
In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the Food and Drug Administration in the United States, does not constitute patent infringement for a limited term before the end of patent term. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration. In the United States, this exemption is also technically called Section sign 271(e)(1) exemption or Hatch-Waxman exemption. In Canada, this exemption is known as the Bolar provision or Roche-Bolar provision, named after the case ''Roche Products v. Bolar Pharmaceutical''. == International framework == This type of exemptions fall under Article 30 of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights: :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 == * Hatch-Waxman Act * ''Merck KGaA v integra Lifescience Ltd'', decision of the Supreme Court of the United States (2005) [http://www.supremecourtus.gov/opinions/04pdf/03-1237.pdf] (pdf - 17 pages) * Supplementary protection certificate (SPC) patent law
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Words begining with Research_exemption:
Research_exemption
Research_exemption_doctrine
Research exemption
In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the Food and Drug Administration in the United States, does not constitute patent infringement for a limited term before the end of patent term. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration. In the United States, this exemption is also technically called Section sign 271(e)(1) exemption or Hatch-Waxman exemption. In Canada, this exemption is known as the Bolar provision or Roche-Bolar provision, named after the case ''Roche Products v. Bolar Pharmaceutical''. == International framework == This type of exemptions fall under Article 30 of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights: :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 == * Hatch-Waxman Act * ''Merck KGaA v integra Lifescience Ltd'', decision of the Supreme Court of the United States (2005) [http://www.supremecourtus.gov/opinions/04pdf/03-1237.pdf] (pdf - 17 pages) * Supplementary protection certificate (SPC) patent law
See other meanings of words starting from letter:
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RA | RB | RC | RD | RE | RF | RG | RH | RI | RJ | RK | RL | RM | RN | RO | RP | RS | RT | RU | RW | RX | RY | RZ |Words begining with Research_exemption:
Research_exemption
Research_exemption_doctrine
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