Warner Chilcott Can't Undo Teva's Win on Atelvia

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By Dana A. Elfin

March 21 — Warner Chilcott Co. couldn't convince an appeals court to reverse its loss in patent litigation with Teva Pharmaceuticals USA Inc. over the osteoporosis treatment Atelvia.

In a nonprecedential, unpublished opinion released March 18, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court ruling that patent claims related to Atelvia (risedronate sodium delayed-release tablets) were invalid because they were obvious.

The ruling means that Teva, which launched its generic version of Atelvia delayed-release tablets in May 2015, will be able to continue selling the generic product and won't face any patent damages claims as a result of its sales.

The lower court hadn't erred in concluding that the claims were invalid, Judge Alan D. Lourie said, writing on behalf of the Federal Circuit panel that heard argument in the case. Timothy B. Dyk and Todd M. Hughes were the other judges on the panel.

The litigation over Atelvia dates to 2011 when Warner Chilcott sued Teva for patent infringement after Teva filed an abbreviated new drug application with the Food and Drug Administration to sell a generic version of Atelvia delayed-release tablets before the patents on the drug expired.

In March 2015, Judge Faith S. Hochberg of the U.S. District Court for the District of New Jersey ruled that the asserted claims of Warner Chilcott's U.S. Patents No. 7,645,459 (the ’459 patent) and 7,645,460 (the ’460 patent) “considered as a whole, are obvious” .

Warner Chilcott subsequently appealed the invalidity ruling to the Federal Circuit and asked the district court to stay enforcement of the patent invalidity judgment pending the appeal. But the district court refused to stay the judgment, finding that Warner Chilcott hadn't shown that it was likely to suffer irreparable harm without preliminary relief .

A Federal Circuit panel subsequently agreed that Warner Chilcott had failed to demonstrate that it was entitled to an injunction pending appeal , and Teva launched its generic Atelvia product shortly thereafter.

Warner Chilcott also sued Watson Laboratories Inc., Ranbaxy Laboratories Ltd. and Impax Laboratories Inc. over their Atelvia ANDAs, but settled each of those actions.

Atelvia is indicated to treat postmenopausal osteoporosis.

Warner Chilcott is now part of Ireland-based Actavis, which acquired the company for $8.5 billion in 2013.

The law firms of Covington & Burling LLP, in Washington represented Warner Chilcott. The law firm of Goodwin Procter LLP, in New York represented Teva Pharmaceuticals USA Inc., a subsidiary of Israeli company Teva Pharmaceutical Industries Ltd.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Allison Gatrone at agatrone@bna.com