Carvedilol - USA

On March 28, 2018, U.S. District Judge Leonard Stark of District of Delaware found that Teva did not infringe a patent covering Coreg® as there was not substantial evidence to support the jury's decision that Teva's generic version caused doctors to infringe the patent.

Beginning on June 12, 2017, the Court held a seven-day jury trial in this patent infringement action resulting in a verdict of: (1) willful induced infringement of claims 1, 2, and 3 of U.S. Patent No. RE40,000 ("the '000 patent") by Defendant Teva during the "skinny label" (also referred to as "partial label" or "carve-out") period; (2) no induced infringement of claims 6, 7, 8, and 9 of the '000 patent by Teva during the skinny/partial label period; (3) willful induced infringement of all asserted claims ( claims 1-3 and claims 6-9) of the '000 patent by Teva during the "full label" (also referred to as "amended label") period; (4) no invalidity of the ' 000 patent; and (5) an award to Plaintiffs GlaxoSmithKline and SmithKline Beecham (Cork) Ltd. ("GSK") of $234,110,000 in lost profits and $1,400,000 in reasonable royalty damages.

Parties thereafter filed post-trial motions. Teva filed a renewed motion for judgment as a matter of law ("JMOL"), or in the alternative for a new trial, on five grounds: (1) no inducement of infringement of any claims at any time - that is, during either the skinny label or full label periods - and no lost profits; (2) no inducement of any claims during the skinny label period; (3) no inducement of claims 6 and 7 during the full label period; ( 4) no willful infringement; and (5) invalidity. GSK filed a motion for enhanced damages, attorney fees, and pre- and post-judgment interest. Finally, Teva has moved to strike multiple exhibits GSK submitted in support of its post-trial motion that Teva contends were not part of the trial record.

The Court heard oral argument on October 26, 2017.

With respect to infringement, Court held that substantial evidence does not support the jury's finding on causation, and therefore does not support its verdict that Teva is liable for induced infringement, during both the skinny and full label periods. GSK failed to prove by a preponderance of the evidence that "Teva's alleged inducement, as opposed to other factors, actually caused 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 therefore granted Teva's JMOL. Court further held that without a finding of infringement, there is no liability, so Teva cannot be found to be a willful infringer and cannot be ordered to pay GSK any damages. Accordingly, the Court granted Teva's JMOL motion on each of these grounds.

With respect to invalidity, GSK's evidence that the prior art taught away from and discouraged beta-blockers in heart failure, was sufficient to render the jury's finding that the patent was non-obvious reasonable. Therefore, the Court denied Teva's motion for JMOL or a new trial on invalidity. Also because substantial evidence does not support a finding of induced infringement, there is no basis for enhanced damages, attorney fees, and interest. Accordingly, GSK's motion and Teva's motion to strike multiple exhibits GSK submitted in support of its motion were denied as moot.