The Washinton Times reported that a so-called wild-card patent provision, expected to be proposed to Congress as part of the Bioshield II bill (Senate Bill S.3, Protecting America in the War on Terror Act of 2005), has been modified to overcome objections from companies that manufacture generic drugs.

S.3 would make changes to the earlier Project Bioshield, which authorizes $5.6 billion over 10 years to encourage pharmaceutical and biotechnology companies to work with the NIH to develop antidotes, vaccines and other products to treat and protect against a number of potential biological weapons.

The wild card provision, if enacted, would add up to two years to the exclusive patent term for a patented drug. It’s called a wild card because its designee would get to apply it to any drug for which it holds a patent. For a major pharmaceutical, those two extra years could be worth billions of dollar in revenue. Generic firms are worried that drug companies would wait to apply the wild card until the last minute – thus throwing a monkey wrench into their business plans.

The draft language in the new bill was changed to require the winner of a contract to name the designated drug within 180 days of receiving the contract. Since the wild card cannot be applied until after the company actually gains FDA approval for the new countermeasure, there is a risk that the wild card could be applied to a drug that would go off patent before it can be used, effectively nullifying the whole scheme for the pharmaceutical company.

However, even then not all would be lost. If the patent on the wild-card product does expire, there is still an option in the bill to extend the patent on the countermeasure to make up the time lost getting FDA approval. Under a provision in S.3, the firm with a winning countermeasure drug can choose to have the life of the patent on the new product extended to 17 years. Again, this can mean a massive windfall for the pharma.

The Generic Pharmaceutical Association opposes the changes on serveral grounds. See their position paper here. More info here.

In general, S.3 sets forth provisions concerning bioterrorism preparedness and defense, including provisions for: (1) extending the patent terms for certain countermeasure products; (2) exempting meetings between the Secretary of Health and Human Services and parties developing priority countermeasures from antitrust laws; (3) establishing the Commission on Countermeasure and Vaccine Regulation; (4) prohibiting a State from establishing requirements different from certain Federal food and drug laws; (5) allowing tax credits for vaccine and countermeasures manufacturing and research; and (6) requiring procedures for inspecting imported live animals.

In a bit of a gruesome political tie-in, it also increases the death gratuity payable to survivors upon the combat-related death of a member of the Armed Forces and increases the maximum life insurance payable for a member of the uniformed service or a veteran. This will put anyone opposed to the bill in a bind – they have to choose between allowing the controversial measures or looking like they are “against the fallen troops” – a no win situation.

Several groups, such as the National Vaccine Information Center (NVIC), are concerned about vaccine safety and have come out against the bill because of its provision that would preempt any state legislation regulating vaccines or vaccine components (read: Thimerosal or mercury) and it proposes to take away the rights of states to even warn citizens about potential injuries attributable to vaccines and drugs.

Other proposed provisions that raise eyebrows include the broadening of the definition of “countermeasure,” which could make almost any medicine eligible for patent extensions. The definition could be applied to commonly prescribed drugs that treat secondary effects of a bioterrorist attack, such as migraines, anxiety and even erectile dysfunction.

“To retain respect for sausages and laws, one must not watch them in the making.”

– Otto von Bismarck

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  1. Blawg Review #4

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