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PAT E N T S
Safe harbors in Europe: an update on the research and Bolar exemptions to patent infringement
npg 201 5 Nature America, Inc. All rights reserved.
Andrs Kupecz1, Kristof Roox2, Christian Dekoninck2, Denis Schertenleib3, Marco Stief4, Fabrizio Sanna5, Matteo Orsingher5, Sergio Miralles6, Elena Molina6, Trevor Crosse7, Mike Gilbert7 & Will James7
Though the major European Union member states all have research and Bolar exemptions in their patent laws, the scope and effect differs considerably from country to country.
The strength and economic importance of patent protection in the pharmaceutical
and biotech industries is commonly known.
The scope of a patent owners monopoly is, however, not unlimited. The patent laws of many countries have certain safe harbor provisionsrules that allow acts that would otherwise be considered patent infringement.Here, we discuss two particular safe harbors: the so-called research exemption and the Bolar exemption. The research exemption excludes scientific research from patent infringement, whereas the Bolar exemption relates to clinical trials performed in the context of generic or biosimilar drug development and approval.The term Bolar exemption stems from Roche Products v. Bolar Pharmaceutical1 in which the US Court of Appeals for the Federal Circuit held that Bolar could not benefit from the research exemption to conduct bioequivalency studies and therefore infringed Roches patent. Shortly after the decision, the Hatch-Waxman Act was adopted, which allows generic studies and trials in the current system.
As there still is no single European patent law and court system, different European countries have their own sets of rules for patent infringement safe harbors. Moreover, this area of the law is constantly evolving. For example, questions regarding the Bolar exemption were
referred to the European Unions highest court, the European Court of Justice, and several European countries including the United Kingdom, Belgium and Spain have adopted or are in the process of adopting new legislation in this area.
This article highlights the most recent developments regarding research and Bolar exemptions in Belgium, France, Germany, Italy, Spain, the Netherlands and the UK, and aims to provide up-to-date practical insights into what is exempted in each country.
The research exemptionThe exclusive right of a patentee typically covers all uses of a patented product or method. A research exemption exempts from infringement certain research...