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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On January 3, 2023, the U.S. Food & Drug Administration (FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. 

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FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS | MoFo Life Sciences

Brigid DeCoursey Bondoc

Kate Driscoll

On January 3, 2023, the U.S. Food & Drug Administration <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" target="_blank">(FDA) modified the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program</a> to remove the in-person dispensing requirement and allow dispensing of mifepristone at certified retail pharmacies. FDA announced this forthcoming modification in December 2021 and, as we <a href="https://lifesciences.mofo.com/topics/fda-oks-mail-order-mifepristone-state-laws-may-inhibit-its-use.html" target="_blank">predicted</a>, the process took approximately one year. Below we discuss the modified REMS and recent related legal developments.Removing the In-Person Dispensing RequirementUntil recently, healthcare providers were required to dispense mifepristone in person, greatly limiting access to the drug. As discussed in our prior post, <a href="https://www.supremecourt.gov/opinions/20pdf/20a34_3f14.pdf" target="_blank">FDA was enjoined from enforcing this requirement</a> from July 13, 2020 until January 12, 2021, when the injunction was vacated by the Supreme Court. On April 12, 2021, FDA issued a guidance document stating its intent to <a href="https://www.aclu.org/sites/default/files/field_document/fda_acting_commissioner_letter_to_acog_april_12_2021.pdf" target="_blank">exercise enforcement discretion</a> with respect to in-person dispensing of mifepristone during the COVID-19 pandemic.  This became an especially relevant issue in light of the 2022 Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade.  The new ability of states to set their own policies protecting or banning abortion without any federal standard created a new focus on medication abortion, which accounts for over half of all abortions performed in the United States. Implementation of FDA’s policy change took approximately one year and, on January 3, 2023, FDA announced the modification of the REMS to remove the in-person dispensing requirement.When FDA issued the modified REMS, it also denied two related citizen petitions:<ul><li>The <a href="https://downloads.regulations.gov/FDA-2022-P-3209-0003/attachment_1.pdf" target="_blank">first petition</a> from Students for Life of America requested that FDA reinstate the Mifepristone REMS to its 2011 form (i.e., reinstatement of the in-person requirement and other restrictions), but FDA found the petition did not include new data to support the argument and denied the petition.</li><li>The <a href="https://downloads.regulations.gov/FDA-2022-P-2425-0003/attachment_1.pdf" target="_blank">second petition</a> from American College of Obstetricians and Gynecologists requested that FDA ask the drug sponsor to file a supplemental new drug application (sNDA) for a miscarriage management indication and exercise its enforcement discretion to allow the use of mifepristone for miscarriage management without complying with the REMS. FDA denied the petition and determined that an sNDA or a different new drug application would need to be submitted with data to support a finding of safety and effectiveness. FDA also determined that a request for enforcement discretion is not an appropriate use of a citizen petition.</li></ul>Certified Retail Pharmacies May Dispense MifepristoneThe modified Mifepristone REMS allows both mail-order and brick-and-mortar retail pharmacies to dispense the drug under certain conditions. In order to become a certified pharmacy, the pharmacy must complete the “Pharmacy Agreement Form,” a single-page document containing approximately 20 conditions, including:<ul><li>Maintaining comprehensive records relevant to all processes, procedures, prescribers, and recipients of the drug;</li><li>Training all relevant staff on the Mifepristone REMS;</li><li>Complying with mifepristone sponsor audits; and</li><li>Verifying each mifepristone shipment as well as the prescriber’s certification status.</li></ul>Uncertainties Surround Application of State Laws Banning or Otherwise Restricting AbortionAs discussed above, a key development prior to FDA’s recent modification of the Mifepristone REMS was the U.S. Supreme Court’s decision in <a href="https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf" target="_blank">Dobbs</a>, which allows states to restrict a person’s right to an abortion. This decision resulted in approximately <a href="https://reproductiverights.org/our-regions/united-states/" target="_blank">12 states</a> to date completely banning abortion with very limited exceptions for medical emergencies and many other states implementing various restrictions on abortion, including prohibitions on the provision of abortion-inducing drugs and abortion-related equipment. As of now, there is no clear answer whether these states can restrict the prescription of mifepristone. Further, <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" target="_blank">FDA stated</a> that “questions regarding preemption of state law [concerning mifepristone availability] should be directed to the DOJ.”One such example of an agency referring a mifepristone legal question to the U.S. Department of Justice (DOJ) is found in the July 2022 query from the U.S. Postal Service as to whether, in light of the Dobbs decision, mailing mifepristone is a violation of 18 U.S.C. Section 1461<a href="#_ftn1" target="_self" id="_ftnref1">[1]</a>. <a href="https://www.justice.gov/olc/opinion/file/1560596/download" target="_blank">DOJ issued a memorandum</a> on this question finding it is not a violation of Section 1461 for a pharmacy to ship mifepristone to states where the local law may otherwise prohibit its use, so long as the pharmacy lacks the intent that the recipient will use the drug unlawfully.<a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> DOJ further noted that “the mere mailing of [mifepristone] to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.” However, this memorandum likely does not prevent state authorities from bringing criminal charges against such pharmacies under state criminal laws.Plaintiffs Challenge FDA’s Approval of MifepristoneThe <a href="https://dockets.justia.com/docket/texas/txndce/2:2022cv00223/370067" target="_blank">Alliance for Hippocratic Medicine and other anti-abortion medical groups</a> are challenging FDA’s treatment of abortion-inducing drugs in the Amarillo Division of the Northern District of Texas. In the suit, plaintiffs allege two primary challenges. First, plaintiffs claim that mifepristone is not safe and effective, and therefore the court should grant a preliminary injunction and order the FDA to withdraw or suspend the approval of Mifeprex and the generic mifepristone. If this request is granted, it would drastically limit the availability of the drug, as marketing or distribution of the unapproved article would likely violate the Food, Drug, and Cosmetic Act. Second, plaintiffs also request that the Court order FDA to reimplement the in-person dispensing requirement. If FDA reinstates the in-person dispensing requirement, access to the drug will be greatly limited, as some populations may not be able to receive the drug absent telehealth prescriptions and retail dispensing.MoFo’s FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Investigations + White Collar Defense, Global Ethics + Compliance, Life Sciences Transactions + Licensing, Privacy + Data Security, and Appellate practice groups to ensure that life sciences companies can navigate the many difficult legal issues that have arisen in light of the challenging federal and state requirements. Please subscribe and follow our <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences Blog</a>, as we continue to update the industry on new developments in compliance, especially with respect to the ongoing mifepristone litigation and other regulatory and state law developments surrounding abortion and abortion-inducing drugs.Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this post.<a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> Section 1461 states that “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” to be “nonmailable matter” that may not lawfully be delivered from any post office or by letter carrier. 18 U.S.C. § 1461.<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> The Comstock Act declares that articles intended to produce abortion may not be lawfully delivered by the U.S. Post Office. 18 U.S.C. § 1461. However, as the DOJ memorandum notes, courts have long held that the Comstock Act is to be construed narrowly, and courts routinely interpret the Act as only prohibiting items that are unlawful, whereas here there are many lawful uses of mifepristone.

FDA Enables Pharmacies to Dispense Abortion-Inducing Mifepristone in Revised REMS

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