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

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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.

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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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, <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. Read the <a href="https://lifesciences.mofo.com/topics/key-considerations-for-sponsors-of-clinical-trials-under-the-eu-clinical-trial-regulation" target="_blank">full blog post</a>.

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Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.His practice focuses on complex collaborations (R&D), high-volume licensing initiatives, and commercial transactions relating to the procurement, development, commercialization, and use of technology and life sciences products. He also regularly advises on the related regulatory aspects of medical device law.Robert counsels clients on comprehensive IP protection strategies, know-how protection schemes, and employee invention regimes. He provides trademark and advertising claims clearances, including environmental advertising, as well as trademark prosecution and portfolio management services.In addition, he represents clients in court and in out-of-court disputes in matters of patent, trademark, employee invention, and competition law. He has extensive experience in proceedings before the European Union Intellectual Property Office, the German Patent and Trademark Office, and the Federal Patent Court.Robert is a regular contributor to the <a href="https://lifesciences.mofo.com/" target="_blank">MoFo Life Sciences Blog</a> and the <a href="https://impact.mofo.com/" target="_blank">MoFo Impact Blog</a>.Robert received his LL.M. in Intellectual Property from the Benjamin N. Cardozo School of Law in New York and passed the New York Bar Exam. Before joining Morrison Foerster, he worked as an associate at a renowned German law and patent firm in Munich.Robert is counsel at Morrison Foerster’s German office in Berlin.<h4 dir="ltr">Representative Experience</h4><ul><li>U.S.-based biotech fund on various research collaborations and licensing transactions with German startups or research institutions.</li><li>UK-based digital health company on product roll-out of RMP applications in Germany.</li><li>German specialty pharmaceutical company on sale of its painkiller business to a French-based pharmaceutical company.</li><li>Medios AG on the acquisition of a German-based specialty pharmaceutical company active in the field of ophthalmology, rheumatology, and oncology.</li><li>German conglomerate of industry players on the development and implementation of an online marketplace for artificial intelligence applications and services.</li><li>U.S.-based satellite network provider in a transaction with a French-based satellite manufacturer on the development and supply of certain satellite bus systems.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul><li>Leading chip manufacturer in German part of multijurisdictional patent litigation concerning wireless charging technologies.</li><li>Leading internet retailer on patent litigation concerning touch screen technology.</li><li>Renowned multinational information technology and electronics corporation on adversarial patent licensing negotiations in relation to 5G technology.</li><li>A serial entrepreneur from the biotechnology industry in an out-of-court dispute on remuneration claims with respect to service inventions under the German Employee Inventions Act.</li><li>A German bank in complex trademark litigation proceedings, including several cancellation actions.</li><li>Various clients in trademark, copyright, and competition law matters before the ordinary courts, the German Patent and Trademark Office (DPMA), the Federal Patent Court (BPatG), and the European Union Intellectual Property Office (EUIPO).</li></ul>

Robert Grohmann berät Unternehmen aus der Gesundheits-, Pharma-, Medizintechnik- und Technologiebranche in allen Aspekten des gewerblichen Rechtsschutzes vornehmlich im Zusammenhang mit Life Sciences-, Lizenzierungs- und Technologietransaktionen. Seine Mandanten reichen von multinationalen Unternehmen bis hin zu Start-ups.Der Schwerpunkt seiner Tätigkeit liegt auf komplexen Kooperationen (F&E), großvolumigen Lizenzierungsinitiativen und Transaktionen im Zusammenhang mit der Beschaffung, Entwicklung, Vermarktung und Nutzung von Technologie- und Life-Sciences-Produkten. Regelmäßig berät er auch zu damit verbundenen regulatorischen Aspekten im Bereich des Medizinprodukterechts.Robert Grohmann entwickelt Strategien zum Schutz des geistigen Eigentums sowie zu Know-how-Schutzsystemen und zu Regelungen für Arbeitnehmererfindungen. Er erstellt Risikoanalysen für die Benutzung und Eintragung von Marken und Werbeclaims, einschließlich im Bereich der Nachhaltigkeitswerbung, betreut internationale Markenanmeldeverfahren und verwaltet umfangreiche Markenportfolios.Darüber hinaus vertritt er Mandanten in gerichtlichen und außergerichtlichen Streitigkeiten im Patent-, Marken-, Arbeitnehmererfindungs- und Wettbewerbsrecht. Er verfügt über umfangreiche Erfahrung in Verfahren vor dem Amt der Europäischen Union für geistiges Eigentum, dem Deutschen Patent- und Markenamt und dem Bundespatentgericht.Robert veröffentlich regelmäßig Beiträge auf dem <a href="https://lifesciences.mofo.com/" target="_blank">MoFo Life Sciences Blog</a> und dem <a href="https://impact.mofo.com/" target="_blank">MoFo Impact Blog</a>.Robert Grohmann erwarb seinen LL.M. mit Schwerpunkt  im gewerblichen Rechtsschutz an der Benjamin N. Cardozo School of Law in New York und absolvierte erfolgreich das New York Bar Examen. Bevor er zu Morrison Foerster kam, arbeitete er als Associate bei einer renommierten deutschen Rechts- und Patentanwaltskanzlei in München.Robert ist Counsel des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">U.S. Biotech-Fond bei verschiedenen Forschungskooperationen und Lizenzierungstransaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li></ul><ul><li>Britisches Unternehmen für digitale Gesundheit bei der Einführung von RMP-Anwendungen in Deutschland</li><li>Deutsches Speciality Pharma Unternehmen beim Verkauf seines Schmerzmittelgeschäfts an ein französisches Pharmaunternehmen</li><li>Medios AG bei der Übernahme eines in Deutschland ansässigen und in den Bereichen Ophthalmologie, Rheumatologie und Onkologie tätiges Speciality Pharma Unternehmen</li><li>Deutsches Industriekonglomerat bei der Entwicklung und Implementierung eines Online-Marktplatzes für Anwendungen und Dienstleistungen im Bereich der künstlichen Intelligenz</li><li>US-amerikanischer Satellitennetzbetreiber bei einer Transaktion mit einem in Frankreich ansässigen Satellitenhersteller zur Entwicklung und Lieferung bestimmter Satellitenbussysteme</li></ul><h4 dir="ltr">Repräsentative streitige IP-Angelegenheiten</h4><ul dir="ltr"><li>Führender Chiphersteller im deutschen Teil eines Patentstreits über drahtlose Ladetechnologien</li><li>Führender Internet-Einzelhändler in einem Patentrechtsstreit über Touchscreen-Technologie.</li><li>Beratung eines renommierten multinationalen Informationstechnologie- und Elektronikkonzerns bei Patentlizenzierungsverhandlungen in Bezug auf 5G-Technologie</li><li>Serienunternehmer aus der Biotechnologiebranche in einer außergerichtlichen Auseinandersetzung über Vergütungsansprüche im Zusammenhang mit Diensterfindungen nach dem deutschen Arbeitnehmererfindungsgesetz</li><li>Eine deutsche Bank in komplexen Markenrechtsstreitigkeiten, einschließlich mehrerer Löschungsklagen</li><li dir="ltr">Verschiedene Mandanten in marken-, urheber- und wettbewerbsrechtlichen Angelegenheiten vor den ordentlichen Gerichten, dem Deutschen Patent- und Markenamt (DPMA), dem Bundespatentgericht (BPatG) und dem Amt der Europäischen Union für geistiges Eigentum (EUIPO)</li></ul>

Robert Grohmann

Counsel

<div class="videoWrapper"><iframe title="Meet Alex van der Wolk, Privacy and Data Security Partner" src="https://www.youtube-nocookie.com/embed/DP4avINgkB8?rel=0" frameborder="0" allow="autoplay; encrypted-media" allowfullscreen="1" class="sticky-video" title="iframe"></iframe></div>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. Alex’s clients benefit from his practical approach and global perspective, saying: “he quickly gets to the heart of the issue and provides solid, pragmatic advice based on the experience he has gained,” “in addition to having very strong legal knowledge, he has a commercial understanding and provides great insight in global matters,” and  “Alex is a true privacy expert with the ability to offer practical guidance on complex problems” (Chambers EU).Alex helps clients develop privacy and data strategies at the forefront of their digital and data-driven endeavors, especially those involving new technologies, such as artificial intelligence and the metaverse. He has particular experience assisting clients with structuring their approach to data in specialized areas, such as health-tech, Agtech, and Adtech. Alex is an experienced litigator, representing clients in privacy litigation in Europe, including successfully representing clients in the first class action cases in the Netherlands and the UK. Additionally, Alex is often called upon to head crisis management teams for clients facing investigations by data protection authorities or responding to cybersecurity incidents. He counsels clients on their incident and cyber preparedness and has done significant work advising clients on EU cyber and data regulatory frameworks, such as NIS2, DORA, the Cyber Resilience Act, and the EU Data Act.Notably, Alex was one of the first practitioners in Europe to help companies set up Binding Corporate Rules (BCRs), and since that time has used this deep knowledge to develop a longstanding and unparalleled track record in obtaining regulatory approval for BCRs, both in the EU and in the UK.Alex is a frequent speaker at high-profile international conferences, including IAPP and South by Southwest (SXSW), and is a guest lecturer at the Tilburg Institute for Law, Technology, and Society. He is a Dutch-qualified lawyer and a member of the Amsterdam and Brussels Bars. He speaks fluent English and Dutch.

Alex van der Wolk

Managing Partner, Brussels

Marta Hovanesian is an associate in the Privacy + Data Security Group of Morrison Foerster. Based in the Brussels office, she focuses on assisting global clients with the implementation of privacy and data security measures in all aspects of their business. Marta is particularly experienced in working with start-ups and scale-ups seeking to develop privacy compliance strategies for their innovative data-driven products and services. Marta’s practice is defined by her pragmatic counsel. She can successfully translate complex data protection regulations into workable, compliant solutions for innovative companies. Her direct and practical approach often helps her drive forward difficult negotiations for clients. She also has extensive knowledge of international data transfers and binding corporate rules.Marta’s substantial experience includes assisting clients with data protection projects that range from the development of new products and services to the adoption of new technologies within their businesses, as well as handling complex contract negotiations. Marta has represented and advised clients on the implementation of visitor tracking systems and data-sharing strategies, and the development of health application services and fintech products. She has extensive knowledge of GDPR regulations, which she demonstrates through speaking engagements and working on the team tasked with building the MoFo European Law Resource Center.Prior to joining Morrison Foerster, Marta worked at a leading Dutch law firm and simultaneously spent time on secondment as legal counsel to a global manufacturer that has offices in the Netherlands.Marta is a Dutch qualified lawyer. She speaks fluent English and Dutch and is a native speaker of Armenian.