Experimental Use and Bolar Exemptions (Hardcover)

This book explores one of the most contested and thought-provoking questions in patent law: the limits of patent protection. At the heart of this debate lie two crucial legal exemptions—the Experimental Use exemption and the Bolar-type exemption—both of which strike delicate balances between private rights and the public good. The Experimental Use exemption, with roots in 19th-century case law, was designed to foster technological progress by excepting research and innovation from the realm of patent infringement. By contrast, the Bolar-type exemption emerged in the 1980s in response to the public interest in offering affordable medicines, represented by the generic pharmaceutical industry. Their distinct rationales have led to diverging interpretations and implementations across the globe, creating uncertainty for legislators, innovators, and industry alike. Through analysis of landmark cases, statutory developments, and comparative insights from many jurisdictions over the world, the book reveals the ongoing tensions between innovation policy, access to medicines, and the harmonization of international patent law. It also highlights new challenges posed by emerging technologies such as biologics and biosimilars, which further complicate the scope of these exemptions. A vital resource for legislators, policymakers, patent practitioners, and scholars, this book provides essential guidance on navigating the complexities of infringement exemptions worldwide. It will also serve as an indispensable reference for global companies advising their R&D organizations in a fragmented legal landscape.

David Gilat is a Senior Partner in the Israeli IP firm Reinhold Cohn Group. His main fields of expertise are Technology (particularly chemistry, pharmaceutics, physics, high technology) and brands. David has been involved in landmark patent, trademark and copyright cases. David is currently teaching at the law faculty of the Reichman University as an adjunct professor, in a course on Law, Technology and Science, and for almost two decades has taught the patent law course at the law faculty of the Tel Aviv University. He served as a research fellow at the Max Planck Institute for Foreign and International Patent, Copyright and Competition Laws, 1992-3, and is the author of “Experimental Use and Patents” IIC Studies (Vol 16 1995). David is an active member of AIPPI’s Pharma Committee.

Charles A. Boulakia is a Principal with Smart & Biggar. His practice is primarily directed towards the preparation and prosecution of patent applications in the biotechnology, chemistry, biofuel, oil and gas, and pharmaceutical areas. Charles is Vice-Chair of the AIPPI Standing Committee on Pharma, and the Chair of the AIPPI Canada Patent Committee. He is a member of the selection committee for the Norman Esch Engineering Innovation and Entrepreneurship Award and is a mentor at Toronto Metropolitan University’s Law and Business Clinic, iBoost, and the University of Toronto Hatchery. He is also a panelist of the Discipline Committee of the College of Patent and Trademark Agents, where he presides on professional discipline matters.

Daphné Derouane is a European Patent Attorney and holds a Ph.D. in Organic Chemistry from UCLouvain in Belgium. She has over 25 years of experience as in-house patent counsel in industry. Currently, she serves as Associate General Patent Counsel at UCB Biopharma (Belgium), where she leads the IP support for the Research Organization. Her expertise encompasses defining the overall IP strategy of UCB’s early-stage assets and technologies, patent drafting & prosecution, providing freedom-to-operate opinions, and the negotiation of a variety of agreements. She also closely monitors external IP developments which are relevant to the pharmaceutical industry to ensure UCB’s IP strategies remain fit-for-purpose. Additionally, she is a member of the Board of AIPPI-Belgium and has recently been appointed Vice-Chair of the AIPPI Pharma Standing Committee.

Dr Ralph Nack is a Partner with Noerr in Germany. Ralph is the current Reporter General of AIPPI and has been a member of the AIPPI Bureau since 2014. His practice is directed towards patent litigation and licensing, as well as trade secret litigation. He has particular expertise in litigating standard-essential patent (SEPs) and issues of FRAND licensing. His practice further covers litigious and non-litigious advice in the life science sector, in particular regarding biologics and medical devices. Further, he handles high profile IP transactions and freedom-to-operate projects, in particular in connection with M&A and VC matters. Ralph studied law in Heidelberg, Munich, Washington DC (George Washington University) and Tokyo (Todai University). He is an alumnus of the Max Planck Institute for Intellectual Property and was awarded the Otto Hahn Medal of the Max Planck Society for his scientific work.