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Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security
Wendy H. Schacht (au)
Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. During the 109th Congress, several bills were introduced (although not enacted), including S. 3, the Protecting America in the War on Terror Act, S. 975, the Project Bioshield II Act, and S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act, 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. Contents of this Congressional Research Service (CRS) report, updated Nov. 27, 2006: (I) Introduction; (II) Patents and Innovation; (III) Role of Patents in Pharmaceutical/Biomedical R&D; (IV) Legislative Developments: The Bayh-Dole Act; The Hatch-Waxman Act; Orphan Drug Act; (V) Proposals for Change: Patent Term Fundamentals; Proposed Patent Term Restoration Reforms; Proposed Patent Term Extension Reforms; Proposed Marketing Exclusivity Reforms; March-In Rights; (VI) Concluding Observations.
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