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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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

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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

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

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

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MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now <a href="https://soundcloud.com/user-496742723/03-27-lifescience-podcast01-v1" target="_blank">available</a>. The podcast features interviews with legal experts who share insights and advice you just might need when your life sciences are on the line.The special guest for Episode 1 was Jim Krenn, a MoFo partner whose practice is focused on major corporate transactions for emerging and established companies in the life sciences. Jim, Nate, and Kate discuss strategies to maximize and protect the value of trade secrets, how investing in compliance early pays dividends as companies mature, and where companies may face government scrutiny on the journey from startup to public company.Trade secrets play a central role in raising capital, selling a company, and going public, and the rise of cyber breaches and sophisticated intellectual property theft has pushed investors to look closely at how trade secrets are safeguarded. Jim maps out strategies for maximizing the value of trade secrets at key stages and discusses with Nate and Kate how to protect a critical asset for many life sciences companies.Early-stage companies often focus on development and growth, but an appropriate compliance function is important to control present and future downside risk. Jim explains the decision dynamics at play, and Kate discusses how increased scrutiny on life sciences companies makes good compliance a winning value proposition.Outside scrutiny on company systems peaks when the time comes to take a company public or consider a merger or acquisition. Interested parties pore over compliance functions at this stage, particularly in the highly regulated life sciences industry. Nate and Kate discuss corresponding risks for company insiders.

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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. 

Nathaniel Mendell

Nathaniel R. Mendell

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Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. 

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications submitted to the US Food and Drug Administration contained artificial intelligence and machine learning (AI/ML) components.According to Brigid Bondoc, Partner at Morrison Foerster in Washington, DC, the FDA shares an industry optimism that "AI/ML can help bring safe, effective, and high-quality treatments to patients faster," to quote Patrizia Cavazzoni, M.D., the director of the Center for Drug Evaluation and Research (CDER) at the FDA.How the agency evaluates and manages emerging AI/ML technologies in drug and biologic applications were addressed in the panel "Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape," presented by Morrison Foerster (MoFo), on May 11, 2023, at the Association for Corporate Counsel (ACC) live CLE event "2023 Life Sciences Conference: Future-Ready Resilience: Preparing to Face Challenges in the Uncertain Future."The panel, consisting of Bondoc; Anna Yuan, Senior Associate at MoFo; Wendy Chow, counsel to MoFo; and Lauren Wu, Head of Privacy, Sr. Dir. of Legal for Regulatory and Compliance, US Privacy Officer, and Global DPO at Evidation Health, discussed the evolving FDA policies and regulation on AI, data privacy implications, and protecting AI technology in life sciences.FDA RegulatoryBondoc presented the big picture on the FDA's AI regulation, where the agency actively monitors AI/ML software in medical devices and clinical developments. The agency may expand coverage into FDA-regulated activities, such as automation and learning of medical devices, diagnostic and therapeutic development efficiency, regulatory assessment, and post-market surveillance.The 21st Century Cures Act excludes five types of software from the FDA's medical device definition and regulation, including administrative support software, wellness, and electronic patient records. Still, the act allows the FDA to "claw back any exception if it identifies risks associated with the software as a medical device," said Wu. With AI technologies, wellness, and electronic records, "the waters get muddier," commented Wu—for example, what to do with a pedometer that monitors sleep and blood pressure. It may become more than a wellness device and move into the regulated medical device space.The FDA appears flexible and careful in developing an AI/ML regulation framework, offsetting the need to facilitate innovation while protecting public health. For example, Bondoc pointed to the agency's drafted guidance on Predetermined Change Control Plans (PCCP) for AI/ML-enabled device software functions, attempting to address a significant issue facing emerging technology.Historically, changes to a cleared or approved medical device that could significantly affect the safety or effectiveness of the device required submitting a premarket notification 510(k). Yet, the notification program is "fundamentally at odds with the use of AI/ML in medical devices that facilitate continual improvements and modifications to the device based on data gathered while in use," said Bondoc. The FDA aims to develop a regulatory approach tailored to AI/ML-enabled devices, allowing for safe and rapid modifications in response to new data while ensuring safety and effectiveness.The FDA sees ethical, privacy, and security issues using AI/ML in drug development. The agency is also concerned with the lack of transparency in algorithms that can lead to amplification errors or preexisting biases. "Although recognizing the problem, the potential regulatory solutions have yet to be provided," said Bondoc. Still, the agency aims to prevent algorithmic discrimination and advance the use of AI/ML techniques. It recently released a discussion paper, "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." And to further address issues of AI in drug manufacturing, the FDA released “Artificial Intelligence in Drug Manufacturing.”Protecting AI Technology in Life SciencesYuan confirmed an eight-fold increase in AI patents from 2017 to 2020, citing WIPO Technology Trends 2019: Artificial Intelligence and Mondaq, and observed a shift in the types of things patented. In the past, patents were more theoretical, such as novel AI algorithms for speech recognition. Nowadays, there are more patents on concrete, practical applications of machine learning in drug discovery and medical diagnostics.Patent applications include novel, practical applications of AI algorithms, drugs developed by AI, and computer hardware configurations and optimizations to facilitate AI training and inference processes. The patents fall into two buckets: one, the application of known AI to specific fields and sectors, and two, new AI models and algorithms. Yuan said the first is generally a higher value in patenting with broader and more detectable claims vis-à-vis the second with narrow and mathematically oriented claims.Privacy and AIThe use of AI/ML in life sciences involves data from individuals, even protected health information (PHI). At some point, whether it is the process's training input, inference, or output, the data use may run afoul of state privacy laws, implicate new legislation regulating AI and automated decision-making, or trigger federal law, including the Health Insurance Portability and Accountability Act (HIPAA) or the Federal Trade Commission Act prohibiting unfair and deceptive practices, such as the sale and use of racially biased programs.Chow also detailed the states with comprehensive privacy laws, including California, Virginia, and Tennessee, with numerous state laws pending in Connecticut, Indiana, Iowa, Montana, and Washington. State legislatures complement privacy laws with laws regulating AI and automated decision-making, such as the New York AI Bias Law. Still, Wu put privacy legislation into context: "It's not necessarily the driver for AI; it's a stakeholder."

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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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Of Counsel

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. 

Anna Yuan

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Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion. This article originally appeared on JDSupra and is reprinted with permission.

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

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

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