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 FDA in the United States, does not constitute 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. A patent is a set of exclusive rights granted by a government to a person for a fixed period of time in exchange for the regulated, public disclosure of certain details of an invention. ... Law (a loanword from Old Norse lag), in politics and jurisprudence, is a set of rules or norms of conduct which mandate, proscribe or permit specified relationships among people and organizations, provide methods for ensuring the impartial treatment of such people, and provide punishments for those who do not follow... Many drugs are provided in tablet form. ... Research is an active, diligent and systematic process of inquiry in order to discover, interpret or revise facts, events, behaviours, or theories, or to make practical applications with the help of such facts, laws or theories. ... The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ... In law, a patent infringement occurs when the subject-matter claimed in a patent has been utilized by someone other than the rightholder, without the owners approval or in disagreement with the terms of use given by the owner. ... A generic drug is a drug which is bioequivalent to a brand name drug with respect to pharmacokinetic and pharmacodynamic properties, but is normally sold for a lower price. ...

In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. The section sign (§; Unicode U+00A7, HTML entity §) is a typographical character used mainly to refer to a particular section of a document, such as a legal code. ...

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 WTO's TRIPs Agreement: The World Trade Organization (WTO) is an international organization which oversees a large number of agreements defining the rules of trade between its member states (WTO, 2004a). ... The WTO Agreement on Trade_Related Aspects of Intellectual Property Rights (TRIPs) is an international treaty which sets down minimum standards for most forms of intellectual property regulation within all member countries of the WTO. Specifically, TRIPs deals with copyright and related rights (ie. ...

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) [1] (http://www.supremecourtus.gov/opinions/04pdf/03-1237.pdf) (pdf - 17 pages)
• Supplementary protection certificate (SPC)