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Analysis:Patentee motive is target of bill...

 
By admin at Thu, 2006-02-16 01:42

WASHINGTON, Feb. 15 (UPI) -- The label of Pravigard Pac, a drug used to prevent heart disease, specifically says it should not be taken by anyone under age 18.

But that did not stop the medication's manufacturer from getting a six-month patent extension to test the drug's possible benefits for children.

And this is just one example of tactics that companies use to delay the introduction of generic drugs that are costing patients and tax payers huge sums of money, Sens. Trent Lott, R-Miss., and Debbie Stabenow, D-Mich. said at a press conference Wednesday where they unveiled bipartisan legislation they say will close such loopholes.

"This is important because it directly relates to what Americans have to pay for prescription drugs," Stabenow said. "We know that the growing availability of generic drugs translates into savings."

Inventors of new drugs are granted patents so they can exclusively sell drugs at a high price for several years to recover their often-astronomical research and development costs. Once the patent expires, other manufacturers can produce and sell versions of the medication at a much lower price--about 70 percent lower, according to the National Association of Chain Drug Stores.

The law allows for patent extensions to consider additional information for a variety of purposes, and sometimes important details are brought to light.

The Lower Priced Drugs Act would tighten requirements for such pediatric exclusivity patent extension requests, remove a technicality that prevents certain generic uses of antibiotics patented before 1997 and specifically require courts to consider the motives of filers before granting 30-month stay-of-effectiveness periods, which are now virtually automatic.

"We allow patents in this country to encourage research and development," Stabenow said, "but what we are seeing is, as they come to the end of a patent, companies are looking for ways to keep it going."

Lott emphasized the importance of patents, but added that they should not be allowed to be misused.

"We should articulate that there's a terrific benefit here and we don't want to kill the goose that laid the golden egg," he said, "but you want to find ways to encourage the move toward generics where laws allow for that."

The bill will likely encounter the stiff opposition from drug manufacturers that earlier generic drug legislation has faced, but enjoys the support of some equally powerful proponents including labor unions, insurance companies and the AARP.

Additional support for the bill has come from large employers, like General Motors, which hope the wider availability of generic drugs would help reign in their mounting healthcare costs, Stabenow told United Press International.

The bill also has widespread bipartisan support in Congress, Lott said, and should reach the Senate floor, even as an amendment if necessary.

The bill will probably be referred to the Senate Committee on Health, Education, Labor and Pensions where the senators expect the support of committee chairman Mike Enzi, R-Wyo., Stabenow said.

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