GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

GSK adequately pled a claim of induced infringement alleging facts concerning ways in which Teva actively promoted its generic product and the content of Teva’s skinny label.

October 25, 2016

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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 caused by congestive heart failure” as being covered by the ’000 patent. In February 2008, the ’000 patent was listed in the Orange Book with patent use code U-233 (“decreasing mortality caused by congestive heart failure”). Although Teva had originally submitted a PIV certification against the ’069 patent, in August 2007, Teva amended its ANDA to a section viii statement, and did not include in its proposed label those portions of GSK’s label directly relating to the CHF indication. Teva received FDA approval for its generic version of carvedilol in September 2007; and until May 2011, the label for its generic carvedilol tablets “carved out” the CHF indication.

GSK sued Teva and Glenmark in July 2014. GSK brought claims of indirect infringement (one count of induced infringement and one count of contributory infringement) against Teva and Glenmark concerning the ’000 patent. Defendants moved to dismiss the complaints, and in response, GSK filed a First Amended Complaint (“FAC”) in each action. Glenmark and Teva again moved to dismiss. The court issued a Report and Recommendation to: (i) grant of the motions to dismiss as to GSK’s claims regarding induced infringement during the time periods where the CHF indication was not on Defendants’ labels, with leave to amend; (ii) deny the motions as to GSK’s claims regarding induced infringement during the time periods where the CHF indication was on Defendants’ labels; and (iii) deny the motions as to GSK’s claims for contributory infringement. GSK then filed its Second Amended Complaint (“SAC”) in this action. Teva filed this motion, seeking dismissal of GSK’s claims for inducement of infringement for the pre-May 2011 time period, i.e., when Teva’s label carved out the CHF indication. The court recommended that Teva’s motion be denied.

Why GSK prevailed: GSK points to two primary aspects of the SAC to support its argument that it sufficiently articulated a plausible claim in the SAC.

The first is the SAC’s allegations regarding certain ways in which Teva actively promoted its generic carvedilol tablets, i.e., by publicizing the drug’s AB rating and by disseminating certain press releases, both prior to and during the relevant time period. As it held previously in dismissing GSK’s induced infringement claim from the FAC, advertising a product as an AB-rated bioequivalent to a brand name drug is the only realistic way for a generic manufacturer to market its product. Therefore, alone, it is not enough to establish an induced infringement claim. But unlike its FAC, GSK in its SAC also points to two press releases as further evidence of Teva’s specific intent to target the entire market for carvedilol, including the treatment of CHF patients. Teva countered that the press releases are irrelevant to the induced infringement inquiry since they were published before the ’000 patent issued. Because it is possible that what a party does or says before its patent issues might at least bear on what its mindset was in the crucial post-issuance time period, the press releases could be evidence that wents to Teva’s intent to capture the CHF market.

The second relates to the explicit contents of Teva’s carve-out label. GSK alleged that its second indication was drafted in such a way that it still included an indication to reduce cardiovascular mortality in CHF patients who also suffered from a heart attack such that by including the second indication on its skinny label, Teva was knowingly instructing and encouraging physicians to prescribe its generic carvedilol to patients, including patients with CHF, for a period of more than six months to reduce the risk of mortality. In response, Teva argued that an induced infringement claim against a generic manufacturer can never be successful if (i) the generic has attempted to utilize a section viii carve-out; (ii) has asserted to the FDA that in doing so, it is not seeking approval for a different, patented use for the drug; and (iii) the FDA permits the generic to go to market with the carved-out label. Citing the Federal Circuit’s decision in AstraZeneca v. Apotex, 633 F.3d 1042 (Fed. Cir. 2010), the court disagreed. It held that it was plausible that Teva’s promotion of its skinny label encouraged infringement of the ’000 patent during the relevant time period. The second indication in Teva’s proposed label—that Teva’s generic carvedilol tablets were indicated “to reduce cardiovascular mortality in clinically stable patients…with…symptomatic heart failure”—was similar to the carved-out CHF indication, which stated that carvedilol tablets were “indicated for the 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.” In light of the similarity in the wording of the two indications, it was plausible that Teva’s skinny label alone could inevitably lead some consumers to practice the claimed method.

Finally, the court found that in its SAC, GSK alleged facts that plausibly suggested that: (i) despite Coreg’s multiple approved indications, GSK had marketed the drug in the US only for the CHF indication; (ii) uses of carvedilol tablets for the other two indications (hypertension and post-MI LVD) were not substantial; and (iii) Teva was aware that its generic carvedilol tablets were not suitable for substantial non-infringing uses. Taken together and considered in the context of the other relevant allegations, the court found that those allegations could further suggest Teva’s intent to induce use of its generic drug for the patented treatment of CHF during the pre-May 2011 time period.

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