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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In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the <a href="https://www.fda.gov/media/139638/download" target="_blank" dir="ltr">Development and Licensure of Vaccines to Prevent COVID-19</a> (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023, when it announced that the current policy on Emergency Use Authorizations (EUAs) for COVID-19 vaccines would expire on November 7, 2023, unless superseded by another policy before that date. While the Guidance does not indicate that it replaces the previous EUA guidance, it is significant because FDA does clearly state that, “At this time, the goal of new vaccine development programs to prevent COVID-19 should be to pursue traditional approval[.]”The Guidance provides extensive recommendations on how to conduct pre-clinical and clinical studies and what FDA expects from sponsors regarding the data to support their Biologics License Application (BLA) submissions. Some of the noteworthy aspects of the Guidance include the following:<ul><li dir="ltr">The Guidance suggests that because the immunogenicity of COVID-19 is still not well understood, developers should focus on vaccine efficacy in their trials.</li><li>FDA recommends late phase trials with thousands of participants and at least six months of monitoring.</li><li>FDA also takes important steps in the Guidance to address health inequities related to vaccine trials and the effects of COVID-19, noting that the agency “strongly encourages” enrollment of racial and ethnic minorities. FDA also encourages vaccine developers to include pregnant women in trials.</li><li>FDA encourages sponsors to consider more innovative clinical trial designs that may speed up the development process, such as adaptive trials and seamless trials.</li><li>To facilitate the ability to make comparisons across vaccines, FDA recommends the standardization of efficacy endpoints across trials.</li><li>Screening trial participants and evaluating the efficacy of trials will require high quality in vitro diagnostic testing to accurately detect infection. However, the Guidance merely states that the testing should be “sensitive and accurate” and “validated before use in pivotal clinical trials” without further specifying a standard or regulatory status of the testing to be used.  </li><li>The Guidance also provides that accelerated approval may be appropriate for a vaccine that can more fully protect against COVID-19, but FDA will require a better understanding of COVID-19 immunology.</li></ul>Overall, it appears that FDA is taking steps to ensure that some of the criticisms of the government’s response to COVID-19 are addressed, for example, by encouraging diverse trials in acknowledgment of the health inequities of those populations who have been most affected by COVID-19. FDA also continues to recognize the need for public transparency regarding the standards of vaccine approval and the importance of establishing rigorous standards for the approval of COVID-19 vaccines. However, it seems that other criticisms, such as the concern among many in the public that the vaccines do not prevent diseases, will remain unaddressed for now. Until the immunology of COVID-19 is better understood, we will likely continue to see members of public skeptical of future vaccines because they do not prevent infection.As an administrative law matter, it is noteworthy that FDA issued the Guidance without prior comment, invoking the provisions of FDA’s statutes and regulations that say a guidance can be immediately implemented without public comment when a public comment period is not feasible or appropriate. Most of FDA’s COVID-19 guidance publications have been immediately issued without the opportunity for public comment, given the exigencies of the COVID-19 pandemic. However, with the Public Health Emergency no longer in place, it is unclear what FDA’s basis was for immediate publication of the Guidance, and FDA did not provide any explanation.

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023, when it announced that the current policy on Emergency Use Authorizations (EUAs) for COVID-19 vaccines would expire on November 7, 2023, unless superseded by another policy before that date.

New FDA Guidance on COVID-19 Vaccines

Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas by as early as 2030 (Global cleantech market size by country 2030 | Statista). The Inflation Reduction Act of 2022 provided for up to 400 billion dollars in clean energy infrastructure and subsidies. And clean energy is just one aspect of clean technology. Other examples include recycling waste products that would otherwise fill landfills, carbon sequestration, and low-carbon footprint industrial solutions.Read the <a href="https://mofotech.mofo.com/topics/top-10-considerations-in-licensing-cleantech-innovations" target="_blank">full blog post</a>.

Top 10 Considerations in Licensing Cleantech Innovations

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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Anita Choi has decades of experience providing strategic advice to companies and investors in the Life Sciences and Food + Agriculture industries. She has helped start-up companies build IP portfolios around their core technologies, and counseled them on issues related to patents versus trade secrets.

Anita Choi

Anita Choi’s practice focuses on patent prosecution, portfolio management, IP due diligence, and IP litigation support. Her clients range from early-stage start-up enterprises to established domestic and international companies. She is well-versed in building and managing worldwide patent portfolios across many sectors and technologies, including small-molecule pharmaceuticals, medical devices, diagnostics, industrial chemicals and advanced materials, food and agtech.

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Emily’s practice focuses on patent preparation, prosecution, and counseling.

Emily Jane Roberts Ph.D.

Emily Roberts

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Top 10 Considerations in Licensing Cleantech Innovations

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Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. 

10 Considerations in Licensing Cleantech Innovations

On September 19, FDA released a highly anticipated new draft guidance for industry titled <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-based-one-adequate-and-well-controlled-clinical" target="_blank" dir="ltr">Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence</a>. The draft guidance expands on Section 115 of the Food and Drug Administration Modernization Act (FDAMA), as well as corresponding <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products" target="_blank">1998</a> and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products" target="_blank">2019</a> guidance documents, which focused on demonstrating substantial evidence of effectiveness outside of the traditional two-study requirement.The 2019 draft guidance provided several examples of situations when confirmatory evidence may be acceptable but did not provide much detail to be helpful to sponsors. This new draft guidance provides more examples and additional clarification on how the substantial evidence of effectiveness requirement can be met with one adequate and well-controlled clinical investigation and additional confirmatory evidence. The draft guidance does not address related topics such as demonstrating safety or demonstrating substantial evidence of effectiveness with a single, multicenter study.FDA offers several general principles that sponsors should adhere to if they intend to demonstrate substantial evidence of effectiveness with a single adequate and well-controlled clinical investigation and confirmatory evidence. Like the earlier guidance, this draft guidance highlights that the quantity of confirmatory evidence required to demonstrate substantial evidence of effectiveness may vary depending on the clinical investigation. Adequate and well-controlled clinical investigations that are particularly strong may require less confirmatory evidence compared to a clinical investigation that is less compelling. Additionally, sponsors should have “scientific support” for their plan to demonstrate substantial evidence of effectiveness, including taking into account relevant “clinical context” factors. FDA also recommends that sponsors engage with the agency as soon as possible if they intend to use confirmatory evidence to demonstrate substantial evidence of effectiveness.The draft guidance offers several examples of when certain types of confirmatory evidence could be appropriate for demonstrating substantial evidence of effectiveness:<ul><li>Related Indication. According to the draft guidance, clinical evidence from a drug’s use in a related indication can serve as confirmatory evidence in some instances. The two indications must be sufficiently similar for the evidence from a related indication to serve as confirmatory evidence. Additionally, the drug’s mechanism of action in each indication should be similar.</li><li>Mechanistic or Pharmacodynamic Evidence. Another category of evidence that the draft guidance indicates could serve as confirmatory is mechanistic or pharmacodynamic evidence. Use of this type of evidence requires extensive understanding of both the underlying disease and the drug’s mechanism of action with respect to the disease. The draft guidance states that this type of evidence may be collected in vitro or by measuring a clinical endpoint.</li><li>Animal Studies. The draft guidance also identifies certain instances in which animal studies may serve as confirmatory evidence. In order for animal data to qualify as confirmatory evidence, the disease state in the animal model must be well understood and sufficiently similar to the human disease state. Additionally, the drug’s mechanism of action between the animal model and humans should be similar. Given that animal studies are often conducted in the preclinical stage, FDA recommends consulting with the agency before those studies are conducted if the sponsor intends to use data from animal models as confirmatory evidence.</li><li>Drugs in the Same Pharmacological Class. Clinical evidence from drugs that are in the same pharmacological class as the drug being developed can serve as confirmatory evidence, provided that the drugs have the same mechanism of action. The draft guidance states that using data from drugs in the same pharmacological class as confirmatory evidence is more appropriate when the pharmacological class is large and has an established, uniform effect.</li><li>Natural History. The draft guidance also highlights instances in which natural history evidence may successfully act as confirmatory evidence. The primary instance in which natural history evidence may prove useful is demonstrating that the control group is an accurate representation of the typical disease course. To do so, there should be no overlap in the natural history data and the control data.</li><li>Real World Evidence (RWE). Of particular interest to industry is the draft guidance on when real world data (RWD) and evidence can be used as confirmatory evidence. The draft guidance clarifies that RWD and RWE can be used as confirmatory evidence in two contexts: when seeking approval of a new indication for a previously approved drug and when completing post-study requirements. This has generated some concern that FDA may be limiting the instances in which RWD and RWE can serve as confirmatory evidence, including barring it from serving as confirmatory evidence for a first-time drug approval. Furthermore, the agency will look to factors such as the rigor of study design and statistical analysis to determine if the RWD meets the requisite standards for generating RWE.</li><li>Expanded Use of an Investigational Drug. The final example of confirmatory evidence that the draft guidance provides is evidence from the expanded use of an investigational drug. The draft guidance points out that rarely will expand access protocols generate the requisite information for the data to be used for research. However, in the instances where expanded access data is reliable and complete, it can serve as confirmatory evidence for the results of an adequate and well-controlled clinical investigation.</li></ul>The examples of confirmatory evidence listed in the new draft guidance on demonstrating substantial evidence of effectiveness are not exhaustive. However, these examples indicate the types of confirmatory evidence that may be accepted by FDA and highlight the factors that the agency looks to when determining whether data can serve as confirmatory evidence. This provides a roadmap for industry as to when sponsors may be able to demonstrate substantial evidence of effectiveness outside of the traditional two-clinical-investigation model.Lauren Limbach, a law clerk in our Boston office, contributed to the drafting of this post.

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On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. The draft guidance expands on Section 115 of the Food and Drug Administration Modernization Act (FDAMA), as well as corresponding 1998 and 2019 guidance documents, which focused on demonstrating substantial evidence of effectiveness outside of the traditional two-study requirement.

FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence

On October 10, 2023, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a groundbreaking decision that reflects a major change in how formal priority is assessed at the EPO during examination and in post-grant opposition proceedings, to the benefit of applicants/patentees. Prior to the decision, a European patent could be found not to be entitled to claim priority to its priority date if all applicants on a priority provisional application were not also named as applicants on the International PCT application.  Without the benefit of the earlier priority date, intervening references published in the priority year between a provisional application and International PCT application could wipe out novelty and patentability of an invention. This formal review of priority entitlement by the EPO has resulted in revocation of numerous patents in Europe; most famously, Broad Institute’s patent relating to CRISPR gene editing technology was revoked in 2020 for not meeting formal priority entitlement.In the recent decision, the Enlarged Board ruled that “[t]here is a rebuttable presumption … that the applicant claiming priority … is entitled to priority.”  This rebuttable presumption was ruled to also apply “in situations where the European patent application derives from a PCT application and/or where the priority applicant(s) are not identical with the subsequent applicant(s).” For instance, if a provisional application was filed by Party A and a PCT application was filed jointly by Parties A and B claiming priority to the provisional application, there will be a presumption that the PCT application filed by Parties A and B is entitled to the formal priority of the provisional application filed by Party A.  However, the Enlarged Board confirmed that the presumption also applies in the reverse scenario—where a provisional application was filed by Parties A and B and the PCT application claiming priority to the provisional application was filed only by Party A.This ruling represents a groundbreaking shift in how formal priority is assessed at the EPO into being strongly in favor of applicants/patentees by giving them a newfound rebuttal presumption that the applicant is entitled to priority.  This presumption is, however, rebuttable “since in rare exceptional cases the priority applicant may have legitimate reasons not to allow the subsequent applicant to rely on priority,” namely when the claim of priority “appears to be unjustified.”  The Enlarged Board explained that these legitimate reasons can, for example, “be related to bad faith behaviour on the side of the subsequent applicant or to the outcome of other proceedings such as litigation before national courts about the title to the subsequent application.”  Further, this presumption is “a strong presumption under normal circumstances” and “[t]he party challenging the entitlement to priority can thus not just raise speculative doubts but must demonstrate that specific facts support serious doubts about the subsequent applicant’s entitlement to priority.”  As such, the Enlarged Board notes that, practically speaking, this rebuttable presumption “substantially limits the possibility of third parties, including opponents, to successfully challenge priority entitlement.” For now, Applicants should still take steps to ensure assignment documents are in place from inventors to a Company Applicant before filing an International PCT application. However, this decision may have the effect of aligning with US practices, which has always been more relaxed in its view of priority entitlement.   Practically speaking, this ruling is likely to greatly reduce the number of attacks on formal priority by third party opponents at the EPO seeking to revoke a patent based on mere “speculative doubts.”  This ruling will also make it increasingly difficult for third party opponents to satisfy the evidentiary burden necessary to rebut this presumption. Although this presumption will be binding at the EPO during examination and post-grant opposition proceedings, proceedings taking place outside of the EPO, such as patent disputes in national courts of European countries in which the EP patent was validated, are not bound by the Enlarged Board’s ruling on formal priority. While the same presumption may be considered persuasive by such national courts in many instances, it may be some years until this issue is addressed in a national court.

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Dr. Jeff Schmidt is a member of the firm’s Patent Group. His practice focuses on patent prosecution in the areas of life sciences, biotechnology, and pharmaceuticals, which includes the preparation an

Jeffrey W. Schmidt Ph.D.

Jeffrey Schmidt

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Karen Potter

Retaining Your Patent Priority Date in Europe: Formal Priority Given a Rebuttable Presumption in Favor of Applicant/Patentee