Worldwide Bolar Exemptions -

Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption, commonly known as a “Bolar exemption”, permits activities with a commercial benefit as long as the activities are reasonably related to obtaining information relevant to a submission for regulatory approval. The December 2017 issue of Sterne Kessler’s Global Patent Prosecution Newsletter includes information on Bolar exemptions worldwide.