Generic Pharmaceutical Company Defeated Competitor’s Challenge for Market Exclusivity

With health care costs skyrocketing, generic pharmaceutical products offer an important alternative for consumers who cannot afford brand-name drugs. Generic companies, however, are frequently blocked from manufacturing less expensive versions of popular drugs because of questionable patents held by brand-name companies. To encourage generic competition, the Hatch-Waxman Act allows for generic drug applicants to challenge such patents when they submit their applications for approval to the Food and Drug Administration. The first generic applicant to successfully challenge a brand-company patent for a particular drug (the “first filer”) is eligible to receive 180 days of “generic market exclusivity,” during which no competing generic can be approved by the FDA and the first filer’s product is the lone generic version of a particular drug on the market. This exclusivity can be very lucrative (often worth hundreds of millions of dollars or more), and there are frequent disputes over the Food and Drug Administration’s (FDA) decisions awarding such exclusivity—some of which result in litigation involving the FDA, the generic company eligible for exclusivity, and the company challenging the exclusivity.

One such dispute centered around the eligibility of longtime Zuckerman Spaeder LLP client Ranbaxy Laboratories’ eligibility for 180-day exclusivity for a generic version of the blood pressure/heart failure medication valsartan (brand name Diovan®). Ranbaxy, as the first generic applicant to successfully challenge one of the patents for Diovan®, was determined by the FDA to be eligible for 180-day exclusivity for its generic valsartan product. In October 2012, however, one of Ranbaxy’s generic competitors sued the FDA in the U.S. District Court for the District of Columbia, claiming that Ranbaxy had forfeited its exclusivity under certain provisions added to Hatch-Waxman in 2003. Ranbaxy’s competitor sought a preliminary injunction that would have required the FDA to deny Ranbaxy’s eligibility for exclusivity and instead grant the competitor’s application for its own generic valsartan product.

Represented by Zuckerman Spaeder partners Carlos Angulo and Alexandra W. Miller, Ranbaxy intervened in the litigation on behalf of the FDA, joining the agency in filing motions for summary judgment against the plaintiff. After expedited briefing and oral argument before the Hon. John Bates on December 7, 2012, in which Mr. Angulo argued on behalf of Ranbaxy, the court denied the plaintiff’s motion for a preliminary injunction and granted Ranbaxy’s and the FDA’s motions for summary judgment. This decision preserves Ranbaxy’s eligibility for 180-day exclusivity for generic valsartan, which the company estimates to be worth approximately $200 million.

This victory represents the second time that Zuckerman Spaeder has successfully defended Ranbaxy’s eligibility for exclusivity for one of its generic products. In 2011, Zuckerman Spaeder’s Food and Drug Practice, alongside the FDA, successfully obtained dismissal of a lawsuit brought by a generic competitor of Ranbaxy’s challenging Ranbaxy’s exclusivity for generic atorvastatin (brand name Lipitor®).

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