IP Law Daily Court tosses jury’s verdict that generic drug maker infringed carvedilol patent
Thursday, March 29, 2018

Court tosses jury’s verdict that generic drug maker infringed carvedilol patent

By Sara Cracau, J.D.

In a patent infringement action involving patents held by GlaxoSmithKline LLC ("GSK") for carvedilol—a drug used to treat congestive heart failure—substantial evidence did not support a jury’s finding of induced infringement by generic drug maker Teva, the federal district court in Wilmington, Delaware, has ruled, overturning a damages award by the jury of over $235 million. The court granted Teva’s motion for judgment as a matter of law on induced infringement, although the court rejected Teva’s argument that GSK’s patent was invalid for obviousness. Because there was no induced infringement, there was no basis for awarding enhanced damages, attorney fees, or interest to GSK, the court also ruled (GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., March 28, 2018, Stark, L.).

GSK secured a patent for its launch of Coreg®, the brand name of its carvedilol tablets for the treatment of congestive heart failure (CHF), U.S. Patent No. 5,760,069 ("the '069 patent"), entitled "Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure." GSK subsequently undertook further patent prosecution efforts to correct certain errors in the ’069 patent, which resulted in reissuance of the patent as U.S. Patent No. RE40,000 ("the '000 patent"). The compound carvedilol itself was covered by GSK’s U.S. Patent No. 4,503,067 ("the '067 patent"), which expired in 2007 and was not at issue in the current case.

Teva filed an application with the Food and Drug Administration seeking permission to market generic carvedilol tablets. Teva initially asserted that the ’069 patent was invalid and then later sought a carve-out so that it could label its generic tablets for indications that were not covered by GSK’s ’000 patent.

In 2007, with expiration of the ’067 patent, GSK’s period of exclusivity for carvedilol ended, and generic carvedilol entered the market. Numerous companies, including Teva, marketed the generic version of the drug. In 2007, Teva received FDA approval for its generic tablets and launched its drug product with the carved out/skinny label—that is, excluding the CHF indication. As a result of de-listing of certain GSK patents from the Orange Book, the FDA instructed Teva to revise its labeling; therefore, Teva amended its label to be essentially a copy of GSK’s full label, covering three indications for use, including CHF.

The ’000 patent expired in 2015, on the date the ’069 patent was due to expire. When Teva originally launched its generic version of the drug, during the skinny label period of January 2008 through April 2011, its label identified as approved indications which did not include CHF. Teva’s label included the previously-patented method of use, treatment of CHF, only in the full period, May 2011 through the expiration of the ’000 patent in June 2015.

Infringement action. GSK sued Teva for infringement, and a jury trial resulted in a verdict of: (1) willful induced infringement of claims 1, 2, and 3 of the ’000 patent by Teva during the skinny period; (2) no induced infringement of claims 6, 7, 8, and 9 of the ’000 patent by Teva during the skinny period; (3) willful induced infringement of all asserted claims of the ’000 patent by Teva during the full label period; (4) no invalidity of the ’000 patent; and (5) an award to GSK of approximately $234.1 million in lost profits and $1.4 million in reasonable royalty damages. Both parties filed post-trial motions. Teva moved for judgment as a matter of law (JMOL) or a new trial.

Induced infringement. The court concluded that substantial evidence did not support the jury’s findings on inducement during the skinny period or the full label period. Consequently, the court granted this portion of Teva’s JMOL motion.Without a finding of liability, Teva could not be found to be a willful infringer and could not be required to pay damages.

The court agreed with Teva that the record lacked substantial evidence that Teva’s skinny label, together with other acts or omissions undertaken by Teva during the skinny period caused any physician’s direct infringement. In fact, one physician witness testified that he had relied on other sources, none attributable to Teva, in deciding to prescribe carvedilol. Teva’s skinny label did not instruct physicians to prescribe the drug for off-label use. Furthermore, the label identified the approved uses which were not covered by GSK’s patent and could not be considered infringing uses.

With respect to the full label period, Teva presented substantial, unrebutted evidence of multiple factors unrelated to Teva that in fact caused doctors to infringe the ‘000 patent. Consequently, noted the court, a reasonable factfinder could only have found that these alternative, non-Teva factors caused the physicians to prescribe carvedilol for an infringing use.

No invalidity verdict. The court was not persuaded, however, by Teva’s arguments in support of its JMOL regarding a prior art reference anticipating the asserted claims and that the asserted claims were obvious in light of that reference. Factual issues existed as to whether the prior art disclosed a maintenance period of more than six months, whether the prior art’s patient population was the same as the population covered by the claims, and whether the prior art was too theoretical.

The case is No. 1:14-cv-00878-LPS-CJB.

Attorneys: William Chad Shear (Fish & Richardson, PC) for GlaxoSmithKline LLC. Alexandra Lu (Goodwin Procter LLP) for Teva Pharmaceuticals USA Inc.

Companies: GlaxoSmithKline LLC; Teva Pharmaceuticals USA Inc.

MainStory: TopStory Patent DelawareNews

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