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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Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc, f

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Possession of an "Effective" Dose | MoFo Life Sciences

Kelsey J. Roberts Kingman Ph.D.

Bu Yin Ph.D.

Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit <a target="_blank" href="https://cafc.uscourts.gov/opinions-orders/20-1933.ORDER.3-16-2022_1922220.pdf">denied Biogen International’s petition for panel rehearing and rehearing en banc</a>, following a November split decision discussed below.Judges Lourie, Moore, and Newman dissented on the denial of en banc rehearing. Judge O’Malley had dissented from the November panel decision, but retired on March 11, 2022 and only participated in the decision on panel rehearing, not the decision on rehearing en banc.The dissent indicates that the court remains divided regarding application of the written description requirement to the facts in this case.________________________________When does an applicant have “enough” to file a patent application and be granted a patent?That question continues to dog applicants in the biopharmaceutical industry, particularly in view of recent Federal Circuit decisions concerning whether a patent application provides adequate written description for claims requiring functional limitations, such as administering an “effective” amount of a therapy.Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021).In this <a href="https://cafc.uscourts.gov/opinions-orders/20-1933.OPINION.11-30-2021_1871902.pdf" target="_blank">recent split decision from the Federal Circuit</a>, the majority affirmed a District Court decision that Biogen failed to demonstrate possession of a method of treating Multiple Sclerosis (MS) with a therapeutically effective dose of dimethyl fumarate (DMF) of about 480 mg per day claimed in Biogen’s U.S. patent 8,399,514 (the ’514 patent).Claim 1 of the ’514 patent is representative and recites:A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 [milligrams] per day [(mg/day)].In its decision, the majority focused on the fact that the DMF480 dose is listed only once in the specification, and that the sole reference to DMF480 appears at the end of one range among a series of ranges, including DMF concentrations of 100–1,000, 200–800, 240–720, and 480–720 mg/day. In addition, the majority observed that the specification defines the term “effective” within a therapeutic, rather than drug-discovery, context, and the sole DMF-dosage paragraph is not linked to treatment of any specific disease, much less a neurological disorder including MS. The majority contrasted this disclosure with the description of DMF720, which is referenced independently as one dose and was known to be effective in treating MS as of the February 2007 priority date. The majority agreed with the district court that it was not necessary to distinguish between clinical efficacy and therapeutic efficacy, particularly because the specification’s definition of “therapeutically effective dose” indisputably featured both clinical and therapeutic insignia.Judge O’Malley dissented, arguing that the District Court erred by disregarding Biogen’s explanations of the distinction between clinical efficacy and therapeutic efficacy, and that “the district court’s conflation of therapeutic and clinical efficacy caused it to erroneously require clinical data, rather than therapeutic effects.” Judge O’Malley further argued that the District Court erred in applying the Court’s “blaze marks” precedent to the claimed DMF480 dose, because the specification does not provide a “laundry list” of therapeutically effective doses, and begins one of several disclosed ranges with the exact DMF480 dose that is claimed.Biogen filed a petition for rehearing en banc, saying the majority incorrectly created a heightened written description standard to “require that Biogen prove the efficacy of its claimed method, rather than describe the claimed invention.” It also objected to the majority’s “insistence on further repetition or singling out” of the DMF480 dose, saying that there is “no requirement that a specification repeat or single out a claimed embodiment.”Several industry groups have urged the Federal Circuit to review the decision.[1] After Mylan filed a response on February 3, it remains to be seen whether the court will provide additional clarity to applicants regarding what is “enough” for written description.Practice TipsPatentees must balance competing factors for timing disclosure of inventions. Filing a patent application too late risks being beaten by a competitor. Filing too soon risks not adequately describing the claimed invention, while potentially poisoning the well for future filings. In particular, care should be taken in the timing for describing specific dosing regimen. The majority noted in Biogen that an inventor need not prove that a claimed pharmaceutical compound actually achieves a certain result, but when that result is expressed claimed in the claims, “our case law provides that [such] result must be supported by adequate disclosure in the specification.” Nuvo, 923 F.3d at 1384. Thus, applicants may want to avoid early disclosure of specific dosing regimens and pursue tailored dosing claims in later filings.When disclosing a series of ranges, applicants should consider providing “blaze marks” to the ranges or values that are more likely to be effective. As highlighted in Biogen, even a short list of ranges may not be considered adequate support for claiming a particular endpoint within the ranges that is later proven to be effective. For example, calling out DMF480 individually or specifically connecting DMF480 (or even a range covering DMF480) to therapeutic efficacy for MS would have strengthened Biogen’s case for written description.Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of biotech and biopharmaceutical industries. [1] Biotechnology Innovation Organization, a division of the American Chemical Society, and Pharmaceutical Research and Manufacturers of America all filed amicus briefs on January 19, 2022, supporting Biogen’s petition for rehearing en banc.

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