Health Law Daily The long and skinny of Teva’s labels saves $235M, no induced infringement
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Thursday, March 29, 2018

The long and skinny of Teva’s labels saves $235M, no induced infringement

By Anthony H. Nguyen, J.D.

A federal court found no direct evidence was presented at trial that any doctor was ever induced to infringe brand name drug maker GlaxoSmithKline’s (GSK) reissued patent based on generic drugmaker Teva’s label for carvedilol, a beta blocker used to treat congestive heart failure (CHF). GSK had alleged that Teva’s drug labels, in both narrow indications for use and complete indications for use form, induced physicians to infringe on GSK’s patents. The district court found no substantial evidence to support the jury's finding on causation, and overturned its $235 million verdict, granting Teva's motion for judgment as a matter of law (GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., March 23, 2018, Jackson, L.).

‘Skinny’ patent. In 1997, the FDA approved carvedilol as the first beta-blocker for the treatment of CHF, and GSK launched its branded version of carvedilol tablets, Coreg®, with the FDA approval to market for three indications: (1) hypertension; (2) mild-to-severe CHF; and (3) left ventricular dysfunction (LVD) following myocardial infarction (MI) (heart attack) in clinically stable patients. In the United States, Coreg was only marketed for the CHF indication.

GSK’s patent was published in the FDA’s Orange Book, which includes a listing of approved drug products and, among other things, information about the patents that cover each drug product, with use pertaining to "decreasing mortality caused by congestive heart failure." In 2008, the patent was reissued (after corrections) with the same use code and the original patent was delisted. In the interim between the original and reissued patent, Teva filed with the FDA an abbreviated new drug application (ANDA), seeking permission to market generic carvedilol tablets.

Teva’s submission included assertions that GSK’s delisted patent was invalid and requested that its ANDA not be given final approval until a second Orange Book listed patent (one which covered the carvedilol compound) expired in March 2007. However, in August 2007, Teva sought to "carve out" FDA approval of its ANDA pursuant to 21 U.S.C. §355G)(2)(A)(viii) in order to "skinny" label its generic carvedilol tablets as indicated only for uses not covered by GSK's reissued patent—specifically for treatment of hypertension and post-MI LVD.

At this point, since reissued patent only claimed a method of using carvedilol for treatment of mild to severe CHF, Teva's position was that its "skinny label" generic product would not run afoul of the reissued patent because Teva's product would not be approved or labeled as being approved—for the infringing use of treatment of CHF.

Generics and ‘skinny label.’In March 2007, with the expiration of the patent related to carvedilol compound, GSK's period of exclusivity with respect to carvedilol ended and generic carvedilol entered the market. Fourteen companies marketed generic carvedilol, including Teva. Subsequently in September 2007, Teva received FDA approval of its generic tablets and launched its drug product with the carved out/skinny label, in other words, excluding the CHF indication.

In April 2011, the FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book, and instructed Teva to revise its drug product’s label to include information associated with the delisted patent. In response, Teva amended its label to be a copy of GSK’s full label, covering all three indications: hypertension, CHF, and post-MI LVD. GSK’s reissued patent expired on June 7, 2015.

Although GSK obtained FDA approval to market carvedilol as safe and effective also for the treatment of hypertension and post-MI LVD, it did not have patent protection on such uses, and it has never marketed its branded drug, Coreg, to be used to treat anything other than CHF. As for Teva, it was not until the full label period, May 2011 through the expiration of the reissued patent in June 2015, that Teva's label also included the previously-patented method of use—treatment of CHF—as an approved indication for Teva's generic product.

Trial. At trial, a jury found that Teva had infringed certain claims of the reissued patent during the "skinny label" period and other claims during the full label period. Teva moved for judgment as a matter of law of no inducement or no lost profits damages on the basis that the jury could not reasonably have found that Teva caused doctors to infringe these claims of GSK's during any of the periods in question. As such, the district court evaluated whether substantial evidence supported the jury's finding that Teva did cause the alleged infringement.

Inducement. The district court agreed 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, whether as a class or individually, to directly infringe by prescribing generic carvedilol and to do so for the treatment of mild to severe CHF. Even the physician offered by GSK as "induced" by Teva’s label specifically stated that he did not read Teva's label prior to administering generic carvedilol and assumed they were the same based on the information the generic company provided. The physician testified that he relied on various other sources, none of which are attributable to Teva, in deciding to prescribe carvedilol, both before and after generics entered the market.

The court noted that the record lacked substantial evidence that Teva's skinny label, in combination with other acts Teva took (or refrained from taking) during the skinny label period, caused any physician's direct infringement. Instead, the record conclusively demonstrated, and a reasonable jury could only have found, that any infringing use by any physician during the skinny label period was caused by factors unrelated to Teva. Teva's skinny label omitted from its label the language contained on GSK' s Coreg label regarding the use of carvedilol to treat CHF. In addition, Teva's skinny label did not instruct doctors to prescribe generic carvedilol for an off-label use, i.e., treatment of CHF.

GSK had argued that Teva’s skinny label listing and marketing of the generic drug went beyond an AB rating (a required comparison between the generic drug and some branded reference drug) of Teva’s drug to GSK’s Coreg, because Teva’s drug did not that it was not approved for the CHF indication. The court rejected this line of reasoning, noting that there is no FDA requirement that a generic drug company specify for which uses it is (or is not) AB rated. Therefore, there is not legally sufficient evidence to support a finding that Teva encouraged infringement.

As to the full label period, the court noted that regardless of Teva's actions after it amended its label in May of 2011, as directed to by the FDA, including its elimination of the carve-out from its label, physicians were already prescribing generic carvedilol to treat CHF at that time. The court noted that a reasonable jury could not find that Teva caused any direct infringement and held that Teva could not be held liable for inducement of infringement.

The case is No. 14-878-LPS-CJB.

Attorneys: William Chad Shear (Fish & Richardson, PC) for GlaxoSmithKline LLC and SmithKline Beecham [Cork] Ltd. Alexandra Lu (Goodwin Procter LLP) for Teva Pharmaceuticals USA Inc.

Companies: GlaxoSmithKline LLC; SmithKline Beecham [Cork] Ltd.; Teva Pharmaceuticals USA Inc.

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