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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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

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Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable.As discussed below, the outlook for successful application of DOE to biologics remains uncertain. But with careful prosecution strategies, patentees can better preserve their DOE arguments to block design-arounds with insubstantial differences and/or those that perform substantially the same function in substantially the same way.DOE for Biologics<a href="https://lifesciences.mofo.com/topics/analyzing-biologics-under-doctrine-of-equivalents-prosecution-history-estoppel">Ajinomoto Co., Inc. v. ITC</a> provides a rare example of successful DOE application to protein sequences.[2] There—applying the “function-way-result” (FWR) test for analyzing equivalence—the Federal Circuit concluded that a bacterial strain engineered to express a particular amino acid sequence was equivalent to a strain engineered to express a different amino sequence of a related protein.[3] In finding that the proteins functioned in substantially the same way, the court relied on the facts that the two proteins were 95% identical in primary amino acid sequence and were predicted to be 85% identical in structure.[4] Thus, when applying the FWR test to large biomolecules, sequence similarity will likely be an important consideration as it was in the Ajinomoto decision.A more recent case, Teva Pharmaceuticals International GmbH v. Eli Lilly & Co., illustrates that relying on DOE to broaden the scope of claims reciting biological sequences (e.g., antibody sequences) can be challenging.[5] There, Teva asserted two claims reciting antibody CDR sequences and variable region sequences against Lilly under DOE. The antibodies at issue shared only 29.9% sequence similarity in the CDRs, and the heavy chain of the closest variant disclosed in Teva’s patent shared only 52.5% similarity with Lilly’s antibody.[6] In this case, the court said that application of DOE would be “a bridge too far” and would effectively read the amino acid sequence limitation out of the claims.[7] Thus, DOE arguments that essentially vitiate the sequence limitations would not be likely to succeed.It is worth noting that the court in Teva decided on the DOE issue using the “insubstantial differences” test, which the court viewed as more appropriate for evaluating equivalents in chemical compounds. Although it is clear from Teva that application of DOE to biologics likely requires “insubstantial differences” between the claimed and accused products, how much sequence identity or similarity in primary amino acid or nucleic acid sequence amounts to insubstantial difference is far from being clear. Moreover, large biological molecules having low sequence identity in primary sequences may nevertheless assume highly similar three-dimensional structures and/or functions – in such cases, would the difference be insubstantial?Despite these uncertainties and the paucity of examples successfully applying DOE to biological drugs and particularly antibodies in district court litigation or before the Federal Circuit, DOE may be an important tool in view of genus claim vulnerabilities. Patent applicants looking to apply DOE in any field must take care during prosecution to avoid estoppel, as discussed below.DOE Prosecution Strategies<ul><li>Consider initially pursuing narrow claims with a high likelihood of patentability without amendments to the claims during prosecution to avoid estoppel issues.[8] Fewer written arguments during prosecution may help reduce the risk of estoppel issues. Consider making greater use of examiner interviews to help focus amendments and arguments.</li><li>Remember that preliminary amendments can also create prosecution history estoppel.[9]</li><li>Take care to avoid new matter or written description rejections when introducing dependent claims. Dependent claim cancellations can also invoke prosecution history estoppel.[10]</li><li>The “disclosure dedication” rule may bar application of DOE for equivalents that are disclosed in the specification.[11] Rather than relying on DOE in such cases, applicants should consider pursuing a continuation application to cover specific competitor products disclosed in the specification but not initially claimed.</li></ul>[1] Amgen Inc. v. Sanofi, No. 21-757, 2023 WL 3511533 (U.S. May 18, 2023).[2] See, generally, 932 F.3d 1342 (Fed. Cir. 2019).[3] Id. at 1356-1357.[4] Id. at 1357.[5] No. 18-CV-12029-ADB, 2022 WL 4824318, at *18 (D. Mass. Oct. 3, 2022).[6] Id. At *16.[7] Id. at *18.[8] Narrowing amendments made during prosecution create a rebuttable presumption that the patentee has surrendered the broader claim scope, typically referred to as “prosecution history estoppel.” This presumption is rebuttable if (1) the equivalent would have been unforeseeable at the time of the amendment; (2) the rationale underlying the amendment is only tangentially related to the equivalent in question; or (3) “there [is] some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1365 (Fed. Cir. 2003.[9] In Amgen Inc. v. Hoechst Marion Roussel, Inc., for example, the Federal Circuit found that a preliminary amendment limiting the claims to a 166-amino acid sequence of human erythropoietin (EPO) surrendered coverage of EPO with a 165-amino acid sequence (the mature, cleaved form of the protein). 457 F.3d 1293, 1297 (Fed. Cir. 2006).[10] Consider UCB, Inc. v. Yeda Research & Development Co., Ltd., 117 F. Supp. 3d 755 (E.D. Va. 2015). There, Yeda added dependent claims reciting “chimeric” claims, which Yeda explained encompassed humanized antibodies. Yeda canceled these dependent claims after the examiner rejected them for lack of written description. Although the independent claim reciting “monoclonal antibodies” had not been amended, the court held that the main claim could not be construed to cover humanized antibodies literally or under DOE in view of the claim cancellation in response to a rejection.[11] In Morphosys AG v. Janssen Biotech, Inc., for example, disclosure of human or humanized anti-CD38 antibodies precluded the patentee from asserting that a claim limited to human antibodies also covered humanized antibodies under DOE. 358 F. Supp. 3d 354 (D. Del. 2019).

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Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable.

Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents

The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch:1. What is the impact on other technology?The Court emphasized that “aspects of antibody science remain unpredictable.” How will courts evaluate the predictability of other technologies, such as nucleic acid and gene editing technologies, small molecules, and artificial intelligence?Providing some direction, the Court explained that it might suffice to disclose one or a few examples if there is “some general quality” running through the class that would reliably enable a person skilled in the art to make and use the entire class of molecules. This suggests that other technologies may be better situated to withstand enablement attacks. As an example, unlike antibodies, the target of an antisense oligonucleotide can be determined by its sequence alone, suggesting that the reasoning applied by the Court to antibodies to limit the scope of claims may not be as generalizable as it first appears.2. What is the outlook for other antibody claim types?It is not yet clear how the Court’s decision will be applied to other antibody claim types, particularly where the innovation is not centered on antigen binding properties of an antibody. Examples include chimeric antigen receptor therapies, antibody-drug conjugates, modifications to antibodies outside of the antigen binding region (e.g., Fc mutations), and methods that use antigen binding moieties. Functional genus claims that sweep in a broad class of well-characterized antigen binders may not suffer from the same unpredictability in determining the sequence of antibody variable domains that are responsible for conferring antigen or epitope binding, which the Court relied upon heavily in making its determination. These types of inventions may be in a stronger position to obtain broader claims. 3. How will AI impact antibody patents going forward?Predictability of a given technology is an important consideration for enablement. In this case, the Court noted that translating an antibody’s amino acid “sequence into a known three-dimensional structure is still not possible.”But artificial intelligence (AI) and machine learning based computational models for predicting protein structures are rapidly evolving.[1] Will courts respond in the future by allowing broader functional claims as the link between amino acid sequence, three-dimensional structure, and functional properties becomes more predictable?At a minimum, applicants should consider how developments in AI can be harnessed to enable broader claim scope at the time of filing a new application and even during prosecution as these developments continue to play out.4. Will the doctrine of equivalents (DOE) be applied more regularly moving forward?The doctrine of equivalents has rarely been applied to claims reciting sequences of large molecules. But in Ajinomoto v. ITC (2019), the Federal Circuit made it clear that DOE can apply to a claim reciting amino acid sequences.In the future, we may see more examples of patent owners asserting DOE, particularly when enablement of broader, literally infringed claims is questionable. Patent owners and applicants should monitor how DOE-related issues play out in the district courts and at the Federal Circuit.5. Are claims that recite conservative substitutions or percentage identity thresholds still viable?While not ruling out enablement of such claims, the Supreme Court’s opinion may cast a shadow over enablement of claims reciting conservative substitutions or percentage identity thresholds for antibodies or other proteins. The Court noted that conservative substitution “requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too,” concluding that it was “[n]ot much different” than a roadmap for de novo antibody discovery.The Court left the door open for enablement of conservative substitution for other claims, such as where the inventor identifies a quality common to the functional embodiments. But the holding could have a wide-ranging impact on protein and nucleic acid claims beyond antibodies, such as enzyme and nucleic acid sequences that allow sequence variation.Subscribe to MoFo Life Sciences to stay up to date on the latest developments impacting IP protection of life science tools, biologics, and pharmaceuticals. [1] See, e.g., Ruffolo et al., Fast, accurate antibody structure prediction from deep learning on massive set of natural antibodies, Nat. Commun. 14, 2389 (2023).

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. 

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The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants.

Five Questions after Amgen v. Sanofi

Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, <a href="https://lifesciences.mofo.com/topics/prevent-a-clinical-trial-from-turning-into-a-criminal-trial" target="_blank">Prevent a Clinical Trial from Turning into a Criminal Trial</a>, the United States has recently seen a surge in clinical trial fraud investigations and enforcement actions, highlighting the need to ensure that appropriate compliance measures are in place to mitigate enforcement risks.Meanwhile, across the pond, the European Union adopted the <a href="https://ec.europa.eu/health/document/download/f724d198-9ec8-4cad-9ce7-b6d2ac1ec44e_en" target="_blank">Clinical Trials Regulation</a> (CTR or “Regulation”) in 2022, which will apply to all newly submitted clinical trials from January 31, 2023. One of the aims of the CTR is to increase public transparency in the way clinical trials are conducted in Europe. This means that sponsors will have to follow a strict regime of publication rules, allowing for greater scrutiny of the trial data by regulators, researchers, and the general public.In this article, we give an overview of the transparency requirements that sponsors face under the CTR, and we summarize other key aspects of the new EU clinical trial regime that sponsors should be aware of when developing compliance strategies for clinical trials conducted in the EU and the European Economic Area (EEA).BackgroundThe CTR applies to interventional and low-interventional clinical trials with medicinal products for human use.[1] It replaces the <a href="https://ec.europa.eu/health/document/download/1b90a1ed-9959-4e18-948a-4c02e6d6b1fa_en" target="_blank">Clinical Trials Directive</a> (CTD) and national implementing legislation in the EU Member States. Since January 31, 2023, all clinical trial applications have been subject to the CTR. However, trials approved under the CTD before January 31, 2023, can continue to be regulated under the CTD until January 31, 2025.The CTR aims to simplify and accelerate the authorizing process of clinical trials, as well as harmonize administrative procedures across the EU and the EEA. It is directly applicable in the EU Member States without the need for transposition into national law. Other regulatory aspects, such as authorization and monitoring procedures, are governed by the <a href="http://data.europa.eu/eli/dir/2001/83/2022-01-01" target="_blank">Directive 2001/83/EC</a> and <a href="http://data.europa.eu/eli/reg/2004/726/2022-01-28" target="_blank">Regulation (EC) 726/2004</a>.Increased transparency requirementsAmong other things, the CTR focuses on increasing public transparency of clinical trial data. In the past, there have been concerns about selective reporting of trial results, where only positive results are published and negative or inconclusive results are not. This can lead to a biased view of the safety and efficacy of a particular treatment.The CTR requires the sponsor to make all clinical trial information available in the recently launched Clinical Trial Information System (CTIS) for access by the competent authority of the Member State(s) where the trial is being conducted. This includes information such as the trial protocol, clinical trial results, and adverse events. After a review process, the information is made publicly available on the <a href="https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en" target="_blank">CTIS website</a>. The information must be updated throughout the trial, and once the trial is completed, the sponsor must publish a summary of the results, including a layperson summary, within one year of the end of the trial.Sponsors may request a delay in the publication or redaction of certain information if the disclosure of such information would jeopardize the protection of personal data, trade secrets, or the sponsor’s legitimate commercial interests. However, it should be noted that certain information, such as essential characteristics of a clinical trial or reasons for the temporary halt and early termination of a clinical trial, is generally not considered confidential. Furthermore, a delay of publication of confidential information in results of the clinical trial may be granted only for a limited time.In summary, more information needs to be made available to national competent authorities and the public, including data that was not previously made available. This increases transparency and enables patients and healthcare professionals to make informed treatment decisions. For the sponsor, however, there is a risk that potentially confidential information may be inadvertently disclosed to the public, which could, for example, be detrimental to the sponsor’s ability to secure patent protection for inventions that are the subject of, or made during, the clinical trial.Consent requirementsWhen conducting a clinical trial, the sponsor must also be aware of different consent requirements.The CTR simplifies the informed consent process by laying out procedures to obtain effective consent of patients participating in the clinical trial, which in principle apply in all EU and EEA countries. This also includes more detailed guidelines for vulnerable subjects like minors or incapacitated people and pregnant or breastfeeding women. It also allows for a simplified consent process for low-risk trials, which could reduce the burden on trial participants and investigators.Data protection considerations for consentSponsors should clearly distinguish between informed consent for purposes of conducting the trial, and consent obtained for purposes of data protection. The <a href="https://eur-lex.europa.eu/eli/reg/2016/679/oj" target="_blank">General Data Protection Regulation</a> (GDPR) requires a legal basis whenever personal data are processed. Where explicit consent is relied upon as a legal basis under GDPR, in particular to process health and genetic data, this should be obtained separately from the informed consent under the CTR.However, in the EU there is no clear consensus on whether explicit consent is always appropriate in a privacy context for the processing of personal data for research activities. In its <a href="https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_opinionctrq_a_final_en.pdf#_blank" target="_blank">opinion concerning the Q&A on the interplay between the CTR and the GDPR</a>, the <a href="https://edpb.europa.eu/concernant-le-cepd/concernant-le-cepd/who-we-are_en#_blank" target="_blank">European Data Protection Board</a> (EDPB), a consortium of national EU data protection authorities, concluded that consent may not be the appropriate legal basis in some cases. Legal bases other than consent, such as public interests in the area of health or scientific research, should preferably be relied upon. However, these other legal bases require a corresponding implementation in national Member State law, which not all Member States may have arranged for at this time.Other key considerationsOther notable changes under the CTR regime that are relevant to sponsors of clinical trials are the following:1. Simplified application process: The CTR harmonizes the procedures for obtaining authorization and conducting clinical trials across the EU and in EEA countries, by introducing a single application process through the CTIS. This allows sponsors to submit a single application for authorization to conduct a clinical trial in several European countries, making the conduct of such multinational trials more efficient. The CTIS also allows national regulators to collaboratively process clinical trial applications, request information, authorize or refuse a trial, and oversee an authorized trial. This aims to stimulate innovation and research in the EU by facilitating the conduct of larger clinical trials in several EU/EEA countries.2. Shorter authorization and response times: The timeline to authorize clinical trials is set at 60 days. If no decision is made within this period, the trial may go ahead (“tacit approval”). Decisions on applications for substantial modifications of clinical trials must be made within 49 days. Where no decision is issued, the authorization is considered to have been given. However, the other side of the coin is that response times for sponsors have also drastically shortened. Sponsors now have a maximum of 12 days to respond to application queries or requests for information. Otherwise, applications will lapse by default.3. Simplified safety reporting:The CTR strengthens safety monitoring by requiring the sponsor to submit safety reports on unexpected adverse reactions to regulatory authorities within strict timelines between 7 and 15 days. However, whereas the CTD required multiple safety submissions to national competent authorities and ethics committees, the CTR requires all safety reporting via EudraVigilance and allows for submission of a single report for all trials involving more than one investigational medicinal product.4. Harmonization of ethical review: The CTR aims to harmonize the ethical review process. Although the ethical review must be performed by an ethics committee in accordance with the law of the respective EU or EEA country concerned, the procedures and the timelines for the ethical review must be compatible with the authorization procedure stipulated by the Regulation.ConclusionGiven that all future clinical trial applications in the EU will be subject to the CTR rules, it is high time for sponsors to develop and adopt appropriate compliance measures for their upcoming clinical trials. Sponsors would be well advised to consider the shortened response times and increased transparency and reporting requirements. They should put in place rapid response teams and processes to ensure that the relevant information is made available to the national competent authorities in a timely manner. Sponsors should also be aware that the burden of requesting a deferral of publication or a redaction of confidential information or personal data rests with the sponsor. Therefore, mechanisms should be put in place to ensure that such deferral and redaction requests are made for all documents containing such information. If such information is relevant to patent protection, the filing strategy and timing should be considered as well. Watch our blog for further news on clinical trials.[1] There is a simpler framework at the European level for clinical investigations of medical devices and in vitro diagnostic medical devices. The <a href="http://data.europa.eu/eli/reg/2017/745/2020-04-24" target="_blank">Medical Devices Regulation</a> (MDR) and <a href="http://data.europa.eu/eli/reg/2017/746/2022-01-28" target="_blank">In Vitro Diagnostic Medical Devices Regulation</a> (IVDR) form the core legal framework (read more about the MDR and IVDR on our MoFo Life Sciences Blog).

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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Managing Partner, Amsterdam and Brussels

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Amsterdam and Brussels offices, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management. 

With more than a decade of experience, Mr. van der Wolk helps clients develop privacy strategies for digital transformations, industrial IoT, telematics, Big Data, commercial and marketing programs, a

Alex van der Wolk

Alex van der Wolk, co-chair of Morrison Foerster’s preeminent Global Privacy & Data Security practice and managing partner of the firm’s Brussels office, employs his nearly 20 years of experience to advise global companies on their most complex data strategies and compliance programs governing all aspects of information management.

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Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

Is 2021 the Value-Based and Shared Savings Revolution?

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Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial, the United States has recently seen a surge in clinical trial fraud investigations and enforcement actions, highlighting the need to ensure that appropriate compliance measures are in place to mitigate enforcement risks.

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi, a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was brought up several times during oral arguments as an avenue to capture additional claim scope. Prior to the oral arguments, legal scholars had proposed, at least in the antibody context, to marry means-plus-function claim drafting to DOE as an approach to potentially salvage genus claims.[1] This article provides some insights on the use of DOE in life sciences cases.DOE is a long-standing doctrine judicially created to protect patent owners from alleged infringers who may circumvent the literal scope of a patent claim by making “unimportant and insubstantial” modifications to a patented invention. Over the decades since the doctrine was first established, courts have imposed major limitations on DOE to strike a balance between the inventor’s interest and public interest. One such limitation is prosecution history estoppel, which bars a patentee from recapturing through DOE subject matters surrendered during prosecution. However, in 2019, the Federal Circuit affirmed a finding of infringement under DOE in Eli Lilly & Co. v. Hospira, Inc.,[2] in spite of a narrowing amendment made during prosecution of Eli Lilly’s patent related to Alimta® for treatment of certain types of cancer with antifolates. The equivalents at issue were two pemetrexed salt forms, pemetrexed disodium and pemetrexed ditromethamine. An amendment from “an antifolate” to “pemetrexed disodium” was presented by Eli Lilly during prosecution in response to a prior art rejection. Finding that the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question, the Federal Circuit affirmed that prosecution history estoppel did not bar Eli Lilly’s infringement claim under DOE.Following the guidance from the Federal Circuit, there has been an uptake on DOE related issues in the lower courts. For example, in 2020, the U.S. District Court for the District of Delaware addressed DOE in ViiV Healthcare Co. v. Gilead Sciences,[3] where ViiV alleged that Gilead’s product for HIV treatment, bictegravir, infringed claim 6 of U.S. Patent No. 8,129,385 (the “’385 patent”). Claim 6 of the ’385 patent is directed to dolutegravir, an active pharmaceutical ingredient used in HIV treatments. Based on the structural differences between the difluoro benzyl ring in ViiV’s dolutegravir and the trifluoro benzyl ring in Gilead’s bictegravir, Gilead moved for summary judgment, arguing the two-fluorines limitation in claim 6 specifically excludes compounds with three fluorines. The court denied Gilead’s motion for summary judgment of non-infringement, finding that ViiV was not barred from asserting an infringement claim under DOE. To end the legal battle, Gilead and ViiV reached a US$1.25 billion global settlement and licensing agreement in 2022. Given the recent attention on DOE, stakeholders should be aware that, even with its limitations, DOE can be a viable infringement theory in certain cases and should not be overlooked in strategic thinking on IP issues.[1] Lemley, Mark A. and Sherko, Jacob S., The Antibody Patent Paradox (February 2023), The Yale Law Journal.[2]Eli Lilly and Co. v. Hospira, Inc., No. 18-2126 (Fed. Cir. 2019).[3]ViiV Healthcare Co. v. Gilead Scis., Inc., No. 18-224 (D. Del).

Seagen Inc. v. Daiichi Sankyo Co. Ltd. et al. (AAA Arbitration, Eastern District of Texas, District of Delaware, and Patent Trial and Appeal Board)

Evolve BioSystems, Inc. v. Abbott Laboratories (Northern District of Illinois)

Driscoll’s, Inc. v. California Berry Cultivars, LLC (Eastern District of California)

Bayer CropScience LP v. Tenfold Tech., LLC (Eastern District of Texas)

The Regents of the University of California v. California Berry Cultivars, L.L.C. et al.  (California Superior Court and Northern District of California)

Arch Development Corp. v. Genentech, Inc. (Northern District of Illinois, Patent Trial and Appeal Board, and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. (Northern District of California and Federal Circuit)

Phigenix, Inc. v. Genentech, Inc. and ImmunoGen, Inc. (Patent Trial and Appeal Board and Federal Circuit)