GlaxoSmithKline LLC. v. Glenmark Generics Inc.

Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) 

Drug Product and Patent(s)-in-Suit:  Coreg^® (carvedilol); U.S. Pat. No. RE 40,000 ("the '000 patent") 

Nature of the Case and Issue(s) Presented: The ’000 patent is a reissue of U.S. Patent No. 5,706,069 ("the ’069 patent"). Those patents contain method claims concerning the drug carvedilol. Approximately two decades previously Glaxo had filed its NDA on carvedilol tablets for the management of hypertension. That application was granted in September 1995. Fearing an overcrowded hypertensive treatment market, Glaxo did not immediately launch its drug. Instead, it concentrated its research on using carvedilol to treat chronic heart failure. The FDA approved the use of carvedilol for treatment of chronic heart failure in 1997. Then, Glaxo began selling and marketing a branded version of carvedilol known as Coreg in different dosages. In 2003, Glaxo received FDA approval to prescribe Coreg for management of hypertension, for treatment of mild-to-severe chronic heart failure and for treatment of left ventricular dysfunction following myocardial infarction in clinically stable patients. Despite being FDA-approved for multiple uses, Glaxo marketed Coreg only for the treatment of chronic heart failure. The ’069 issued to Glaxo in 1998 claiming a method using carvedilol to decrease the risk of mortality caused by chronic heart failure. The ’000 patent issued in January 2008, and included a limitation claiming a maintenance period greater than six months.

Teva’s ANDA contained a Paragraph IV certification alleging that the ’069 patent was invalid. Teva also sought a Section viii carve out to label its generic carvedilol tablets only for uses not covered by the ’069 patent. Teva obtained this approval in September 2007 and immediately began selling its generic product. In May 2011, Teva amended its label so that it would be identical to Glaxo’s, which contained the patented method of treating chronic heart failure. Glenmark followed Teva’s lead and launched its generic carvedilol product. Like Teva’s, Glenmark’s generic product originally included a Section viii carve out. But from August 2009 to August 2010, Glenmark also amended its label so that it was identical to Glaxo’s, which included the patented method of treating chronic heart failure. After that period of time, Glenmark changed the label back to the original carve-out-compliant version and removed reference to treatment of chronic heart failure.

Glaxo filed separate suits against Teva and Glenmark on July 3, 2014, alleging contributory infringement and induced infringement based on the content of the Defendants’ generic drug labels. Defendants responded by filing their respective motions to dismiss pursuant to Rule 12(b)(6). The court dismissed without prejudice Glaxo’s claims of induced infringement with regard to the carve-out-compliant labels. The court denied the motion to dismiss Glaxo’s induced infringement claim for the period of time that the Defendants’ drugs had labelling that was substantially identical to the labelling found on Glaxo’s branded drug. The court also denied the Defendants’ motion to dismiss Glaxo’s claims for contributory infringement.

Why Glaxo Prevailed: Glaxo’s complaint alleged that the Defendants indirectly infringed the ’000 patent by inducement and by contributory infringement. The induced infringement claim was further subdivided into two parts: (i) Defendants infringed the ’000 patent with their carve-out-compliant labels (which did not explicitly contain the patented method for treatment of chronic heart failure); and (ii) Defendants infringed the ‘000 patent with their revised labels which made reference to using carvedilol to treat chronic heart failure. Concerning claim (i), Glaxo argued that the Defendants induced infringement because they caused their generic carvedilol tablets to be listed in the Orange Book with a therapeutic equivalence rating of “AB.” An AB rating implies that generic copies of a drug are considered therapeutically equivalent to Coreg.

In its complaint, Glaxo alleged that the Defendants touted the AB rating, but never informed the public that their generic carvedilol was not approved by the FDA for treatment of chronic heart failure. Glaxo reasoned that many states and third-party payers of prescription drugs have policies that require the substitution of AB-rated generics regardless as to whether the generic drug labels include all of the indications contained in the brand drug label. The court dismissed Glaxo’s argument, finding that it required too much speculation about what other parties may or may not do. The court also noted that the Orange Book itself specifically states that an AB rating is limited to what is on the generic drug’s label. As such, the court could not accept Glaxo’s argument that an AB rating alone was sufficient evidence that the Defendants had engaged in induced infringement. The court found that Glaxo’s other allegations relating to marketing and promoting activities engaged in by the Defendants were also devoid of enough factual detail to survive the motion to dismiss.

The court next addressed Glaxo’s argument (ii). There was no question that statements in the package insert that encouraged infringing use of a drug product were alone sufficient to establish intent to encourage direct infringement for purposes of an induced infringement claim. But the Defendants attempted to avoid this result by making the narrow argument that the Glaxo label could not be read to encourage administration of carvedilol to treat chronic heart failure for a maintenance period of greater than six months, which was the time-period claim limitation added by reissue in the ‘000 patent. The court found this argument lacking because chronic diseases by their very nature tend to last for periods in excess of six months. The court also concluded that it was not necessary for the generic labelling to precisely parrot the six month period limitation. Instead, the relevant question was whether the allegations, when considered in their entirety and in context, plausibly suggested an intent and actions to encourage administration of carvedilol in a manner that would meet the claim limitation. The court found that they did and that Glaxo had alleged such facts with adequate specificity in its complaint.

Last, the court addressed Glaxo’s contributory infringement allegation. Here the court focused its attention on the Defendants’ argument that Glaxo failed to sufficiently allege that carvedilol tablets had no substantial non-infringing uses. The court noted that there were, in fact, a number of non-infringing uses for the Defendants’ carvedilol tablets, such as treatment of hypertension, left ventricular dysfunction, and for chronic heart failure patients for periods of less than six months. These non-infringing uses were not disputed. Rather, Glaxo alleged in its complaint that the tablets were used in these non-infringing ways on an extremely limited basis. Glaxo noted that carvedilol was generally not recommended in the treatment of hypertension because studies had shown poor results and a there was a general lack of clinical trial data establishing the drug’s effectiveness. With respect to the left ventricular dysfunction indication, Glaxo alleged that the patient population was exceedingly small compared to the population of patients taking the drug to treat chronic heart failure. Essentially, Glaxo alleged that the vast majority of patients who had been prescribed carvedilol had taken it to treat chronic heart failure, and had taken it for a period in excess of six months. Thus, dismissal of Glaxo’s contributory infringement claim was denied.