This session will examine the impact of recent case law and forthcoming legislative reforms on Bolar exemptions and safe harbor provisions in the US and Europe. Experts will discuss how evolving legal frameworks affect patent enforcement strategies, particularly concerning timing for preliminary injunctions and defining “imminent infringement.” Key cases and jurisdictional nuances will be analysed to help patentees and generics understand the shifting landscape.
• Review recent US case law on the § 271(e)(1) research exemption and its enforcement implications.
• Analyse anticipated changes to the European Medicines Directive broadening the Bolar exemption and their effects on patent litigation.
• Discuss jurisdictional differences in preliminary injunction trigger points and the challenges posed by the UPC’s holistic approach to imminent infringement.
Christoph Rehfuess
Andreas Robinson
Cecile Teles
Cecile is Head Patent Attorney at Zentiva. She has over a decade of experience in the pharmaceutical industry.
Cecile is uniquely experienced and knowledgeable in the pharma space as she has experience in-house at an elite innovator company (Sanofi), biologics (Merck Serono), and extensive generic experience she gained as Zentiva.
Cecile is an enthusiastic manager of her team and was a key member of the IP team in leading the transformation of Zentiva into an independent and competitive generic company after divestment from Sanofi.
Cecile is a qualified European Patent Attorney. She also holds a certificate from CEIPI in patent litigation and most recently completed her diploma as a Master of Laws in France.