EU regulatory: Pharma, medical devices and biotech

Partner

Kristof focuses on (IP) litigation. With more than 25 years’ experience, he is widely respected for his pragmatic, innovative approach to dispute resolution. He is a seasoned advisor and perseverant litigator in complex patent and SPC litigation and regulatory cases, parallel import matters and cross-border issues. He often litigates before the Belgian and European courts, regulatory bodies and in mediation/arbitration. Kristof is experienced in the interplay between antitrust and IP and is sought out for his thought leadership regarding commercial, civil and criminal disputes, and for his knowledge of (international) procedural law issues. Clients include industrial conglomerates and major players in the life sciences and TMT sectors. Kristof frequently speaks at professional and academic conferences and has published many articles on intellectual property and private international law.

Partner

Jurgen Figys is a counsel in Crowell & Moring's Brussels office and a member of the Intellectual Property Group. Jurgen is one of the few lawyers in Belgium also to be trained as a biomedical scientist. He is therefore able to combine his scientific reasoning with his legal knowledge, a considerable asset in the technology-driven IP field.Jurgen predominantly works with clients in the pharmaceutical and biotechnology industry, with a particular focus on complex patent litigation and regulatory advice. He has particular experience in patent litigation with regard to invalidity, third-party opposition proceedings against counterfeit seizure, and preliminary injunction proceedings. His pre-contentious experience includes freedom-to-operate patent analysis and drafting protective letters. Jurgen is also involved in a number of trademark cases, such as parallel import litigation.Within life sciences, Jurgen provides strategic regulatory advice to pharmaceutical and biotech companies as well as national and European industry associations. His experience covers a broad range of regulatory issues like data exclusivity, EU marketing authorizations, pricing and reimbursement of medicinal products, advertising, medical devices, clinical trials, and data. Digital transformation in the health sector is also one of his main focus areas.Thanks to his scientific background, Jurgen is also able to advise clients on other EU regulatory issues with a technical angle. For example, Jurgen has an impressive, substantive knowledge of REACH through his work for a wide range of U.S. and EU-based clients. He also regularly advises on CLP issues. In addition to providing legal and strategic advice on REACH/CLP compliance, Jurgen is able in particular to assist clients with their more science-driven submissions to the European Chemicals Agency (ECHA) (preliminary risk assessments of potential chemicals of concern, etc.).