U.S. appeals court upholds Shire's patents on hyperactivity drug

By Brendan Pierson

Sept 24 (Reuters) - A U.S. appeals court has uphelddrugmaker Shire's patents for its top-selling drugVyvanse, blocking five generic drug makers from launchingcheaper versions of the drug to treat attention deficithyperactivity before 2023.

The U.S. Federal Circuit Court of Appeals on Thursdayrejected the generic manufacturers' claims that Shire's patentswere invalid, leaving in place a ruling from a New Jerseyfederal court last year.

The generic drugmakers - Amneal, Mylan, Allergan's Actavis unit, Novartis's Sandoz unit and RoxaneLaboratories, which Hikma Pharmaceuticals recently agreedto acquire from Boehringer Ingelheim - had all sought U.S. Foodand Drug Administration approval for generic versions ofVyvanse. That prompted Shire to file a series of lawsuits in2011 and 2012.

In June 2014, Shire won summary judgment in the U.S.District Court for the District of New Jersey that its 16patents on the drug were valid and would be infringed by theplanned generics, prompting the generic drugmakers to appeal.

"We are extremely pleased that the Federal Circuit affirmedthe District Court's ruling that the patents are valid, whichfurther confirms that Shire has strong patents protectingVyvanse," said Mark Enyedy, Shire's interim general counsel, ina press release.

Representatives of Roxane and Amneal declined to comment.The other generic drugmakers did not immediately return requestsfor comment.

Vyvanse is approved by the FDA to treat ADHD and bingeeating disorder. The drug brought Shire $841.6 million inrevenue in the first half of 2015, about 28 percent of its totalrevenue.

The case is Shire LLC et al v. Amneal Pharmaceuticals LLC etal, U.S. Court of Appeals, Federal Circuit, No. 2014-1736. (Reporting By Brendan Pierson in New York; Editing by FrancesKerry)