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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Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023, <a href="https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf">a proposal</a> (Proposal) to amend the transitional regime under the <a href="https://eur-lex.europa.eu/eli/reg/2017/745/2020-04-24">Medical Device Regulations</a> (MDR) and certain related rules under the<a href="https://eur-lex.europa.eu/eli/reg/2017/746/2022-01-28"> In Vitro Diagnostic Medical Device Regulations</a> (IVDR). It is based on suggestions made by the Commission at the end of last year, which we have already discussed on our <a href="https://lifesciences.mofo.com/topics/eu-mdr-and-ivdr-implementation-signs-of-relaxing-transitioning-regime-and-bridging-measures#_ftnref4">MoFo Life Sciences blog</a>.The Commission proposes:<ul><li>an extension of the validity of certificates (MDR),</li><li>an extension of the transition period (MDR), and</li><li> the removal of the “sell-off” periods (MDR and IVDR).</li></ul>As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended already at the beginning of 2022, so that the Commission deems the capacity challenges to no longer be so severe for in vitro diagnostics. We discussed the IVDR transitional periods in our previous blog post <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html">here</a>.BackgroundThere is a uniform understanding that an extension of the MDR/IVDR transitional regime is indispensable to combat a potential European health crisis and maintain patients’ access to a wide range of medical devices while ensuring the transition to the MDR framework. Our previous blog post discussed the lack of clarity in the <a href="https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf">Commission’s initial suggestions of December 2022</a> (Initial Suggestions). Among other things, the Initial Suggestions imprecisely specified the conditions to be fulfilled for a device to be covered by the proposed extended transitional periods. In terms of the extension of the validity of certificates, it was also unclear whether certain “legal and practical reasons” would serve as a criterion for such an extension and how the Commission would fill these terms with live. Moreover, it was unclear whether an extension would be granted retroactively to certificates already expired at the time of entering into force of the proposal.Details of the ProposalThe new Proposal brings more clarity for stakeholders.Extension of the transition period (Article 1(1), point (b) of the proposal)The Commission suggests to extend the transition period for higher-risk devices (class III and class IIb implantable devices, except certain devices for which the MDR provides exemptions) from May 26, 2024, until December 31, 2027, and for medium- and lower-risk devices (other class IIb devices and class IIa, Im, Is, and Ir devices) until December 31, 2028.The extended transitional periods only apply if the following conditions are met:<ul><li>devices continue to comply with <a href="https://eur-lex.europa.eu/eli/dir/1993/42/oj">Medical Devices Directive</a> (MDD) and <a href="https://eur-lex.europa.eu/eli/dir/1990/385/2007-10-11">Active Implantable Medical Devices Directive</a> (AMDD);</li><li>there are no significant changes in the design and intended purpose;</li><li>the devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health;</li><li>no later than May 26, 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9) MDR;</li><li>no later than May 26, 2024, the manufacturer, or its authorized representative, has lodged a formal application in accordance with Annex VII, Section 4.3 of the MDR for a conformity assessment in respect of a “legacy device” covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3 of the MDR.</li></ul>The proposed amendment further introduces a transition period until May 26, 2026, for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR.Extension of the validity of certificates (Article 1(1) point (a) of the proposal)The Commission further proposes to amend Article 120(2) MDR to extend the validity of certificates previously issued under the MDD that were valid on the day of the MDR’s date of application (May 26, 2021) and have not been withdrawn by a notified body. Certificates are intended to remain valid for the duration of the proposed extended transition period of the respective risk class applicable for the device set forth above.For certificates that have already expired at the time the amendments to the MDR, as suggested by the Proposal, take effect, the extension would be subject to the condition that, before the date of expiry of the MDD certificate, the manufacturer signed a written agreement with a notified body for the conformity assessment of the device in question. Or if no such agreement has been signed at the time of the expiry of the validity of the MDD certificate, a national competent authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 MDR or has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 MDR.Removal of the “sell-off” deadline in the MDR and IVDR (Article 1(1), point (c) and Article 2(1) of the proposal)It is further proposed to remove the current “sell-off” date in Article 120(4) MDR (May 27, 2025) and in Article 110(4) IVDR (May 25, 2025 to May 26, 2028). In this case, devices placed on the market before the respective end of the transition period could be made further available on the market without a legal time restriction.Assessment of the proposed amendmentsAlbeit announced for the beginning of 2023, many stakeholders doubted that the Commission would issue the Proposal at this rapid pace. By doing so, the Commission clearly recognized the urgent risks of medical device shortages in the European Union as a result of MDR implementation challenges.Stakeholders in the industry have already signaled that they very much welcome the proposed extensions. From a legal perspective, the Proposal brings one thing above all: more clarity.In particular, the conditions to be met for a device to be covered by the proposed extended transitional periods have been clarified. Whereas the Commission’s Initial Suggestions vaguely stated that certain steps to initiate certification procedures under the MDR are required, it is now clear that the manufacturer must, among other things, have lodged a formal application for a conformity assessment and have signed a written agreement with such notified body. Of course, this does not mean that manufacturers can lean back and slow down their transition efforts. To the contrary, given the notorious capacity issues at notified bodies, it will be critical for them to move fast to secure a signed contract with a notified body in time.Moreover, it is a huge step that MDD certificates will be extended and that even MDD certificates already expired at the time of entering into force of the Proposal’s amendments will benefit from such an extension. Yet, these manufacturers will have to be able to demonstrate that the devices in question are in “transition” before expiry of the respective MDR certificate. This is not only a prerequisite under the Proposal, which requires a written contract with the notified body, but, according to the position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), also a criterion to obtain an extension by a competent authority pursuant to Article 97 MDR. Finally, the removal of the “sell-off” period in the MDR and IVDR is a major step toward reducing the risk of overstocking and preventing unnecessary disposal of safe medical devices and in vitro diagnostic medical devices.OutlookThe Proposal needs to be adopted by the European Parliament and the Council, and it might still undergo some changes in this process. While it is unclear when and if the proposed amendments will become effective, the previous corrigenda of the MDR have demonstrated that adoption can be swift, which in this case is necessary to ensure that patients and healthcare systems have continuous access to all categories of medical devices. At the moment, stakeholders should further pursue their transition strategy but should closely monitor these critical developments in the coming months. Watch this spot for more updates on this and other EU regulatory matters.MoFo research assistant Nicole Gebert has contributed to this article. ***

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

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

Robert Grohmann

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

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EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

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Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023,a proposal (Proposal) to amend the transitional regime under theMedical Device Regulations (MDR) and certain related rules under the In Vitro Diagnostic Medical Device Regulations (IVDR). It is based on suggestions made by the Commission at the end of last year, which we have already discussed on ourMoFo Life Sciences blog.

EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

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.

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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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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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

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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. 

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

In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines. Even with the steady stream of opinions in 2022, key questions about BIPA’s scope remain open for future interpretation.Read our <a href="https://www.mofo.com/resources/insights/230125-year-in-review-data-breach-litigation" target="_self">client alert</a>.

Wiretap Act Class Action for Technology Company

BIPA Class Action for Social Media App

RICO and Fraud Class Action for Waste Management Company 

Copyright Class Action for AI Company

CCPA and Data Breach Class Action for Leading Software Company

TCPA and Other Class Actions for Major Technology Company

Wiretap Act Action Against a Major Consumer Electronics Manufacturer

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Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

Tiffany Cheung

Clients seek out Tiffany for her successful track record in defending class action claims on behalf of clients in a broad range of industries, including technology, healthcare, and consumer product companies. She represents numerous Fortune 500 companies in high-stakes litigation involving privacy and marketing claims in courts throughout the United States.

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Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)

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In 2022, Illinois’s Biometric Information Privacy Act (BIPA) litigation was bustling. Defendants in BIPA cases ranged from pharmacies, insurance companies, and social media platforms to software companies, schools, and airlines.

Privacy Litigation 2022 Year in Review: Biometric Information Privacy Act (BIPA)