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.

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On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato produced by Norfolk Plant Sciences is unlikely to pose an increased plant pest risk compared to a conventional tomato, and is therefore not subject to regulation under the SECURE rule. This means that these tomato plants, which have been engineered to produce deep purple tomatoes with enhanced nutritional quality, may be legally imported, moved interstate, or “released” into the environment (including, for example, in a field trial) in the United States without a permit from APHIS.Notably, this finding also means that subsequent genetic transformation events involving the same combination of plant species, trait, and mechanism of action (“PTMOA”) as Norfolk Plant Sciences’ purple tomatoes are also no longer regulated under the SECURE rule. Thus, other subspecies and varieties of Solanum lycopersicum that have been modified to produce the same trait by the same mechanism of action—even if by different transgenic events—are now exempt under § 340.1(c) of the SECURE rule. More information on this so-called PTMOA exemption is available in APHIS’s “Guide for Requesting a Confirmation of Exemption from Regulations under 7 CFR part 340” (published August 31, 2022; document ID BRS-GD-2020-0001). This approach is different from the “event-by-event” regulation that was previously required, and represents the first time that APHIS has made an RSR determination under its new rules.Additional information about the contours of the SECURE rule and the genetic engineering that Norfolk Plant Sciences used to produce their purple tomato is provided below.About the SECURE RuleThe SECURE rule (7 CFR part 340) governs how APHIS regulates certain organisms developed using genetic engineering, with the goal of protecting U.S. agriculture from plant pest risks under the Plant Protection Act of 2000 (7 U.S.C. §§ 7701 et seq.). It replaced the previous version of 7 CFR part 340, which had been in place largely unchanged since APHIS’s biotechnology regulations were established in 1987, in phases between May 18, 2020 and October 1, 2021.The new regulations completely overhauled and streamlined the regulatory process for assessing the plant pest risk of organisms developed using genetic engineering, taking into account advances in scientific understanding, and focusing more on the properties of the engineered organism and less on the method(s) used to produce it.The revised regulations exempt certain types of modifications from regulation; such exemptions are self-determined, though developers may voluntarily request confirmation from APHIS that a given exemption applies. This exemption/confirmation process replaced the previous “Am I Regulated?” process on June 17, 2020, and APHIS has since issued 15 confirmation letters as of this writing, with the earliest in April 2021.However, no plant had made it through the new RSR process until now. The RSR process is an option for instances in which no SECURE rule exemptions apply to a given engineered plant, but the developer feels that the plant nonetheless does not pose an increased plant pest risk and should therefore not be regulated by the SECURE rule. The RSR process replaced the previous “petition” process for requesting deregulation from 7 CFR part 340 due to low likelihood of posing a plant pest risk.The RSR process became available for corn, soybean, cotton, potato, tomato, and alfalfa on April 5, 2021, and for all other plant species on October 1, 2021. APHIS received Norfolk Plant Sciences’ RSR request on August 4, 2021 and responded on September 6, 2022 (both the request and the response documents are available under RSR number 21-166-01rsr). As of this writing, Norfolk Plant Sciences’ tomato is the only RSR request publicly available on APHIS’s website.Under the RSR process, APHIS reviews “the biological properties of the plant; and the trait (or new characteristic); and the mechanism of action (or how the genetic modification causes the new trait to occur)” in order to evaluate plant pest risk. There are two potential steps to this process, depending on what APHIS determines during the first step. In Step 1, APHIS identifies whether the engineered plant poses a plausible pathway to increased plant pest risk compared to a “comparator” plant. If APHIS finds no such pathway, the RSR process concludes, and APHIS notifies the requestor that the plant in question is not subject to regulation under the SECURE rule. This was the outcome for Norfolk Plant Sciences’ tomato.On the other hand, if APHIS does determine that the engineered plant may plausibly pose an increased plant pest risk, there are several potential next steps. First, the developer may accept that the plant is regulated under the SECURE rule, and then either request a permit before moving or releasing the plant, or take no further action and not move or release the plant. Alternatively or additionally, the developer may request that APHIS proceed to Step 2 of the RSR process, which entails a more involved review, subsequent publication in the Federal Register, and solicitation and review of public comments before a final determination. As of this writing, no plant has gone through this second step of the RSR process.About the Purple TomatoAs described in its RSR request, Norfolk Plant Sciences created its purple tomato plant by Agrobacterium-mediated insertional mutagenesis of the “MicroTom” tomato variety, and subsequent crossing into other tomato varieties. The plants are engineered to increase expression of their natural anthocyanin pigments, which is what causes the fruits to have a deep purple color and also enhances their nutritional value.Specifically, the inserted DNA contains two transcription factors from the snapdragon plant (Antirrhinum majus), which serve to activate production of the tomato’s native anthocyanin biosynthesis pathway, causing increased anthocyanin production. Each of these two transcription factor genes, called Del and Ros1, is expressed from the T-DNA under a native tomato promotor that causes fruit-specific expression. The T-DNA also includes the nptII selectable marker with a promotor and terminator from Agrobacterium tumefaciens, which have a decades-long history of safe use and consumption.Complete genome sequencing revealed that the T-DNA was inserted at a single site in chromosome 4, accompanied by several small deletions. Phenotypic evaluation of the transformed plants revealed that they grew effectively the same as non-transgenic tomatoes, except that they produce deep purple fruit with significantly higher anthocyanin content. Photos of the plants and fruit are available in the published RSR request.APHIS considered the information disclosed in Norfolk Plant Sciences’ RSR request, alongside “publicly available resources, and APHIS’ familiarity with tomato and knowledge of the trait, phenotype, and mechanism of action” and “did not identify any plausible pathway by which [the] modified tomato, or any of its sexually compatible relatives, would pose an increased plant pest risk relative to a comparator tomato” (21-116-01 RSR Response, page 1). As such, APHIS concluded that these purple tomatoes are not subject to regulation under the SECURE rule.Other Regulatory AgenciesIt is important to note that deregulation from APHIS’s SECURE rule does not mean that the plant is wholly removed from U.S. federal regulatory oversight. For example, regulations implemented by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and/or other arms of USDA (such as Plant Protection and Quarantine (PPQ) import and export regulations, and/or Agricultural Marketing Service (AMS) labeling requirements) may still apply. Along those lines, Norfolk Plant Sciences’ RSR request states that Norfolk Plant Sciences submitted a food and feed safety and nutritional assessment of the Purple Tomato to FDA under the voluntary <a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=NewPlantVarietyConsultations&sort=BNF_No&order=DESC&type=basic&search=">Biotechnology Notification Consultation program</a>, which was received as BNF number 178. As of this writing, FDA has not yet published a completed consultation for Norfolk Plant Sciences’ purple tomato.ConclusionThis regulatory review is an important milestone for regulation of genetically engineered plants in the United States. It is the first public test of the SECURE rule’s RSR process since its implementation more than a year ago, when it became one of the most scientifically progressive such review processes in the world, at least on paper. The deregulation of Norfolk Plant Sciences’ purple tomatoes shows that USDA-APHIS is embracing its new product-focused regulations. Although the review took more than a year—significantly longer than the 180 days promised by APHIS for Step 1—the process will likely become more efficient as the agency and developers become more familiar and comfortable with the new system. It will be interesting to see how the exemption and review processes grow and possibly become more streamlined with additional use.

Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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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

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Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. 

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

On May 6, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice, proposing to amend the Rules of Practice in Patent Cases to allow electronic submissions of patent term extension (PTE) applications, interim PTE applications, and any related submissions to the USPTO via the USPTO patent electronic filing system (EFS-Web or Patent Center).[1]Electronic filing of initial submissions for PTE was prohibited prior to the COVID-19 pandemic. Due to the workplace changes caused by the pandemic, the USPTO temporarily waived its prohibition on the electronic filing of initial submissions for PTE and the triplicate copy requirements in <a target="_blank" href="https://www.ecfr.gov/current/title-37/section-1.740#p-1.740(b)">37 CFR 1.740(b)</a> and <a target="_blank" href="https://www.ecfr.gov/current/title-37/section-1.790#p-1.790(b)">1.790(b)</a>. Since then, the USPTO has received informal feedback from stakeholders that communicated unanimous support for electronic filing of initial PTE submissions. Additionally, the USPTO and its partner agencies have successfully implemented a new system that allows the USPTO to electronically transmit a copy of the PTE submission to the relevant agency without causing any processing errors. Accordingly, the USPTO is proposing to change its rule of practice permanently.The USPTO has created several new document descriptions for electronic submissions, including “Limited POA and/or Change of Address for a Patent Term Extension Application” for limited powers of attorney and/or changes of correspondence address that are filed specifically for the PTE application. These new descriptions are likely to reduce processing errors by the USPTO, especially where the PTE applicant engages a different law firm for prosecution of the PTE application than for the underlying patent, or where the PTE applicant is a different entity than the patent applicant.Furthermore, as has been the case since the June 2020 electronic filing waiver went into effect, the proposed rule changes will result in PTE applications being viewable on the USPTO electronic viewing systems (Patent Application Information Retrieval (PAIR) system or Patent Center) immediately upon filing. This provides an opportunity for companies to have better competitive intelligence. Whereas third parties previously had to wait weeks or months after a product’s approval to view the associated PTE applications, electronic filing provides the public with real-time visibility into PTE applications that have been filed.Overall, these are welcome improvements to the PTE filing process, reducing the administrative burden on applicants, streamlining various aspects of the filing process, and improving public availability of PTE applications. If anyone wishes to submit a comment about this proposed amendment, it must be received by the USPTO by July 5, 2022 to ensure consideration. The comment must be submitted through the Federal eRulemaking Portal at <a target="_blank" href="http://www.regulations.gov/">www.regulations.gov</a> (search docket number “PTO-P-2021-0061”).[1] The full text of the Notice can be found at <a href="https://www.federalregister.gov/documents/2022/05/06/2022-09535/establishing-permanent-electronic-filing-for-patent-term-extension-applications" target="_blank">Federal Register: Establishing Permanent Electronic Filing for Patent Term Extension Applications</a>.

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Lisa N. Silverman focuses on patent portfolio management and strategic patent counseling in the areas of chemistry and life sciences. She has extensive experience in securing U.S. and foreign patent p

Lisa N. Silverman Ph.D.

Lisa Silverman

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Dr. Kate You is a member of the firm’s Patent  Group and focuses her practice on patent prosecution and counseling, including  domestic and international patent preparation and prosecution, and litiga

Yuying (Kate) You Ph.D.

Yuying (Kate) You

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The USPTO Proposes to Establish Permanent Electronic Filing for Patent Term Extension Applications

This Week At the Ninth:  Surgical Robots and Scienter

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On May 6, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice, proposing to amend the Rules of Practice in Patent Cases to allow electro

The USPTO Proposes to Establish Permanent Electronic Filing for Patent Term Extension Applications

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

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