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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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare services models, startups and established companies alike are positioning themselves to take advantage of the growing market for technologies and products that enable non-lab-based diagnostics capable of being purchased without a prescription and conducted entirely at home.

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Non-Lab Diagnostics: FDA Regulatory Considerations | MoFo Life Sciences

Brigid DeCoursey Bondoc

Matthew A. Ferry

Matt Karlyn

Hannah Koo

FDA REGULATORY ISSUES[1]The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare services models, startups and established companies alike are positioning themselves to take advantage of the growing market for technologies and products that enable non-lab-based diagnostics capable of being purchased without a prescription and conducted entirely at home.[2] MoFo’s FDA Regulatory team has described the top three issues developers of these tests should consider.<ol><li>Understand Your Regulatory Obligations</li></ol>Companies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations. FDA has authority to regulate in vitro diagnostics (IVDs) for end-to-end use at home (such as pregnancy tests or COVID rapid tests) under both the Federal Food, Drug, and Cosmetics Act (FDCA) and the Public Health Service Act.[3] This regulatory authority extends throughout the product lifecycle, from premarket clinical studies to post-market obligations like adverse event reporting and manufacturing controls.a. OTCs Are Not LDTsFDA has issued a significant rulemaking proposal to regulate “laboratory developed tests” (LDTs), a category that FDA has not actively regulated in the past, citing a policy of “enforcement discretion.” [4] The proposed changes to FDA’s regulations do not specifically define LDTs, but the proposed rule would add language to the regulatory definition of IVD to clarify that laboratories may be deemed manufacturers of IVDs and thus subject to regulation.However, FDA’s rulemaking around LDTs would not apply to OTC tests. In the past and in the preamble to the proposed rule, FDA defines LDTs as tests that are “designed, manufactured and used within a single laboratory.”[5] When FDA uses the term “OTC,” it means a test for which the end user collects a specimen at home and performs the test at home. Although there is often thought to be some overlap between tests that use “self-collected” specimens[6] and LDTs, OTC tests, by definition, cannot be LDTs and have never been the subject of FDA’s enforcement discretion.b. Premarket ReviewFor IVDs sold OTC, premarket review is required because FDA generally considers these tests, as a category, to be moderate-risk or high-risk.[7] This means that FDA will likely require a de novo review for a test that has no legally marketed predicate. If there are already similar tests on the market, it may be possible to obtain clearance through the generally less-burdensome 510(k) process.[8] Companies undergoing premarket review for an OTC test should plan to complete a user-comprehension test and/or usability study, as well as prepare for FDA to review the product’s accuracy, reliability, clinical validity, and claims.A de novo request will include a description of the “probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended.”[9] For OTC devices, risks might include “misinterpretation or over-reliance on device output,” which might be addressed through human factors and usability engineering testing under simulated conditions of use, and risk mitigation measures, including appropriate information within labeling.[10]c. Post-market ObligationsEven after regulatory clearance or approval has been granted, a cleared or approved product and its manufacturer are subject to extensive regulatory requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, and promotion for the product.Companies launching a new diagnostic product, as well as companies converting a lab-based test to an at-home test, should carefully consider labeling. The label must contain adequate information so that a lay user can select the device as an appropriate match for their condition, understand how to use the device, correctly interpret the results, and appropriately manage their condition—all without assistance from a healthcare provider.[11] Such information includes the test’s intended use, recommended procedures from specimen collection to results, test limitations, specific performance characteristics, and list of interfering substances.[12]Any advertising or promotion of the product should strictly adhere to the FDA-cleared indication, and any claims made about the safety or efficacy of the product should be consistent with any FDA-cleared or approved labeling. This is an area where many companies have struggled and faced not only enforcement actions from FDA but also civil and criminal enforcement for false claims made to government healthcare programs.Device manufacturers are required to follow FDA’s Quality System Regulation (QSR), a complex regulatory scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation, servicing, and shipping of their marketed products. FDA enforces QSR and other requirements through periodic announced and unannounced inspections of manufacturing facilities.Medical Device Reporting (MDR) is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters, including manufacturers, device user facilities, and importers, must submit to FDA certain types of reports for adverse events and product problems about medical devices.<ol start="2" class=""><li class="">Talk to FDA Early and Often or Face the Consequences</li></ol>Companies considering launching an at-home diagnostic test should consult with FDA early and often. Proactive communication generally limits unexpected regulatory hurdles, clarifies the regulatory costs associated with bringing a test to market, and may help prevent regulatory tangles. Using tools like the pre-submission process to ask clarifying questions of the relevant review division prior to making a submission can save valuable time and avoid wasting resources on studies that will not satisfy FDA’s requirements.When test companies do not comply with their regulatory obligations, FDA has a number of enforcement tools that it can employ. Failure to comply with the regulatory requirements of the FDA may cause a company to be subject to administrative or judicially imposed sanctions, including restrictions on the products, manufacturers, or manufacturing process; adverse inspectional observations (Form 483), warning letters, or untitled letters; civil or criminal penalties or fines; injunctions; product seizures, detentions, or import bans; voluntary or mandatory product recalls and publicity requirements; suspension or withdrawal of regulatory clearances or approvals; total or partial suspension of production; imposition of restrictions on operations, including costly new manufacturing requirements; refusal to clear or approve pending applications or premarket notifications; and import and export restrictions.<ol start="3" class=""><li class="">Keep COVID-19 Lessons in Mind</li></ol>As noted above, the COVID-19 pandemic marked a turning point in consumer demand for at-home diagnostics and more widespread dissemination of information about how FDA thinks about this category diagnostics, but did not necessarily make it easier to bring an OTC diagnostic test to market. Recognizing this shift in the IVD market, FDA has now created a <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm" target="_blank">searchable database</a> for approved OTC diagnostic tests, linking would-be test developers to more readily available details about FDA’s review of those tests. FDA also issued guidance documents, templates, and summary review documents to aid the development of rapid antigen tests that shared learnings from the COVID-19 experience, highlighting the issues that were a focus of FDA oversight.[13]Companies looking to bring at-home diagnostics to market can learn from FDA’s regulation of COVID rapid tests by not underestimating the data requirements. During the pandemic, FDA required OTC COVID rapid test manufacturers to meet high accuracy standards, as well as conduct separate usability studies.[14] After rapid tests were slow to come to market, the agency’s approval process was criticized as too stringent.[15] While FDA has vocally supported increasing at-home diagnostic testing, the same high standards that applied to COVID rapid tests continue to be used for all OTC diagnostic tests. By fully understanding and planning to meet stringent standards, companies can be better prepared for the premarket review process.[1] This is the third in a series of three articles addressing the licensing and regulatory considerations for at-home diagnostic companies. The first article focuses on issues in structuring customer agreements and can be found [<a href="/topics/fda-regulatory-considerations?_gl=1*17zsyv4*_ga*MjA0NTYxMDg1Ny4xNzA3MzI0ODE3*_ga_3HVRG7GH76*MTcxMTY1OTY5MC44MS4wLjE3MTE2NTk3ODUuMC4wLjA." target="_self">here</a>]. The second focuses on issues in structuring manufacturer, supplier, and vendor agreements and can be found [<a href="/topics/at-home-diagnostics-articles-non-lab-diagnostics-supply-manufacturing-and-distribution-agreements" target="_self">here</a>].[2] Some diagnostic tests are marketed “direct-to-consumer,” but the consumer is not able to perform the entire test because the self-collected specimen must be analyzed by a laboratory. This article deals exclusively with tests that can be performed end-to-end by the consumer. We note, however, that FDA has recently issued a rulemaking proposing to regulate laboratory developed tests (LDTs), a category that FDA claims has long been subject to enforcement discretion. That proposal clearly distinguishes between tests performed by the consumer at home from LDTs, noting that OTCs have never been the subject of FDA’s enforcement discretion.[3] 21 C.F.R. § 809.3(a).[4] FDA, Proposed Rule: Medical Devices; Laboratory Developed Tests, 88 Fed. Reg. 68006 (Oct. 3, 2023).[5] FDA, Draft Guidance for Industry, FDA, and Clinical Laboratories: Framework for Regulatory Oversight of LDTs (Oct. 2014).[6] This article deals exclusively with tests that can be performed end-to-end by the consumer. We note that some diagnostic tests that use self-collected specimens are marketed as “direct-to-consumer” (DTC) tests. This category is outside the scope of this article because the consumer is not able to perform the entire test, i.e., the sample must be analyzed by a laboratory.[7] Direct-to-Consumer Tests, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests" target="_blank">https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests</a> (last visited October 9, 2023).[8] For a diagnostic test to be cleared for its intended use, FDA must find that the product is substantially equivalent to a legally marketed predicate device. See 21 U.S.C. §§ 360c(i) & (f)(1); see also FDA, Guidance for Industry and FDA: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (July 2014).[9] FDA Website, Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers, <a href="https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers" target="_blank">https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers</a>.[10] Id.[11] Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers" target="_blank">https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers</a> (last visited October 9, 2023).[12] In Vitro Diagnostic Device Labeling Requirements, U.S. Food & Drug Admin., <a href="https://www.fda.gov/medical-devices/device-labeling/in-vitro-diagnostic-device-labeling-requirements" target="_blank">https://www.fda.gov/medical-devices/device-labeling/in-vitro-diagnostic-device-labeling-requirements</a> (last visited October 9, 2023).[13] See, e.g., FDA, Molecular and Antigen Home Use Test Template, <a href="https://www.fda.gov/media/140615/download" target="_blank">https://www.fda.gov/media/140615/download</a>; FDA, In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2, <a href="https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2" target="_blank">https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2</a>.[14] William Rinehart, Improving the FDA: Lessons Learned from COVID-19 Rapid Tests 9 (Center for Growth and Opportunity at Utah State University 2023).[15] Id. at 8–11.

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