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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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.

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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Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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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

Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office requirements for the written descriptions and disclosures that are necessary to obtain a patent for biologic products. The sequence listings are used by patent offices during examinations to search for identical or similar sequences when assessing novelty and nonobviousness of the invention sought to be patented. Sequence listings also become publicly available when a patent application is published, allowing the public to access the sequence information. This is especially important when reviewing the patent landscape for freedom to operate analyses for third-party patents.Starting July 1, 2022, all World Intellectual Property Organization (WIPO) member patent offices, including the U.S. Patent and Trademark Office (USPTO), will transition to new sequence listing procedures that will require sequence information be provided in .xml format. Since 1992 – the first year the USPTO required a separate sequence listing – the format for sequence listings has been ASCII .txt.The new format, designated WIPO standard ST.26, is intended to synchronize sequence listings among different patent offices and various international sequence repositories and therefore enable better sequence searches. Where ASCII .txt files are generally smaller in size and easier to interpret, XML files allow for more in-depth annotation via computer tags that also expedite structured information retrieval.More information about the sequence listing changes is available from WIPO and can be found <a target="_blank" href="https://www.wipo.int/standards/en/sequence/faq.html">here</a>. In order to comply with the new standards, WIPO has developed a software tool (“<a target="_blank" href="https://www.wipo.int/standards/en/sequence/?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term">WIPO Sequence</a> tool”) that both generates and validates sequence listings. The WIPO Sequence tool can also be used to convert the previous WIPO standard ASCII ST.25 listings from .txt format to .xml format. There is no transition period in the new rules, and the ability to file a sequence listing in the previous ST.25 format will disappear as of July 1, 2022.The new sequence listing standard will apply to any patent application filed on or after July 1, 2022, including any continuation or divisional application in which the original sequence listing had been prepared in the ST.25 ASCII .txt format. If an applicant desires to continue prosecution of an application family with a new patent filing, the preparation of the sequence listings must be made or converted to the new format. Practitioners and applicants should be aware of the extra time that may be needed to implement the new format. In addition, due to the format differences under the new rules, care also should be taken to ensure that a new matter is not being added when a sequence listing is converted to the new ST.26 format. The sequence listing changes may also have a profound negative impact on the ease with which patent sequences from any published application can be reviewed by the public. XML files are not instantly readable and will require a dedicated display program in order to interpret the sequence input. When downloaded, XML listings will include various coding elements, and it will be necessary to upload an XML file on the WIPO Sequence tool (or another XML viewing platform) in order to decipher the information. While WIPO has indicated that Patent Cooperation Treaty (PCT) applications will have their listings available as XML files, it is not clear how individual patent offices will publish listings under the new standards. Producing a PDF copy of the XML file will most likely present a very difficult task for any practitioner or applicant because there is no way to convert the file via the WIPO Sequence tool.These changes are significant and will impact the accessibility and ease with which applicants and practitioners alike approach the preparation and analysis of sequence listings. Life sciences patentees are encouraged to seek input from counsel to discuss the sequence listing changes in order to ensure compliance with the new rules.

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Patent Agent

Dr. Elizabeth (Liz) Newman focuses her work on patent  drafting and assisting prosecution. She also has experience in IP due diligence  inquiries, including freedom-to-operate analyses, with an emphas

Liz Newman Ph.D.

Liz Newman

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

Karen G Potter Ph.D.

Karen Potter

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The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

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Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in 

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

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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