IP Law Daily, PATENT NEWS: Supreme Court turns down case on scope of assigned patent enforcement rights, (Dec 8, 2014)

By Thomas Long, J.D.

The U.S. Supreme Court has turned down a request by a generic drug manufacturer for review of whether the U.S. distributor of brand-name antihypertension drug Tarka® had standing to sue the manufacturer for patent infringement. Left undisturbed is a decision of the U.S. Court of Appeals for the Federal Circuit, affirming a district court’s ruling that U.S.-based Abbott Laboratories and Abbott Laboratories, Inc. (“ALI”) had standing to sue Glenmark Pharmaceuticals for infringement of U.S. Patent No. 5,721,244 (the ’244 patent). Glenmark was held liable for over $16 million in damages.

The ’244 patent combines into a single dosage product two active ingredients: the angiotensin converting enzyme (ACE) inhibitor trandolapril and the calcium channel blocker verapamil hydrochloride. Sanofi-Aventis Deutschland GmbH is the owner by assignment of the ’244 patent. Aventis Pharma S.A. is the patent’s exclusive licensee.

Aventis Pharma granted the “irrevocable, sole and exclusive right” to Abbott GmbH, a German company, to make products under the ’244 patent. Since 2001, Abbott Laboratories has been the owner of the FDA-approved New Drug Application for the product, and ALI is the exclusive United States distributor for Abbott Laboratories. Sanofi-Aventis, Aventis Pharma, Abbott GmbH, U.S. Abbott Laboratories, and ALI all joined as plaintiffs in the infringement action against Glenmark.

Before the district court, Glenmark asserted that Abbott Laboratories and ALI lacked standing to sue because they did not have exclusive licenses to the ’244 patent. The district court held that the companies had exclusive rights to the patented product in the United States, based on Abbott Laboratories’ ownership of the NDA and the relationships and various express and implied agreements among the plaintiffs. The Federal Circuit affirmed.

In its petition for certioari, Glenmark noted that the Section 261 of the Patent Act states that the patentee shall have a remedy for patent infringement and that an interest in a patent may be assigned by “an instrument in writing.” According to Glenmark, the Federal Circuit erroneously held that the U.S. distributor of a patented product had standing to recover lost profits for infringement on the ground that it was an “implied” exclusive license, even though no written or oral agreement conveyed to that entity an interest in the patent-in-suit. The question presented by Glenmark was “whether a distributor of a patented product, to which no interest in the patent has been assigned, has standing to recover damages for infringement.”

The petition in Glenmark Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH (Docket No. 14-417) was denied December 8, 2014.

Attorneys: James Gailbraith and Michael S. Chang (Kenyon & Kenyon LLP) for Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd. Benjamin C. Hsing (Kaye Scholer, LLP) for Sanofi-Aventis Deutschland GmbH and Aventis Pharma S.A. Stuart E. Pollack (DLP Piper LLP) for Abbott GmbH & Co. KG and Abbott Laboratories.

Companies: Glenmark Pharmaceuticals Inc.; Glenmark Pharmaceuticals Ltd.; Sanofi-Aventis Deutschland GmbH; Aventis Pharma S.A.; Abbott GmbH & Co. KG; Abbott Laboratories

News: Patent