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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The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. 

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Supreme Court Denies Review of Cost Sharing Assistance Program | MoFo Life Sciences

Adam L. Braverman

Seth W. Lloyd

The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food & Drug Administration (FDA) to treat a rare heart condition. In 2019, Pfizer sought an advisory opinion from the Department of Health and Human Services (HHS) regarding the subsidy program, and in September 2020, HHS advised Pfizer that the program “plainly would” involve prohibited conduct under the Anti-Kickback Statute (AKS) because it would induce Medicare patients to purchase this medication. Pfizer brought a suit to challenge the determination, which ended with the Supreme Court’s denial of certiorari. The decision has special implications for the pharmaceutical industry and potentially impacts any entity that conducts business with federal health care programs.Covering copays potentially encouraged Medicare patients to seek Pfizer’s drug, implicating the Anti-Kickback Statute.The AKS, <a href="https://www.govinfo.gov/content/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap7-subchapXI-partA-sec1320a-7b.pdf" target="_blank">42 U.S.C. § 1320(a)-7b(b)</a>, aims to prevent fraud in federal health care programs and financial “renumerations” (including kickbacks, bribes, or rebates) for inducing the purchase of particular health care products or services. AKS violations can carry felony criminal liability with up to 10 years’ imprisonment. In addition, HHS has the authority to exclude any individual or entity from federal health care programs if it determines they have violated the AKS.The HHS Office of Inspector General (HHS-OIG) issued a special advisory bulletin in 2005 that first alerted companies how patient assistance programs may violate the AKS. The bulletin stated that manufacturers’ programs could implicate the AKS because “the manufacturer would be giving something of value (i.e., a subsidy) to beneficiaries to use its product.” <a href="https://www.govinfo.gov/content/pkg/FR-2005-11-22/pdf/05-23038.pdf" target="_blank">70 Fed. Reg. 70, 623 (Nov. 22, 2005)</a>. The bulletin explained that these programs induce patients to seek specific drugs and “present all of the usual risks of fraud and abuse associated with kickbacks, including steering beneficiaries to particular drugs; increasing costs to Medicare; providing a financial advantage over competing drugs; and reducing beneficiaries’ incentives to locate and use less expensive, equally effective drugs.” Id. at 70,625.In 2019, Pfizer sought an HHS-OIG advisory opinion regarding a proposed Direct Copay Assistance Program for eligible Medicare patients that need tafamidis. Pfizer wanted to cover the majority of the approximately $13,000 annual cost sharing obligations, and eligible patients would only pay $35 a month. Pfizer was concerned that many “middle-income” Medicare patients are unable to afford the annual cost sharing obligations and that even if they were to cut the price of tafamidis in half, the patient annual cost sharing obligations would be approximately $8,000, which still remains a significant financial barrier for many patients. Pfizer pointed to one study that indicated 49% of cancer patients failed to refill prescriptions when there was a $2,000 copay. Pfizer emphasized that it would not provide financial incentives to physicians to favor tafamidis or use the program to solicit new patients.In 2020, HHS-OIG issued an unfavorable opinion that found Pfizer’s proposed program would involve conduct prohibited under the AKS. The opinion specified the program would induce a beneficiary to purchase tafamidis by “removing the financial impediment, and the Medicare program would bear the costs.” <a href="https://oig.hhs.gov/documents/advisory-opinions/768/AO-20-05.pdf" target="_blank">HHS-OIG Advisory Opinion No. 20-05</a>. HHS-OIG held that the program “plainly would involve remuneration to an individual to induce that individual to purchase an item for which payment may be made under a Federal health care program.” As a result, HHS-OIG concluded that the program could violate the AKS because it presented some of the same concerns of fraud and abuse associated with kickbacks that it alerted the public to in its 2005 bulletin – increased costs to Medicare, beneficiary steering and anti-competitive effects, and interference with or skewing clinical decision-making.Pfizer argued that violating the AKS requires “corrupt intent,” but the district court and Second Circuit disagreed.Pfizer sued in federal court under the Administrative Procedure Act to challenge the HHS-OIG determination. The district court agreed with HHS-OIG, granted summary judgment for the government and the Second Circuit affirmed in a unanimous <a href="https://aboutblaw.com/37z" target="_blank">decision</a>. The Second Circuit explained “Pfizer’s primary argument was that the Direct Copay Assistance Program must be administered with a ‘corrupt intent’ to violate the AKS, and Pfizer defines ‘corrupt’ intent as a quid pro quo that ‘improperly or corruptly’ skews the patient’s decision-making.” The district court and the Second Circuit examined the plain language of the AKS which prohibits “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person . . . to purchase . . . any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program.” Because nothing in the text of the AKS requires a “corrupt intent,” the courts sided with the government because the Direct Program would persuade or induce Medicare beneficiaries to purchase the drug.    The Supreme Court’s denial fits into a broader government crackdown on high-cost medications.Pfizer <a href="https://www.supremecourt.gov/DocketPDF/22/22-339/242710/20221007141713303_No.%20-__%20Pfizer%20Petition%20and%20Appendix.pdf" target="_blank">sought review of</a> the Second Circuit decision, using the same argument that corrupt intent to improperly skew patient decision-making was a required element in an AKS violation. The Supreme Court denied review earlier this month.The Second Circuit decision remains in effect and will likely reinforce the Department of Justice’s efforts to target programs designed to help patients pay for high-cost medications, netting the federal government <a href="https://www.bloomberglaw.com/product/blaw/bloomberglawnews/bloomberg-law-news/XA30SOB8000000?#jcite" target="_blank">over $1 billion in settlements</a> between 2017 and 2021. These enforcement efforts coincide with a federal and state legislative efforts to reduce drug prices, including new sweeping requirements of the Inflation Reduction Act that, among other things, require the federal government to negotiate prices for some Medicare Part B and D drugs, require drug companies to pay rebates to Medicare if prices rise faster than inflation, cap out-of-pocket spending for Part D enrollees and limit monthly cost sharing for insulin. Targeting the overall cost of prescription drugs, including high-cost medications, clearly remains a priority for regulators in many levels of government, and the AKS is another tool with a legal standard that favors regulators.Takeaway: Seek advice early because even companies with good intentions can unintentionally violate the AKS.Pfizer’s strategy to seek an HHS advisory opinion on the proposed program was prudent, even if it did not end with the desired result. Pharmaceutical manufacturers are under special scrutiny when providing any financial benefit related to their own drugs, even if it is aimed at helping patients that are in special need. The Department of Justice and other regulators are likely to continue the broader push to enforce cost-control functions within Medicare and other federal programs and scrutinize any programs associated with high-cost medications. Thus, it is similarly prudent for any health care company to seek advice early when designing financial assistance programs that may implicate federally funded programs like Medicare or Medicaid.

Supreme Court Denies Review of Cost Sharing Assistance Program

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