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Teva Files Certiorari Petition in "Skinny" Label Case

  • August 9, 2022
  • Article

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On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.

In finding that Teva induced infringement of GSK’s patent Re. 40,000 (‘000) a reissue of U.S.P. 5,760,069 (‘069), the Federal Circuit pieced together disparate sections of Teva’s label for carvedilol along with the FDA’s determination that Teva’s carvedilol product was AB substitutable for GSK’s carvedilol product. Such a finding was not for all purposes but only those on the Teva label. The ‘000 patent claimed treating congestive heart failure in combination with other drugs for a period greater than six months. The label for GSK’s carvedilol product, Coreg®, had three indications, post-MI LVD treatment, hypertension treatment, and congestive heart failure (CHF). At the time Teva launched its generic product only the CHF indication had patent protection. Teva sought approval only for the unpatented post-MI LVD and hypertension treatments and had, following the FDA’s instructions omitted the portions of the GSK label related to CHF. In 2007 upon the expiration of GSK’s patent to drug carvedilol Teva launched its generic product with the FDA approved label. In 2008 the ‘000 patent issue with substantially narrower claims than the original patent. GSK withdrew the ‘069 patent from the Orange Book and added the ‘000 patent in its place. In 2011, following GSK’s delisting of certain patents from the Orange Book, including the ’069 patent and U.S. Patent No. 5,902,821, the FDA instructed Teva to “revise [its] labeling to include the information associated with pa- tent ’821 (delisted) and the associated Use Code (U-313).” J.A. 5557. It told Teva to submit labeling “that is identical in content to the approved [GSK Coreg®] labeling (including the package insert and any patient package insert and/or Medication Guide that may be required).” The FDA also requested Teva “provide information regarding [its] position on [the ’000 patent].”

In response to the FDA’s inquiry regarding the ‘000 patent Teva told the FDA it believed it need not “provide certification to the [’000 patent]” because it received final approval of its ANDA before the ’000 patent issued. Teva failed to consider that its label now included the patented indication, i.e., as 2011 it was no longer a “skinny label”. Three years later, July 3, 2014, GSK filed suit asserting Teva was inducing infringement of the ‘000 patent. The evidence was that Teva’s sales of carvedilol did not increase after it put the CHF indication on its label. Thus, GSK could not prove inducement by the Teva’s non-skinny label as no additional infringement took place. The entire case turned on whether the Teva skinny label induced infringement. In its second decision the Federal circuit focused on notices by both the FFDDA and Teva that its carvedilol was AB substitutable for GSK’s. However, substitutability in the context of Teva’s carvedilol was for the indications on Teva’s label, post-MI LVD treatment and hypertension treatment. The Federal Circuit relied on Teva’s failure to disclaim the use of its product for CHF. Teva did not have to advise anyone of using its carvedilol for CHF since sate laws require the substitution of a generic for a brand product if it’s been rated AB substitutable by the FDA unless the doctor specifically required the use of brand by not allowing substitution.

The Federal Circuit ignored the testimony of GSK’s expert that he had not read Teva’s label before administering generic carvedilol, and that generic substitution happened automatic[ally]” at pharmacies. He went on to testify that he would not have used Teva’s skinny-labeled product to treat CHF if he had read the label, because it was “missing too much in- formation” about CHF. Finally, the Federal Circuit ignored its own precedent where it had held that “[m]erely ‘describing’ an infringing mode is not the same as ‘recommending,’ ‘encouraging,’ or ‘promoting,’ an infringing use, or suggesting that an infringing use ‘should’ be performed.” Takeda Pharms. USA, Inc. v West-Ward Pharm. Corp.785 F.3d 625 at 631 (Fed. Cir. 2015) (brackets and citations omitted). In HZNP Medicines LLC v. Actavis Labs. UT, Inc., 940 F.3d 680, 702 (Fed. Cir. 2019) the court found no inducement where the generic label permitted but did not require each step in the claimed method. The court explained at 701 “[t]he focus is not on whether the instructions describe the mode of infringement, but rather on whether the instructions teach an infringing use.” The Federal Circuit in Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1322 (Fed. Cir. 2012) where the indications section contained only one unpatented use Bayer argued that other portions of the label described patented uses. In deciding that mentioning the uses was not enough court explained that “while the label mention[ed] [those patented uses], it [did] not do so in any way that recommend[ed] or suggest[ed] to physicians that the drug [was] safe and effective for administration to patients for [those] purposes.” [Emphasis added]. The Teva label fits squarely within the facts of the holdings of these cases.

Here the Federal Circuit by ignoring its own precedent has created uncertainty as to what constitutes a proper “skinny label.” Unfortunately, the individual panels of the Federal Circuit feel free to ignore prior decisions where they wish to reach a different outcome. The concept of stare decisis and the Federal Circuithave never met creating unnecessary uncertainty in patent law.  This is simply the most recent example.