Senators To Propose ‘Wild-Card Exclusivity’ Provision To Encourage Participation in Project BioShield
Sens. Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) in the next few months plan to propose legislation to provide pharmaceutical companies that develop products used to respond to a bioterrorist attack or an outbreak of an infectious disease with a six-month to 24-month extension of a patent of their selection, the Wall Street Journal reports. The senators are among several lawmakers who maintain that Project BioShield, a program enacted by President Bush in July 2004, "didn't go far enough," the Journal reports (Lueck, Wall Street Journal, 4/1).
Project BioShield authorizes $5.6 billion over 10 years to encourage pharmaceutical and biotechnology companies to work with NIH to develop antidotes, vaccines and other products to treat and protect against a number of potential biological agents (California Healthline, 2/9).
Supporters of the "wild-card exclusivity" provision maintain that such incentives are "needed to entice big drug companies to join in fighting bioterrorism threats -- a riskier and less profitable business than traditional pharmaceuticals," the Journal reports. Lieberman said, "We are currently unprepared to respond to a bioterror attack and some infectious disease outbreaks. We're racing against the clock."
Generic pharmaceutical companies have said that the wild-card exclusivity provision and other patent-related incentives would delay market entry of less-expensive generic medications and lead to increased prescription drug costs. The Generic Pharmaceutical Association, employer groups and insurance companies oppose wild-card exclusivity and other patent-related incentives and support tax incentives and liability protections to encourage more pharmaceutical companies to participate in Project BioShield.
Pfizer supports the wild-card exclusivity provision and other patent-related incentives, which company spokesperson Jack Cox said would encourage "large companies to invest capital and divert the necessary resources to develop promising compounds for countermeasure uses." He added that Project BioShield currently "isn't enough to spur the development of new drugs to counter bioterrorism attacks."
The Pharmaceutical Research and Manufacturers of America has not taken a position on the wild-card exclusivity provision and other patent-related incentives. PhRMA has said that "it is most interested in" increased liability protections for pharmaceutical companies. Ian Spatz, vice president for public policy for Merck, said that the company supports "a strong, guaranteed purchase commitment and liability protection" and has not lobbied for the wild-card exclusivity provision.
GlaxoSmithKline also is "not lobbying actively" for the wild-card exclusivity provision, according to company spokesperson Mary Anne Rhyne. Rhyne said, "We're interested in seeing what the proposal actually turns out to be."
Meanwhile, Senate Republicans earlier this year introduced a bill (S 3) that would extend patent protection by as many as two years on current products used to respond to a bioterrorist attack or an outbreak of an infectious disease. In addition, the legislation would allow the federal government to provide pharmaceutical companies with extended patent protection for new products used to respond to a bioterrorist attack or an outbreak of an infectious disease equal to the amount of time that they must wait for FDA approval. Under the bill, pharmaceutical companies could not receive both patent extensions for the same product.
Bill sponsors maintain that the legislation does not include a wild-card exclusivity provision. However, "some who have seen the bill say its language is ambiguous," and "generic-industry experts say it contains the wild-card provision," the Journal reports (Wall Street Journal, 4/1).