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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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

Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit <a target="_blank" href="https://cafc.uscourts.gov/opinions-orders/20-1933.ORDER.3-16-2022_1922220.pdf">denied Biogen International’s petition for panel rehearing and rehearing en banc</a>, following a November split decision discussed below.Judges Lourie, Moore, and Newman dissented on the denial of en banc rehearing. Judge O’Malley had dissented from the November panel decision, but retired on March 11, 2022 and only participated in the decision on panel rehearing, not the decision on rehearing en banc.The dissent indicates that the court remains divided regarding application of the written description requirement to the facts in this case.________________________________When does an applicant have “enough” to file a patent application and be granted a patent?That question continues to dog applicants in the biopharmaceutical industry, particularly in view of recent Federal Circuit decisions concerning whether a patent application provides adequate written description for claims requiring functional limitations, such as administering an “effective” amount of a therapy.Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021).In this <a href="https://cafc.uscourts.gov/opinions-orders/20-1933.OPINION.11-30-2021_1871902.pdf" target="_blank">recent split decision from the Federal Circuit</a>, the majority affirmed a District Court decision that Biogen failed to demonstrate possession of a method of treating Multiple Sclerosis (MS) with a therapeutically effective dose of dimethyl fumarate (DMF) of about 480 mg per day claimed in Biogen’s U.S. patent 8,399,514 (the ’514 patent).Claim 1 of the ’514 patent is representative and recites:A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 [milligrams] per day [(mg/day)].In its decision, the majority focused on the fact that the DMF480 dose is listed only once in the specification, and that the sole reference to DMF480 appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day. In addition, the majority observed that the specification defines the term “effective” within a therapeutic, rather than drug-discovery, context, and the sole DMF-dosage paragraph is not linked to treatment of any specific disease, much less a neurological disorder including MS. The majority contrasted this disclosure with the description of DMF720, which is referenced independently as one dose and was known to be effective in treating MS as of the February 2007 priority date. The majority agreed with the district court that it was not necessary to distinguish between clinical efficacy and therapeutic efficacy, particularly because the specification’s definition of “therapeutically effective dose” indisputably featured both clinical and therapeutic insignia.Judge O’Malley dissented, arguing that the District Court erred by disregarding Biogen’s explanations of the distinction between clinical efficacy and therapeutic efficacy, and that “the district court’s conflation of therapeutic and clinical efficacy caused it to erroneously require clinical data, rather than therapeutic effects.” Judge O’Malley further argued that the District Court erred in applying the Court’s “blaze marks” precedent to the claimed DMF480 dose, because the specification does not provide a “laundry list” of therapeutically effective doses, and begins one of several disclosed ranges with the exact DMF480 dose that is claimed.Biogen filed a petition for rehearing en banc, saying the majority incorrectly created a heightened written description standard to “require that Biogen prove the efficacy of its claimed method, rather than describe the claimed invention.” It also objected to the majority’s “insistence on further repetition or singling out” of the DMF480 dose, saying that there is “no requirement that a specification repeat or single out a claimed embodiment.”Several industry groups have urged the Federal Circuit to review the decision.[1] After Mylan filed a response on February 3, it remains to be seen whether the court will provide additional clarity to applicants regarding what is “enough” for written description.Practice TipsPatentees must balance competing factors for timing disclosure of inventions. Filing a patent application too late risks being beaten by a competitor. Filing too soon risks not adequately describing the claimed invention, while potentially poisoning the well for future filings. In particular, care should be taken in the timing for describing specific dosing regimen. The majority noted in Biogen that an inventor need not prove that a claimed pharmaceutical compound actually achieves a certain result, but when that result is expressed claimed in the claims, “our case law provides that [such] result must be supported by adequate disclosure in the specification.” Nuvo, 923 F.3d at 1384. Thus, applicants may want to avoid early disclosure of specific dosing regimens and pursue tailored dosing claims in later filings.When disclosing a series of ranges, applicants should consider providing “blaze marks” to the ranges or values that are more likely to be effective. As highlighted in Biogen, even a short list of ranges may not be considered adequate support for claiming a particular endpoint within the ranges that is later proven to be effective. For example, calling out DMF480 individually or specifically connecting DMF480 (or even a range covering DMF480) to therapeutic efficacy for MS would have strengthened Biogen’s case for written description.Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of biotech and biopharmaceutical industries. [1] Biotechnology Innovation Organization, a division of the American Chemical Society, and Pharmaceutical Research and Manufacturers of America all filed amicus briefs on January 19, 2022, supporting Biogen’s petition for rehearing en banc.

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Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

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Associate

Dr. Bu Yin has nearly 10 years of experience in life sciences patent application drafting, global portfolio management, and strategic counseling. Dr. Yin frequently counsels on issues relating to pate

Bu Yin Ph.D.

Bu Yin

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Possession of an "Effective" Dose

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Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc, f

Possession of an "Effective" Dose

At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within its medical practice. Below, we discuss the decision and how this could impact national virtual care platforms that offer services to New Jersey patients and refer those patients to pharmacies within a related corporate structure.Case SummaryThe Petitioner in this case is a medical practice that is wholly owned by four doctors. These doctors sought to open a “closed door clinic pharmacy” within their practice to provide pharmacy services exclusively for the patients of its physicians. The Board denied Petitioner’s pharmacy application, finding that the proposed pharmacy would violate New Jersey’s “Codey Law,” which prohibits physicians from referring patients to healthcare services where they hold “a significant beneficial interest.”[1] This is analogous to the federal Stark Law,[2] which prohibits physicians from referring patients to an entity to receive certain designated health services, including outpatient prescription drugs, if the physician has an ownership or investment interest or other compensation relationship with that entity.   The Board also concluded that the proposed pharmacy would not fit within the Codey Law exception allowing referral of patients to medical treatments or procedures provided at the practitioner’s office and for which a bill is issued directly in the name of the practitioner or the practitioner’s medical office, similar to the in-office ancillary services exception under Stark, because pharmacies do not provide medical treatment. The Board noted its decision was consistent with several advisory opinions from the Board of Medical Examiners stating that “although physicians may own pharmacies, the Codey Law would prohibit a physician from referring the physician’s own patients to the pharmacy in which he or she held an ownership interest.”The Appellate Division rejected each of Petitioner’s claims, finding in part that the Board’s actions did not fall beyond the scope of its authority and did not amount to impermissible anti-competitive conduct. This holding makes it clear that New Jersey does not permit ownership of pharmacies by physicians in connection with their medical practice. ImpactNew Jersey healthcare providers, both brick and mortar practices and digital health practices, should be aware of the Codey Law and its broad prohibitions on referrals to entities that the providers have an interest in. The issues surrounding the referral of patients to these “in-house” ancillary services like pharmacies have broad implications that extend to virtual care platforms operating in different jurisdictions and offering a variety of connected healthcare services within the overall platform. For example, digital health companies with captive pharmacies or pharmacies with related ownership will need to navigate this New Jersey law in addition to federal and state fraud and abuse laws, licensing, and reimbursement questions. With many virtual healthcare companies looking to build out their services nationwide and offer patients a one-stop-shop solution, these entities must steer their way through the federal and state regulatory landscape to be compliant.At the forefront of both the life sciences and technology industries, MoFo is uniquely qualified to understand the challenges in the digital health industry and to help clients embrace analytics-driven insights to identify solutions to the most pressing issues they face. We help clients navigate complex regulatory, compliance, healthcare system, and marketplace issues. For more information, please contact a member of our <a href="https://www.mofo.com/capabilities/fda-life-sciences-compliance.html" target="_blank">FDA Regulatory and Compliance</a> Team. [1] N.J.S.A. § 45:9-22.5(a). N.J.S.A. § 45:9-22.4 defines “significant beneficial interest” to mean “any financial interest but does not include ownership of a building wherein the space is leased to a person at the prevailing rate under a straight lease agreement, or any interest held in publicly traded securities.”[2] 42 U.S.C. § 1395nn.

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New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy

The EU General Court’s Ruling on Pay for Delay

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At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the appli

New Jersey Court Affirms Prohibition of Physician Practice from Opening and Operating In-Office Pharmacy

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile of a single drug, the committee was, in a significant departure from typical Advisory Committee practice, asked to vote on a single question: Whether additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. The committee ultimately voted 14–1 in support of the need for additional clinical trials, potentially delaying sintilimab’s approval in the United States by years. Yet, with more than 25 drug applications from China pending before the FDA, according to Dr. Richard Pazdur in his February 4, 2022 article in The Lancet, the more pressing question is whether the panel’s decision has any relevance beyond sintilimab. While there is no quick answer, the loud and clear message is that sponsors need to engage with the FDA early and formally if they seek FDA approval for their drugs.   ORIENT-11 is a randomized, double-blind, placebo-controlled phase 3 trial assessing the safety and efficacy of sintilimab in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). With trials exclusively in China, sintilimab’s review hinges on the FDA’s regulatory flexibility under <a target="_blank" href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-D/section-314.106">21 C.F.R. 314.106</a>, which stipulates that “[a]n application based solely on foreign clinical data meeting U.S. criteria for marketing approval may be approved if the foreign data are applicable to the U.S. population and U.S. medical practice.” After hearing presentations from both the FDA and the sponsor, the majority of the ODAC members decided that the study was not generalizable to the U.S. population because (1) the patient demographics in ORIENT-11 do not reflect the diverse U.S. population; (2) the study endpoint and comparator arm were not the standard of care for U.S. medical practice; (3) the consent forms should have been updated when pembrolizumab was approved by the Chinese regulatory agency seven months after study initiation; and (4) the inspections were too limited in scope to assess trial conduct and data integrity.Despite calling into question ORIENT-11’s trial design and conduct, the FDA did not conclude that trials conducted exclusively in a single foreign country could never be approved in the United States. Instead, the FDA indicates that the agency will apply 21 C.F.R. 314.106 in a flexible manner according to the nature of the drug and data considered. For “me-too” drugs that do not address unmet medical needs, rare diseases, or novel drug classes, the agency has to determine the applicability of the foreign data to the U.S. population, the recognized competence of the clinical investigators, and the FDA’s validation of the data. Sintilimab review provides valuable insights for sponsors that seek FDA approval based on a foreign-only clinical strategy.(1) Early engagement with the FDA. Regardless of the clinical strategy, sponsors should engage with the FDA formally and early if they want their drugs to be marketed in the United States. Relying on informal communication with the FDA can be a costly mistake. Eli Lilly and Innovent were reportedly prepared to launch sintilimab in the U.S. market when Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, openly welcomed Chinese sponsors to bring their PD-1/PD-L1 inhibitors to the U.S. market during the March 2019 American Association for Cancer Research (AACR) meeting. Yet, on February 4, 2022, less than one week before the committee meeting, Dr. Pazdur, writing for The Lancet, argued that drug applications seeking approval based on data from a “single foreign country” need to be representative of the U.S. population in order for regulators to be flexible. Defending his change of position, Dr. Pazdur declared that “I have a right to change my mind” in an interview with STAT News four days later. During the committee meeting, Dr. Pazdur emphasized again that “comments that were made at an AACR meeting should not be viewed as regulatory policy.”Sintilimab’s bumpy ODAC meeting sends a strong message that informal communication from the FDA should never be the basis for any business or regulatory decision. Additionally, if a product wants to enter the U.S. market, the sponsor needs to engage with the FDA during the early phases of drug development or early enough in advance of submission to have meaningful engagement with the FDA regarding the data development.The benefit of engaging the FDA early and formally is that the FDA can provide formal regulatory advice with regard to both study design and trial conduct. This can be particularly important when conducting trials in countries with different standards of care, or regulatory structures that are different from the ones in the United States. For ORIENT-11, the FDA has now indicated that it would have advised the sponsors to conduct a non-inferiority trial, comparing sintilimab with an FDA-approved anti-PD-(L)1/chemotherapy regimen with an overall survival (OS) endpoint, rather than a placebo arm with a progression-free survival (PFS) endpoint.  (2) Data Integrity. Data integrity is a critical underlying concern for all clinical trials, and is especially important for foreign sites. For ORIENT-11, the FDA conducted in-person inspections of two of the forty-eight clinical sites and one remote inspection of the sponsor. The inspections uncovered some minor issues, such as under-reporting of adverse events and the use of concomitant medications. However, the FDA cautioned that its inspections and data validation are limited in scope. The agency’s concerns, expressed during the ODAC meeting, are two-fold: first, most study investigators have limited experience conducting clinical trials, and second, historical data integrity problems in China make the agency less confident about clinical data generated locally. Citing a 2016 report by China’s State Food and Drug Administration that 80% of clinical trial data from China were “fraudulent or substandard,” Dr. Pazdur asked the sponsor during the ODAC meeting to clarify whether any site investigators were previously involved in data integrity scandals. To mitigate the potential or perceived issue of investigator competence and prevent fraudulent conduct in clinical trials, the FDA highlighted the need for international, multi-regional clinical trials (MRCTs) with “investigators who have gained experience in regulatory submissions to the FDA.” Further, MRCTs can enable regulators to “look at sites in different countries and take a look at differences . . . in adverse event reporting, in efficacy, and compare them and to see if there is any outlier.”(3)  Diversity. Both FDA officials and the committee members emphasized the need for trial subject diversity. Dr. Pazdur, responding to his comments at the 2019 AACR when recently questioned, stressed that “[t]he world has changed since those comments were made,” adding that the agency has to address ethnic and racial diversity concerns in clinical trials. The agency highlighted some known differences between the U.S. population with non-squamous NSCLC and the patient population enrolled in ORIENT-11, pointing out that ORIENT-11 enrolled only Chinese patients, while the U.S. racial/ethnic breakdown is 79% white, 15% Black, and 6% Asian. The FDA acknowledged that the majority of the studies approved by the agency do not reflect racial representation of the U.S. population. However, Dr. Pazdur avowed the agency’s commitment to “address ethnic and racial diversity,” adding that the agency cannot be deaf to the outcry even though it will require a major shift throughout the FDA.  (4) Human Subject Protections. Another area of focus by both the FDA and during the ODAC meeting was the troubling consent process. Seven months after ORIENT-11 was activated, pembrolizumab was approved by the Chinese regulatory agency as a first-line therapy for NSCLC. However, the consent form was not updated to reflect the change, a severe deviation from good clinical practice (GCP) requiring that patients be informed of any new and available treatment options for their conditions. The sponsor explained that, although the written consent form was not revised, all patients were informed by their treating physicians that another treatment option was available. Further, the sponsor pointed out that pembrolizumab was never a real option for ORIENT-11 patients due to its low availability and prohibitive cost.Informed consent is at the heart of modern clinical trials. Neither the agency nor the committee found the sponsor’s rationale reasonable. As pointed out by Dr. Ravi Madan, clinical director for the Genitourinary Malignancies branch at the National Cancer Institute, “while data integrity is of utmost importance in clinical research, moral integrity is of greater importance,” and regulatory agencies need to ensure in large studies like ORIENT-11 that “patients have the appropriate informed consent that is updated as needed over time.”The fate of sintilimab might be jeopardized, but its review process can provide insightful messages to future sponsors who plan to use foreign data when seeking FDA approval. The loud and clear message for sponsors is to engage with the FDA early and formally if the product is intended to be marketed in the United States. Informal communication can be a great way to learn the current thinking of the agency; however, it is critically important to follow up with a formal meeting to receive formal regulatory advice. Second, the FDA clearly favors MRCTs as a way to promote diversity and data integrity. It could be very beneficial to engage with study sites that have a known reputation with the FDA, such as prior involvement in FDA regulated clinical studies. Last, but not least, all clinical studies need to be conducted ethically, with informed consent as the cornerstone of all research ethics. Sponsors need to put in the utmost effort to ensure that patients are fully informed throughout the study.

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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’s Loud and Clear Message: Engage with FDA Early and Formally

Is 2021 the Value-Based and Shared Savings Revolution?

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On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab appl

FDA’s Loud and Clear Message: Engage with FDA Early and Formally

Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S. Food and Drug Administration (FDA).  Because the suit was brought pursuant to the private right of action provided by the Lanham Act, the case also called into question whether such a claim was precluded by the authority of the FDA (or U.S. Federal Trade Commission (FTC)) over the product’s labeling.  In particular, the case addressed whether fluoride is most appropriately classified as a drug or dietary supplement and whether product labeling, including the use of “Rx” in labeling for a purported dietary supplement is misleading. This is not the first case to address the propriety of labeling for “prescription” dietary supplements, and a prior case addressing prenatal vitamins reached the opposite result, finding that the Rx mark was not misleading.  While the cases are factually distinct, strident competition in the dietary supplement industry may lead other manufacturers to edge out the competition by implying that their products have undergone the rigorous review for prescription drugs or are eligible for medical coverage or reimbursement.  Without a definitive statement from the FDA regarding whether such claims are false or misleading, we expect to see more unfair competition and false advertising cases like this one.BackgroundMethod Pharmaceuticals LLC and H-2 Pharma LLC produce fluoride products.  Because excessive consumption of fluoride supplements may cause tooth damage, some manufacturers, like Method, require prescriptions for their fluoride supplement products.  H-2, on the other hand, offers its fluoride products either by prescription or by general purchase as dietary supplements.  The FDA has not yet determined if H-2’s fluoride supplements should be treated as drugs or as dietary supplements,<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn1">[1]</a> an important distinction, given the costs of complying with myriad drug regulations in the United States.  Method claimed that: (1) H-2’s use of the “Rx” mark on its fluoride products misleads consumers to believe they are prescription drugs; and (2) that H-2 uses the Rx mark to have its products linked to Method’s prescription drugs in pharmaceutical databases that track substitute drugs for use by physicians, effectively pricing them out of the market.  In an <a target="_blank" href="https://www.law360.com/articles/1461691/attachments/0">order</a> filed on February 3, 2022, Chief Judge Emily C. Marks found that all but one of the five claims brought by Method could go forward, as these claims adequately allege a false representation and do not circumvent FDA’s regulatory authority.Use of “Rx” on LabelingMethod argued that use of an “Rx” mark on non-prescription products is likely to be interpreted as misleading, and insufficiently distinguished from the official “Rx only” or “R only” labeling required for prescription products.  Judge Marks found H-2’s distinction between “Rx” and “Rx only” insufficient because H-2 marks its products with “Rx” regardless of whether they actually are prescription products.  Judge Marks wrote, “Indeed, if H-2 is correct that FDA regulations do require all prescription drugs to be marked with ‘Rx Only,’ that it marks its products with the similar ‘Rx’ appears to make it more likely that the market would be confused, not less.”  Judge Marks also pointed to allegations that H-2 knowingly omitted the customary disclaimer that products are not FDA approved, painting “a broader picture of H-2’s alleged misrepresentations than a mere ‘Rx’ on its labels.”There have been a few other recent cases touching on the use of “Rx” and “prescription only” labels for non-drug products.  For example, the Northern District of Illinois in Lupinetti v. Exeltis considered prenatal vitamins labeled with the “Rx” mark or phrase “prescription only” and the allegation that this labeling was intended to cause government coverage under Medicaid.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn2">[2]</a>  The court rejected that claim, finding that it was objectively reasonable for the prenatal vitamin manufacturers to believe they could label their prenatal vitamins as “prescription only.”  In that case, the manufacturers’ “prescription only” labeling and statements were based on Centers for Medicare and Medicaid Services (CMS) guidance explaining that “prescription prenatal vitamins continue to meet the definition of a covered outpatient drug and are rebate-eligible” and issuance of a “covered outpatient drug” code for prescription prenatal vitamins.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn3">[3]</a>FDCA Implications: Claim Preclusion and Federal PreemptionMethod also highlights apparent tension between Federal Food, Drug, and Cosmetic Act (FDCA) and the Lanham Act.  As the opinion explains, the FDCA proscribes misbranding of food and drugs and vests exclusive enforcement authority in the FDA, while the Lanham Act allows competitors to sue each other for false or misleading product descriptions.  It is clear from the Supreme Court’s decision in POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 120-21 (2014), that the FDCA does not preclude lawsuits concerning misleading labels between private competitors when it comes to food and beverage products.  Since then, courts across the country have grappled with whether Pom Wonderful extends to dietary supplements.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn4">[4]</a>Method reaches a reasonable conclusion: if the Lanham Act claim does not require courts to contradict the FDA or make a determination committed to the FDA’s sole discretion, then it is permissible.  That rule allows companies to limit unfair competition, but respects the FDA’s authority and expertise with respect to safety.Along those lines, Method is relevant to the larger topic of FDA preemption of state law labeling claims.  This is an important issue because labeling claims are influential in driving consumer behavior.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn5">[5]</a>  In this case, the court weighed whether private lawsuits were foreclosed by the FDCA but in other cases, courts have resolved conflicts between the FDA and state regulators enforcing state laws.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftn6">[6]</a>  A major theme in all of these cases is determining the proper role for the FDA.  On one hand, the FDCA vests sole enforcement authority for its regulations in the FDA for good reason—not only because of the FDA’s expertise, but also because complex national issues require dynamic federal solutions.  On the other hand, the FDA cannot possibly respond to every complaint from the industry regarding unfair or misleading labeling.  Moreover, reading the FDCA and its preemption provisions too broadly could jeopardize other vehicles for limiting misbranding and false advertising. <a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref1">[1]</a> Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, 2:20-CV-753-ECM (M.D. Ala. February 3, 2022).<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref2">[2]</a> See Lupinetti v. Exeltis USA Inc., 2021 WL 5407424 (N.D. Ill Nov. 19, 2021).<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref3">[3]</a> CMS, Release No. 159 (Dec. 28, 2011). <a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref4">[4]</a> The Eleventh Circuit, which was binding on the Method court, has held that the FDCA does not preclude labeling claims under the Lanham Act.  Belcher Pharmaceuticals, LLC v. Hospira, Inc., 1 F.4th 1374, 1380-81 (11th Cir. 2021).  And the Ninth Circuit has reached a similar conclusion in ThermoLife Intern., LLC v. Gaspari Nutrition Inc., 648 Fed. App’x 609, 612 (9th Cir. 2016).  But in Amarin Pharma, Inc. v. International Trade Commission, 923 F.3d 959, 968-69 (Fed. Cir. 2019), the Federal Circuit held that the FDCA precluded that plaintiff’s particular Lanham Act claims.<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref5">[5]</a> See Amanda Berhaupt-Glickstein, Neal H. Hooker, & William K. Hallman, Qualified Health Claim Language affects Purchase Intentions for Green Tea Products in the United States, 11 Nutrients 924 (Apr. 2019); Johann Steinhauser, Meike Janssen, & Ulrich Hamm, Who Buys Products With Nutrition and Health Claims? A Purchase Simulation with Eye Tracking on the Influence of Consumers’ Nutrition Knowledge and Health Motivation, 11 Nutrients 2199 (Sept. 2019).<a href="file:///C:/Users/cxm41/Desktop/PROOF-Method%20H-2%20Blog%20Post%20DRAFT%2002.10.2022%20-%202332645%20(bb%20comments).DOCX#_ftnref6">[6]</a> See, e.g., Johnson & Johnson v. Fitch ex rel. State, 315 So. 3d 1017 (Miss. 2021), cert. denied, 142 S. Ct. 732 (2021) (assessing whether the FDCA preempts labeling claims under the Mississippi Consumer Protection Act). Morrison & Foerster filed an amicus curiae brief on behalf of former FDA officials in support of Johnson & Johnson’s petition for certiorari.

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labe

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for PTE, a patent must claim a drug product, a method of using a drug product, or a method of manufacturing a drug product, and PTE is only available for the first approval of an “active ingredient.”The Federal Circuit has addressed the question of what constitutes an active ingredient[1] several times in the context of small molecules. For example, claims directed to a metabolite do not cover the active ingredient,[2] enantiomers of the same compound are different active ingredients,[3] and different salts of the same compound are considered the same active ingredient for purposes of PTE.[4] Although the Federal Circuit case law on small molecules is more developed, it is not clear how the court will apply the current case law and statutory framework to biologics including cell-based therapies and gene therapies.Recent approval of a cell therapy, YESCARTA®, provides insight into considerations from the U.S. Patent & Trademark Office (USPTO) on what constitutes the active ingredient in the context of biologics. The YESCARTA PTE application illustrates two challenges for defining the active ingredient in cell-based therapies to meet the first approval requirement.[5] One challenge is how to define the active ingredient for certain cell-based therapies, where the product differs from patient to patient. Moreover, there is the related challenge of providing a detailed enough description of the active ingredient in the PTE application to allow the USPTO to distinguish the active ingredient of the product from previously approved active ingredients.YESCARTA (Axicabtagene ciloleucel) is an immunotherapy approved to treat B-cell lymphomas. YESCARTA comprises autologous T cells (a type of immune cell that plays a crucial role in detecting and killing cancer cells) derived from an individual patient and engineered specifically to target the patient’s cancer cells. The engineered T cells comprise: (1) T cells harvested from a patient and (2) a foreign protein (i.e., a chimeric antigen receptor (CAR)) specifically targeting a cell-surface protein. The T cells vary from patient to patient, but the CAR is the same for all patients. The T cells containing the CAR are responsible for the anti-tumor activity. All of this raises the question of whether the active ingredient is the T cells and/or the CAR.In the YESCARTA PTE application, applicant Cabaret Biotech Ltd. (“Cabaret”) defined the active ingredient as the engineered T cells. After reviewing the PTE application, the USPTO issued a letter to Cabaret, stating that (a) the cells could not be the active ingredient because the cells differ from patient to patient and (b) the CAR was not an active ingredient because it was not defined in the application as filed. Aside from the challenge surrounding the question “What is the active ingredient?” the USPTO also indicated that the applicant’s description of the structure of YESCARTA was insufficient. The USPTO requested that the applicant comment on whether an earlier approved antibody that targeted the same cell-surface protein was actually the first approval for the active ingredient in YESCARTA.The USPTO never squarely addressed what it considered the active ingredient of YESCARTA to be. After multiple communications between the USPTO and Cabaret, and between the USPTO and FDA, the USPTO approved the YESCARTA PTE application. The information the USPTO finally relied upon for determining that YESCARTA was eligible for PTE was the DNA sequence encoding the CAR. It appears that, based upon the differences in sequences between the YESCARTA CAR and the previously approved antibody, the USPTO determined that YESCARTA contained a new active ingredient.Interestingly, YESCARTA is not the first cell-based product with patient-to-patient variability to receive a grant of PTE. LAVIV® (Azficel-T) is an autologous cell product used for treating moderate to severe wrinkles. In its PTE application, Fibrocell Technologies, Inc. described the active ingredient of LAVIV as an autologous cellular product composed of fibroblasts suspended in a particular cell medium, and listed the active ingredient as “fibroblast cells.”[6] Although LAVIV shares the patient-to-patient variability seen in CAR T cells, the USPTO accepted this designation without further comment.The YESCARTA PTE application illustrates the challenges in applying the active ingredient analysis developed in the small molecule realm to biologics technologies. Precisely how the USPTO views the question of what constitutes an active ingredient in cell-based therapies remains an open question that will most likely be resolved by the courts. This uncertainty, however, has not impeded the grant of PTE for these cell-based therapies. Thus, patentees should not be deterred from filing PTE applications to secure an additional patent term for biologics products, but should keep these challenges in mind when drafting the description of the active ingredient in the PTE application.Follow us to stay up to date on developments regarding PTE. [1] Title 21 of the Code of Federal Regulations defines an “active ingredient” as any component that is “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.”[2] Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392 (Fed. Cir. 1990).[3] Ortho McNeil Pharm. v. Lupin Pharm., 603 F.3d 1377 (Fed. Cir. 2010).[4] Pfizer Inc. v. Dr. Reddy Labs. Ltd., 359 F.3d 1361 (Fed. Cir. 2004).[5] U.S. Patent No. 7,741,465; received at the USPTO on December 14, 2017.[6] U.S. Patent No. 5,591,444; received at the USPTO on August 17, 2011.

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. 

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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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PATENT TERM EXTENSION FOR BIOLOGICS

Transforming the U.S. Healthcare Industry with Blockchain Technology

mofolifesciences-biotech

Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent t

PATENT TERM EXTENSION FOR BIOLOGICS

Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets.Digital Transformation in the Life Sciences<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt05435bfbc3932ff8/6273179623c6cf2a1c3af5cf/mofolifesciences-digital-transformation-life-sciences-themes.jpg?format=auto&quality=60" width="650" height="366" type="asset" sys-style-type="download"> The Digital Health sector had a record-breaking year across the board, with investment and M&A at an all-time high and funding for digital therapeutics and mental health tech more than doubled in the last year. Discussion topics included:<ul><li>Best practices for digital health partnerships <ul><li>How to attract the right partners whether you are a startup or a more established digital health company</li><li>Defining your value proposition</li><li>How to partner with payors and other research organizations</li></ul></li><li>Keeping up momentum <ul><li>Access and consumer adoption</li><li>Focusing on personalization</li><li>Reimbursement challenges</li><li>Working with providers</li></ul></li></ul>View the recording <a href="https://www.youtube.com/watch?v=vOMifzAICH8&t=2s" target="_blank">here</a>. Future of Drug Discovery and Diagnostics<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blta22f4b1dbaf8de84/627317964886af2aa2be10fa/mofolifesciences-future-drug-discovery-diagnostics.jpg?format=auto&quality=60" type="asset" sys-style-type="download"> The life sciences industry has experienced tremendous change over the last decade and innovation is moving at a rapid rate, fueled not only by new technologies, but also by strategic collaborations to advance next-gen therapeutics and diagnostics in ways we have not seen before. Discussion topics included:<ul><li>How companies are sourcing deals to expand R&D and product pipelines</li><li>The role of food to influence drug discovery and diagnostics and produce more positive outcomes for patients</li><li>How companies are assessing new technologies to treat disease and the tools of the    future that will lead to effective treatments and diagnostics</li><li>Challenges for startups in drug discovery, including financing and finding the right      talent in a competitive market</li></ul>View the recording <a href="https://www.youtube.com/watch?v=mtLiRhsW3_w&t=4s" target="_blank">here</a>.

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MoForum Recap: Transformation Across the Industry

2022 Life Sciences MOFORUM Starts This Week

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Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and

MoForum Recap: Transformation Across the Industry

Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the biotechnology, digital health, and healthcare ecosystems on what is driving the industry forward and the challenges and opportunities for new innovation across the sector.Recordings from Day 1 and Day 2 of our program are now available.Digital Transformation in the Life SciencesModerated by: Brigid Bondoc, Of Counsel, FDA Regulatory and Compliance practicePanelists:<ul><li>Melinda Decker, Digital Health Advisor and former Chief Commercial Officer, Mymee</li><li>Chris Bergstrom, President, Amalgam Rx</li><li>Laura Taraboanta, Sr. Manager, Head of Clinical Innovations, Click Therapeutics</li><li>Shaheen Lakhan, Chief Medical Officer, Click Therapeutics</li></ul> <div class="media-wrap embed-responsive embed-responsive-16by9"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" frameborder="0" title="2022 Life Sciences MoForum: Day One YouTube video" src="https://www.youtube-nocookie.com/embed/vOMifzAICH8" height="315" width="560" style="width: 560%; height: 315;" title="iframe"></iframe></div> The Future of Drug Discovery and DiagnosticsModerated by: Matthew Karlyn, Partner, Life Sciences Transactions & Licensing practicePanelists:<ul><li>Scott Carter, Assistant General Counsel, BeiGene</li><li>Michelle Egger, Co-founder & CEO, BIOMILQ</li><li>Daniel Oliver, Co-founder & CEO, Rejuvenate Bio</li><li>William W. Li, M.D., President and Medical Director, The Angiogenesis Foundation</li></ul> <div class="media-wrap embed-responsive embed-responsive-16by9"><iframe allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" frameborder="0" title="2022 Life Sciences MoForum: Day Two YouTube video" src="https://www.youtube-nocookie.com/embed/mtLiRhsW3_w" height="315" width="560" style="width: 560%; height: 315;" title="iframe"></iframe></div>