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10 February 2014Americas

Appeals court ruling blocks Lyrica competition until 2018

The US Court of Appeals for the Federal Circuit has upheld a patent covering Pfizer’s pain drug Lyrica, closing the market to any generic challengers until 2018.

On February 6 it confirmed a district court’s decision that a group of generic makers, including Teva, Actavis, Sun and Mylan, had infringed a patent covering Lyrica’s active ingredient pregabalin by seeking to market a generic version of the drug.

The court also said that a challenged claim of the patent was valid, despite the generics’ arguments that there is lack of enablement, insufficient written description or obviousness.

Lyrica is used in the treatment of fibromyalgia, nerve pain and pain after shingles. It is Pfizer’s biggest selling drug, making the company nearly $4.6 billion in revenues in 2013.

Pfizer sued the generic makers at the US District Court for the District of Delaware in 2009 after they sent Abbreviated New Drug Applications to the US Food and Drug Administration seeking approval to market a generic version of Lyrica.

In its complaint, Pfizer initially asserted four patents, though the appeals court found that the case rested entirely on a single claim of the composition of matter patent covering pregabalin, US patent number 6,197,819.

“We hold that the district court did not err in its conclusion that claim 2 of the ‘819 has been infringed, and that appellants failed to prove that the claim is not enabled, insufficiently described, or obvious,” Judge Prost wrote in the judgment. He added that the generics’ arguments about the validity of the other disputed patents are moot.

Pfizer’s senior vice president and associate general counsel Michael Parini said: “We are pleased with today’s decision by the Court of Appeals for the Federal Circuit ensuring Pfizer will exclusively provide pregabalin as Lyrica to patients through December 30, 2018 in the US, pending a possible rehearing or appeal of this decision and pending other litigation.”

The generic companies may now request a rehearing by the appeals court or a review by the Supreme Court.

Mylan did not respond to a request for comment.