GlaxoSmithKline v. Teva, No. 14-878-LPS-CJB (D. Del.)
In an opinion last week, Judge Stark of the District of Delaware granted Teva's motion for judgment as a matter of law that GSK failed to present sufficient evidence to support a jury verdict that Teva induced infringement of U.S. Patent No. RE40,000. Judge Stark's decision effectively vacates a jury award of more than $200 million to GSK.
Here is an abbreviated chronology of the relevant facts:
- May 1997: GSK obtains FDA approval of Coreg® (carvedilol) tablets for the treatment of congestive heart failure (CHF)
- June 1998: U.S. Patent No. 5,760,069 issues to GSK, claiming a method of treating CHF by administering carvedilol
- March 2002: Teva files an ANDA for carvedilol tablets with a para. III certification to U.S. Patent No. 4,503,067, which claims the carvedilol compound, and a para. IV certification to the '069 patent
- March 2007: the '067 patent expires
- August 2007: Teva amends its para. IV certification against the '069 patent to a section viii statement, carving out the CHF indication from its label and leaving indications for hypertension and left ventricular dysfunction
- September 2007: FDA approves Teva's ANDA; Teva launches generic carvedilol
- January 2008: the '069 patent reissues as the '000 patent
- April 2011: Teva amends its label, adding back the CHF indication, making Teva's label essentially a copy of GSK's full label
- June 2015: the '000 patent expires
Judge Stark held a seven-day jury trial last year. The jury found that Teva willfully induced infringement of certain claims of the '000 patent during two time periods: (1) January 2008 to April 2011 (the "skinny label" period); and (2) May 2011 to June 2015 (the "full label" period). The jury awarded $234 million in lost profits and $1.4 million in reasonable royalty damages to GSK. The parties then filed post-trial motions.
In granting Teva's motion for JMOL, the court summarized its conclusion as follows:
The Court agrees with Teva that neither sufficient nor substantial evidence supports the jury's finding of inducement. GSK failed to prove by a preponderance of the evidence that "Teva's alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe," by prescribing generic carvedilol and to do so for the treatment of mild to severe CHF. Without proof of causation, which is an essential element of GSK's action, a finding of inducement cannot stand.
The court's decision that no reasonable jury could have found that Teva induced infringement of the '000 patent during the skinny label period is not surprising. But the court's decision of no inducement during the "full label" period is unexpected.
The court found that many factors--but not Teva's label or marketing materials--caused doctors to prescribe generic carvedilol. For instance, the court found:
In addition to the knowledge and experience that ordinarily skilled cardiologists had acquired by July 2007 about the benefits of treatment with carvedilol, such doctors had access to American Heart Association and American College of Cardiology guidelines, carvedilol research studies published in the New England Journal of Medicine, The Lancet, and the British Heart Journal, GSK's own Coreg® label and product insert, and GSK's extensive promotional activity--totaling nearly $1 billion--which included sending doctors to hospitals, giving seminars, and detailing, marketing, and advertising Coreg®.
Further, Teva showed that once generic carvedilol entered the market in September 2007, and continuing beyond 2007, doctors continued prescribing carvedilol (be it Coreg® or a generic) in the same manner as they had prior to the generics' entrance, as they based their prescription decisions on the various factors addressed above without relying on Teva's--or any other generic manufacturers'--label. GSK's expert, Dr. McCullough, testified that he had not read Teva's generic label before he started writing prescriptions for carvedilol. As GSK concedes, prior to the generics' entrance into the market in 2007, physicians already knew how to use carvedilol for treating CHF. Three cardiologists testified at trial . . . and all three agreed that even in September 2007, when generic companies (including Teva) began selling carvedilol, doctors relied on guidelines and research, as well as their own experience, in addition to GSK marketing. None viewed generic labeling, including Teva's label, as impacting prescribing behavior.
As Teva correctly notes, no direct evidence was presented at trial that any doctor was ever induced to infringe the '000 patent by Teva's label (either skinny or full). There was no direct evidence that Teva's label caused even a single doctor to prescribe generic carvedilol to a patient to treat mild to severe CHF. Hence, in order to uphold the verdict, the Court must find in the record substantial evidence to render it reasonable for the jury to have inferred that at least one doctor was so induced. GSK, as the verdict winner, is entitled to the benefit of all reasonable inferences that may be drawn from the evidence presented to the jury. The Court's determination, however, is that--given the dearth of evidence that doctors read and understand and are affected by labels, and given the vast amount of evidence that doctors' decisions to prescribe carvedilol during the relevant periods were influenced by multiple non-Teva factors--such an inference was an unreasonable one for the jury to have drawn.
The court distinguished more typical ANDA cases that involve a method-of-use patent, in which the patent owner alleges inducement of infringement before a generic launch and the court heavily relies on the proposed ANDA label when evaluating the inducement claim:
For instance, GSK directs the Court to Sanofi v. Watson Laboratories Inc., 875 F.3d 636, for the proposition that the marketing of a generic drug with labeling that encourages infringement can be viewed as causing infringement despite the fact that the innovator company published the results of clinical studies and promoted the patented use. That case does not persuade the Court to reach a different conclusion than described above. Sanofi involved the ordinary Hatch-Waxman framework, where a claim of induced infringement is filed before the generic has launched its product, and necessarily, before the generic has even attempted to communicate with any direct infringer. In those cases, as this Court held during earlier portions of this case, the focus must be on intent, rather than actual inducement. Here, by contrast, GSK filed its case almost seven years after Defendants launched their generic carvedilol products into the market. Hence, GSK's inducement claims are not premised on a hypothetical, but instead must be supported by sufficient evidence as to what actually happened during the relevant time period. This Court has decided that reliance on a label and speculation about what may occur in the future cannot substitute for actual evidence about what has actually occurred in the past when, as in this case, there has been a period of actual, past conduct that is pertinent to infringement.
This case is relatively unique--particularly because it involved an at-risk launch. It will be interesting to see how the case affects litigation strategies used in other ANDA cases involving method-of-use patents. And we will certainly be paying attention to the inevitable appeal.