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.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

230315-new-mofo-life-sciences-logo.jpg

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.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

Patent Strategy + Prosecution

Patent Prosecution | Patent Firm

Band 1: Intellectual Property: Patent Prosecution, California

Tier 1: Patent Strategy & Management

Recommended: Patent Prosecution

Patent Strategy Firm Of The Year

 Intellectual Property: Patents: Prosecution

Recommended for Patent Prosecution in California and DC Metro Area

Highly Recommended: Patent Prosecution, California

Patent Prosecution, US 

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>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

Life Sciences: IP/Patent Litigation

Life Sciences

Global: Life Sciences

Asia-Pacific Region: Life Sciences

Healthcare: Life Sciences

China Healthcare and Life Sciences: Foreign Firms

US: Biotechnology Law

Japan: Life Sciences

China: Life Sciences: International Law Firm

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech Blog

MOFO TECH

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

SOCIALLY AWARE

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

LinkedIN

The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to pay a rebate to the federal government if prices for certain drugs and biologics covered under Medicare Part B and Part D increase faster than the rate of inflation (CPI-U). Price changes will be measured based on the average sales price for Part B drugs and the average manufacturer price for Part D drugs. If price increases exceed inflation, drug manufacturers will be required to pay the difference in a rebate to Medicare equal to the total number of units sold in Medicare multiplied by the amount by which a drug’s price in a given year exceeds the inflation-adjusted price. Manufacturers that fail to pay the required rebate amount will face a penalty of at least 125% of the original rebate amount.The Part D inflation rebate provisions took effect in October 2022, and the Part B inflation rebate provisions took effect in January 2023. CMS intends to send the first invoices to drug companies for the rebates beginning in 2025. Invoices for Part B inflation rebates for Medicare for calendar quarters in 2023 and 2024 will be issued by September 30, 2025, and invoices for Part D inflation rebates owed to Medicare for the 12-month periods beginning October 1, 2022 and October 1, 2023 will be issued by December 31, 2025. Please see a more detailed timeline in Figure 1 below.On Thursday, February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released its initial guidance for the Medicare <a href="https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf" target="_blank">Part B</a> and <a href="https://www.cms.gov/files/document/medicare-part-d-inflation-rebate-program-initial-guidance.pdf" target="_blank">Part D</a> Prescription Drug Inflation Rebate Program outlining the process for collecting rebates for both Medicare Part B and Part D drugs in line with changes from the IRA.CMS is seeking public input on various topics, including, but not limited to, the following:<ul><li>Process to determine the number of drug units for Part B and Part D rebatable drugs</li><li>Process to identify and remove excluded 340B units</li><li>Processes to address reduction or waiver in rebates for certain Part B and Part D drugs in times of drug shortages and severe supply chain disruptions</li><li>Process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates</li><li>Mechanisms to ensure the integrity of the inflation rebate determination process</li></ul>Comments may be submitted to <a href="mailto:IRARebateandNegotiation@cms.hhs.gov">IRARebateandNegotiation@cms.hhs.gov</a> with the subject line “Medicare Part D Inflation Rebate Comments” or “Medicare Part B Inflation Rebate Comments” by March 11, 2023.Key Dates for Implementation:<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt2bba44a0c9fe2cde/63fe5b738d9f9910878e60c5/230228-medicare-prescription-drug.png?format=auto&amp;quality=60" alt="Medicare Prescription Drug Inflation Rebate Program Initial Guidance"/></div>Figure 1: CMS Factsheet: Medicare Prescription Drug Inflation Rebate Program Initial Guidance

220923-content.jpg

CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

220923-content

The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to pay a rebate to the federal government if prices for certain drugs and biologics covered under Medicare Part B and Part D increase faster than the rate of inflation (CPI-U).

CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

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

braverman_adam_blog_150x150.png

braverman_adam_common_640x280.jpg

braverman_adam_heroretina_2700x1160.jpg

braverman_adam_mobileretina_750x1040.jpg

braverman_adam_social_600x600.jpg

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense practice. Adam formerly served as an Associate Deputy Attorney General for the U.S. Department of Justice (DOJ) and as the U.S. Attorney for the Southern District of California. 

Adam L. Braverman

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense group. He represents companies and their executives in internal and government investigations, white collar criminal defense matters, and parallel civil litigation related to allegations of bribery, government procurement fraud, COVID-19 and CARES Act fraud, anti-money laundering violations, and matters involving organized crime.

Adam Braverman

lloyd_seth_blog_150x150.png

lloyd_seth_common_640x280.jpg

lloyd_seth_heroretina_2700x1160.jpg

lloyd_seth_mobileretina_750x1040.jpg

lloyd_seth_social_600x600.jpg

Seth Lloyd, a member of Morrison Foerster’s Appellate and Supreme Court practice, has been counsel in more than a hundred appeals in federal and state courts nationwide.

Seth W. Lloyd

Seth Lloyd is an associate in Morrison Foerster’s Appellate and Supreme Court Practice with broad experience briefing and arguing appeals. Seth has particular experience in patent appeals before the Federal Circuit. He has been a primary author of successful briefs on a wide range of technologies, from medical devices to chemistry to computer hardware and software. He also has successfully argued multiple times in that Court, including obtaining reversal of three Patent Trial and Appeal Board decisions in a consolidated appeal for a computer memory designer. Before joining Morrison Foerster, Seth served as a law clerk for Judge Richard G. Taranto of the Federal Circuit. He earned his J.D. from Stanford Law School and also holds a Ph.D. in electrical engineering from Stanford University.

Seth Lloyd

lifesciences-medical-device-2.jpg

Supreme Court Denies Review of Cost Sharing Assistance Program

De Novo Classification Final Rule to Take Effect Next Year

lifesciences-medical-device-2

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

On December 20, 2022, the Federal Trade Commission (FTC) issued its <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf" target="_blank">Health Products Compliance Guidance</a> (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Key updates and changes include:<ul><li>23 new examples to broaden the guidance to cover foods, over-the-counter drugs, devices, and other health-related products;</li></ul><ul><li>Clarification of FTC’s coordination with the Food and Drug Administration (FDA) regarding health product claims;</li><li>Detailed guidance on FTC’s standards for proper “clear and conspicuous” disclosure of claim qualifications; and</li><li>Expanded discussion on the required “competent and reliable scientific evidence” and testing methodology required to substantiate health-related claims.</li></ul>I. FTC AND FDA – JURISDICTION AND COOPERATIONFTC and FDA both have jurisdiction over marketing of dietary supplements, foods, non-prescription drugs, devices, and other health-related products. The agencies signed a <a href="http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm" target="_blank">memorandum of understanding</a> that clarifies FDA has primary responsibility for labeling claims (“including the package, product inserts, and other promotional materials available at point of sale”) and FTC has primary responsibility for advertising claims (“traditional TV, radio, print, and internet ads, but also more broadly to [a] variety of marketing techniques and promotion methods”). But as explained in the Health Products Guidance, the agencies may regulate the same type of claims for the same type of product differently. For example, while FDA evaluates a claim differently depending on whether the product is a supplement, food, or drug, FTC treats all health product claims the same. Unlike FDA, FTC does not pre-approve health claims or require notification for structure/function claims. And while FTC gives great deference to claims that FDA has endorsed, an FDA assessment is not dispositive of whether a claim may be deceptive according to FTC.II. FTC’S EVALUATION OF HEALTH-RELATED PRODUCT ADVERTISINGThe Health Products Guidance outlines FTC’s two-step process for evaluating the truthfulness and accuracy of advertising of dietary supplements, foods, over-the-counter drugs, and other health-related products. The first step of the process is to “identify all claims the advertising materials communicate to reasonable consumers.” The second step is “FTC assesses the scientific evidence upon which the company relies to determine whether there is adequate support for those claims.” Examples throughout the Health Products Guidance help illustrate how FTC applies these standards to claims and advertising.Step One: Identifying and Interpreting Claims and AdvertisementsWhen identifying and interpreting advertising claims, FTC focuses on the consumer’s understanding of an advertisement rather than the marketer’s intent because the intended audience may have special attributes that render them more susceptible to certain claims. For example, “terminally ill consumers might be particularly susceptible to exaggerated cure claims.” The Health Products Guidance explains that deceptive advertising may arise from either: (1) direct or implied claims about the benefits, safety, or other characteristics of the product, or (2) omitted information that “is material in light of the claims in the ad or with respect to how consumers would customarily use the product,” such as not indicating that a vitamin may cause fatigue.When disclosure of material information is necessary to prevent advertising from being false or misleading, the disclosure must be “clear and conspicuous.” In other words, mere inclusion of qualifying information is insufficient, and to prevent an ad from being deceptive, advertisers should ensure that a written disclosure is “easily noticed, read, and understood” and that an audible disclosure is “delivered in a volume, speed, and cadence so that it can be easily heard and understood.” Ultimately, whether a disclosure is sufficiently clear and conspicuous depends on whether it has an effective impact on a reasonable consumer.Step Two: Evaluating Claim SubstantiationFTC’s updated guidance dives deep on its second step in evaluating an advertisement’s truthfulness: whether a health product claim is properly substantiated with “competent and reliable scientific evidence.” When evaluating whether the advertiser has a reasonable basis to make a claim, FTC considers the following five factors.<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltf85bc77f18179737/63d97ed3ca59cf11374cf0c6/230130-ftc-issues-graph.jpg?format=auto&amp;quality=60" alt="life science chart"/></div>Under this framework, FTC generally requires randomized, controlled human clinical trials for most health benefit claims because they are needed to prove a causal link, but may make some exceptions where experts in the field accept alternative substantiation and human clinical trials are not feasible. The Health Product Guidance explains that to serve as adequate substantiation, a reliable, quality clinical trial should generally include randomization, a control group, double blinding, statistically significant results, and clinically meaningful results, among other characteristics.But the totality of the evidence must be considered in the context of the available scientific evidence in the applicable field and the actual claim being made. An individual study supporting a claim is not enough to make a claim truthful if the surrounding evidence in the field runs contrary to the study.III. OTHER ADVERTISING ISSUESThe Health Product Guidance also discusses five distinct health product advertising issues that may draw FTC scrutiny.<ol><li>Consumer testimonials or expert endorsements.FTC cautions against claims based on consumer testimonials or expert endorsements, unless those claims can be substantiated, as the advertiser is ultimately responsible for the misleading use of an endorsement.</li><li>Traditional use claims. Claims based on traditional use, such as an advertisement that indicates an herbal tea mixture has been used to aid digestion for hundreds of years, are not per se acceptable, and will be considered misleading if such claims are not substantiated.</li><li>DSHEA disclaimers. Mere use of the Dietary Supplement Health and Education Act (DSHEA) disclaimer stating that the product has not been evaluated by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease will not cure an otherwise deceptive advertisement or claim.</li><li>FDA oversight.Advertisers should be mindful “not to mischaracterize the extent to which a product or claim[GJL1]  has been reviewed, authorized, or approved by the FDA.”</li><li>Third-party literature. FTC will evaluate whether reference to third-party literature may constitute an implied and deceptive claim on a case-by-case basis.</li></ol>Advertisers of health-related products must be especially diligent about what claims they are making. Both FTC and FDA have jurisdiction over this area and both agencies have increased enforcement efforts in recent years for false and misleading claims. And as FTC’s updated Health Products Guidance demonstrates, advertising for health-related products must be nuanced and thoughtfully considered to avoid potential pitfalls that could lead to regulatory enforcement and litigation.Kai Mindick, a former law clerk in our Austin office, contributed to the writing of this post.

An orthopedic implant company

A children&rsquo;s monthly subscription service product

A fertility company

A major technology company

A smart fitness equipment company

Fitbit

park_julie_blog_150x150.png

park_julie_common_640x280.jpg

park_julie_heroretina_2700x1160.jpg

park_julie_mobileretina_750x1040.jpg

park_julie_social_600x600.jpg

Julie Park provides analytic and strategic counsel for issues in product life cycle, product liability and defective products, consumer class actions, and more.

Julie Park

Julie Park | Product Liability Lawyer

Julie Park protects her clients’ products no matter what kind of product issue they face—whether it is planning for new product development, recalling an existing product, or defending clients against product liability or consumer class actions. Drawing on her deep technical and legal expertise, Julie counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption while also managing complex and multijurisdictional litigation both in state and federal court.

Julie Y. Park

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

robinson_matt_blog_150x150.png

robinson_matt_common_640x280.jpg

robinson_matt_heroretina_2700x1160.jpg

robinson_matt_mobileretina_750x1040.jpg

robinson_matt_social_600x600.jpg

Associate

Matt is an associate in the Litigation Department in MoFo’s San Diego office. Matt’s practice focuses on the product lifecycle, from early product development to litigation to end-of-life advisement. He counsels clients through complex consumer product safety regulatory landscapes and product recalls.











Matt Robinson

FTC Issues Updated Health Products Claims Guidance