Brand Name Drug Makers Defend Existing Patent Laws
Mon May 6, 5:36 PM ET
By Todd Zwillich

WASHINGTON (Reuters Health) - With congressional hearings set to continue this week on efforts to revise federal drug patent laws, the brand name pharmaceutical industry on Monday strongly defended the existing law as essential to maintaining market fairness for its products.


Representatives of the industry's main trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), said that moves attempting to limit their ability to go after generic drug makers with lawsuits threaten to expose brand-name companies to unfair patent infringement.

That's because the rest of the laws in question are already tilted toward helping generic drug makers bring more affordable copies of brand name drugs to market, they said.

At issue this week on Capitol Hill will be a Senate proposal that would limit brand-name drug makers' ability to prevent Food and Drug Administration (news - web sites) (FDA) approval of generic competitors. Under the 1984 Hatch-Waxman Act, brand name drug makers can prevent a generic from coming to market for 30-months simply by alleging patent infringement by the generic.

Generic drug makers and many consumer groups argue that brand name pharmaceutical companies have abused the system by using it to file frivolous lawsuits that artificially keep lower-cost generics off the market. A study sponsored by the generic drug industry and the Blue Cross and Blue Shield Association argued that the delays cost consumers and the health care system hundreds of millions of dollars.

Several US senators agree. On Wednesday the Health, Education, Labor, and Pensions Committee is scheduled to hold the second Senate hearing on a bill effectively banning the 30-month stays. The proposal is sponsored by Sens. John McCain (R-AZ) and Charles Schumer (D-NY).

Brand-name companies counter that changing the Hatch-Waxman law and the 30-month stays contained within it would shift the US patent system away from the innovation of new drugs and tilt the market toward copies.

"You're not just tweaking around the edges of some law," said Bruce N. Kuhlik, an attorney who spoke to reporters on behalf of PhRMA. "This is a complete turnaround", said Kuhlik, who is with the firm of Covington and Burling.

Kuhlik and attorney Gregory J. Glover, who plans to testify in the Senate committee Wednesday, emphasized that another part of the 1984 law allows generic drug makers to develop their copies even before the patent on a brand-name drug has expired. The 30-month stay was put in place as a way to resolve patent disputes before already-developed generics begin selling to consumers.

Under the Hatch-Waxmanlaw, stays can only be sought in so-called 'paragraph IV' applications where generic drug makers ask for approval of their copy before the brand name patent has expired.

McCain and Schumer want to disallow 30-month stays and replace them with a system that requires brand-name drug makers to seek injunctions for specific patent violations. That system is the one used for most other US industries.


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