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ARTICLE · 05 SEPTEMBER 2013

Contradictory Statements In Prosecution May Lead To Invalidity By Indefiniteness

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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In a recent case, the Federal Circuit affirmed the district court’s judgments of infringement and no invalidity with respect to one set of claims, reversed its judgment of no invalidity with respect to another set of claims, and remanded for further proceedings.

United StatesLitigation, Mediation & Arbitration

In Teva Pharmaceutials USA, Inc. v. Sandoz, Inc., Nos. 12-1567, -1568, -1569, -1570 (Fed. Cir. July 26, 2013), the Federal Circuit affirmed the district court's judgments of infringement and no invalidity with respect to one set of claims, reversed its judgment of no invalidity with respect to another set of claims, and remanded for further proceedings.

Teva Pharmaceuticals USA, Inc. ("Teva") markets Copaxone®, a drug used for treating multiple sclerosis.  Sandoz, Inc. ("Sandoz") and Mylan Pharmaceuticals Inc. ("Mylan") (collectively "Defendants") submitted ANDAs to the FDA seeking approval to market generic versions of Copaxone®.  Teva sued the Defendants for infringement of the patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ("Orange Book") entry for Copaxone®. 

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