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Diana L. Courson

Zuckerman Spaeder LLP Client Ranbaxy Laboratories Preserves 180-Day Marketing Exclusivity for Generic Blood Pressure Drug

January 3, 2013

Zuckerman Spaeder LLP is pleased to announce that the U.S. District Court for the District of Columbia has upheld a pivotal Food and Drug Administration (FDA) determination involving its client Ranbaxy Laboratories Limited (Ranbaxy). Judge John D. Bates granted summary judgment in the case, rejecting the challenge of one of Ranbaxy’s generic competitors to the FDA’s decision upholding Ranbaxy’s 180-day marketing exclusivity for a generic version of the blood pressure/heart failure drug valsartan—the brand version of which is known as Diovan®.

Partners Carlos Angulo, Kate C. Beardsley, and Alexandra W. Miller have represented Ranbaxy in this matter since October 2012, when Ranbaxy’s competitor sought a preliminary injunction to overturn the FDA’s decision that Ranbaxy had not forfeited the 180-day exclusivity it had earned under the Hatch-Waxman Amendments (Hatch-Waxman) to the Federal Food, Drug and Cosmetic Act (FDCA) as the first generic company to successfully challenge one of the patents for Diovan®. The competitor sought to have the FDA approve its own generic valsartan product in spite of Ranbaxy’s 180-day exclusivity, claiming that, contrary to the FDA’s determination, Ranbaxy’s exclusivity had been forfeited under provisions of the Medicare Modernization Act of 2003 amending Hatch-Waxman and the FDCA.

Represented by the Zuckerman Spaeder team, Ranbaxy intervened in the litigation on behalf of the FDA, and both Ranbaxy and the FDA sought summary judgment against the plaintiff. After full briefing and oral argument before the U.S. District Court for the District of Columbia, in which Mr. Angulo participated on behalf of Ranbaxy, Judge Bates denied the plaintiff’s request for a preliminary injunction and granted the FDA’s and Ranbaxy’s motions for summary judgment. The decision preserves Ranbaxy’s 180-day exclusivity for generic valsartan, which the company estimates to be worth $200 million.

Zuckerman Spaeder’s Food and Drug Practice represents generic and biotechnology drug companies, device companies, nonprofits, advocacy organizations, state and local governments, trade associations, individuals, and other clients in a wide range of matters before courts across the nation, Congress, FDA, CPSC, and other agencies. Attorneys in the practice have worked at the FDA and other federal agencies, and have been involved in significant lawsuits and legislation during their time in public service. The attorneys in this practice combine their food and drug law expertise with broad experience in Congress, civil litigation, criminal defense, and negotiation and conflict resolution with federal agencies.