{
  "id": "RL32400",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL32400",
  "active": false,
  "source": "EveryCRSReport.com, University of North Texas Libraries Government Documents Department",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 341283,
      "date": "2007-06-01",
      "retrieved": "2016-04-07T18:05:56.473029",
      "title": "Patents and Drug Importation",
      "summary": "Prescription drugs often cost far more in the United States than in other countries. Some consumers have attempted to import medications from abroad in order to realize cost savings. The practice of importing prescription drugs outside the distribution channels established by the brand-name drug company is commonly termed \u201cparallel importation.\u201d Parallel imports are authentic products that are legitimately distributed abroad and then sold to consumers in the United States, without the permission of the authorized U.S. dealer.\nParallel importation may raise significant intellectual property issues. Many prescription drugs are subject to patent rights in the United States. In the Jazz Photo decision, the U.S. Court of Appeals for the Federal Circuit confirmed that the owner of a U.S. patent may prevent imports of patented goods, even in circumstances where the patent holder itself sold those goods outside the United States. The Jazz Photo opinion squarely declined to extend the \u201cexhaustion\u201d doctrine\u2014under which patent rights in a product are spent upon the patent owner\u2019s first sale of the patented product\u2014to sales that occurred in foreign countries. The court\u2019s ruling will in some cases allow brand-name pharmaceutical firms to block the unauthorized parallel importation of prescription drugs through use of their patent rights.\nSeveral state and local governments are either themselves importing, or encouraging others to import, patented medications from foreign jurisdictions. The Eleventh Amendment of the U.S. Constitution provides that a federal court may not adjudicate a lawsuit by a private person against a state, except under certain limited circumstances. The ability of a private party to obtain a remedy for patent infringement against a state government is therefore uncertain. Eleventh Amendment immunity may in some cases extend to political subdivisions of a state as well.\nIn addition to any patent rights they possess, brand-name drug companies may place label licenses on their medications. It is possible to draft a label license restricting use of a drug to the jurisdiction in which it was sold. As a result, in addition to a charge of patent infringement, an unauthorized parallel importer may potentially face liability for breach of contract.\nLegislation introduced before the 110th Congress, S. 1082, addresses the importation of prescription drugs. Titled the Food and Drug Administration Revitalization Act, this bill would amend the Patent Act of 1952 to provide that importation into the United States of a regulated pharmaceutical sold abroad by a patent proprietor or its representative is not a patent infringement. Introduction of an \u201cinternational exhaustion\u201d rule restricted to pharmaceuticals does not appear to be prohibited by the provisions of the so-called TRIPS Agreement, which is the component of the World Trade Organization (WTO) agreements concerning intellectual property. Another possible legislative response is the immunization of specific individuals, such as pharmacies or importers, from patent infringement liability. Alternatively, no legislative action need be taken if the current possibility of an infringement action against unauthorized importers of patented pharmaceuticals is deemed satisfactory.",
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    {
      "source": "University of North Texas Libraries Government Documents Department",
      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc807817/",
      "id": "RL32400_2007Jan17",
      "date": "2007-01-17",
      "retrieved": "2016-03-19T13:57:26",
      "title": "Patents and Drug Importation",
      "summary": "This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.",
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      "active": false,
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      "topics": [
        {
          "source": "LIV",
          "id": "Intellectual property",
          "name": "Intellectual property"
        },
        {
          "source": "LIV",
          "id": "Patents",
          "name": "Patents"
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        {
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          "id": "Drug industry",
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    {
      "source": "University of North Texas Libraries Government Documents Department",
      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc822377/",
      "id": "RL32400_2004May25",
      "date": "2004-05-25",
      "retrieved": "2016-03-19T13:57:26",
      "title": "Patents and Drug Importation",
      "summary": "This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.",
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      "typeId": "REPORT",
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      "topics": [
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          "source": "LIV",
          "id": "Intellectual property",
          "name": "Intellectual property"
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          "source": "LIV",
          "id": "Patents",
          "name": "Patents"
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          "id": "Drug industry",
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          "source": "LIV",
          "id": "Trade",
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  "topics": [
    "Economic Policy",
    "Foreign Affairs",
    "Health Policy"
  ]
}