Skinny-label ruling will ‘decimate’ Hatch-Waxman, Fed Circuit told
One of the architects of the Hatch-Waxman Act has urged judges to reverse a decision which he says nullifies a key provision of the generic drug legislation.
Former Congressman Harry Waxman was just one of several parties, including academics and generic manufacturers, to file amicus briefs at the US Court of Appeals of the Federal Circuit, calling for the reversal of the court’s decision in GSK v Teva.
The fear expressed by Waxman, and other amici such as Apotex and Mylan, is that drug companies could keep generics off the market by filing new patents covering novel uses of their drugs.
Last October, the Federal Circuit reinstated a $235 million judgment finding Teva liable for inducing doctors to infringe GlaxoSmithKline (GSK) patents covering heart drug Coreg (carvedilol).
Teva claimed it was protected under the Hatch-Waxman Act because its generic product’s “skinny label” excluded patent-protected uses of Coreg, even though it may have been prescribed and used for infringing purposes.
But a 2-1 majority of a Federal Circuit panel accepted evidence that Teva had induced doctors to infringe the patent by prescribing generic carvedilol for patent-infringing purposes.
The decision has been met with protest from academics and generic drug companies, who say it undermines the Hatch-Waxman Act and congressional intent. Teva has asked the Federal Circuit to review the decision en banc.
In his brief, Waxman said Congress had “plainly anticipated the exact situation involved in this case” and included provisions to protect market access for skinny label generics.
“The majority’s decision thus threatens to decimate the compromise at the heart of the Hatch-Waxman Act, which in turns threatens to undermine the generic pharmaceutical industry,” Waxman said.
He added: “Generic drugs saved the US nearly $2.2 trillion over the past ten years, but if the majority’s decision stands, name-brand companies like GlaxoSmithKline will be encouraged to file serial patents for novel methods of use and effectively bar generics from entering the market indefinitely.”
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