The Bolar Exemption

Published byKatia Armejo

The Bolar Exception was included in the Peruvian Patent Law in 2009, as a result of the Free Trade Agreement signed between Peru and the United States of America. Thus, Article 16.9.5 of this Agreement states that any person can freely use a patented invention to generate the information necessary to support an application for marketing approval of a pharmaceutical product or an agrochemical product.

This Exemption was originally established in the US Patent Act in 1984, as a result of the case Roche Products Inc. vs. Bolar Pharmaceutical Co. (1983-1984).

The case arose when Bolar, around the middle of 1983, imported 5 kg of the compound flurazepam hydrochloride, with the purpose of carrying out the tests established by the Federal Food, Drug and Cosmetic Act to authorize the coming into the market of a generic product.  Nevertheless, said compound had been patented by Roche, which right just expired in January 1984. 

Although Bolar alleged that the import it conducted fell within the Exemption of Experimental Use, since the compound would be used only to carry out scientific tests, the US Court of Appeals for the Federal Circuit considered that such import did not fall within the referred Exemption, since said tests, despite being experimental, would be conducted with a commercial purpose, the future marketing of a generic product.

The Experimental Use Exemption is not regulated in the US Patent Act, but it is a case law interpretation built through the years and which arose in the case Whittemore vs. Cutter (1813), in which the US Supreme Court established that a patented invention could be used without the authorization of its owner in a private sphere to carry out experiments with the purpose of verifying if said invention complied with its function. In the case Pitcairn vs. United States (1976) it was explicitly indicated that carrying out experimental tests with a marketing purpose did not fell within this Exemption.


Katia Armejo