Bolar exception
Bolar exception: named after a case in 1983 in the United States District Court launched by Roche Products Inc., a research-oriented pharmaceuticals company, against Bolar Pharmaceutical Co., a manufacturer of generic products. The gist of the case was that Bolar had begun an effort to obtain federal approval for the marketing of a generic drug based on a patent held by Roche before that patent expired. Roche alleged that this violated United States patent law. The court held that Bolar’s use of the patented compound federally mandated testing was not an infringement of the law because it was de minimis and experimental. An appeal by Roche, heard in 1984 by the Court of Appeals, was successful. Later that year the United States Congress passed the Drug Price Competition and Patent Term Restoration Act which gave backing to the practice at issue in the Bolar case. It stated that it was not an infringement to make, use, or sell a patented drug if that was done solely for uses reasonably related to the development and submission of information under a federal law regulating the manufacture, use, or sale of drugs. The thinking underlying this provision was that if a manufacturer of generic drugs had to wait until the expiry of a patent for a drug before being allowed to start developmental work, the patent term of the drug would be extended de facto, probably by several years, until approval could be obtained. See also generic springboarding and intellectual property rights.
Source: http://ctrc.sice.oas.org/trc/WTO/Documents/Dictionary%20of%20trade%20%20policy%20terms.pdf
Web site to visit: http://ctrc.sice.oas.org
Author of the text: W. Goode
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