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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Because No One is Immune to the Law

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On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab appl

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FDA’s Loud and Clear Message: Engage with FDA Early and Formally

FDA’s Loud and Clear Message: Engage with FDA Early and Formally | MoFo Life Sciences

Brigid DeCoursey Bondoc

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in China. Rather than following the traditional paradigm of assessing the risk-benefit profile of a single drug, the committee was, in a significant departure from typical Advisory Committee practice, asked to vote on a single question: Whether additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. The committee ultimately voted 14–1 in support of the need for additional clinical trials, potentially delaying sintilimab’s approval in the United States by years. Yet, with more than 25 drug applications from China pending before the FDA, according to Dr. Richard Pazdur in his February 4, 2022 article in The Lancet, the more pressing question is whether the panel’s decision has any relevance beyond sintilimab. While there is no quick answer, the loud and clear message is that sponsors need to engage with the FDA early and formally if they seek FDA approval for their drugs.   ORIENT-11 is a randomized, double-blind, placebo-controlled phase 3 trial assessing the safety and efficacy of sintilimab in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). With trials exclusively in China, sintilimab’s review hinges on the FDA’s regulatory flexibility under <a target="_blank" href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-D/section-314.106">21 C.F.R. 314.106</a>, which stipulates that “[a]n application based solely on foreign clinical data meeting U.S. criteria for marketing approval may be approved if the foreign data are applicable to the U.S. population and U.S. medical practice.” After hearing presentations from both the FDA and the sponsor, the majority of the ODAC members decided that the study was not generalizable to the U.S. population because (1) the patient demographics in ORIENT-11 do not reflect the diverse U.S. population; (2) the study endpoint and comparator arm were not the standard of care for U.S. medical practice; (3) the consent forms should have been updated when pembrolizumab was approved by the Chinese regulatory agency seven months after study initiation; and (4) the inspections were too limited in scope to assess trial conduct and data integrity.Despite calling into question ORIENT-11’s trial design and conduct, the FDA did not conclude that trials conducted exclusively in a single foreign country could never be approved in the United States. Instead, the FDA indicates that the agency will apply 21 C.F.R. 314.106 in a flexible manner according to the nature of the drug and data considered. For “me-too” drugs that do not address unmet medical needs, rare diseases, or novel drug classes, the agency has to determine the applicability of the foreign data to the U.S. population, the recognized competence of the clinical investigators, and the FDA’s validation of the data. Sintilimab review provides valuable insights for sponsors that seek FDA approval based on a foreign-only clinical strategy.(1) Early engagement with the FDA. Regardless of the clinical strategy, sponsors should engage with the FDA formally and early if they want their drugs to be marketed in the United States. Relying on informal communication with the FDA can be a costly mistake. Eli Lilly and Innovent were reportedly prepared to launch sintilimab in the U.S. market when Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, openly welcomed Chinese sponsors to bring their PD-1/PD-L1 inhibitors to the U.S. market during the March 2019 American Association for Cancer Research (AACR) meeting. Yet, on February 4, 2022, less than one week before the committee meeting, Dr. Pazdur, writing for The Lancet, argued that drug applications seeking approval based on data from a “single foreign country” need to be representative of the U.S. population in order for regulators to be flexible. Defending his change of position, Dr. Pazdur declared that “I have a right to change my mind” in an interview with STAT News four days later. During the committee meeting, Dr. Pazdur emphasized again that “comments that were made at an AACR meeting should not be viewed as regulatory policy.”Sintilimab’s bumpy ODAC meeting sends a strong message that informal communication from the FDA should never be the basis for any business or regulatory decision. Additionally, if a product wants to enter the U.S. market, the sponsor needs to engage with the FDA during the early phases of drug development or early enough in advance of submission to have meaningful engagement with the FDA regarding the data development.The benefit of engaging the FDA early and formally is that the FDA can provide formal regulatory advice with regard to both study design and trial conduct. This can be particularly important when conducting trials in countries with different standards of care, or regulatory structures that are different from the ones in the United States. For ORIENT-11, the FDA has now indicated that it would have advised the sponsors to conduct a non-inferiority trial, comparing sintilimab with an FDA-approved anti-PD-(L)1/chemotherapy regimen with an overall survival (OS) endpoint, rather than a placebo arm with a progression-free survival (PFS) endpoint.  (2) Data Integrity. Data integrity is a critical underlying concern for all clinical trials, and is especially important for foreign sites. For ORIENT-11, the FDA conducted in-person inspections of two of the forty-eight clinical sites and one remote inspection of the sponsor. The inspections uncovered some minor issues, such as under-reporting of adverse events and the use of concomitant medications. However, the FDA cautioned that its inspections and data validation are limited in scope. The agency’s concerns, expressed during the ODAC meeting, are two-fold: first, most study investigators have limited experience conducting clinical trials, and second, historical data integrity problems in China make the agency less confident about clinical data generated locally. Citing a 2016 report by China’s State Food and Drug Administration that 80% of clinical trial data from China were “fraudulent or substandard,” Dr. Pazdur asked the sponsor during the ODAC meeting to clarify whether any site investigators were previously involved in data integrity scandals. To mitigate the potential or perceived issue of investigator competence and prevent fraudulent conduct in clinical trials, the FDA highlighted the need for international, multi-regional clinical trials (MRCTs) with “investigators who have gained experience in regulatory submissions to the FDA.” Further, MRCTs can enable regulators to “look at sites in different countries and take a look at differences . . . in adverse event reporting, in efficacy, and compare them and to see if there is any outlier.”(3)  Diversity. Both FDA officials and the committee members emphasized the need for trial subject diversity. Dr. Pazdur, responding to his comments at the 2019 AACR when recently questioned, stressed that “[t]he world has changed since those comments were made,” adding that the agency has to address ethnic and racial diversity concerns in clinical trials. The agency highlighted some known differences between the U.S. population with non-squamous NSCLC and the patient population enrolled in ORIENT-11, pointing out that ORIENT-11 enrolled only Chinese patients, while the U.S. racial/ethnic breakdown is 79% white, 15% Black, and 6% Asian. The FDA acknowledged that the majority of the studies approved by the agency do not reflect racial representation of the U.S. population. However, Dr. Pazdur avowed the agency’s commitment to “address ethnic and racial diversity,” adding that the agency cannot be deaf to the outcry even though it will require a major shift throughout the FDA.  (4) Human Subject Protections. Another area of focus by both the FDA and during the ODAC meeting was the troubling consent process. Seven months after ORIENT-11 was activated, pembrolizumab was approved by the Chinese regulatory agency as a first-line therapy for NSCLC. However, the consent form was not updated to reflect the change, a severe deviation from good clinical practice (GCP) requiring that patients be informed of any new and available treatment options for their conditions. The sponsor explained that, although the written consent form was not revised, all patients were informed by their treating physicians that another treatment option was available. Further, the sponsor pointed out that pembrolizumab was never a real option for ORIENT-11 patients due to its low availability and prohibitive cost.Informed consent is at the heart of modern clinical trials. Neither the agency nor the committee found the sponsor’s rationale reasonable. As pointed out by Dr. Ravi Madan, clinical director for the Genitourinary Malignancies branch at the National Cancer Institute, “while data integrity is of utmost importance in clinical research, moral integrity is of greater importance,” and regulatory agencies need to ensure in large studies like ORIENT-11 that “patients have the appropriate informed consent that is updated as needed over time.”The fate of sintilimab might be jeopardized, but its review process can provide insightful messages to future sponsors who plan to use foreign data when seeking FDA approval. The loud and clear message for sponsors is to engage with the FDA early and formally if the product is intended to be marketed in the United States. Informal communication can be a great way to learn the current thinking of the agency; however, it is critically important to follow up with a formal meeting to receive formal regulatory advice. Second, the FDA clearly favors MRCTs as a way to promote diversity and data integrity. It could be very beneficial to engage with study sites that have a known reputation with the FDA, such as prior involvement in FDA regulated clinical studies. Last, but not least, all clinical studies need to be conducted ethically, with informed consent as the cornerstone of all research ethics. Sponsors need to put in the utmost effort to ensure that patients are fully informed throughout the study.

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