Federal Circuit affirms Roxane’s patent not infringed

The US Court of Appeals for the Federal Circuit has affirmed a district court’s ruling holding that Camber Pharmaceuticals and Invagen Pharmaceuticals do not infringe Roxane Laboratories’ patent.

The patent involved is US number 8,563,032. It covers a capsule formulation of calcium acetate granules, with each capsule containing a dose of 667mg calcium acetate on an anhydrous basis.

Calcium acetate is used to treat patients suffering from end-stage kidney failure.

Pharmaceutical capsules for human use come in multiple sizes, including size 5 (the smallest), 4, 3, 2, 1, 0, 00, and 000 (the largest).

The claims of the ’032 patent require that the calcium acetate granules be contained within “a pharmaceutically acceptable capsule … that is size 00 or less”.

Camber and Invagen’s products are sized  00el. A size 00el capsule has the same diameter as a standard size 00 capsule, but has a greater length and a larger fill volume.

In March 2014, Roxane sued the companies in the US District Court for the Southern District of Ohio, alleging infringement of the patent.

The case was transferred to the District of New Jersey and in July 2015, the district court issued an order construing the claim limitation “size 00 or less”.

The court concluded that the meaning of “‘size 00 or less’ is unambiguous” and that it means “precisely size 00 or less”, which excludes capsules of size 00el.

Roxane then appealed, claiming that the court had erred in construing the claims as excluding size 00el capsules.

The Federal Circuit said in its ruling: “We have considered Roxane’s remaining arguments but find them to be unpersuasive.”

It agreed with the district court “that the intrinsic record of the ’032 patent unambiguously indicates” that size 00 refers to a capsule of a specific diameter, length, and fill volume.

The ruling is non-precedential.