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- Research_exemption abstract "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.In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. In 2005, the U.S. Supreme Court 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.In the European Union, equivalent exemptions are allowed under the terms of EC Directives 2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC).".
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- Research_exemption wikiPageExternalLink 36311146.pdf.
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- Research_exemption wikiPageLength "6617".
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- Research_exemption wikiPageRevisionID "645215430".
- Research_exemption wikiPageWikiLink Affirmative_defense.
- Research_exemption wikiPageWikiLink Canada.
- Research_exemption wikiPageWikiLink Category:Biotechnology_law.
- Research_exemption wikiPageWikiLink Category:Patent_law.
- Research_exemption wikiPageWikiLink Circuit_split.
- Research_exemption wikiPageWikiLink Common_law.
- Research_exemption wikiPageWikiLink Directive_(European_Union).
- Research_exemption wikiPageWikiLink Doctrine.
- Research_exemption wikiPageWikiLink Drug_Price_Competition_and_Patent_Term_Restoration_Act.
- Research_exemption wikiPageWikiLink Duke_University.
- Research_exemption wikiPageWikiLink European_Union.
- Research_exemption wikiPageWikiLink Food_and_Drug_Administration.
- Research_exemption wikiPageWikiLink Generic_drug.
- Research_exemption wikiPageWikiLink Investigational_New_Drug.
- Research_exemption wikiPageWikiLink Joseph_Story.
- Research_exemption wikiPageWikiLink Law.
- Research_exemption wikiPageWikiLink Law_of_the_United_States.
- Research_exemption wikiPageWikiLink Merck_KGaA_v._Integra_Lifesciences_I,_Ltd..
- Research_exemption wikiPageWikiLink New_drug_application.
- Research_exemption wikiPageWikiLink Patent.
- Research_exemption wikiPageWikiLink Patent_infringement.
- Research_exemption wikiPageWikiLink Pharmaceutical_drug.
- Research_exemption wikiPageWikiLink Research.
- Research_exemption wikiPageWikiLink Research_exemption.
- Research_exemption wikiPageWikiLink Roche_Products,_Inc._v._Bolar_Pharmaceutical_Co..
- Research_exemption wikiPageWikiLink Section_sign.
- Research_exemption wikiPageWikiLink Supplementary_protection_certificate.
- Research_exemption wikiPageWikiLink Supreme_Court_of_the_United_States.
- Research_exemption wikiPageWikiLink TRIPS_Agreement.
- Research_exemption wikiPageWikiLink Term_of_patent.
- Research_exemption wikiPageWikiLink Test_data_exclusivity.
- Research_exemption wikiPageWikiLink United_States.
- Research_exemption wikiPageWikiLink United_States_Court_of_Appeals_for_the_Federal_Circuit.
- Research_exemption wikiPageWikiLink University.
- Research_exemption wikiPageWikiLink World_Trade_Organization.
- Research_exemption wikiPageWikiLinkText "FDA safe harbor".
- Research_exemption wikiPageWikiLinkText "Research exemption".
- Research_exemption wikiPageWikiLinkText "Research exemption#madey".
- Research_exemption wikiPageWikiLinkText "gathering data for a regulatory submission".
- Research_exemption wikiPageWikiLinkText "om Hatch Waxman Exemption".
- Research_exemption wikiPageWikiLinkText "research exemption".
- Research_exemption wikiPageWikiLinkText "safe harbor".
- Research_exemption wikiPageUsesTemplate Template:Anchor.
- Research_exemption wikiPageUsesTemplate Template:Cquote.
- Research_exemption wikiPageUsesTemplate Template:Reflist.
- Research_exemption wikiPageUsesTemplate Template:Regulation_of_therapeutic_goods_in_the_United_States.
- Research_exemption subject Category:Biotechnology_law.
- Research_exemption subject Category:Patent_law.
- Research_exemption hypernym Exemption.
- Research_exemption type Diacritic.
- Research_exemption type Redirect.
- Research_exemption comment "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.".
- Research_exemption label "Research exemption".
- Research_exemption sameAs Q7315157.
- Research_exemption sameAs m.06j1nr.
- Research_exemption sameAs Q7315157.
- Research_exemption wasDerivedFrom Research_exemption?oldid=645215430.
- Research_exemption isPrimaryTopicOf Research_exemption.