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 U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distincti

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

Pediatric Exclusivity for Biologics | MoFo Life Sciences

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights.At the outset, it is important to recognize that the patent term of a biologic product is distinct from the FDA’s regulatory market exclusivity period for the same product; these two public policies are governed by entirely separate laws and regulations. Patent term and the FDA’s exclusivity programs run concurrently and in parallel. As such, pediatric exclusivities (or other FDA exclusivities) do not formally extend the term of any patent rights. However, both of these legal frameworks have the same effect of extending the biologic product’s market monopoly and preventing competitors from introducing biosimilar products into the marketplace. In the event that certain patents rights are invalidated prior to the expiration of the full patent term, FDA exclusivities provide an additional safeguard against competitors seeking to enter the market. Thus, Sponsors should consider using both patent rights and FDA exclusivities to recoup research and development investments.Biologics are eligible to participate in the FDA’s pediatric exclusivity program.[i] Under Section 351 of the Public Health Service Act, in order to receive six months of pediatric exclusivity in addition to the 12-year exclusivity period granted under the Biologics Price Competition and Innovation Act,[ii] the FDA must issue a Written Request for the Sponsor to conduct specific pediatric studies for a given biological product.[iii] The Sponsor may choose (but is not required) to conduct the pediatric studies outlined in the Written Request, at its own expense, in exchange for an additional six months of exclusivity for its biological product. The exclusivity grant is based on whether the applicant complied with the terms of the Written Request and is not conditioned on approval of a pediatric indication.[iv] Any unauthorized deviation from the Written Request may result in non-compliance and can jeopardize the Sponsor’s ability to earn pediatric exclusivity. The FDA maintains discretion over issuing Written Requests for pediatric studies, and thereby controls the Sponsor’s ability to obtain multiple pediatric exclusivities. The FDA may issue multiple Written Requests, which are each eligible for an additional six-month exclusivity period, provided that the Sponsor appropriately complies with each Written Request.[v] Examples of previous Written Requests for biologics can be found on the FDA’s <a target="_blank" href="https://www.fda.gov/drugs/development-resources/list-determinations-including-written-request">List of Determinations Including Written Request</a> web page (see, e.g., ipilimumab and tocilizumab). It appears that the FDA has not yet issued multiple Written Requests for a single biologic. In fact, it appears rare for the FDA to issue multiple Written Requests for the same drug. In a previous Guidance, the FDA explained that a Sponsor of a new drug under Section 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) may submit a detailed proposal to the FDA for a Written Request, which is equally applicable to the holder of an approved Biologics License Application under Section 351 of the Public Health Service Act.[vi] The proposal for a Written Request should substantially follow the template that the FDA has previously used for a Written Request (see, e.g., <a target="_blank" href="https://www.fda.gov/media/106997/download">ipilimumab</a> and <a target="_blank" href="https://www.fda.gov/media/115367/download">tocilizumab</a>). The proposal should contain sufficient information to execute the studies such as the objective of the study, trial design, number and kinds of patients and other relevant patient characteristics, inclusion and exclusion criteria for the study, drug dosing for the treatment arm, statistical information for analyzing the results, and other pertinent information.[vii] The FDA will then evaluate the proposal and decide whether to issue a formal Written Request based on the information submitted. In addition, the FDA maintains a <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">FAQ web page</a> dedicated to qualifying for pediatric exclusivity under Section 505A of the FDCA. To qualify for pediatric exclusivity, the pediatric studies conducted to satisfy the requirements of the Pediatric Research Equity Act (PREA) must also satisfy all of the requirements for pediatric exclusivity under Section 505A of the FDCA.[viii]Fulfilling the Written Request for pediatric exclusivity is separate from meeting the Sponsor’s PREA obligations or any other requirements to perform phase 4 post-market surveillance studies.[ix] PREA requires that all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration contain an assessment of the safety and effectiveness of the product for the claimed indication(s) in pediatric patients, unless this requirement is waived, deferred, or inapplicable.[x] In terms of scope, PREA is more limited and requires a pediatric assessment of those indications included in the pending biologics license application (BLA), which addresses the safety and effectiveness of the claimed indications with respect to the drug or biological product. The FDA’s authority to issue a Written Request for pediatric exclusivity extends to the use of an active moiety for all indications that occur in the pediatric population, regardless of whether the indications have been previously approved in adults or approval for those indications is being sought in adults.[xi] The FDA has previously advised that an applicant seeking to qualify for pediatric exclusivity should obtain a Written Request for studies from FDA before submitting the pediatric studies to satisfy PREA.[xii]  [i] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Notice that under § 262(m)(1), the rules for submitting pediatric studies are the same for both drugs and biologics under § 505A of the Federal Food, Drug, and Cosmetic Act (FDCA) (codified as 21 U.S.C. § 355a). More precisely, § 262(m)(1) carves out the exclusivity benefits in §§ 505A (b)-(c) for drugs, which are then re-inserted as §§ 262(m)(2)-(3) as applicable to biologics given the different exclusivity periods.[ii] See 42 U.S.C. § 262(k). [iii] See 42 U.S.C. § 262(m) (Section 351 of the Public Health Service Act). Under both §§ 262(m)(2) and m(3), the Secretary makes a written request to the applicant to perform additional pediatric studies, and the applicant accepts that request (at its own expense), the applicant is rewarded another six months of exclusivity. Note that under 21 U.S.C § 355a(h) (carried over into 42 U.S.C. § 262(m)(1) for biologics), pediatric exclusivity shall only be granted for a study or studies that are the subject of a Written Request from the FDA and prior to nine months from expiration.[iv] See <a target="_blank" href="https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently">https://www.fda.gov/drugs/development-resources/qualifying-pediatric-exclusivity-under-section-505a-federal-food-drug-and-cosmetic-act-frequently</a>.[v] See Guidance for Industry, Qualifying for Pediatric Exclusivity Under Section 505(A) of the Federal Food, Drug, and Cosmetic Act (June 1998, revised Sept. 1999). [vi] See id. (listing specific requirements for a Proposed Pediatric Study Request).[vii] See id.[viii] See Sections 505A(d) and 505A(h) of the FDCA (codified as 21 U.S.C. §§ 355a(d) and (h), respectively).[ix] See Section 505B of the FDCA (codified as 21 U.S.C. § 355c). PREA also authorized the FDA to waive the required assessments when the drug or biological product (1) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients and (2) is not likely to be used in a substantial number of pediatric patients.[x] See id.[xi] See Section 505A(a) of the FDCA, codified as 21 U.S.C. § 355a(b)(1).[xii] <a target="_blank" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-comply-pediatric-research-equity-act">See Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act (Sept. 2005)</a>.

Pediatric Exclusivity for Biologics

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