Eli Lilly Alimta Patent Validity Upheld On Appeal

By Joseph Mandour on August 24, 2012

Patent Infringements California – The U.S. Court of Appeals for the Federal Circuit on Friday affirmed a lower court’s ruling that Eli Lilly & Co.’s patent for the chemotherapy drug pemetrexed, marketed under the name Alimta, is valid, overruling a challenge from generic pharmaceutical makers Teva Parenteral Medicines Inc., Barr Laboratories Inc. and APP Pharmaceuticals Inc.

The compound patent provides protection for Alimta in the U.S. through January of 2017, Eli Lilly said Friday. Pemetrexed won FDA approval in 2004 for use in treating mesothelioma and then in 2008 for treatment of non-small cell lung cancer.

“We are pleased with today’s ruling from the Court of Appeals affirming the validity of the compound patent for Alimta,” Eli Lilly senior vice president and general counsel Robert A. Armitage said. “By affirming the district court ruling, we believe that the Court fairly applied long-standing patent law principles.”

“Protection of intellectual property rights is extremely important to the biopharmaceutical industry and the physicians and patients we serve, as these rights help support the development of the next generation of innovative medicines to treat unmet medical needs,” he said.

Teva, Barr and APP had appealed a Delaware federal judge’s ruling that U.S. Patent 5,344,932 is not invalid for obviousness-type double patenting.

The Delaware case centered on applications the generic pharmaceutical manufacturers filed seeking regulatory approval to market generic formulations of the chemotherapy agent pemetrexed.

The generics makers’ abbreviated new drug applications with the FDA each included a certification asserting that the ‘932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products. Eli Lilly responded with an infringement suit against the generics makers.

During the proceedings, Teva conceded infringement but maintained that the asserted claims of the ‘932 patent were invalid for obviousness-type double patenting over two earlier-issued claims: one claim of a related compound patent and one claim of a related intermediate patent.

The Delaware judge rejected Teva’s arguments and held that the claims of the ‘932 patent were not invalid for obviousness-type double patenting over either the compound or the intermediate.

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