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In the United States , this exemption is also technically called § 271(e)(1) exemption or '''Hatch-Waxman exemption'''. The U.S. Supreme Court recently considered the scope of the Hatch-Waxman exemption in '' Merck V. Integra ''. The Supreme Court held that the statute exempts from infringement ''all'' uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs. In Canada , this exemption is known as the Bolar provision or '''Roche-Bolar provision''', named after the case '' Roche Products V. Bolar Pharmaceutical ''. COMMON LAW RESEARCH EXEMPTION The Common Law research exemption is an Affirmative Defense to infringement where the alleged infringer is using a patented invention for research purposes. The Doctrine originated in the 1813 decision by Justice Joseph Story appellate decision ''Whittemore v. Cutter'', 29 Fed. Cas. 1120 (C.C.D. Mass. 1813). Story famously wrote that the intent of the legislature could not have been to punish someone who infringes "merely for {Link without Title} experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects." Subsequent decisions later distinguished between commercial and non-commercial research. In 2002 , the Court Of Appeals For The Federal Circuit dramatically limited the scope of the research exemption in ''Madey v. Duke University'', 307 F.3d 1351, 1362 (Fed. Cir. 2002). The court did not reject the defense, but left only a "very narrow and strictly limited experimental use defense" for "amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." The court also precludes the defense where, regardless of profit motive, the research was done "in furtherance of the alleged infringer’s legitimate business." In the case of a research University like Duke University , the court held that the alleged use was in furtherance of its legitimate business, and thus the defense was inapplicable. INTERNATIONAL FRAMEWORK This type of exemptions fall under Article 30 of the WTO 's TRIPs Agreement : :Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. SEE ALSO
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