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Roxane Gets the Red Light from the Federal Circuit

Posted on Nov 17, 2016 in News

On November 17, 2016, in Roxane Laboratories, Inc. v. Camber Pharmaceuticals Inc., Invagen Pharmaceuticals Inc., Appeal No. 16-1028, the Court of Appeals for the Federal Circuit sided with Defendants-Appellees Camber and Invagen, for the second time, in holding that the claim term “size 00 or less” meant “precisely size 00 or less” and excluded the elongated version size 00EL which Defendants were using. Robert S. Silver argued the appeal and Salvatore Guerriero and Pei-Ru Wey also represented Appellees.

On March 2014, Roxane sued Invagen for infringement of U.S. Patent No. 8,563,032 in the Southern District of Ohio. Defendants successfully moved to transfer the case to New Jersey where Judge Chesler denied a Preliminary Injunction motion, siding with Defendants’ claim construction of size 00 or less. On appeal, the Court of Appeals for the Federal Circuit affirmed, without opinion, the denial of the Preliminary Injunction motion and affirmed the preliminary claim construction.

Roxane then lost the Markman hearing where Judge Chesler affirmed his preliminary claim construction ruling in Defendants’ favor, relying only upon intrinsic evidence. On appeal, the Court used a de novo review standard since Judge Chesler rejected the extrinsic evidence.

Upon de novo review, the Court noted that the size 00EL capsule has the same diameter as a standard size 00 capsule but has a greater length, a larger fill volume and presumably a larger weight. Further, that in July 2015, the district court concluded that the meaning of “size 00 or less” is unambiguous and that “nothing in the patent …suggests that the applicants understood ‘size 00’ to mean a family of capsule sizes” that included both standard and elongated sizes. Roxane was therefore unsuccessful on this issue in two appeals before the Court.

Roxane also unsuccessfully appealed the transfer of the case from Ohio to New Jersey pursuant to 28 U.S.C. §1040(a) where the Ohio court, applying Sixth Circuit law, found that the convenience of the parties and witnesses as a whole and the balance of public and private interests favored the transfer of venue to New Jersey. The Court held that the Ohio court, did not abuse its discretion in transferring the case, an extremely high burden to overcome.

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