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

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

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

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate 

Blogs -  Home Button

Home

Blog - Topics

AI + Robotics

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

CARES Act of 2020:  Guide for Drug and Device Companies

CARES Act of 2020:  Guide for Drug and Device Companies | MoFo Life Sciences

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward.  The Act includes many provisions addressing specific needs that have come to light during the COVID-19 pandemic, but some of these provisions have important impacts on the drug and device industry well beyond the current pandemic.  The CARES Act, unsurprisingly, also contains provisions unrelated to the COVID-19 pandemic but that have potentially significant impacts on life science and medical device companies.This summary blog post outlines some of the key provisions in the CARES Act that may be of interest to Morrison & Foerster’s life science and medical device clients.  In the coming months, Morrison & Foerster will track these issues and provide more comprehensive updates on the practical application and any intended (or unintended) consequences of these new legal requirements. <h4>Provisions to meet the needs of COVID-19 and future pandemics</h4>The CARES Act includes a number of provisions impacting different financial aspects of healthcare related to COVID-19.  For example, it authorizes the allocation of $1.32 billion for fiscal year 2020 for the detection of the virus that causes COVID-19 (SARS-CoV-2) or the prevention, diagnosis, and treatment of COVID-19.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3211</a>.)  It also requires insurers to cover diagnostic tests and qualifying preventative services for COVID-19.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3201–3203</a>.)  These changes should help increase the availability of and maintain a fair pricing scheme for such tests and services.  But note that any healthcare or laboratory provider offering COVID-19 diagnostic tests is required to disclose the cash price of the test on the provider’s public website during the emergency period.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3202</a>.)The severe respiratory issues caused by COVID-19 in some patients has led to a shortage of ventilators.  The CARES Act adds certain respiratory devices to the existing list of covered countermeasures for use during public health emergencies.  As a result, manufacturers and distributors that meet the statutory requirements will not be liable for issues arising from the use of covered respiratory devices during a public health emergency.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3103</a>.)  This, in conjunction with the <a target="_blank" href="https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ventilators">FDA EUA process for ventilators</a>, is expected to help with this critical supply need during the pandemic.  Please see our related blog post <a target="_blank" href="https://classdismissed.mofo.com/fda/fda-inspires-modifications-and-quick-authorizations-for-ventilators/">FDA Inspires Modifications And Quick Authorizations For Ventilators</a>.Another means for tackling the COVID-19 pandemic is through expedited review of both relevant abbreviated new drug applications (ANDAs) and supplements to NDAs/ANDAs, and expedited inspections or re-inspections of establishments, if such action could help prevent or mitigate a drug shortage.  (See Section 3111.)  Prior to the CARES Act, expedited reviews and inspections were optional, but the Act now requires the FDA to carry out such expedited procedures.  This change applies not only to current shortages related to COVID-19, but to all potential drug shortages going forward. A unique issue arising from the risk of infection during the COVID-19 pandemic is the widespread need for remote access to healthcare.  The Public Health Services Act previously acknowledged the need for improved telephone-based healthcare (telehealth) systems.  The CARES Act reauthorizes and extends telehealth network and telehealth resource center grant programs.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3212</a>.)  The Act also increases access to telehealth services by, for example, increasing private insurance and Medicare coverage during emergency periods.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3701, 3703–3706</a>.)  However, it is important to note that the federal changes to telehealth regulatory requirements do not fully address the myriad of state law requirements addressing the practice of telemedicine and the licensing requirements needed to permit telemedicine practice.  Thus, we are tracking each state’s emergency response and telemedicine regulatory changes. <h4>Heightened reporting requirements for medical devices, drugs, and active pharmaceutical ingredients</h4>Both medical device and drug manufacturers are now subject to immediate, new, or heightened reporting and risk management requirements.  Importantly, these new requirements for the first time also apply to medical devices critical to human health going forward. Manufacturers of life-saving drugs were already required to notify relevant authorities, including the FDA, of any discontinuation or interruption of the manufacture of a life-saving drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, and the reasons for such discontinuance or interruption.  The CARES Act expands the reporting requirements to include “any such drug that is critical to the public health during a public health emergency” and the active pharmaceutical ingredient(s) of such life-saving drugs.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3112</a>.) Manufacturers of life-saving drugs, their active pharmaceutical ingredients, and any associated medical device included with a drug for its preparation or administration are also now required to develop a redundancy risk management plan identifying and evaluating risks to the supply of the drug for each establishment in which the drug or active pharmaceutical ingredient is manufactured.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3112</a>.)The CARES Act also imposes new reporting requirements regarding discontinuances or interruptions in the production of medical devices that are critical to public health during or in advance of a public health emergency.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3121</a>.)  Any discontinuances or interruptions must be reported 6 months in advance or as soon as practicable.  In the immediate term, these requirements most obviously apply to ventilators (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Section 3103</a>), but they will also apply to any medical devices critical to public health in future public health emergencies.<h4>Regulatory changes to market entry for over-the-counter drugs, unrelated to COVID-19</h4>The CARES Act implements a new administrative order process that replaces the existing over‑the-counter (OTC) drug monograph process.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3851–3853</a>.)  The OTC reform legislation has been pending for some time and, as part of political negotiations, is now embedded and enacted through the CARES Act.The marketability of category I–III drugs under the new system will depend on the current monograph status of the drug (proposed, tentative final monograph (TFM), or final) and the generally recognized as safe and effective (GRASE) category. Category I ingredients in a final monograph or tentative final monograph (TFM) would generally be considered GRASE and eligible for continued OTC marketing under the new process.  Category III ingredients subject to a TFM, and Category I ingredients subject to an advanced notice of proposed rulemaking (ANPRM), can continue to be marketed without an approved new drug application (NDA), unless otherwise directed by an Administrative Order.  Category II and other OTC ingredients that were already determined as not GRASE must file NDAs and will be required to leave the market within 180 days unless approved.Further, Category I and III ingredients can only be marketed in a dosage form that has been used to a material extent and for a material time prior to enactment of the CARES Act.  Only a “minor change” (i.e., one that does not change the safety, effectiveness, or material absorption of, or exposure to, the ingredient) to a dosage form is allowed.The new provisions convert existing final monographs and TFMs, and disallowed OTC ingredients, to final Administrative Orders.  The FDA may now also make GRASE decisions for OTC drugs using the existing GRASE standard and issue Administrative Orders.  The Act requires the FDA to develop further guidance on these processes.Any OTC drug currently on the market that fails to meet the new requirements or is not subject to an FDA Administrative Order will be deemed a “new drug” subject to the FDA’s new drug approval process.To promote innovation, the CARES Act provides for a new 18-month market exclusivity process for certain OTC drugs that contain an active ingredient not previously used or provides for a change in the conditions of use of a drug for which new human data studies were conducted.  The Government Accountability Office (GAO) will evaluate the new process within four years, including, among other things, the impact on FDA resources, consumer access, OTC drug prices, and sunscreens.Finally, to fund this new Administrative Order process, the CARES Act authorizes the FDA to collect user fees from the OTC drug industry, with payments starting in July of 2020.  (See <a target="_blank" href="https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf">Sections 3861–3862</a>.)

What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

LinkedIN