{
  "id": "RL33288",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL33288",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 312873,
      "date": "2006-02-28",
      "retrieved": "2016-04-07T19:11:20.531029",
      "title": "Proprietary Rights in Pharmaceutical Innovation: Issues at the Intersection of Patents and Marketing Exclusivities",
      "summary": "In combination, patents and marketing exclusivities provide the fundamental framework of\nintellectual property incentives for pharmaceutical innovation in the United States. Patents, which\nare administered by the United States Patent and Trademark Office (USPTO), provide their owner\nwith the ability to exclude others from practicing the claimed invention for a limited time. In\ncontrast, marketing exclusivities are administered by the Food and Drug Administration (FDA). \nAlternatively known as \u201cdata exclusivity\u201d or \u201cdata protection,\u201d a\nmarketing exclusivity prevents\ngeneric competitors from referencing the preclinical and clinical test data that manufacturers of\nbrand-name pharmaceuticals generated in order to demonstrate the safety and effectiveness of their\nproducts. The FDA currently awards qualifying innovators with marketing exclusivities for the\ndevelopment of new chemical entities or orphan drugs, as well as for the performance of new clinical\nstudies and pediatric studies.\n \n Although patents and marketing exclusivities are separate entitlements that are administered\nby different federal administrative agencies and that depend upon distinct criteria, they both create\nproprietary rights in pharmaceutical innovation. These rights in turn allow innovators to receive a\nreturn on the expenditure of resources leading to the discovery. Once these rights expire, the\nmarketplace for that drug is open to generic competition.\n \n Several innovation policy issues have arisen concerning the relationship of patents and\nmarketing exclusivities. Some observers believe that marketing exclusivities are unnecessary\nbecause patents are generally available for pharmaceutical innovation. On the other hand, some\nobservers believe that the terms of the marketing exclusivities established by U.S. law are too short. \nIn particular, they note that comparable European standards are often considerably longer than their\nU.S. counterparts.\n \n International agreements require each World Trade Organization (WTO) member state to treat\nall patented inventions in the same manner. As a result, marketing exclusivities provide Congress\nwith a more flexible option for stimulating specific sorts of desirable private activity than do patents. \nIndeed, the 109th Congress is currently considering expanding upon existing marketing exclusivities\nin order to encourage the development of bioterrorism countermeasures. WTO Agreements, as well\nas recent Free Trade Agreements to which the United States is a signatory, also oblige nations to\nprovide some manner of protection to pharmaceutical test data.\n \n Although general patent reform legislation has been the subject of significant discussion during\nthe 109th Congress, current legislative proposals do not appear particularly to impact the relationship\nbetween patents and marketing exclusivities. Some maintain that continued attention to the impact\nof broadly oriented patent reforms upon the pharmaceutical industry is appropriate.",
      "type": "CRS Report",
      "typeId": "REPORTS",
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      "topics": []
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  "topics": [
    "Health Policy"
  ]
}