Bolar Exception

Abstract

AbstractThis chapter discusses the exemption from liability of patent infringement for activities related to regulatory approval for medicines, also known as the “regulatory review” or “Bolar” exception. The Bolar exception supports the market entry of generics by allowing the use of a patented invention by a third party without the consent of the patent holder for the sole purpose of obtaining regulatory approval. This constitutes an important defense for generic manufacturers when undertaking activities such as studies and trials to provide the information required by regulatory agencies. In this regard, the Bolar exception can respond to a public policy objective of facilitating market entry of generics to support competition and exerting downward pressure on prices for medicines. The Bolar exception is included in many country patent laws and is compatible with international legal instruments regarding patent law.