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.

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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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Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

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FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read <a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-product-safety-part-I.html">Part I</a> of our series and <a href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-supply-chain-part-II.html" target="_blank">Part II</a> of our series. The U.S. Secretary of Health and Human Services declared the novel 2019 coronavirus a U.S. public health emergency on Friday, January 31, 2020 and this determination was formalized pursuant to pursuant to section 564(b)(1)(C) of the Food Drug and Cosmetic Act on February 4, 2020. CDC developed a new laboratory test kit for use in testing patient specimens for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The test kit is called the “Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.” This test is intended for use with upper and lower respiratory specimens collected from persons who meet CDC criteria for COVID-19 testing. CDC’s test kit is intended for use by laboratories designated by CDC as qualified and, in the U.S., certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. On Monday, February 3, 2020, CDC submitted an <a target="_blank" href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" title="Emergency Use Authorization">Emergency Use Authorization</a> (EUA) package to FDA in order to expedite use of the CDC diagnostic panel in the United States.The EUA process enables FDA to consider and authorize the use of unapproved but potentially life-saving medical or diagnostic products during a public health emergency. FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a declared public health emergency, such as currently in effect in the U.S. relating to COVID-19. On February 4, 2020, FDA granted the EUA request to the CDC, permitting use of the CDC test kit in labs certified to perform high complexity tests. FDA simultaneously developed an EUA review template for tests to detect the virus, which outlines the data requirements for a Pre-EUA package available to developers upon request. This revised template for these EUA submissions is available now on FDA’s website. FDA reports it has shared its EUA review template with more than 50 developers who have expressed interest in developing diagnostics for this virus.On February 25, 2020, the agency <a target="_blank" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior" title="Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency">issued a new policy</a> for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the United States. The new policy authorizes certain laboratories to develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their EUA requests—allowing the immediate use of these tests and not requiring the laboratory to await FDA approval of the EUA. This emphasizes FDA’s public health role in the rapid detection of COVID-19 to assist in controlling community spread of the virus. Only laboratories certified under the <a target="_blank" href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia" title="Clinical Laboratory Improvement Amendments (CLIA)">Clinical Laboratory Improvement Amendments</a> to perform high complexity tests can take advantage of this unprecedented policy, and only after appropriate analytical validity testing is completed and documented by the laboratory. The new policy requires a laboratory taking advantage of this process to notify FDA of such usage and submit a complete EUA request to FDA within 15 days of the use of the test to detect COVID-19.Then, on February 29, 2020, FDA completed its review and authorized the EUA of Wadsworth Center, New York State Department of Public Health’s “New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel,” which is indicated for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic locations where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation). Testing is limited to the Wadsworth Center and certain authorized state and city laboratories. A <a target="_blank" href="https://www.fda.gov/media/135662/download">Fact Sheet for Health Care Professionals</a> details the use and limits of the test. Only one day after receiving the EUA approval, New York’s Wadsworth Center identified <a target="_blank" href="https://www.democratandchronicle.com/story/news/politics/albany/2020/03/01/new-york-has-first-case-coronavirus-here-details/4925681002/">New York’s first case of COVID-19</a> using its FDA EUA authorized RT-PCR Diagnostic Panel.FDA is also drawing on its vast public health expertise in providing regulatory advice, guidance and technical assistance to sponsors. Although media reports indicate a number of drug and vaccine firms are working toward medical products to address COVID-19, there are no FDA-approved vaccines or therapeutics to prevent or treat COVID-19. The National Institutes of Health began a <a target="_blank" href="https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-treat-covid-19-begins">randomized controlled trial</a> for the treatment of COVID-19 patients. While sponsors are usually expected to allow 30 days between submission and initiation of an initial Investigational New Drug (IND) protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible.

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FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)

Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment

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FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including 

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Diagnosis & Treatment (Part III)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and FDA’s focused efforts. Please read <a href="https://lifesciences.mofo.com/topics/FDA-working-to-address-2019-novel-Coronavirus-product-safety-part-I.html" target="_blank">Part I of our series</a>.FDA is anticipating that supply chain disruptions will occur as a result of the COVID-19 outbreak. In fact, FDA confirmed on February 27, 2020, that a drug manufacturer with a human drug product is now included on the <a href="https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm" target="_blank">drug shortages list</a> as a result of the impact of the outbreak on a site that is manufacturing the active pharmaceutical ingredient of the drug product. The COVID-19 outbreak follows shortly on the heels of FDA’s focused efforts last fall on drug shortage issues and, in October 2019, FDA issued a report, “<a href="https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions" target="_blank">Drug Shortages: Root Causes and Potential Solutions</a>,” that attempts to identify root causes and offer recommendations to help prevent and mitigate drug shortages.FDA has redirected agency resources to proactively communicate with drug and device firms that could be impacted by the outbreak. Since January 24, 2020, FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China. Also, as part of FDA’s proactive supply chain management efforts, they have identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China and FDA has been in direct contact with those firms to assess whether they face any drug shortage risks due to the outbreak. Drug firms are required by law to proactively communicate drug shortage risks and also respond to FDA inquiries regarding management of drug supply issues.No law exists requiring medical device manufacturers to notify FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when FDA requests information about potential supply chain disruption. FDA has identified 63 manufacturers which represent 72 facilities in China that produce essential medical devices and has proactively contacted these firms. FDA has confirmed that a number of these facilities are impacted by the outbreak, but is not reporting any medical device shortages in the U.S. market as of February 27, 2020. Despite reported challenges in obtaining personal protective equipment, such as respirators, gloves and masks, FDA is not reporting a shortage in the supply chain at this time. FDA has established a unique email box to receive information about device shortages: <a href="mailto:deviceshortages@fda.hhs.gov" target="_blank">deviceshortages@fda.hhs.gov</a> and is encouraging voluntary cooperation from device firms in assessing supply chain impacts.FDA also has a number of regulatory tools available, beyond the immediate surveillance and monitoring activities described above, to address the supply chain impact of the coronavirus outbreak. In addition, the President’s budget contains specific proposals that FDA is now emphasizing could help FDA address coronavirus supply chain disruption. First, FDA is strongly advocating that Congress update the legal authority regarding medical device supply chain disruption reporting and cooperation. Second, FDA advocates that it be able to obtain infrastructure information, such as manufacturing quality and capacity, in a proactive process. Third, FDA recommends that it be given the legal authority to require medical product firms (drugs and devices) to prepare and test against risk assessments of supply chain vulnerabilities and be required to maintain emergency contingency plans. Finally, FDA suggested that it should be granted the legal authority to require drug manufacturers to revise and lengthen expiration dates to the maximum date scientifically validated to address supply chain disruptions. We will continue to monitor these proposed changes to FDA’s legal authorities.

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Supply Chain (Part II)

FDA has been working intensely, mostly behind the scenes both in the United States and abroad, to address a number of important public health issues, including product safety, monitoring supply chain disruptions, and supporting emergency efforts to diagnose and treat the disease. In addition, FDA is addressing safety concerns with its own workforce. In this three-part series, we explain FDA’s efforts in each of these areas and highlight the impact on different sectors of the healthcare industry impacted by the coronavirus and also FDA’s focused efforts. The current outbreak of respiratory disease caused by the novel coronavirus first detected in 2019 in Wuhan City, Hubei Province, China has now been detected in more than 60 locations internationally, including cases in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on healthcare systems and causing disruption throughout our society. As of March 2nd, the state of Washington confirmed six deaths relating to COVID-19, and confirmed or presumptive cases were investigated in California, Florida, New Jersey, Rhode Island and New York. FDA’s focus on product safety is a two-pronged approach: leveraging the full breadth of FDA’s available public health tools, including enforcement tools to stop fraudulent activity in product promotion and marketing in the United States, while simultaneously engaging in a number of efforts to ensure the safety and quality of FDA-regulated products for patients and consumers.Importantly, at this point in time, there are no drugs, OTC products or medical devices (such as hand or surface sanitizers, dietary supplements, or face masks) that have FDA authorization to make claims of treatment or prevention against COVID-19. FDA has formed a cross-agency task force to review and address fraudulent activities in this regard and reiterated that FDA will use available enforcement tools against entities or individuals who are “bad actors” taking “advantage of a crisis to deceive the public.” FDA is reaching out to major retailers, requesting removal of dozens of such fraudulent products from their online listings and has requested cooperation in monitoring for, and preventing, coronavirus claims on health and wellness products. Therefore, retailers should be vigilant about monitoring for product claims that could cause consumer confusion or deception, and product manufacturers and distributors should exercise caution in changing their product labels or claims without FDA review and approval. In Part III we will discuss the specific processes that FDA has made available for expedited review and emergency access to products designed to address the COVID-19 outbreak.FDA is focusing on products imported from China. Presently, 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging). FDA has not seen the impacts of this outbreak resulting in an increased public health risk for U.S. consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. FDA uses its inspectional authority to inspect regulated products in an effort to provide post-market surveillance and assure ongoing product safety. FDA typically uses a risk-based model to approach inspections. On average, FDA conducts approximately 500 inspections per year in China with the majority of these inspections being for drugs, foods and medical devices, and 90% of those being routine surveillance (as opposed to for-cause inspection). On February 14, 2020, FDA confirmed that it is no longer conducting inspections in China, consistent with the State Department travel warnings. Scheduled inspections were either postponed or, for drug facility inspections, the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections. FDA hopes that the increased reliance on record-request-based inspectional activities will reduce a presumed backlog of inspections in the future and help FDA prioritize future site inspections. Firms in China manufacturing FDA-regulated products should be operating at heightened awareness, as FDA ultimately holds firms and individuals who manufacture and sell FDA-regulated products responsible for ensuring the quality of their products. The FDA can pursue regulatory and enforcement action, such as warning letters, seizures or injunctions, against products on the market that are not in compliance with the law, or against firms or individuals who violate the law, including those offering adulterated or misbranded products.FDA is also relying heavily on its collaboration with U.S. Customs and Border Protection to target products intended for importation into the United States that violate applicable legal requirements for FDA-regulated products. FDA has the ability, through a risk-based import screening tool called PREDICT, to focus import examinations and sample collections based on heightened concerns about specific products entering U.S. commerce. The PREDICT screening will adjust risk scores as necessary throughout the COVID-19 outbreak. FDA has reiterated that the combination of these risk-based tools are providing a comprehensive approach to product safety. Firms importing FDA-regulated products into the U.S., regardless of origin, should be aware of the increased utilization of import controls as a mechanism for product safety evaluation during the COVID-19 outbreak.Finally, it’s worth noting that there are no vaccines, gene therapies or blood derivatives licensed by FDA that are manufactured in China. The potential for transmission of COVID-19 by blood and blood components is unknown at this time; however, respiratory viruses, according to FDA and CDC, are not known to be transmitted by blood transfusion. There have been no reported cases of transfusion-transmitted COVID-19. Thus, this class of products is not a central focus of FDA’s product safety efforts, although FDA is aware that certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) establishments are revising donor screening criteria to account for risk factors associated with COVID-19, including recent travel or familial exposure.Please check back tomorrow for Part II, when we will discuss FDA’s approach to supply chain disruptions caused by the response to COVID-19.

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)

FDA Working to Address 2019 Novel Coronavirus (COVID-19): Product Safety (Part I)

As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our January recap is below.1. <a href="https://www.fda.gov/news-events/press-announcements/fda-usda-and-epa-announce-joint-platform-streamline-information-about-agricultural-biotechnology" target="_blank">FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products</a> (Jan. 9, 2020). The U.S. Food and Drug Administration (FDA), the Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) launched a <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/" target="_blank">Unified Website for Biotechnology Regulation</a>. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s <a href="https://www.usda.gov/media/press-releases/2019/06/11/secretary-perdue-statement-president-trumps-biotech-eo" target="_blank">Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products</a>. The website describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations. This collaboration emphasizes the need for considering multiple regulatory frameworks when dealing with biotechnology innovations.2. <a href="https://www.justice.gov/opa/pr/patient-services-inc-agrees-pay-3-million-allegedly-serving-conduit-pharmaceutical-companies" target="_blank">Patient Services Inc. Agrees to Pay $3 Million for Allegedly Serving as a Conduit for Pharmaceutical Companies to Illegally Pay Patient Copayments</a> (Jan. 21, 2020). Patient Services Inc. (PSI), a foundation based in Virginia, has agreed to pay $3 million to resolve allegations that it violated the False Claims Act by acting as a conduit to enable certain pharmaceutical companies to provide kickbacks to Medicare patients taking the companies’ drugs, by paying the patients’ copayments. When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible (collectively, copays). Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on healthcare costs, including the prices that pharmaceutical manufacturers can demand for their drugs. The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration — which includes money or any other thing of value — to induce Medicare patients to purchase the companies’ drugs, and it prohibits third parties, such as copay foundations, from acting as a conduit for such payments. Additionally, state insurance fraud statutes protect private insurers against actions, such as copay assistance or waiver.3. <a href="https://www.fda.gov/news-events/press-announcements/fda-informs-health-care-providers-facilities-and-patients-about-potential-cybersecurity" target="_blank">FDA informs healthcare providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers</a> (Jan. 23, 2020). The FDA issued a safety communication informing healthcare providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers. These devices are primarily used in healthcare facilities, for displaying patient information, such as the physiologic status (i.e., temperature, heartbeat, blood pressure, etc.) of a patient and monitoring patient status from a central location in a facility, such as a nurse’s bay. The cybersecurity vulnerabilities identified could allow an attacker to remotely take control of the device to silence alarms, generate false alarms, or interfere with the function of patient monitors connected to these devices. These cybersecurity vulnerabilities were identified by a third-party security firm, which may have been engaged by the FDA directly or by GE Healthcare; it is not clear. The FDA’s safety communication alerts healthcare providers and facilities of the risk posed by these vulnerabilities and provides recommendations on actions that can be taken to mitigate risks. These recommendations include advising healthcare facilities to segregate the network connecting the patient monitors with the affected GE Healthcare Clinical Information Central Stations and Telemetry Servers from the rest of the hospital network and using firewalls, segregated networks, virtual private networks, network monitors, or other technologies that minimize the risk of remote or local network attacks. The FDA has continued to develop guidance for medical device manufacturers on cybersecurity standards, and this safety alert provides additional emphasis on this important issue that spans FDA regulatory, healthcare and public health, and privacy protections.4. <a href="https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0" target="_blank">Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations</a> (Jan. 27, 2020). Practice Fusion Inc., a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software. As part of the criminal resolution, Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications. The resolution announced by the Department of Justice (DOJ) addresses allegations that Practice Fusion extracted unlawful kickbacks from pharmaceutical companies in exchange for implementing clinical decision support (CDS) alerts in its EHR software designed to increase prescriptions for their drug products. Specifically, in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS alerts in ways aimed at increasing sales of the companies’ products. Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself. The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards. In discussions with pharmaceutical companies, Practice Fusion touted the anticipated financial benefit to the pharmaceutical companies from increased sales of pharmaceutical products that would result from the CDS alerts. Between 2014 and 2019, healthcare providers using Practice Fusion’s EHR software wrote numerous prescriptions after receiving CDS alerts that pharmaceutical companies participated in designing.“Practice Fusion’s conduct is abhorrent. During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” said Christina E. Nolan, U.S. Attorney for the District of Vermont.The FDA has issued two draft guidance documents focused on CDS products, with the <a href="https://www.fda.gov/media/109618/download" target="_blank">most recent version</a> focusing on a risk-based approach to determining the FDA regulation over software that is clinical decision support. Changes to the Food, Drug, and Cosmetic (FD&C) Act made by the 21st Century Cures Act in late 2016 amended section 520 and excludes certain software functions from the device definition, including limited types of CDS products. Technology companies developing electronic medical records, clinical decision support, or other software or a medical device should be made aware of both the DOJ position on external sponsorship of CDS and also the pending FDA regulatory framework for CDS.

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January FDA Updates

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As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and produ

January FDA Updates

The United States Patent and Trademark Office (USPTO) just issued new rules that directly affect trademark owners.  Going forward, trademark applicants, registrants, and parties to a proceeding before the Trademark Trial and Appeal Board will need to provide their email address in USPTO filings. Unfortunately for trademark owners, unscrupulous third parties will likely take advantage of this new rule and start to use the email addresses to spam trademark owners, as they will be publicly available on the USPTO website. We therefore recommend trademark owners set up an email address specifically for the purpose of complying with the rule.Read our <a target="_blank" href="https://www.mofo.com/resources/insights/200218-new-uspto-rule-likely-increase-spam.html?utm_source=publication&utm_medium=email">client alert</a>

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Of Counsel

Muzamil Huq represents clients in the protection and enforcement of U.S. and non-U.S. trademark matters and other IP transactions. 

Muzamil Huq

Muzamil Huq represents clients in the protection and enforcement of U.S. and non-U.S. trademark matters and other IP transactions.

New USPTO Rule Likely to Increase Spam

The United States Patent and Trademark Office (USPTO) just issued new rules that directly affect trademark owners.  Going forward, trademark applicants, registr

New USPTO Rule Likely to Increase Spam

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the agency in evaluating the potential use of real-world evidence (RWE) in regulatory decisions involving drug and biological products.[2] The Framework laid out a “three-part approach” identifying data quality, study design, and regulatory requirements as focal points of the evaluation. In addition, the Framework pointed to the importance of data standards in enabling efficient processing of real-world data (RWD), from which RWE is derived. In 2019, to refine its understanding of these four areas (data quality, study design, regulatory requirements, and data standards) in the context of RWE, FDA coordinated a multifaceted effort including demonstration projects, development of guidance documents, the Sentinel System, and active engagement with sponsors and other stakeholders.In 2019, FDA expanded some of its existing demonstration projects, while funding new ones. In April, Aetion announced that FDA and Brigham and Women’s Hospital/Harvard Medical School will expand the scope of their demonstration project to include predicting seven ongoing randomized control trials (RCTs) with RWE, in addition to the original scope of replicating 30 completed RCTs.[3] In August, a San Francisco-based company Syapse announced that it will work with FDA to assess the potential of RWE especially in the context of precision medicine.[4] While some have criticized these studies,[5] demonstration projects seem to remain a core part of FDA’s Real-World Evidence Program (the “Program”).In May, FDA published a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.”[6] The industry reaction was mixed, some cautioning while others encouraging the use of RWE.[7] Notably, some of the pharmaceutical companies asked the agency to consider data from Expanded Access programs as a source of RWD, in response to the draft.[8] While expanding the scope of RWD in such a way may incentivize companies to more actively engage in FDA’s Expanded Access and Right to Try programs,[9] it remains to be seen how the agency’s subsequent treatment of RWE interacts with the level of industry participation in those programs.The Sentinel contract in September marked another step forward in FDA’s endeavor to incorporate RWE into its regulatory practice. According to Jacqueline Corrigan-Curay, FDA’s Director of CDER’s Office of Medical Policy, the contract “will really enable FDA to continue to grow its own RWE capabilities.”[10] The contract will fund up to $220 million for five years starting in 2019, for the next phase of the Sentinel System,[11] which is to become a platform that generates RWE for FDA.[12]Lastly, FDA supported and sponsored workshops to exchange insights with stakeholders. In July, through a public workshop titled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes,” FDA explored the potential use of RWD not only in single-arm trials but also in randomized clinical trials.[13] Also in July, FDA sponsored a workshop titled “FDA-AACR Real-world Evidence Workshop,” discussing the use of large genomic databases and digital data as RWD, among other things.[14] In October, at a conference entitled “Developing Real-World Data and Evidence to Support Regulatory Decision-Making,” FDA and various stakeholders exchanged thoughts on the key evaluation areas laid out in the Framework.[15] Through these workshops, FDA has shown that it is open to a wide range of creative solutions, while understanding that it may have to take one step at a time.[16]In parallel with its pursuit under the Program, FDA in September announced a Technology Modernization Action Plan.[17] In justifying the timeliness of this plan, FDA explained that a modernized technical infrastructure will be necessary for the agency to accept and process RWD and to derive RWE for its regulatory decision-making, specifically referring to the Framework and the Program. This explanation seems to reach beyond the scope of the Program (and the congressional mandate by the 21st Century Cures Act), which simply sets out to evaluate the potential use of RWE.[18]Finally, it is worth noting how RWE continued to play a role in supporting drug approvals in 2019, especially in the context of cancer and rare diseases. For instance, FDA’s Oncology Drugs Advisory Committee last month unanimously recommended accelerated approval of a drug (tazemetostat) for a rare form of cancer,[19] where the approval was supported in part by a Natural History Study.[20] Further, FDA in April approved a new indication of a drug (palbociclib) primarily based on RWD such as electronic health records and post-marketing reports.[21] The approval is one of the rare cases where FDA accepted RWE to support an effectiveness decision (rather than a safety evaluation), and will serve as a precedent for future drug approvals. Given FDA’s willingness apparent in the Framework to further explore the use of RWE in effectiveness decisions, it seems likely that RWE will play a bigger role in drug approval processes in 2020.In short, FDA in 2019 tapped into multiple channels to gather input from stakeholders and also to broaden its own experience with RWD and RWE. Although the exact outcome of these endeavors remains to be seen in 2020, the agency appears to be slowly but surely getting ready to incorporate more RWE into its regulatory decisions. [1] Framework for FDA’s Real-World Evidence Program, FDA (December 2018)[2] <a target="_blank" href="https://www.fda.gov/drugs/webinar-framework-fdas-real-world-evidence-program-mar-15-2019">Webinar: Framework for FDA’s Real-World Evidence Program, FDA (March 2019)</a>[3] <a target="_blank" href="https://www.prnewswire.com/news-releases/fda-expands-real-world-evidence-partnership-with-brigham-and-womens-hospital-and-aetion-300829517.html">FDA Expands Real-World Evidence Partnership with Brigham and Women’s Hospital and Aetion, PR Newswire</a>[4] Syapse Announces Research Collaboration with the FDA Focused on the Regulatory Use of Real-World Evidence (August 2019)[5] <a target="_blank" href="https://www.statnews.com/2019/07/03/replicate-clinical-trials-real-world-evidence">Attempt to Replicate Clinical Trials with Real-World Data Generates Real-World Criticism, Too, Matthew Herper (July 2019)</a>[6] <a target="_blank" href="https://www.fda.gov/media/124795/download">Draft Guidance: Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics, FDA (May 2019)</a>[7] <a target="_blank" href="https://www.policymed.com/2019/09/industry-reaction-mixed-to-fda-draft-guidance-on-real-world-data-and-evidence.html">Industry Reaction Mixed to FDA Draft Guidance on Real World Data and Evidence, Thomas Sullivan (September 2019)</a>[8] Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence, Zachary Brennan (July 2019)[9] Public Meeting Report: Leveraging Real World Treatment Experience from Expanded Access Protocols, Silver Spring (November 2018); Pre-Approval Access and Real-World Evidence: A Win-Win Proposition, Jane Reese-Coulbourne (November 2017); Working Group on Compassionate Use & Preapproval Access Frequently Asked Questions (“If companies see expanded access programs as a source of valuable RWE, they may become more willing to run expanded access programs alongside their clinical trials.”)[10] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a>[11] <a target="_blank" href="https://www.populationmedicine.org/pressrelease/Sentinel">Harvard Pilgrim Health Care Institute Funded up to $220 Million for The Next Phase of FDA Sentinel System, Harvard Department of Population Medicine (September 2019)</a>[12] <a target="_blank" href="https://www.fda.gov/media/120333/download">Sentinel System: Five-Year Strategy 2019-2023, FDA (January 2019)</a>[13] Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes, FDA & Duke-Margolis Center for Health Policy (July 2019), <a target="_blank" href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes</a>; <a target="_blank" href="https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes">https://healthpolicy.duke.edu/events/leveraging-randomized-clinical-trials-generate-real-world-evidence-regulatory-purposes</a>[14] FDA-AACR Workshop: Real-world Evidence, FDA & AACR (July 2019), <a target="_blank" href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-aacr-workshop-real-world-evidence-07192019-07192019">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-aacr-workshop-real-world-evidence-07192019-07192019</a>; <a target="_blank" href="https://www.fda.gov/media/128598/download">https://www.fda.gov/media/128598/download</a>[15] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a>[16] <a target="_blank" href="https://healthpolicy.duke.edu/events/developing-real-world-data-and-evidence-support-regulatory-decision-making">E.g., Developing Real-World Data and Evidence to Support Regulatory Decision-Making, FDA & Duke-Margolis Center for Health Policy (October 2019)</a> (“We know that today data (does) not just seamlessly flow from the EHR or claims data for use in research. Today we’re going to hear maybe how we might get one step closer to that: whether that will require re-imagination of the EHR and the clinical work flow to capture data that is relevant to both quality practice and research … or maybe it’s more relying on natural language processing and artificial intelligence.”)[17] <a target="_blank" href="https://www.fda.gov/media/130883/download">FDA’s Technology Modernization Action Plan, FDA (September 2019)</a>[18] <a target="_blank" href="https://www.fda.gov/drugs/webinar-framework-fdas-real-world-evidence-program-mar-15-2019">Webinar: Framework for FDA’s Real-World Evidence Program, FDA (March 2019)</a>[19] <a target="_blank" href="https://medcitynews.com/2019/12/fda-panel-recommends-approval-of-epizyme-drug-for-rare-cancer/?rf=1">FDA Panel Recommends Approval of Epizyme Drug for Rare Cancer, Alaric Dearment (December 2019)</a>[20] NDA211723: Tazemetostat for the Treatment of Patients with Metastatic or Locally Advanced Epithelioid Sarcoma Who Are Not Eligible for Curative Surgery, Epizyme (December 2019)[21] <a target="_blank" href=" https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_ibrance_palbociclib_for_the_treatment_of_men_with_hr_her2_metastatic_breast_cancer">U.S. FDA Approves Ibrance® (Palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer (April 2019)</a>

FDA and Real-World Evidence in 2019

Around the end of 2018, FDA published the “Framework for FDA’s Real-World Evidence Program” (the “Framework”).[1] The Framework is to provide a basis for the ag

FDA and Real-World Evidence in 2019

On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of asexually reproduced plants for the first time.Extending PVP rights to all asexually reproduced plants means that breeders of plants, such as fruit trees, which are typically propagated asexually rather than by seed, may now obtain PVP certificates for their varieties in the United States. This addition is also notable for breeders of hemp—the regulated production of which was legalized by the 2018 Farm Bill—because hemp can be reproduced both asexually and by seed.The 2018 Farm Bill Extended PVPA Protection to Asexually Reproduced PlantsThe new PVPO rule was prompted by the 2018 Farm Bill (Public Law No: 115-334, Sec. 10108), which dramatically expanded the scope of the U.S. Plant Variety Protection Act (PVPA) to include protection for asexually reproduced plant varieties. Prior to this amendment, the PVPA had been limited to sexually reproduced plants (i.e., seed-bearing plants) and tuber‑propagated plants. Although the Farm Bill was passed over a year ago, the PVPO needed time to revise the Plant Variety Protection Regulations (7 C.F.R. part 97; “Regulations”), which guide the implementation of the PVPA, prior to accepting applications for asexually reproduced plant varieties. A draft rule proposing such revisions was published for comment in the Federal Register in July 2019 (84 Fed. Reg. 33176, 33178), and comments closed in September 2019. In the intervening period, the PVPO revised the draft into a final rule, which was reviewed and approved by the PVPO Administrator and the Secretary of Agriculture before being released on January 6, 2020.The 2018 Farm Bill included the following amendments to the PVPA: 1) the sections on rights provided (7 U.S.C. § 2402), infringement (7 U.S.C. § 2541), and false marking and cease and desist orders (7 U.S.C. § 2568) were revised to include language for asexually reproduced plants and 2) the definitions section (7 U.S.C. § 2401(a)) was revised to provide a definition for the term “asexually reproduced.” Specifically, the PVPA now defines “asexually reproduced” as “produced by a method of plant propagation using vegetative material (other than seed) from a single parent, including cuttings, grafting, tissue culture, and propagation by root division.” (2018 Farm Bill, Public Law No: 115-334, Sec. 10108, 132 Stat. 4906 (Dec. 20, 2018).)In implementing these changes, the PVPO’s new rule demonstrates how the Office will handle PVP applications for asexually reproduced plants. Many of the changes merely broaden the Regulations’ existing language to include asexually reproduced plants. For instance, with regard to the publication of pending applications, amended § 97.19(c) states that information relating to pending applications shall show the “name of the crop” rather than the “name of the kind of seed.” Notably, however, there are two key areas that Applicants interested in obtaining PVP protection for their asexually reproduced varieties should be sure to understand: 1) the testing requirements and 2) the deposit requirements (discussed in detail below).Distinctness, Uniformity, and Stability (DUS) TestingAs is the standard for sexually reproduced and tuber-propagated plants, the PVPO will not conduct its own DUS trials for asexually reproduced plants. Rather, Applicants will perform DUS testing themselves and provide their data to the PVPO using new Exhibit C forms that the Office has developed for asexually reproduced plants. These new Exhibit C forms are based on the Test Guidelines Table of Characteristics from the International Union for the Protection of New Varieties of Plants (UPOV). The PVPO’s new forms are available on the PVPO website and through the <a target="_blank" href="https://www.ams.usda.gov/services/plant-variety-protection">ePVP online application system</a>. Additionally, the PVPO may also accept DUS reports from other countries on a case-by-case basis.Deposit RequirementsFor PVP applications directed to seed-reproduced and tuber-propagated varieties, the PVPO currently requires Applicants to submit a biological deposit of the candidate variety. When the PVPA was extended to asexually reproduced plants, the PVPO had planned to require deposits for asexual reproduced species as well. However, in response to feasibility concerns raised in the public comment period, the final rule provides for a three-year delay in enforcement of the deposit requirement for asexually reproduced plants. Thus, deposits of propagating material for asexually reproduced plants will not be required until January 6, 2023. In the intervening period, the PVPO will examine the technical feasibility of making deposits for asexually reproduced plants.Therefore, from January 6, 2020, until January 6, 2023, Applicants are not required to make a biological deposit for PVP applications for asexually reproduced plants, though they may do so voluntarily. However, Applicants who choose to not make deposits during this period are required to submit declarations stating that: 1) propagating material will be maintained at a specific physical location that the PVPO can inspect (7 C.F.R. § 97.7(d)(2)(i) 2020) and 2) the propagating material will be provided within three months of a request by the PVPO (7 C.F.R. § 97.7(d)(2)(ii) 2020).The final rule envisions that, after January 6, 2023, deposits will be required for PVP applications for asexually reproduced plants within three months of notice of certificate issuance. As with sexually reproduced and tuber-propagated plants, Applicants seeking protection for asexually reproduced plants will be required to submit a declaration stating that the deposit will be maintained for the duration of the certificate.Although deposits are currently envisioned to become required and enforceable after January 6, 2023, Applicants may request waivers that, if granted by the PVPO, will allow for delayed submission of the deposit. Two types of waivers will be available for asexually reproduced plants:<ol><li>Waiver for “good cause, such as delays in obtaining a phytosanitary certificate” (7 C.F.R. § 97.7(d) 2020); and</li><li>Waiver to withhold deposit due to technical infeasibility.</li></ol>If a technical infeasibility waiver is granted by the PVPO, the Applicant will further be required to:<ol><li>Make the same two § 97.7(d)(2)(i)-(ii) declarations noted above; and</li><li>Submit a deposit within three months of notice that the technical infeasibility has been resolved.</li></ol>Overall, Applicants should be prepared to submit deposits of propagating material for asexually reproduced plants, although such deposits will not be formally required until January 6, 2023. During the intervening time, as noted above, the PVPO is reviewing the technical feasibility of making deposits for asexually reproduced plants. Following this review period, the PVPO may modify the deposit requirements outlined above.PVP Certificates vs. Plant PatentsPrior to the PVPA amendment, intellectual property protection on asexually reproduced plants in the United States was already available in the form of plant patents under 35 U.S.C. § 161. Plant patents continue to be available, but PVP certificates offer broader protection in terms of so-called “essentially derived varieties” (EDVs). That is, in addition to covering the variety owned by the titleholder, PVP certificates also require the titleholder’s permission before commercialization of any variety that has been “essentially derived” from the titleholder’s variety (7 U.S.C. § 2541). In contrast, plant patents cover only the exact plant set forth in the issued patent and clones thereof. Thus, the option to obtain PVP rights expands the scope of protection available for breeders of asexually reproduced plants in the United States. Furthermore, with the addition of asexually reproduced plants, the U.S. PVP system is now more aligned with analogous systems in other UPOV countries, allowing breeders to streamline their international portfolios.While PVP certificates provide broader protection for breeders than do plant patents, they do present some drawbacks. Specifically, the PVPA contains exemptions to infringement for seed-saving, research, and breeding (7 U.S.C. §§ 2543-44), while plant patents do not. Furthermore, unlike PVP applications, plant patent applications do not formally require a deposit. Finally, plant patents are more economical than PVPs. Indeed, PVP certificates require both a $3,000 deposit fee and a $5,150 application fee, while the official fees for a plant patent are likely to total less than half of that amount.Moving ForwardIn addition to incorporating the inclusion of asexually reproduced plants, the PVPO’s revised Regulations updated the fee schedule and modernized administrative procedures. The full text of the new rule is available at the <a target="_blank" href="https://www.federalregister.gov/documents/2020/01/06/2019-27636/regulations-and-procedures-under-the-plant-variety-protection-act">PVPO’s website</a>. Given the cost and the potential technical complications of the deposit requirement, it remains to be seen how popular PVPs for asexually reproduced plants will be. However, the opportunity to obtain PVPs for asexually reproduced plants—particularly considering the EDV protection provided—is a significant step forward for plant intellectual property in the United States.

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Associate

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Sr Patent Agent

Cory Ellison is a patent agent in the San Francisco office of Morrison & Foerster. Dr. Ellison’s practice involves patent application drafting, patent prosecution, matters pertaining to plant variety 

Cory Ellison Ph.D.

Cory Ellison

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Michael Ward

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants