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Resounding Victory in New Jersey Follows Successful Transfer of Pharmaceutical Patent Infringement Litigation from Ohio

Posted on Aug 8, 2014 in News

A New Jersey federal judge on August 6, 2014 rejected Roxane Laboratories, Inc.’s bid for a preliminary injunction in its patent suit over Camber Pharmaceuticals, Inc. and InvaGen Pharmaceuticals, Inc.’s generic calcium acetate capsule product, which is used in the treatment of hyperphosphatemia in patients with chronic kidney disease.

The case had previously been transferred from Ohio pursuant to a motion filed by the Defendants.

U.S. District Judge Stanley R. Chesler ruled that Roxane failed to demonstrate a likelihood of success in proving infringement. The court stated that “the key obstacle for Roxane is found in the undisputed facts that claim 1 of the patent requires a ‘capsule that is size 00 or less,’ while the accused infringing products are capsules that are size ‘00el.’” Size 00el capsules have the same diameter as size 00 capsules, but are slightly elongated and thus have a greater volume.

Roxane’s literal infringement theory depended on its proposed claim construction that the ordinary meaning of “capsule that is size 00” meant “capsule that is in the size 00 family, which includes size 00el.” The court, however, found that the patent’s public record did not support Roxane’s proposed construction.

Additionally, Roxane failed to show that it was likely to prove that the Defendants’ product infringed under the doctrine of equivalents. The court found that the prosecution history made clear that the addition of the “size 00 or less” limitation was a narrowing amendment to overcome a prior art rejection. Because the applicants unambiguously surrendered claim scope involving capsules larger than size 00, prosecution history estoppel barred Roxane from asserting equivalents over Defendants’ calcium acetate capsule.

In addition, the court found that Roxane did not demonstrate that it was likely to suffer irreparable harm. The judge rejected Roxane’s first argument that Defendants would be unable to pay monetary damages. The court also rejected Roxane’s price erosion argument. Significantly, the court found Roxane’s own evidence undermined its price erosion argument, noting that Roxane’s historical average selling prices showed that the price erosion was not irreversible, and thus, did not amount to irreparable harm.

The patent-in-suit is U.S. Patent Number 8,563,032.

Camber and InvaGen are represented by Robert S. Silver and Salvatore Guerriero of Caesar Rivise, PC

Roxane is represented by Latham & Watkins, LLP.

The case is Roxane Laboratories, Inc. v. Camber Pharmaceuticals, Inc., No. 2:14-cv-04042-SRC-CLW, in the U.S. District Court for the District of New Jersey.

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