Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security
LIBRARY OF CONGRESS WASHINGTON DC CONGRESSIONAL RESEARCH SERVICE
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Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. Several bills considered, but not enacted during the 109th Congress, including S. 3, the Protecting America in the War on Terror Act of 2005 S. 975, the Project Bioshield II Act and S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act, would have generated additional incentives for the creation of new products and processes by the private sector 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. Patents appear to be important in the promotion of innovation, particularly in the pharmaceutical sector. This report explores the role of patents in encouraging the development and commercialization of new inventions and discusses the relationships between patent ownership and the generation of biomedical products. However, the grant of a patent on a pharmaceutical does not permit marketing of the product without the approval of the Food and Drug Administration FDA. Thus, this report also examines policies concerning the use of FDA marketing exclusivity as an additional incentive to industry research and development RD in this arena. Current law and suggested legislative changes are discussed to provide a context for any further exploration of related issues during the 110th Congress.
- Sociology and Law
- Medicine and Medical Research
- Manufacturing and Industrial Engineering and Control of Production Systems
- Chemical, Biological and Radiological Warfare