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Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

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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.

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.

S. 3 and S. 975 allowed for the restoration of that portion of the patent term used during the FDA approval process, and/or the extension of a patent term to reward technological innovation in the area of bioterrorism countermeasures. The proposed legislation also provided for additional FDA-administered marketing exclusivities for eligible and designated countermeasures. S. 1873 permitted a countermeasure product to qualify as an orphan drug and increases market exclusivity from seven years to ten years.

Encouraging the development of new counterterrorism technologies and ensuring affordable access to new drugs and medical devices are both significant goals. These aspirations may potentially conflict, however. Introducing augmented patent- and exclusivity-based incentives may stimulate innovative firms to engage in the R&D for new countermeasures, as well as to shepherd these products through time-consuming and costly marketing approval procedures. Commentators have expressed concern, however, over whether such heightened protections for innovators will be in proportion with the risks and costs of developing new countermeasures. Striking a balance between encouraging the development of new countermeasures and maintaining the traditional goals of our public health system is a central concern of the current discussion with respect to homeland security.

This report will be updated if events warrant.