Judge Stark (D. Del.) Holds Generic Label is Insufficient to Prove Induced Infringement

By: Alyson L. Wooten, Pharm.D.

GlaxoSmithKline v. Teva, No. 14-878-LPS-CJB (D. Del)

Following a seven-day trial last year, a jury found that Teva willfully induced infringement of claims of U.S. Patent No. RE40,000 from January 2008 to April 2011 (“skinny label period”) and from May 2011 until June 2015 (“full label period”), and awarded $234 million in lost profits and $1.4 million in reasonable royalty damages to plaintiff. Teva filed a motion for judgment as a matter of law, which was granted in part, in an opinion issued last week by Judge Stark finding that plaintiff failed to present sufficient evidence to support a jury verdict of induced infringement. The product at issue, generic carvedilol, was originally launched by Teva with a section III carve out (which was in effect from January 2008 to April 2011) and then later, in May 2011, Teva amended its label to include the carved out indication for congestive heart failure (“CHF”), making the label essentially a copy of the plaintiff’s full label.

The relevant facts include:

  • March 1985 – carvedilol compound patent issues
  • May 1997 – FDA approval of Coreg® (carvedilol) tablets for the treatment of CHF along with 2 other approved uses (hypertension and left ventricular dysfunction); plaintiff only marketed the CHF indication
  • June 1998 – U.S. Patent No. 5,760,069 issues claiming the use of carvedilol as a method of treating CHF
  • March 2002 – Teva files ANDA for carvedilol tablet with a paragraph III certification to the carvedilol compound patent and a paragraph IV certification to the ’069 patent
  • March 2007 – carvedilol compound patent expires
  • August 2007 – Teva amends its paragraph IV certification to the ’069 patent to a section viii statement, and carves out the CHF indication from its label
  • September 2007 – Teva’s ANDA is approved and Teva launches generic carvedilol
  • January 2008 – the ’069 patent reissues as the ’000 patent
  • April 2011 – Teva amends its label to add back in the CHF indication
  • June 2015 – the ’000 patent expires

In granting Teva’s motion for JMOL, the court determined that no reasonable jury could have properly found that Teva induced infringement of the ’000 patent with respect to the method of treating CHF during both the skinny label period and the full label period. The court concluded that many factors caused doctors to prescribe generic carvedilol, but these factors did not include Teva’s label and marketing materials, and that plaintiff “failed to prove by a preponderance of the evidence that ‘Teva’s alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe,’ by prescribing generic carvedilol and to do so for the treatment of mild to severe CHF.” (emphasis in original)

With respect to the skinny label period, the court found that the evidence of inducement consisted principally of Teva’s label and the label did not instruct doctors to prescribe generic carvedilol for the treatment of CHF. Other evidence of Teva’s AB rating and marketing materials focused on the AB rating was also held insufficient to support a reasonable finding that Teva caused any infringement of the ’000 patent. As product ratings, including an AB rating, are not indication specific but “signif[y] that a generic drug is therapeutically equivalent to a branded drug,” the rating “does not support a reasonable finding that Teva caused infringement.” “Further, Teva showed that once generic carvedilol entered the market in September 2007, and continuing beyond 2007, doctors continued prescribing carvedilol (be it Coreg® or a generic) in the same manner as they had prior to the generics’ entrance, as they based their prescription decision on [other factors, including treatment guidelines and clinical studies] without relying on Teva’s – or any other generic manufacturers’ – label.”

In a more surprising result, the court found that the inclusion of the CHF indication in the label during the full label period also was insufficient evidence of inducement post-launch of a product.

But even if the label were enough in a post-launch world, Dr. McCullough specifically stated that he did not read Teva’s label prior to administering generic carvedilol, but “just assume[d] they were the same” based on the information the generic company provided. As Dr. McCullough concedes that he did not read Teva’s label, he cannot state, for instance, that he noticed or otherwise knew what (if anything) that label said about using carvedilol to treat CHF. Moreover, Dr. McCullough 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. GSK, therefore, has not met its burden to show inducement.

Again emphasizing that proof of causation is necessary for a finding of inducement, the court found that “[r]egardless of Teva’s actions after it amended its label in May of 2011, including its elimination of the carve-out from its label, physicians were already prescribing generic carvedilol to treat CHF at that time. No substantial evidence was presented at trial to support a finding that anything about doctors’ behavior – either as a class, or even a single doctor – was induced to change by Teva’s label, or by anything else Teva did (or failed to do).”

A footnote toward the end of the court’s opinion highlights that both parties raised important policy questions regarding the use of section iii carve-outs under the Hatch-Waxman framework. Does a section iii carve-out allow a generic manufacturer to enter the market at risk and “then argue it was not liable because its label was not the ‘sole cause’ of the direct infringement?” Do generics have an obligation” to “police and affirmatively correct doctor’s misunderstandings of AB-ratings” if the infringement is based on an off-label use? The court, while noting these concerns, found that the “parties’ policy arguments have not impacted the Court’s ruling on these pending motions.” However, these are issues that will be closely followed in the appeal of this case.

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