The Senate Health, Education, Labor and Pensions Committee is considering a proposal to move generics to market more quickly by closing a loophole that lets brand-name drugmakers delay generic versions with patent infringement lawsuits.
The bipartisan compromise, announced June 5 by HELP Chairman Judd Gregg (R-N.H.), ranking member Ted Kennedy (D-Mass.), and Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.), could save $60 billion over 10 years, according to the senators.
The measure will allow cheaper generic drugs to be sold in pharmacies by overhauling portions of the Hatch-Waxman drug patent law. Brand-name drug companies could delay marketing of generics for just one 30-month stay instead of 30 months each time they sue for copyright infringement.
The proposal is different than a similar bill approved by the Senate last year in one significant way. Instead of allowing generic drug manufacturers to challenge frivolous patents that are intended to block generic drugs from coming to market, such as patents on pill color or shape, the new bill allows generic companies to try to remove such a patent by filing a counter claim after the brand-name drugmaker files a lawsuit for patent infringement.
For example, if a name-brand company files a frivolous patent and sues a generic applicant for violating the patent in order to trigger the 30-month stay, the generic company could counter-sue, arguing that the patent never should have been listed.
"After five years of negotiation and discussion, this breakthrough legislation is just what the doctor and the American people ordered," said Gregg in a written statement.
He said the legislation "makes more prescription drugs available more quickly to more people at a lower cost with fewer lawyers involved and with more incentive for innovation."
The full Senate HELP Committee is scheduled to discuss the bill on Wednesday.