Bioterrorism Defense Bill May Extend Market Exclusivity Afforded By Patents

By Jarod Marrot

The Bio Defense Act of 2005 (“bioshield”), a bill which has not been introduced to the Senate yet, has been drafted to provide incentives to the drug industry, including patent extensions to promote the development of defense products and generate a stock pile of vaccine antidotes. For example, the “wild card” exclusivity provision in the bill would offer 6 additional months of market exclusivity on any drug developed as a useful defensive drug. “Engaging the [pharmaceutical] industry as entrepreneurs rather than as defense contractors is likely to be less expensive for the government and more likely to secure the development of medicines that we need,” Senator Joseph Lieberman said in recent testimony to a committee.

However, the generic drug industry is concerned that the Act contains excessive patent extensions and market exclusivity, which may delay affordable medicines from coming to market and exacerbate the problem of high health care for Americans. The genetic drug industry is particularly concerned that companies will use provisions of the Act to extend patent monopolies on drugs that have nothing to do with biodefense. Accordingly, some groups fear that monopoly extensions would undermine improving bioterrorism defense by encouraging brand pharmaceutical companies to focus their resources on already approved products instead of focusing their attention on novel countermeasures. For more information, please contact Jarod Marrot at jmarrot@kmclaw.com.