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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Research assistant Nicole Gebert contributed to this article. After having discussed the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies in part 1 of our 3 part series on the entering into force of the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128 " target="_blank">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR), we will now (i) explore key changes regarding clinical evidence and post-market surveillance, and (ii) discuss applicable transition periods.<h2>Clinical Evidence, Performance Evaluation, and Performance Studies</h2>Ensuring that the clinical evidence can stand up to the scrutiny of the notified bodies will be one of the biggest challenges for manufacturers in IVDR compliance. It is the responsibility of the manufacturers to determine whether they have adequate clinical and performance data to demonstrate conformity with the relevant safety and performance requirements. According to the IVDR, clinical evidence must demonstrate a continuous process of performance evaluation and must support the intended purpose of the device as stated by the manufacturer. Gradually, the level of clinical evidence needed to demonstrate device conformity increases in line with the risk class. A manufacturer must document the clinical evidence in a performance evaluation report once they are satisfied they have all of the data needed to support compliance with the IVDR. The report must include the scientific validity report, the analytical performance report, the clinical performance report, and an assessment of those reports allowing demonstration of the clinical evidence. More detailed information on clinical evidence can be found in the <a target="_blank" href="https://ec.europa.eu/health/system/files/2022-01/mdcg_2022-2_en.pdf">MDCG Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)</a> from January 2022.<h2>Post-Market Surveillance</h2>Similar to the MDR, the IVDR too places a greater emphasis on life-cycle management and continuous product evaluation than the IVDD. In this context, manufacturers are required to have a quality management system (QMS) in place (Article 10 IVDR). As part of the QMS, manufacturers are obligated to plan, establish, document, implement, maintain, and update a post-market surveillance system for each device in a manner that is proportionate to the risk class and appropriate for the type of device (Article 78 (1) IVDR). The requirements for the post-market surveillance system are described in Articles 79-81, Annex III, and Annex XIII of the IVDR. The requirements vary according to the risk class. Many aspects of the IVDR post-market surveillance requirements resemble the requirements of the MDR (for more information on QMS and post-market surveillance under the MDR, please see our previous blog post <a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html">here</a>). Similar to the MDR’s post- market clinical follow-up, the IVDR stipulates that a post-market performance follow-up (PMPF) is required to ensure that an IVD’s safety, performance, and clinical evidence remain based on factual evidence throughout its expected lifespan and that its benefit-risk ratio remains acceptable. In some cases, PMPF can be justified as not required (see Annex III 1b and Annex XIII Part B 8).<h2>Unique Device Identification System</h2>The identification and traceability of IVDs will be improved under the IVDR with the introduction of unique device identifiers (UDI). As laid out in Article 24 IVDR, each IVD must have a UDI composed of two parts: a UDI that is specific to a manufacturer and a device that provides access to the information set forth in Part B of Annex VI IVDR, and a unique device production identifier that identifies the unit of device production and, if applicable, the packaged devices, as specified in Part C of Annex VI IVDR. Manufacturers are responsible for entering and maintaining the necessary data in a UDI database, which is part of the <a target="_blank" href="https://ec.europa.eu/tools/eudamed/#/screen/home">European Database on Medical Devices</a> (EUDAMED). The UDI requirements in the IVDR are in line with the requirements set out by the MDR, which we addressed in more detail in part 5 of our MDR blog series that can be found <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html">here</a>.<h2>Transition Periods</h2>As mentioned above, the Commission proposed a delayed, progressive roll-out of the IVDR in October 2021. The rationale behind this proposal is that due to the resources diverted to address the COVID-19 pandemic and the significant changes introduced by the IVDR, Member State authorities, healthcare facilities, notified bodies, and economic operators would not be able to fully comply with the requirements of the IVDR at the time of application on May 26, 2022. In particular, the inadequate number of notified bodies was highlighted, making it impossible to guarantee that the conformity assessments would be carried out in time. After immense stakeholder pressure, the Commission acknowledged that this situation could lead to a significant disruption in the supply of a multitude of IVDs on the market both for health institutions and for the public (<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0627&qid=1634552565285">Commission proposal</a>, <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209">press release</a>, and <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210">Questions & Answers</a> dated October 14, 2021). The proposal was adopted by the European Parliament in December 2021 (<a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965">Commission press release</a>, <a target="_blank" href="https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html">EU Parliament Resolution</a> of December 15, 2021). Under the amended regulations, the dates on which certain requirements might apply are revised.The extended transition periods apply only to legacy IVDs, meaning devices that were certified or declared compliant before May 26, 2022. Therefore, all devices newly placed on the market after May 26, 2022, must be classified and certified in accordance with the IVDR rules.Furthermore, the IVDR will also immediately apply to any device for which an IVDD declaration of conformity was drawn up before May 26, 2022, and which must be reclassified as a class A non-sterile device under the IVDR. This is because such a device does not require a notified body review and, according to the rationale behind the transition periods, will thus not contribute to the notified bodies becoming a bottle neck that slows down market access or being subject to the same.If a manufacturer has drawn up an IVDD declaration of conformity without the involvement of a notified body before May 26, 2022, and if, under the IVDR reclassification, the device must be classified as a class A sterile device or higher and thus undergo conformity assessment with a notified body, according to the amended Article 110 (3) IVDR, the following new transition periods apply:<ul><li>May 26, 2025, for class D devices; </li><li>May 26, 2026, for class C devices;</li><li>May 26, 2027, for class B devices; and</li><li>May 26, 2027, for class A devices placed on the market in sterile condition. </li></ul>For IVDs which have been certified by an IVDD notified body before May 26, 2022, according to Article 110 (2), the following transition periods apply:<ul><li>Certificates issued by notified bodies under the IVDD prior to May 25, 2017, will remain valid until the date indicated on the certificate (with no amendment of the transition period). It should be noted, however, that IVDD certificates are usually valid for a maximum of five years according to Article 9 (10) IVDD.</li><li>Certificates issued by notified bodies in accordance with the IVDD from May 25, 2017, and certificates issued under the EC Verification in accordance with Annex VI of the IVDD, will become void at the latest by May 27, 2025. </li></ul>It should be noted that for the aforementioned transition periods to apply, the IVD needs to continue to comply with the IVDD requirements and must not undergo significant changes in its design or intended purpose after May 26, 2022, which in particular for IVD software can be challenging because changes in the intended user groups or changed indications, corrections of errors to minimize risks, changes in the user interface (like changed warning messages), or the use of a different runtime environment will likely be deemed significant according to <a href="https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native" target="_blank">MDCG 2020-3 Guidance on Significant Changes</a>. Furthermore, according to Art. 110 (3) IVDR, the IVD manufacturer must comply with post-market surveillance, vigilance, UDI, and market surveillance rules of the IVDR.<h4>CONCLUDING REMARKS</h4> The IVDR brings about increased standards and requirements for IVDs in order for the devices to be placed on the market. Although it can be expected that many legacy IVDs, including IVD software, will benefit from the transition periods, manufacturers will need to assess on a case-by-case basis whether the respective device fulfills the criteria and whether the same can be maintained during the entire transition period (i.e., no significant changes can be made). Furthermore, the transition periods may bring some relief with respect to the certification of IVDs, but they do not necessarily mean that the IVDR requirements do not apply to these devices. Therefore, manufacturers should have adopted IVDR compliance measures by now and should seek. As it can be expected that the run on notified bodies will increase with the end of the transition periods approaching, it would also be advisable to start preparing the transition to IVDR certification and file for the same well in advance of the end of the applicable transition period.

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)

QMSR: Welcomed by the Industry, but Lacking in Practicality

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Research assistant Nicole Gebert contributed to this article. 
After having discussed the general purpose and background of the IVDR, the new definition of IVDs

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE  (PART 2 OF 3)

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Research assistant Nicole Gebert contributed to this article.In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the COVID-19 pandemic. But also apart from the pandemic, <a target="_blank" href="https://www.grandviewresearch.com/industry-analysis/in-vitro-diagnostics-ivd-market">the industry is seeing significant growth</a> with the software component of such devices becoming increasingly important with regard to in vitro testing.Similar to other medical devices, the regulatory framework for IVDs in Europe is undergoing significant changes. About a year ago, the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation (EU) 2017/745</a> (MDR) entered into force and brought about significant challenges for medical device manufacturers with respect to obtaining medical device certification and post-market surveillance compliance (for more information on the MDR find our previous blog series <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">here</a>). Now the new <a target="_blank" href="https://eur-lex.europa.eu/eli/reg/2017/746/oj">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR) entered into full force and effect on May 26, 2022. Whereas certain legacy devices will benefit from transition periods, all new IVDs and certain low-risk IVDs already on the market are now subject to the IVDR requirements.Key changes that the IVDR brings about for stakeholders in the industry are the following:<ul><li>Broader definition of IVDs; </li><li>New risk-based classification system; </li><li>New conformity assessment procedures;</li><li>New requirements for clinical evidence, performance evaluation, and performance studies;</li><li>Post-market surveillance;</li><li>Introduction of a unique device identifier; and</li><li>Transition periods. </li></ul>This article is split into three parts. In this first part, we will discuss the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies.In <a target="_blank" href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html">part 2</a> of this article (to be published on June 6, 2022), we will discuss clinical evidence, post-market surveillance (including unique device identifiers (UDIs)), and transition periods.In <a target="_blank" href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force-part-3-of-3.html">part 3</a> of this article (to be published on June 13, 2022), we will cast light specifically on software as an IVD and the delineation between the MDR and the IVDR.<h2>Background and Purpose of the IVDR</h2>In the European Union, before an IVD can be marketed, manufacturers must obtain a CE mark to certify that the device complies with applicable law. The former regulatory regime was based on the European Directive on In Vitro Diagnostic Medical Devices (<a href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31998L0079">IVDD 98/79/EC</a> (IVDD)).The IVDR initially came into force on May 25, 2017, but contained a transition period that (after an extension during the COVID-19 pandemic) ended on May 26, 2022, and completely replaces the IVDD regime. As an EU Regulation, the IVDR does not need to be implemented into national legislation and will be applicable to all members of the EU and EFTA countries immediately. The regulation is designed to create a framework that sets out to improve clinical safety and establish fair market access for IVD manufacturers. The IVDR aims to bring EU legislation in line with technological advances, changes in medical science, and progress in law. Very similar to the MDR, the IVDR focuses on traceability throughout the supply chain, including the use of UDI systems and new clinical evidence standards. More stringent post-market surveillance is required, bringing the regulation of IVDs more closely in line with the requirements for medicines and other medical devices in the EU. It also sets new standards for the application of a CE mark on IVDs to ensure a higher level of quality, safety, and reliability.<h2>New Definition of IVD</h2>The definition of an IVD has been expanded and clarified to include tests intended to predict medical conditions or diseases, as well as companion diagnostics and software. Similar to the definition of a medical device under the MDR, the definition of an IVD is determined by the intended use of the device (more information on the MDR definition is available <a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">here</a>). In accordance with MDR Article 2(2), the IVDR covers any IVD intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information on one or more of the following:<ul><li>A physiological or pathological process or state;</li><li>Congenital physical or mental impairments;</li><li>A predisposition to a medical condition or a disease;</li><li>Safety and compatibility for potential recipients;</li><li>Predictions for treatment response or reactions; or </li><li>Definition or the monitoring of therapeutic measures.</li></ul>Furthermore, specimen receptacles are also deemed to be IVDs.Notably, the broadened IVDR definition explicitly includes software. While this is a reaction to the increasing use of software in the field (compared to the situation under the IVDD when it was established in 1998), it is also consistent with the general developments in EU legislation, which are also reflected in the definition of medical devices under the MDR, which explicitly includes software as well (for more information see part 2 of our <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">MDR blog series</a>). When software meets the above-mentioned criteria and serves a medical purpose, it qualifies as an IVD and must comply with the requirements of the IVDR. Examples of IVD software include (i) systems that support the process from patient sample to patient results, such as laboratory information systems and work area managers, (ii) expert systems that are intended to provide information by capturing and analyzing results obtained through in vitro examinations, and (iii) image management systems that incorporate functions to support post-processing of images for diagnostic purposes. A particular spotlight on these devices will be cast in part 3 of this article (to be published on June 13, 2022).<h2>New Risk-Based Classification System</h2>The IVDR adopts a new classification system that categorizes products into four classes according to their risk characteristics. Taking into account both patient and public health risks, these range from low to high:<ul><li>Class A - Low individual risk and low public health risk;</li><li>Class B - Moderate individual risk and/or low public health risk;</li><li>Class C - High individual risk and/or moderate public health risk; and</li><li>Class D - High individual risk and high public health risk.</li></ul><a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=de#d1e32-304-1">Annex VIII</a> of the IVDR includes seven classification rules as well as a set of implementing rules, which are intended to aid IVD manufacturers in classifying products according to their risk levels. Additionally, the Medical Device Coordination Group (MDCG), issued its Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 in January 2022, which is a helpful tool for IVD manufacturers to use to self-assess the classification of their products.Under the IVDR, if IVD software is independent of any other device, it shall be classified in its own right (IVDR; Annex VIII 1.4). In contrast to the classification rules under the MDR which provide a specific rule governing the classification of standalone software as a medical device, the classification of software under the IVDR requires consideration of all classification and implementation rules of Annex VIII. Further guidance on the classification of software under the IVDR is provided by the <a target="_blank" href="https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf">MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR</a>, which also contains valuable guidance on the delimitation of software as a medical device versus software as an IVD.<h2>New Conformity Assessment</h2>While the majority of IVDs were permitted to be self-certified by manufacturers under the IVDD, thereby evading the need for a notified body review in order to obtain their CE markings, this will be reversed under the IVDR. Due to the new classification system, the majority of IVDs will undergo a conformity assessment by a notified body, instead of self-certification by manufacturers, before they are deemed to be certified. As can be inferred from the graphic below, only conformity assessment procedures for non-sterile class A devices remain the responsibility of the manufacturer and don’t require the involvement of a notified body. The German notified body <a target="_blank" href="https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification">TÜV Süd</a> estimates that 90 percent of all IVDs will have to be tested by a notified body under the IVDR, compared to less than 15 percent under the IVDD. In order for manufacturers to obtain the declaration of conformity and, where necessary, the CE mark certificate, the IVDR stipulates a conformity assessment route for each risk class.<h2>Notified Bodies</h2>As can be inferred from the above, notified bodies play a critical role in supporting manufacturers in their efforts to place only safe and compliant IVDs on the EU market. The IVDR requires notified bodies to be designated. Notified bodies will have to meet more stringent criteria than under the IVDD, particularly in terms of technical and scientific evaluation proficiency. After a notified body applies for designation, the process can take up to 12 months or more, with both national and European authorities involved in the assessment.The EU Commission maintains a <a target="_blank" href="https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35">list of all IVDR-certified notified bodies</a> on its New Approach Notified and Designated Organizations (NANDO) website. Including the <a target="_blank" href="https://www.3ec.sk/en/news/news/3ec-international-as-ziskalo-autorizaciu-a-notifikaciu-podla-ivdr/">latest designation of a notified body in Slovakia in May 2022,</a> there are only seven notified bodies designated under the IVDR, located in only four countries (Slovakia, France, Germany, and the Netherlands). In October 2021, the <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210">EU Commission</a> already addressed this issue as “a grave shortage of notified body capacity” also saying it will be difficult “for manufacturers to conduct the legally required conformity assessment procedures in time.” Consequently, this led to the Commission’s proposal to extend the roll-out periods and introduce new transition periods.<h2>CONCLUDING REMARKS</h2>The IVDR will make a required careful assessment of the intended purpose of IVDs and IVD software inevitable, which must cover every part of their documentation and advertisement. As most IVDs will be reclassified in class B and higher, and therefore require notified body review, the importance of notified bodies within the EU regulatory regime for IVDs will increase significantly. At the same time, only a handful of notified bodies are currently accredited to review and certify IVDs, which creates a bottle neck for IVD manufacturers’ market access. Stakeholders will thus need to plan well in advance of a launch of new IVD products, and it can be expected that many manufacturers will need to rely on transition periods for legacy devices, which will be discussed in detail in part 2 of this series of consecutive articles.

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EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)

Is 2021 the Value-Based and Shared Savings Revolution?

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Research assistant Nicole Gebert contributed to this article.
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such a

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE  (PART 1 OF 3)

Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post.Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a <a href="https://www.schatz.senate.gov/imo/media/doc/nih__fda_psychedelic_research_letter.pdf" target="_blank">letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA)</a> urging both agencies to advance research on the therapeutic effects of psychedelic drugs.[1] This letter comes at a time when psychedelics are garnering increased attention for their potential medical and therapeutic benefits, and shedding some of the stigma that has dogged them since the 1960s. Widespread approval for psychedelic treatments remains unlikely, but the tide is slowly turning. For the regulated community, this is a trend worth watching.Defining PsychedelicsPsychedelics are “powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes.”[2] Psychedelics include natural substances such as psilocybin (the active compound in mushrooms) and peyote, as well as synthetic substances like LSD and MDMA. Generally speaking, psychedelics are considered to be physiologically safe and non-addictive.[3]While psychedelics are not new, medical research around psychedelics has exploded in recent years. In May 2021, a Nature Medicine study showed the benefits of MDMA in relieving post-traumatic stress disorder.[4] In April 2021, a separate study from the New England Journal of Medicine demonstrated the efficacy of psilocybin in reducing symptoms of depression.[5] The Journal of the American Medical Association published similar findings in May 2021.[6]Around the same time, psychedelics have become increasingly socially acceptable for medicinal purposes. Celebrated author Michael Pollan has published two bestselling books on the topic: How to Change Your Mind and This is Your Mind on Plants. Silicon Valley and Wall Street have begun investing money into psychedelics research and development.[7] And cities around the country are beginning to decriminalize some psychedelics, with advocates for decriminalization citing the potential medical benefits. In May 2019, Denver became the first city to decriminalize psilocybin, followed by Oakland, CA, Washington, D.C., and Seattle, among other municipalities. In 2020, Oregon became the first locale to decriminalize psilocybin and legalize it for therapeutic use on a statewide basis. But despite all of these developments, FDA approval for psychedelics faces an uphill battle.Recent Regulatory DevelopmentsAlthough the path to FDA approval for psychedelics is steep, it is not impossible. In 2019, FDA approved Spravato (esketamine) nasal spray for treatment of depression in adults.[8] Spravato is derived from ketamine and categorized by DEA as a Schedule III controlled substance. FDA granted Breakthrough Therapy designation for Spravato in 2013 and ultimately approved it for adults who have not responded to treatment after trying other antidepressant medications. To mitigate safety risks, FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU) whereby patients self-administer the spray in their healthcare provider’s office under medical supervision.More recently, MDMA therapy has inched closer to FDA approval. In 2017, <a href="https://maps.org/wp-content/uploads/2017/08/2017.08.15-IND063384GrantBreakthroughTherapyDesignation1_Redacted.pdf" target="_blank">FDA granted a request for Breakthrough Therapy designation</a> for MDMA to treat PTSD. As previously mentioned, clinical studies are promising, including a Phase 3 trial (the last step before submitting an NDA) completed last November.[9] Experts predict that this therapy could receive full FDA approval as soon as 2023.[10] In the meantime, FDA has approved some requests for compassionate use.[11]ChallengesResearch institutions or other investigators wanting to explore psychedelics for potential medical uses have numerous regulatory and legal challenges to consider. Here are the top five considerations: 1. Clinical Trials and Human Subject ProtectionsBefore the drug approval process even begins, sponsors must initiate clinical investigations by first filing an Investigational New Drug Application (IND) with FDA. An IND will require a clinical trial protocol in which an Institutional Review Board (IRB) must review and monitor the welfare, rights, and privacy of human subjects in the clinical trial. FDA’s approval of an IND will also require sufficient evidence that the trial will be safe for human subjects. These will likely be significant hurdles to overcome, given the high risks involved in research with controlled substances. 2. DEA and the Controlled Substances ActIn addition to the arduous FDA approval process, potential psychedelic therapies would also require complying with requirements from the Drug Enforcement Administration (DEA). Under the Controlled Substances Act of 1970, DEA classifies drugs into one of five schedules. Schedule I drugs are those that DEA considers to have no medical value and a high potential for abuse.[12] This category includes the psychedelics LSD, ecstasy, and mushrooms. Schedule I controlled substances are the most restricted in terms of research, supply, and access,[13] and possession is criminalized. To perform clinical studies with Schedule I substances, researchers have to apply for a special DEA license.[14] These licenses are hard to get and narrowly proscribe permissible research. These hurdles make it hard to conduct clinical research around psychedelics.The complex regulatory challenges around researching controlled substances have been a hot topic in recent years because of interest around medical marijuana. DEA classifies marijuana as a Schedule I substance, while at the same time researchers have long touted its potential medical benefits.[18] While FDA has not approved cannabis per se for any treatment, FDA has approved four cannabis-derived or -related drug products to date.[20] This underscores that regulatory approval for drugs derived from controlled substances is feasible. 3. Approval PathwaysFDA has developed four approaches for expediting the approval process. Fast Track review is for drugs that treat serious conditions and fill an unmet medical need. Breakthrough Therapy is for drugs that may represent a significant improvement over existing therapies. Accelerated Approval is similar to Fast Track review, but used a surrogate endpoint rather than a measure of a clinical benefit. Finally, Priority Review is a designation that means FDA intends to respond to an application within six months. Researchers developing psychedelics should consider which of these pathways to pursue, as applicable, since they all confer significant advantages in the approval process. 4. REMS RequirementsFDA sometimes requires a REMS to ensure that the benefits of an approved drug outweigh its risks. A REMS with ETASU may be appropriate for a controlled substance, such as strict restrictions on the distribution of the drug product and certifications for prescribers and pharmacists. These requirements are relatively rare, but FDA would almost certainly impose them for approved psychedelics, as it did with Spravato. Sponsors should be aware that REMS with ETASU may increase compliance risk and limit commercial options. 5. Transactional/CorporateResearching and developing a drug product that is a controlled substance also poses unique challenges outside of the regulatory context. Ensuring that contracts that govern the supply of the research substance comply with applicable laws is critical. Furthermore, contracts with research organizations must be properly tailored to ensure appropriate human subject protection and data integrity. Despite the surge in the number of research institutes and universities interested in conducting psychedelics research, many transactional challenges continue to impede the negotiation of research and development agreements in the field. Key challenges include: (i) the necessity of researcher compliance with strict and extensive institutional policies and regulation of controlled substances, separate from, and in addition to, any relevant state and federal licensing and regulatory requirements; (ii) the logistics of legally procuring, storing, securing, and disposing of controlled substances; (iii) the difficulty of obtaining federal or other funding for research and development in this field; (iv) heightened concerns about institutional reputation when researching and developing drugs that are also controlled substances; and (v) the costs of compliance with privacy and data protection laws as well as the consequences of non-compliance with respect to research subjects’ personally identifiable information. From an investor perspective, researching a controlled substance will mean a particularly thorough due diligence, so a rigorous legal and compliance infrastructure should be built at an early stage.ConclusionRecent regulatory and scientific developments—along with the push from Senators Schatz and Booker—signal that FDA approval for psychedelics may be on the horizon. Drug sponsors and investors alike should carefully consider the legal challenges in developing strategic plans in this exciting area of drug development. [1] Letter from Sens. Brian Schatz & Cory Booker to Acting Director Tabak and Commissioner Califf (May 11, 2022), <a href="https://www.schatz.senate.gov/imo/media/doc/nih__fda_psychedelic_research_letter.pdf">https://www.schatz.senate.gov/imo/media/doc/nih__fda_psychedelic_research_letter.pdf</a>.[2] David E. Nichols, Psychedelics, 68 Pharmacological Rev. 264, 266 (Apr. 2016).[3] Id. at 275.[4] Jennifer M. Mitchell et al., MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study, 27 Nature Med. 1025, 1025 (2021)[5] Robin Carhart-Harris et al., Trial of Psilocybin Versus Escitalopram for Depression, 384 New England J. Med. 1402, 1402 (2021).[6] Alan K. Davis et al., Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder, 78 JAMA Psychiatry 1, 1 (2021).[7] Shalini Ramachandran, Silicon Valley and Wall Street Elites Pour Money into Psychedelic Research, Wall St. J. (Aug. 20, 2020), <a href="https://www.wsj.com/articles/silicon-valley-and-wall-street-elites-pour-money-into-psychedelic-research-11597941470">https://www.wsj.com/articles/silicon-valley-and-wall-street-elites-pour-money-into-psychedelic-research-11597941470</a>.[8] FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic, FDA (Mar. 5, 2019), <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified">https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified</a>.[9] Rachel Nuwer, A Psychedelic Drug Passes a Big Test for PTSD Treatment, N.Y. Times (Nov. 11, 2021), <a href="https://www.nytimes.com/2021/05/03/health/mdma-approval.html">https://www.nytimes.com/2021/05/03/health/mdma-approval.html</a>.[10] See id.[11] A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients with Treatment-resistant PTSD (EAMP1), NIH, <a href="https://clinicaltrials.gov/ct2/show/NCT04438512">https://clinicaltrials.gov/ct2/show/NCT04438512</a> (last visited May 16, 2022).[12] DEA, Drug Scheduling, formerly at https://www.dea.gov/drug-information/drug-scheduling (last visited May 13, 2022).[13] See Jennifer M. Mitchell, A Psychedelic May Soon Go to the FDA for Approval to Treat Trauma, Sci. Am. (Feb. 1, 2022), <a href="https://www.scientificamerican.com/article/a-psychedelic-may-soon-go-to-the-fda-for-approval-to-treat-trauma/">https://www.scientificamerican.com/article/a-psychedelic-may-soon-go-to-the-fda-for-approval-to-treat-trauma/</a>.[14] Id.[15] Matt Lamkin, Prescription Psychedelics: The Road from FDA Approval to Clinical Practice, 135 Am. J. Med. 15, 15-16 (Jan. 2022).[16] Douglas C. Throckmorton, Dep. Dir. for Reg. Programs, CDER, Researching the Potential Medical Benefits and Risks of Marijuana (July 12, 2016), <a href="https://www.fda.gov/news-events/congressional-testimony/researching-potential-medical-benefits-and-risks-marijuana-07122016-07122016">https://www.fda.gov/news-events/congressional-testimony/researching-potential-medical-benefits-and-risks-marijuana-07122016-07122016</a>.[17] FDA, Assessment of Abuse Potential of Drugs: Guidance for Industry (Jan. 2017), <a href="https://www.fda.gov/media/116739/download">https://www.fda.gov/media/116739/download</a>; see also 21 U.S.C. § 811(b)–(c).[18] See generally Nat’l Acad. of Sci., Eng’g, and Med., The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017).[19] Throckmorton, supra note 16.[20] FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD), FDA, <a href="https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#whatare">https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#whatare</a> (last visited May 16, 2022).

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Senators Call for Report on State of Psychedelic Research

Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post.
Earlier this m

Senators Call for Report on State of Psychedelic Research

United States

Pharma

Intellectual Property

Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount of protein in the food products. Read the full article below. Since spring 2020, food manufacturers have been hit with a wave of protein-labeling lawsuits all making the same core allegation: that their products' front-label protein content statements violate U.S. Food and Drug Administration regulations, and mislead consumers, by overstating the amount of protein in the food products. While the plaintiffs admit that the FDA regulations are explicitly applicable to back-label claims, they allege that these same regulations do not apply to the same statements being made on front labels. The defendants argue otherwise, claiming that the plaintiffs' proffered theory would result in the illogical result of having different protein statements on the front and back labels. And indeed, the U.S. District Court for the Northern District of California, in a February ruling in Nacarino v. Kashi Co., described the applicable regulatory scheme as "convoluted."[1] That was true — until recently. Earlier this year, the FDA released new guidance clarifying labeling requirements concerning protein claims, undermining the foundation of the labeling plaintiffs' claims. And the Northern District of California has since dismissed these protein lawsuits with prejudice. These decisions highlight the dispositive impact of preemption arguments. But in two cases, plaintiffs have since appealed the district courts' orders dismissing their claims, bringing the regulatory scheme back into question. District Courts' Distaste for Protein Suits On Feb. 10, in Nacarino v. Kashi Co., Judge Vince Chhabria dismissed with prejudice the plaintiff's claims that Kashi mislabels its food products by miscalculating their protein content.[2] The Nacarino court found that Kashi's use of the nitrogen method for calculating protein is appropriate under FDA regulations, and any claims brought by individuals based on the use of this method were preempted by the Federal Food, Drug, and Cosmetic Act.[3] In making its ruling, the Nacarino court relied heavily on the FDA's newly issued guidance on its website clarifying appropriate methods for calculating front-label protein statements. Less than a week after the Nacarino decision, another court in the Northern District of California followed suit, dismissing with prejudice the allegations of the plaintiff in Chong v. Kind LLC that Kind's front-label protein claims were deceptive and unlawful.[4] In Chong, the court declined to follow its own earlier decision in what it admitted was a "nearly identical" lawsuit from 2020, Minor v. Baker Mills, which had permitted protein-labeling claims to proceed past a motion to dismiss.[5] The Chong court acknowledged that "it has now become apparent ... that Minor was incorrectly decided."[6] Referencing Nacarino, the Chong court held that the plaintiff's claims were preempted because federal regulations establish "that producers may state grams of protein even outside the Nutrition Facts panel calculated by the nitrogen method, and without adjustment for digestibility."[7] Furthermore, the court rejected plaintiff's claims based on Kind's failure to include a percentage of the daily value of protein on the back label, in violation of FDA regulations. The court found that, because they were entirely dependent on violations of the FDCA, the plaintiff's claims under California's Sherman Law were impliedly preempted under the U.S. Supreme Court's 2001 ruling in Buckman v. Plaintiffs' Legal Committee.[8] The plaintiffs in both Nacarino and Chong have since appealed the courts' decisions dismissing their claims with prejudice.[9] Opening briefs are due in June, which will provide additional insight into the plaintiffs' basis for challenging the courts' conclusions that FDA guidance on protein claims is definitive. FDA Regulations and New Guidance Under FDA regulations, food manufacturers may calculate protein content for front-label protein claims at least two different ways: (1) calculating the amino acid content of the food directly, or (2) using the nitrogen method, which requires manufacturers to multiply the nitrogen content of the food by a factor of 6.25.[10] When food manufacturers calculate the percentage daily value of protein on the product's back label, federal regulations require that the percentage be adjusted for digestibility using a "protein digestibility-corrected amino acid score."[11] Because plant-based proteins are not fully digestible by the human body, the amount of protein calculated under the nitrogen method may differ from the amount of protein as adjusted for digestibility and as used for calculating the percentage of daily value on the back label. Plaintiffs have seized on these nuances in the federal regulations to argue that front-label protein claims overstate the amount of protein by failing to account for protein digestibility. In essence, plaintiffs claim that, despite manufacturers calculating protein claims in accordance with FDA regulations for back-label protein statements, using this same calculation for front-label claims is misleading. But no requirement to calculate protein digestibility exists for front-label claims. In its Jan. 11 guidance, the FDA made it clear that, contrary to plaintiffs' claims, food manufacturers are not required to use only an amino acid content method for calculating front-label protein statements, nor are they required to adjust the front-label content claims for digestibility. Indeed, the FDA approves of the use of the nitrogen method for front-label protein claims, and does not require that manufacturers adjust protein content for digestibility when making such claims. Looking Ahead Where plaintiffs' claims rest on an interpretation of the federal regulatory scheme that the FDA recently rejected, decisions from the Northern District of California suggest that preemption arguments may present a viable defense — at least for now. As the U.S. Court of Appeals for the Ninth Circuit grapples with Chong and Nacarino, manufacturers can expect some reprieve from the barrage of these protein case filings. Even if they are named in new filings, manufacturers have additional ammunition in their pockets, and should consider and give great weight to asserting preemption arguments and requesting a stay of their proceedings. This article is for general information purposes and is not intended to be and should not be taken as legal advice. [1] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2023409&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2023409&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Nacarino v. Kashi Co. </a>, No. 21-cv-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022). [2] Id. [3] Id. at *5. [4] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2027438&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2027438&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Chong v. Kind LLC </a>, No. 21-cv-04528-RS, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022). [5] Id. at *1; <a target="_blank" href="https://advance.lexis.com/api/search?q=2020%20U.S.%20Dist.%20LEXIS%20258880&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2020%20U.S.%20Dist.%20LEXIS%20258880&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Minor v. Baker Mills Inc. </a>, No. 20-cv-02901-RS, 2020 WL 11564643 (N.D. Cal. Nov. 12, 2020). [6] Chong, 2022 WL 464149, at *1. [7] Id. at *3. [8] Id. at *4. [9] Nacarino v. Kashi Co., No. 22-15377 (9th Cir.) (appeal filed March 14, 2022); Chong v. Kind LLC, No. 22-15368 (9th Cir.) (appeal filed March 11, 2022). [10] See 21 C.F.R. § 101.9(c)(7). [11] Id.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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Associate

Lena is an associate in the Litigation Department in Morrison Foerster’s San Francisco office. Lena’s practice focuses on commercial and class actions litigation, with an emphasis on false advertising, unfair competition, and antitrust. Lena regularly counsels clients in the food and beverage, dietary supplement, cosmetics, retail, and technology sectors.











Lena Gankin

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RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

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Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food m

Product Liability + Class Action

Litigation

On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-gene-therapy-products-incorporating-human-genome-editing" target="_blank">Human Gene Therapy Products Incorporating Human Genome Editing</a> (GE)” and a <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products" target="_blank">draft guidance on Chimeric Antigen Receptor (CAR) T cell product development</a>. These draft guidance documents were issued on the heels of FDA’s <a href="https://lifesciences.mofo.com/topics/fda-clears-crispr-edited-cattle-for-market-through-abbreviated-procedure-a-first-for-food-use-animals.html" target="_blank">first low-risk determination</a> for a food animal with an intentional genomic alteration. These concurrent developments are indicative of FDA’s continued assessment of gene therapy and genome editing technology and attempts to provide guidance to innovators. Moreover, they may portend a growing focus on GE technologies at the regulatory agency. To this end, Center for Biologics Evaluation and Research (CBER) Director Peter Marks is anticipated to publish an op-ed titled “<a href="https://www.tandfonline.com/doi/full/10.1080/14712598.2022.2060736" target="_blank">Enhancing gene therapy regulatory interactions</a>” in Expert Opinion on Biological Therapy.The draft guidance on human genome editing provides recommendations to sponsors developing human gene therapy products incorporating GE in human somatic cells and recommendations on the information that should be included in investigational new drug applications (INDs) for such products. INDs should include information on component design, manufacture and testing, and preclinical and clinical studies; the guidance also details the specific manufacturing and testing data needed for each type of genome editing product. Although the general chemistry, manufacturing, and controls recommendations for GE products are generally the same as previously described in <a href="https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances" target="_blank">other FDA guidance</a>, the draft guidance provides additional recommendations that are specific to human GE products. For example, FDA recommends product sponsors use a design platform that best fits their genomic target and type of intended modification. FDA further suggests sponsors “optimize the GE components to reduce the potential for off-target genome modification, to the extent possible.”Comments to the draft guidance on Human Gene Therapy Products Incorporating Human GE may be submitted by June 14, 2022. <ul><li>Comments may be electronically submitted to <a href="https://www.regulations.gov/docket/FDA-2021-D-0398" target="_blank">https://www.regulations.gov/docket/FDA-2021-D-0398</a>.</li><li>Hardcopies of written comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.</li></ul>

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

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On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and

Cell + Gene Therapy

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the <a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">proposed rule</a> titled "Medical Devices: Quality System Regulation Amendments."  If finalized, the proposed rule will rename the current 21 CFR Part 820 as the Quality Management System Regulation (QMSR).  In our previous <a href="https://lifesciences.mofo.com/topics/quality-management-system-regulation-qmsr--harmonizing-the-quality-system-regulation-qsr-with-iso-134852016.html">post</a>, we noted both the industry representatives and the Committee welcomed the proposed rule but agreed that it may have an overly ambitious implementation timeline, especially in light of the ambiguity in some key areas, such as inspection.  These concerns were echoed by FDA, which acknowledged the need to engage in a variety of implementation activities including personnel training, inspection approach finalization, and revising relevant regulations and other documents impacted by the rule.  Below we discuss some of the major concerns raised by both industry representatives and the Committee during the meeting.<ul><li>A one-year transition period would not give the industry sufficient time to be fully compliant with the new requirements.  QMSR proposes a one-year transition time after the final rule goes into effect.  Representatives from both the Advanced Medical Technology Association (“AdvaMed”) and the Medical Imaging and Technology Alliance (MITA) raised concerns about the short implementation timeline. Jamie Wolszon, Vice President of Technology and Regulatory Affairs at AdvaMed, stressed that “there must be a sufficiently long transition period to avoid disruption. We recommend at least a two-year transition period.”  She emphasized that the one-year transition period proposed by FDA would not give the industry enough time to adapt to the new requirements.  The Committee concurred with the industry’s concern that a one-year transition period would be “quite aggressive,” and a two- or three-year transition period would be more appropriate.</li></ul>Moreover, Committee members reminded FDA that the agency will also need a significant amount of transition time once the proposed rule is finalized.  Robert Phillips of Siemens Healthineers, who serves on the Committee, noted that a significant number of FDA guidance documents will all need to be updated to align with the new regulatory citations, definitions, and systems.  He further noted that these updates need to be worked out and made publicly available before a transition can be effected by device firms.  Committee members reminded the agency that when the current Quality System Inspection Technique (QSIT) was launched, it took two to three years for auditors to fully understand and work with QSIT.<ul><li>Industry representatives demand more clarity on the future inspectional approach.  The agency proposes to replace the current inspection approach for medical devices, the QSIT, with a new inspection model and manual to be determined and announced by FDA.  This regulatory vacuum will leave companies with no guidance on how to prepare for future inspections.  For example, it is unclear whether inspection programs under the current QSR, such as pre-approval, surveillance, and for-cause inspections, will survive.  Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, speaking on behalf of MITA, also asked whether FDA’s process to inspect other requirements (e.g., medical device reporting and labeling) will change.  The industry also urged FDA to harmonize not only regulatory expectations, but also the actual procedures for inspections.  Specifically, the industry wants to avoid a “13485 plus type of approach,” where there could be “additional requirements over and above 13485 that are country-unique.”  These concerns were widely echoed across the industry.   </li><li>The industry demands clarity on whether ISO 13485 certification will be required.  Despite incorporating the ISO 13485 standard, FDA has stated that its inspections “will not result in certificates of conformance to ISO 13485 and manufacturers who have ISO 13485 certificates are not exempt from FDA inspections.”  However, the proposed rule did not clarify whether an ISO 13485 certificate will be required or expected.  Committee member Phillips of Siemens Healthineers noted that “topics about whether certification is required, or even expected … [are] something that needs to be clarified going forward.”  This regulatory uncertainty is particularly relevant for small firms that need to determine whether to apply for formal certification from an accredited auditing body.  Further, even if not explicitly required, questions remain about whether there will be preferential regulatory treatment for companies that are formally certified, which could put smaller firms without international presence at an unfair disadvantage.  AdvaMed’s Jamie Wolszon emphasized that the industry is interested in understanding how FDA intends to leverage existing ISO 13485 certifications, including whether there will be any “potential benefit(s)” for firms that are certified.</li></ul><ul><li>Risk management represents a significant change for small companies not previously subject to the ISO 13485 standard.  Harmonizing FDA regulations with the ISO 13485 standard means implementing risk management processes throughout the total product life-cycle.  Although FDA denies that the harmonization amounts to a policy shift, Melissa Torres, Associate Director for International Affairs at the Center for Devices and Radiological Health (CDRH), acknowledged during the meeting that compared to the current Part 820, ISO 13485 “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices.”  Committee member Scott Sardeson pointed out that the proposed change represents “a very big shift in mindset” for smaller companies that are not currently subject to the ISO 13485 standard and may not be aware of uncodified expectations from FDA.  These concerns add to the case for a longer transition period.</li></ul>The proposed rule may have a significant impact on device manufacturers, especially those not in compliance with the current ISO 13485 standard.  If the one-year proposed implementation timeline is not changed, device manufacturers will face a tight schedule to be in compliance with the new rule.  It is highly recommended that all device manufacturers, especially those without an international presence, review the proposed rule and identify any possible issues with compliance in order to address their challenges head-on.Comments on the proposed rule can be submitted in the Federal Register (<a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">Docket No. FDA-2021-N-0507</a>) until May 24, 2022.

QMSR: Welcomed by the Industry, but Lacking in Practicality

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Med

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that <a href="https://recombinetics.com/acceligen/" target="_blank">Acceligen Inc.</a>’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food supply, and the environment.” This is the first such determination for a genetically engineered food-use animal and will allow the company to bypass many of the usual premarket approval requirements.These cattle, called PRLR-SLICK cattle, produce a short and slick hair coat due to a modification made to the prolactin receptor (PRLR) gene. This slick hair coat phenotype gives cattle the ability to regulate body temperature more effectively. This is important for raising cattle in tropical climates and might mitigate the predicted negative effects on livestock productivity associated with climate change.This intentional genomic alteration (IGA) was accomplished using CRISPR-Cas9 gene editing technology on in vitro fertilized calf embryos. Specifically, the IGA introduces a premature stop codon into the PRLR gene, and thereby truncates the encoded protein. IGAs like the alteration made to the PRLR gene in Acceligen’s cattle are intended to “affect the structure or function” of the altered animal, so FDA regulates them under its animal drug framework.Marketing an animal drug typically requires premarket approval, which entails a lengthy New Animal Drug Application (NADA) process through which FDA can evaluate the animal drug for efficacy, safety to the animal, and safety to the consumer. The only other FDA-approved food-use animals—Revivicor’s GalSafe pigs (2020) and the AquaBounty AquAdvantage salmon (2017)—went through the full NADA determination process.FDA discussed its intent to exercise enforcement discretion with respect to NADA requirements for IGA-containing animals as early as 2009, in guidance that has been updated several times, most recently in its 2017 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-187-regulation-intentionally-altered-genomic-dna-animals" target="_blank">Guidance #187, “Regulation of Intentionally Altered Genomic DNA in Animals</a>.” But this is the first time that such enforcement discretion has been applied to an animal intended for food production.When FDA exercises its enforcement discretion over the NADA requirements, it does not also conduct a National Environmental Policy Act (NEPA) review, which can add significant costs and time to the application process. FDA instead considers the potential environmental risks when determining whether to exercise enforcement discretion.FDA examined four categories of risk factors in its risk assessment and concluded that PRLR-SLICK cattle pose a low risk to people, animals, the food supply, and the environment: 1. Molecular characterization<ul><li>PRLR-SLICK cattle have an IGA that mimics genomic sequences found in conventionally raised cattle</li><li>Analyses of the genomic data found evidence of unintended mutations, but based on their types and locations, they are not expected to result in changes to protein expression</li></ul><div> 2. Phenotypic data and animal safety</div><ul><li>PRLR-SLICK cattle have the same phenotype (i.e., short, slick hair coat) as conventionally raised cattle with naturally occurring slick mutations</li><li>PRLR-SLICK cattle appear healthy based on visual observations and animal health records</li></ul><div> 3. Human food safety</div><ul><li>Conventionally raised cattle with the slick phenotype are routinely consumed as human food </li><li>There is no expected change in the compositional or nutritional content of the edible tissues</li></ul><div> 4. Environmental risk</div><ul><li>The slick phenotype is a well-established trait in several breeds of conventionally raised domestic cattle in the United States</li><li>The likelihood of escape and establishment of PRLR-SLICK cattle in the U.S. environment is low due to the ability to rapidly recover escaped animals and the lack of feral cattle populations in the United States</li></ul>The “low-risk” decision is limited to products (e.g., live cattle, semen, embryos, and meat) derived from the existing two cattle reviewed by FDA and their progeny. FDA also intends to treat facilities or farms engaged in standard agricultural practices for PRLR-SLICK cattle the same as facilities or farms that are engaged in these practices for cattle without IGAs.According to FDA’s press release, meat products from PRLR-SLICK cattle are expected to be available for purchase by general consumers as early as 2024. PRLR-SLICK cattle meat and most other food products in which the cattle’s carcass is the predominant ingredient would not be subject to mandatory labeling under U.S. Department of Agriculture’s <a href="https://www.ams.usda.gov/resources/industry-fact-sheet-national-bioengineered-food-disclosure-standard" target="_blank">National Bioengineered Food Disclosure Standard</a>.

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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