interestingly, the only substantive provisions on biological resources in the Draft all relate to foreign entities or individuals, or alien species. For example, the acquisition or use of China’s biological resources by any overseas organization or individual or any institution established or actually controlled thereby (collectively, “Foreign Persons”), or any international scientific research collaboration using China’s biological resources, must each be approved by the relevant department according to the law. Such collaboration must ensure that the Chinese entity and its researchers are involved in a substantial part of the whole research process, and the relevant rights and interests are shared according to the law, although the Draft does not specify how exactly they should be allocated. The State Council will promulgate a directory of alien invasive species, and will strengthen the investigation, monitoring, early warning, control, evaluation and elimination of alien invasive species set out in the directory in the name of protection of biodiversity. No entity or individual may import, release or discard alien species.Security of human genetic resourcesThe Draft has included a number of provisions of China’s Administrative Regulations on Human Genetic Resources (the “Regulations”), in many instances, almost verbatim, particularly with respect to Foreign Persons. Specifically, the Biosecurity Law, according to the Draft, will prohibit Foreign Persons from collecting or preserving China HGR in China, or providing China HGR abroad. International scientific research collaboration using China HGR is permitted but must be approved by China’s Ministry of Science and Technology (MOST) in advance on a project-by-project basis. The only exception to the approval requirement is “international collaboration in clinical trials” at clinical trial institutions that do not involve the outbound transfer of China HGR materials (which has the same definition in the Draft as in the Regulations). Such clinical trial collaboration, however, must still be pre-registered with MOST and, as part of the pre-registration, the types and numbers of HGR proposed to be used and the actual proposed uses must be disclosed to MOST.The Biosecurity Law, according to the Draft, will require that the permitted international collaboration must ensure that the relevant Chinese entities and their research personnel “can take part in the research substantially in the whole process of the collaboration,” and that the relevant rights and interests resulting from the collaboration be shared in accordance with relevant laws, most likely the Regulations, which dictate that any patent rights based on scientific research results obtained in the collaboration must be jointly owned by the participating Foreign Person and Chinese entity, among other benefit-sharing provisions.Penalties for violation of the HGR provisions by Foreign Persons, according to the Draft, include injunction; confiscation of any China HGR illegally collected or preserved and of any relevant illegal income; and a fine of more than RMB 1 million but less than RMB 10 million. If the illegal income is more than RMB 1 million, the fine will be five to ten times that of the illegal income. These penalties are consistent with the ones imposed on Foreign Persons in the Regulations.The Biosecurity Law, according to the Draft, will permit the provision of, or open access to, China HGR information (which also has the same definition in the Draft as in the Regulations) to Foreign Persons, subject only to registration with MOST; provided, however, that, in the event such provision or access could endanger China’s public health, national security or public interests, MOST’s security examination will be required. This is also consistent with the Regulations.The Draft will obviously need further revisions before its final promulgation. Given the breadth of the Draft, this article does not attempt to address many other areas covered by it, some of which may seem to have more relevance to the current COVID-19 pandemic. In fact, the Regulations (and the corresponding provisions in the Draft) have already played an important role in the global battle against COVID-19. Because the certification or authorization by foreign regulatory authorities of the testing kits developed in China requires the cross-border transfer of development data, which constitutes China HGR information, the data transfer and the product development itself, which involves the use of China HGR materials, are both subject to the Regulations.The Draft’s inclusion of some of the key provisions of the Regulations related to Foreign Persons has sent a strong signal that Chinese legislators intend to codify a significant portion of the Regulations into law. The Biosecurity Law’s legislative progress undoubtedly warrants close monitoring and careful analysis.This article is not a comprehensive review of the Draft, but provides a brief summary and analysis of select provisions in the Draft that may be applicable to foreign entities or individuals. For an in-depth analysis of specific provisions or an English translation of the Draft, please contact the <a href="mailto:CCui@mofo.com?subject=MoFo%20Life%20Sciences%20blog%20post" target="_blank">author</a>. The author’s previous article on the Regulations may be accessed <a href="https://lifesciences.mofo.com/topics/China-regulations-on-human-genetic-resources-foreign-persons.html">here</a>.

China’s Biosecurity Law will cover Human Genetic Resources

During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Bi

China’s Biosecurity Law will cover Human Genetic Resources

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

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FDA Uses EUAs Broadly In The Fight Against Covid-19

IR35 Update: UK Government Postpones “Off-Payroll Working” Reforms

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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

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>

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Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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U.S. government announces new federal funding opportunities related to COVID-19

Updated Coronavirus (COVID-19) Guidelines For Employers