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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Because No One is Immune to the Law

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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

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Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations

Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations | MoFo Life Sciences

Brigid DeCoursey Bondoc

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.

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