The US District Court for the District of Delaware granted in part Teva Pharmaceuticals' renewed motion for judgment as a matter of law (JMOL), finding that substantial evidence did not support the jury's finding of induced infringement, and thus the jury's award of more than $235 million could not stand. GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., Case No. CV 14-878-LPS-CJB (D. Del., Mar. 8, 2018) (Stark, J).
The case involved GlaxoSmithKline's (GSK's) branded version of the drug carvedilol. GSK had received a patent directed towards methods for decreasing congestive heart failure (CHF) mortality by administering carvedilol. GSK also received US Food and Drug Administration (FDA) approval to market its drug under the brand name Coreg for three indications: hypertension, CHF and post-heart-attack ventricular dysfunction. Despite receiving approval for three indications, GSK marketed the drug only for CHF.
In 2007, Teva filed an abbreviated new drug application along with a "Section viii statement," also known as a skinny label or a carve out, which allows the generic to obtain approval to sell the drug as long as it excludes from the label methods of use that are under patent. Here, the FDA approved Teva's generic carvedilol drug with its skinny label, which excluded the indication for CHF. Several years later, Teva revised its label to include the CHF indication once GSK's patent covering methods for decreasing CHF was de-listed from the Orange Book.
At issue was whether substantial evidence supported the jury's finding that Teva induced infringement of the claims in GSK's patent. Teva's skinny label did not instruct physicians to prescribe generic carvedilol to treat CHF. The only approved indications on the skinny label were for hypertension and post-heart-attack ventricular dysfunction.
GSK presented evidence that at least one physician had prescribed Teva's generic version of carvedilol "off-label" for the treatment of CHF in a patient. The court, however, found this insufficient to demonstrate that Teva's alleged inducement caused doctors to infringe GSK's patents. Not only did the label not instruct physicians to infringe GSK patents, but physicians who prescribed generic carvedilol for off-label uses relied on sources other than Teva's label and marketing materials, the court found. Such physicians used their own experience and had access to medical journals, guidelines and GSK's promotional materials that discussed the benefits of carvedilol.
Notably, GSK's own expert witness testified that he had not read Teva's generic label before he started writing prescriptions for carvedilol. GSK also conceded that physicians knew how to use carvedilol for treating CHF prior to the entrance of Teva's generic carvedilol in the market.
The court found that GSK presented no direct evidence that Teva induced any doctor to prescribe generic carvedilol to treat CHF. Therefore, the court granted Teva's JMOL on inducement of infringement and willful infringement.
Practice Note: The court's finding that a generic drug maker cannot induce infringement of a method of use patent for an indication that is not even listed on its drug label seems intuitive. The court's decision, however, highlights an obstacle that branded companies face in enforcing their patents. Even though a generic drug maker may exclude the indications covered by a patent, physicians may still prescribe the generic for the "off-label" patented use based on their broader understanding of the drug. In order for generic drug manufacturers to be found liable for induced infringement, however, the patent holder must prove that the actions of the generic company actually caused the physicians to directly infringe the patent. This may not always be the case—for example, here, GSK's expert did not even read the generic label before prescribing Teva's carvedilol.
Teva's Skinny Label Found Not To Induce Infringement By Off-Label Use
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
