Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security (CRS Report for Congress)
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| Release Date |
Revised Aug. 3, 2007 |
| Report Number |
RL32917 |
| Report Type |
Report |
| Authors |
Wendy H. Schacht and John R. Thomas, Resources, Science, and Industry Division |
| Source Agency |
Congressional Research Service |
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Summary:
Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. While, to date, no relevant bills have been introduced in the 110th Congress, the issue is under discussion. During the 109th Congress, several bills were introduced (although not enacted) that would have generated additional incentives for the creation of new technologies to counteract potential biological threats. These bills proposed reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products. Patent ownership appears to be important in the promotion of innovation, particularly in the pharmaceutical sector. Patent title provides a limited-time monopoly over the use of a discovery in exchange for the public dissemination of information contained in the patent application. This permits the inventor to receive a return on the expenditure of resources but does not guarantee that the patent will generate commercial benefits. The requirement for patent publication is expected to stimulate additional innovation to meet similar demands in the marketplace. Currently, the Bayh-Dole Act and the Hatch-Waxman Act include provisions that utilize patent ownership to facilitate the development and commercialization of new pharmaceuticals. The Hatch-Waxman Act also contains FDA marketing approval policies that are designed to promote the creation of new drugs. Similar market-exclusivity provisions are contained in the Orphan Drug Act.
