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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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.

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In this third of a four-part podcast series, we discuss the science, regulatory framework, and commercial transactions considerations of a COVID-19 vaccine. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with:<ul><li>Otis Littlefield, senior of counsel in our Patent group: Why do we need vaccines? What are the general classes of vaccines? Where are we now with regard to vaccine development?</li><li>Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What is the typical timeline for the development and regulatory approval of a vaccine? What is involved in the process? How does the FDA regulate vaccines under normal circumstances?</li><li>Rufus Pichler, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s Technology Transactions practice: What are some of the unique commercial aspects to an accelerated vaccine development? How are companies assessing risk as they scale up their operations? What is the open COVID patent pledge?</li></ul><div></div><div><h4 style="box-sizing: inherit;margin-top: 0.2rem;margin-right: 0px;margin-bottom: 0.5rem;margin-left: 0px;padding-top: 0px;padding-right: 0px;padding-bottom: 0px;padding-left: 0px;color: rgb(94, 95, 97);font-family: Oswald, sans-serif;line-height: 1.4;text-rendering: optimizelegibility;font-size: 1.4375rem;font-variant-numeric: normal;font-variant-east-asian: normal;text-transform: uppercase;hyphens: none;overflow-wrap: normal;"><a style="box-sizing: inherit;background-color: transparent;color: rgb(77, 169, 197);line-height: inherit;text-decoration-line: none;" target="_blank" href="https://www.mofo.com/resources/video-audio/201103-life-sciences-primer-covid-19-podcast-episode-3.html">LISTEN TO THE PODCAST</a></h4></div>

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Senior Of Counsel

Otis focuses his practice on representing life sciences clients, including biotechnology, pharmaceutical, agricultural biotechnology, and medical device companies.
He has deep experience and knowledge

Otis Littlefield Ph.D.

Otis Littlefield

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

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Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations

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In this third of a four-part podcast series, we discuss the science, regulatory framework, and commercial transactions considerations of a COVID-19 vaccine. Mic

Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations

In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses the issues, among other topics, with:<ul><li>Jean Nguyen, patent associate, founder and co-leader of the firm’s Life Sciences Data Analytics patent group: How are companies using AI and machine learning to combat the coronavirus? Can this technology predict who is at risk? How might this technology be helpful in predicting how COVID-19 or any other virus is spreading?</li></ul><ul><li>Kristen Mathews, partner in MoFo’s Global Privacy + Data Security practice: What are privacy issues involved with contact tracing? Who has access to this data? What kind of government guidelines are being put in place regarding how the data is collected?</li></ul><ul><li>Matt Karlyn, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s Technology Transactions practice: What developments have you seen with regard to cloud computing and AI? How are companies collaborating to use this data in the fight against COVID-19? What are some of the legal issues companies should be aware of when negotiating deals involving data and AI?</li></ul><ul><li>Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What are some of the ways the FDA is addressing the use of AI and software in fighting COVID-19? Is the software critical to new ways of providing care during the pandemic? Any other firsts for the FDA in recent months?</li></ul><div></div><div><h4><a target="_blank" href="https://www.mofo.com/resources/video-audio/201020-life-sciences-primer-on-covid-19-episode-2.html">Listen to the podcast</a></h4></div>

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Associate

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

CSPC Pharmaceutical Group Limited

ACEA Therapeutics

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BluesphereBio

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Matt Karlyn has 23 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensi

Matt Karlyn

Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each

Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

During our fifth <a href="https://www.mofo.com/resources/events/200916-fall-2020-virtual-course.html" target="_blank">Patent Law Course</a> session offered by Morrison & Foerster and GSAS <a href="http://thebiotechclub.org/" target="_blank">Harvard Biotech Club</a> , Steve Rowles, firmwide co-chair of the <a href="https://www.mofo.com/capabilities/emerging-companies-venture-capital.html" target="_blank">Emerging Companies & Venture Capital Group</a>, chair of MoFo’s San Diego Corporate Group, and managing partner of the San Diego office, emphasized that:“nothing is more central to our life sciences practice than assisting budding entrepreneurs in building world-class organizations that address critical unmet needs of patients. The road ahead is fraught with obstacles but the odds of success can be greatly improved by proper planning and learning from the missteps of those who have come before. We appreciate the opportunity to share the insights of our preeminent and global life sciences practitioners to assist founders in avoiding pitfalls and realizing their vision.”Our second speaker, Matt Karlyn, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s <a href="https://www.mofo.com/capabilities/technology-transactions.html" target="_blank">Technology Transactions practice</a>, noted that “it’s such an incredible opportunity to talk to researchers, students, practitioners, and people interested in life sciences about the commercial aspects of the practice. MoFo’s Commercial Life Sciences Transactions + Licensing practice is at the forefront of so many interesting and novel transactions. We love when we have the opportunity to talk about how we structure, draft, and negotiate these transactions, and answer so many interesting questions about some of the nuanced aspects of our work.”

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Steve Rowles is Chair of the firm’s San Diego Corporate Group.  He has practiced in San Diego for over 25 years and has a wealth

Steve Rowles

Steve Rowles is Chair of the firm’s San Diego Corporate Group and firmwide co-chair of the Emerging Companies & Venture Capital Group. He has practiced in San Diego for over 25 years and has a wealth of experience as corporate counsel to public and private companies, and the venture capital and private equity funds that invest in those companies.

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Life Sciences Startup: Top Things to Keep in Mind About Formation and License Agreements

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During our fifth Patent Law Course session offered by Morrison & Foerster and GSAS Harvard Biotech Club , Steve Rowles, firmwide co-chair of the Emerging Compan

Life Sciences Startup: Top Things to Keep in Mind About Formation and License Agreements

Morrison & Foerster Research Analyst Christine Lentz contributed to the writing of this article.The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers. H.R.4439, or the “Creating Hope Reauthorization Act,” aims to amend Section 529(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)(5)) to extend the program cutoff deadlines by four years.<h4>Historical Incentive for Pharmaceutical Companies</h4>To help stimulate new development of rare pediatric disease (RPD) drugs, Congress created the RPD Priority Review Voucher Program in 2012, which offered additional incentives for obtaining FDA approval of these products. Under this program, a pharmaceutical company that receives an approval for a drug or biologic for a RPD may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.Since these vouchers can be redeemed to receive priority review from the FDA with a targeted evaluation time of six months, rather than the 10-month standard review, the program potentially accelerates pharmaceutical companies’ time-to-market, allowing them to begin recouping their considerable drug development costs sooner. For patients with serious conditions, the expedited review means they have earlier access to a potentially life-saving or -changing treatment.While some companies have successfully (and unsuccessfully) redeemed priority review vouchers for their own future drug applications, others have transferred/sold them to other companies for prices ranging from about $67 million to $350 million. According to a <a target="_blank" href="https://www.gao.gov/assets/710/704207.pdf">Government Accountability Office (GAO) study</a>, the FDA awarded 31 vouchers, mostly for drugs to treat RPDs in fiscal years 2009 through 2019. Of those 31 vouchers, 17 were sold to another drug sponsor.This structure has both motivated companies to develop RPD drugs and sped up review of blockbuster therapies that otherwise would not qualify for priority review.<h4>Recent Program Developments</h4><table border="1" cellspacing="0" cellpadding="0" style="width: 0px;"><tbody><tr><td width="228" rowspan="2" style="width: undefined%; height: auto;">Proposed/Effective</td><td width="140" valign="top" style="width: undefined%; height: auto;">December 2016</td><td width="140" valign="top" style="width: undefined%; height: auto;">September 2020</td><td width="140" valign="top" style="width: undefined%; height: auto;">Future TBD</td></tr><tr><td width="140" valign="top" style="width: undefined%; height: auto;">21st Century Cures Act</td><td width="140" valign="top" style="width: undefined%; height: auto;">Congress Short-term Extension</td><td width="140" valign="top" style="width: undefined%; height: auto;">Creating Hope Reauthorization Act</td></tr><tr><td width="228" valign="top" style="width: undefined%; height: auto;">RPD Drug Designation Grant Cutoff</td><td width="140" valign="top" style="width: undefined%; height: auto;">September 30, 2020</td><td width="140" valign="top" style="width: undefined%; height: auto;">December 11, 2020</td><td width="140" valign="top" style="width: undefined%; height: auto;">September 30, 2024</td></tr><tr><td width="228" valign="top" style="width: undefined%; height: auto;">RPD Priority Review Voucher Grant Cutoff</td><td width="140" valign="top" style="width: undefined%; height: auto;">September 30, 2022</td><td width="140" valign="top" style="width: undefined%; height: auto;">December 11, 2022</td><td width="140" valign="top" style="width: undefined%; height: auto;">September 30, 2026</td></tr></tbody></table>In December 2016, the 21st Century Cures Act previously extended the RPD Priority Review Voucher Program, authorizing the FDA to award vouchers through September 30, 2022, limited to drugs with RPD designation granted by September 30, 2020.On September 30, 2020, Congress provided a short-term extension of the RPD Priority Review Voucher Program. According to the current statutory sunset provisions:<ul><li>After December 11, 2020, the FDA may only award a voucher for an approved RPD product application if the sponsor has RPD designation for the drug and that designation was granted by December 11, 2020. </li><li>After December 11, 2022, the FDA may not award any RPD priority review vouchers.</li></ul>The Creating Hope Reauthorization Act, which was received in the Senate on September 30, 2020, proposes to replace those cutoffs with “September 30, 2024” and “September 30, 2026,” respectively, thus extending the authorized period for RPD designation and granting of RPD priority review vouchers from the 21st Century Cures Act by four years.We will continue to monitor the trajectory of the Act and update this post as requested. Keep up with the latest legal and industry insights, news, and events by signing up at <a target="_blank" href="https://www.mofo.com/resources">Morrison & Foerster’s Resource Center</a>.

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Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers

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Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers