GlaxoSmithKline LLC v. Teva Pharma. USA, Inc.

Case Name: GlaxoSmithKline LLC v. Teva Pharma. USA, Inc., No. 14-878, 2018 U.S. Dist. LEXIS 51169 (D. Del. Mar. 28, 2018) (Stark, J.)

Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S. Patent No. RE40,000 (“the ’000 patent”)

Nature of Case and Issue(s) Presented: The ’000 patent is directed to the administration of a therapeutically acceptable amount of carvedilol to decrease the risk of mortality caused by congestive heart failure (“CHF”). Coreg, however, is approved for three indications: (i) hypertension; (ii) mild-to-severe CHF; and (iii) left ventricular dysfunction following myocardial infarction (heart attack) in clinically stable patients (“post-MI LVD”). As a result, Teva sought FDA approval pursuant to a “section viii carve out,” whereby the label for its generic carvedilol tablets were only indicated for uses not covered by GSK’s ’000 patent (i.e., treatment of hypertension and post-MI LVD).

In September 2007, Teva received FDA approval of its generic carvedilol tablets and launched its drug product with the carved-out/skinny label. Thereafter, in April 2011, FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book, instructing Teva to “revise [its] label to include the information associated with the [de-listed] patent.” As a result, Teva amended its label in 2011 to be an essential copy of GSK’s full label, meaning it covered all three indications: hypertension, CHF, and post-MI LVD. 

In June 2017, the Court held a seven-day jury trial, resulting in a verdict of: (i) willful induced infringement of certain claims of the ’000 patent during the skinny-label period and (ii) willful induced infringement of all asserted claims of the ’000 patent during the full-label period. The jury awarded GSK over $235 million in damages.

In post-trial motions, Teva filed a renewed motion for judgment as a matter of law.  The court granted this motion.          

Why Teva Prevailed: The court agreed with Teva, explaining that neither sufficient nor substantial evidence supported the jury finding of inducement. Specifically GSK failed to prove by a preponderance of evidence that Teva’s alleged inducement, as opposed to other factors, actually caused physicians to directly infringe the ’000 patent.

As to the skinny-label period, the court noted that the unrebutted evidence showed that Teva’s skinny label omitted the use of carvedilol to treat CHF. Moreover, GSK’s expert testified that he would not prescribe generic carvedilol for CHF if it were not an approved use on the label. 

In seeking to prove infringement, GSK relied on Teva’s marketing, which stated that its product was “AB rated” to Coreg. The court noted, however, that the undisputed evidence demonstrated that a generic drug cannot be listed as “AB rated” generally, or “AB rated” to a particular indication. Moreover, GSK conceded that there is no FDA requirement that a generic drug company specify the uses for which it is (or is not) AB rated.

The court also explained that prior to launch of generic carvedilol (including by Teva), doctors writing prescriptions for carvedilol relied on various sources other than Teva’s label and marketing materials. In other words, prior to the generics’ entrance into the market in 2007, physicians already knew how to use carvedilol for treating CHF. Because no trial evidence demonstrated that generic labeling, including Teva’s label, impacted prescribing behavior, the court found that no reasonable juror could find that Teva induced infringement of the ’000 patent during the skinny-label period.  

As to the full-label period, GSK presented evidence of Teva’s full label along with various other material, including Teva press releases, Teva’s 2011 product catalog, the 2012 and 2013 editions of Teva’s Monthly Prescribing Reference, and Teva’s AB rating. The Court explained, however, that physicians were already prescribing generic carvedilol to treat CHF when Teva changed to the full label and that GSK presented no evidence to support a finding that anything about doctors’ behavior was induced to change by Teva’s label, or by anything else Teva did (or failed to do). Therefore, no reasonable juror could find that Teva induced infringement of the ’000 patent during the full-label period.