Patent Exclusivity drives innovation to combat Bioterror

The use of patent ownership and marketing exclusivity to encourage innovation in the pharmaceutical industry is reflected in existing law and government policy. Studies have shown that these efforts appear to have been successful in facilitating the development and commercialization of new technologies.114 As such, there appears to be congressional interest in utilizing and expanding this approach for the specific purpose of generating innovative bioterrorism countermeasures. While no legislation was enacted during the 109th Congress, three of the bills introduced, S. 3, S. 975, and S. 1873 established regimes under which patent terms would be restored and/or extended and market exclusivity periods increased to reward innovation in this arena. Although different in the specific provisions, these bills built upon incentives that have been used in the past. Encouraging the development of new counterterrorism technologies, on one hand, and ensuring affordable access to new drugs and medical devices, on the other, 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 research and development of 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. Detractors have also questioned the propriety of financing the development of antiterrorism technologies through increased prices upon distinct medical products via the wild card patent term extension. 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.