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BioWar: Bioshield wild-card patent curbed
By Dee Ann Divis
UNITED PRESS INTERNATIONAL
WASHINGTON, DC, Apr. 27 (UPI) -- A wild-card patent provision expected to be proposed to Congress Thursday as part of the Bioshield II bill has been modified to overcome objections from companies that manufacture generic drugs.
The provision, which is a patent extension -- and one of the more creative ideas in the bill to be proposed by Sen. Joseph Lieberman, D-Conn. -- would add up to two years to the exclusive patent for a drug.
More important, it is called a wild card because its designee would get to apply it to any drug for which it holds a patent. If applied to a blockbuster drug such as Viagra, that two years could be worth hundreds of millions -- even billions -- of dollar in revenue without additional research or direct investment by the company.
The provision is designed specifically to entice large pharmaceutical firms to turn their vast resources and extensive expertise toward developing countermeasures against bioterror weapons.
The first Bioshield bill, signed into law in the summer of 2004, set aside $5.6 billion to buy new countermeasures for a giant national stockpile. The stockpile was to be preparation against a bioterror attack, but also meant to be the floor of a guaranteed market Congress hoped would attract Big Pharma. The guarantees were not enough, however, so legislators have devised the wild card and a package of other inducements to be combined into Bioshield II.
Despite the hint of congressional desperation and opportunism swirling around some 30 provisions in the new bill, the wild card is not an easy giveaway. The company that wins a national stockpile contract must also successfully develop the drug all the way through Food and Drug Administration approval -- and must do this before being able to use the wild card.
Generic firms have worried that drug companies would wait to apply the wild card until the last minute - throwing off their business plans and those of major drug buyers.
"If a generic is ready to come to market, and all the health insurers and Medicare and Medicaid have planned their budgets for the year based on this generic coming to market at a certain time, the wild-card withdrawal will put that off by ... keeping the generic off the market," said Andrea Hofelich, director of media relations for the Generic Pharmaceutical Association in Arlington, Va.
To enable the generics to plan ahead, draft language in the new bill was changed to require the winner of a contract with a wild-card award to name the designated drug within 180 days of receiving the contract.
"We did choose the generics on this point," said Chuck Ludlam, counsel to Sen. Lieberman and an expert on Bioshield. "We did put in this provision to help the generics plan the rollout of their products. ... We realized it may make the wild card somewhat less attractive to the companies."
What makes the choice especially difficult is the wild card cannot actually be used for a number of years, because it cannot be applied until after the company wins FDA approval for the new countermeasure. Approval could take five or more years. It is even possible the patent on the selected wild-card drug could expire by the time the wild card is activated.
If that happens, however, that is it, said a senior Senate aide.
"Once the patent is expired, there is nothing you can do to resurrect a patent is this bill," the aide explained. "When the patent is dead the patent is dead."
The 180 days creates another limitation to keep the focus on innovation, the aide added. The firm with the wild card cannot be acquired for 180 days after winning it and must name the wild-card product within that time. This means large firms cannot simply step in and acquire a smaller company after it has won a wild-card patent contract and then apply the wild card to their own products.
"The company that gets the contract to do the development must own the patent (for the countermeasure) at that time." the aide explained. "It cannot subsequently be acquired."
If the patent on the wild-card product does expire, there is still an option in the bill to sweeten the deal: It would make it possible to extend the patent on the countermeasure to make up the time lost getting FDA approval.
As noted earlier, it can take a number of years for a drug to win final approval. Because a patent is applied for and usually obtained long before the FDA approval process is finished, the money-earning period of the patent is shortened -- sometimes significantly so. Under a provision in Bioshield II, the firm with a winning countermeasure drug can choose to have the life of the patent on the new product extended to its full 17 years.
In fact, a winning firm could choose the extension instead of the wild card -- an option available at any time -- but the firm must choose, the aide said, and cannot use both the wild card and the extension.
"They don't have to choose the wild card," the aide said. "That restoration on the patent ... (could be) as important, or more important, than the wild card would be. Maybe they have no product with respect to which the wild card makes sense. Some companies will have products where the wild card makes sense and other won't."
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Dee Ann Divis is UPI's Senior Science & Technology Editor. E-mail: |
