October 25, 2016
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.)
Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S. Patent No. RE40,000 (“the ’000 patent”)
Nature of the Case and Issue(s) Presented: Carvedilol is a beta blocker, a class of drug used to treat hypertension. In 1993, GSK filed a NDA on carvedilol tablets, which was approved in 1995. But due to the crowded market for hypertension treatment and clinical studies indicating that long-term administration of carvedilol decreased the risk of mortality in patients with congestive heart failure (“CHF”), GSK did not launch. Instead, it worked to obtain FDA approval to market carvedilol for the treatment of CHF. In June 1995, GSK filed a patent application directed to a method of using carvedilol to decrease the risk of mortality caused by CHF, which later issued in June 1998 as U.S. Patent No. 5,760,069 (“the ’069 patent”). In 1997, GSK’s carvedilol tablets became the first beta blocker to receive FDA approval for the treatment of CHF. GSK began selling its carvedilol tablets under the brand name Coreg, promoting only the CHF indication.
Despite those FDA-approved indications, there were patients with CHF who had recently experienced a heart attack and who could not receive Coreg, because the drug was not approved for use in patients who had recently had a heart attack. GSK, hoping to expand the use of Coreg to include those persons, conducted two studies. In light of those study results, carvedilol received FDA approval for the treatment of left ventricular dysfunction (“LVD”) following a heart attack in clinically stable patients. The first two indications in GSK’s label for COREG were: (i) treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization; and (ii) to reduce cardiovascular mortality in clinically stable patients who had survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of @40% (with or without symptomatic heart failure).
In March 2002, Teva filed an ANDA, containing a PIV certification against the ’069 patent, seeking to market generic carvedilol. In January 2008, the ’069 patent reissued as the ’000 patent. After the ’000 patent issued, GSK submitted patent information regarding the ’000 patent and requested the withdrawal of the ’069 patent from the Orange Book. GSK identified “decreasing mortality...
