Carvedilol – USA

Carvedilol – USA

On Aug. 05, 2021, Federal Circuit vacated the District Court’s grant of JMOL and reinstated the Jury’s verdict and damages of $235 million.

 

Previously, in Oct. 2020, Federal Circuit almost gave similar judgment. This is the second time Federal Circuit has heard the case and delivered the judgment. You can read the Oct. 2020 case summary “here” on this blog. To cut it short, Teva filed ANDA against Glaxo’s COREG (carvedilol) drug. COREG had 3 indications: 1. Left Ventricular Dysfunction following Myocardial Infarction(MILVD), 2. Hypertension and 3. Congestive Heart Failure (CHF). After approval in 2007, Teva marketed ANDA with first 2 indications and carved out (section viii) CHF indication, which was protected by US RE40,000 (earlier US 5,760,069) patent, expiring on Jun. 07, 2015. In 2011, After FDA asked to update label, Teva included CHF indication in the label. On July 3, 2014, GSK filed suit for induced infringement of the RE’000 patent. Jury trial was initiated and infringement was found both during skinny label (2007 to 2011) and full label period (2011 to 2015). District court granted JMOL stating that the verdict of induced infringement was not supported by substantial evidence. GSK appealed the JMOL, and Teva conditionally cross-appealed the jury’s damages award. Federal Circuit in Oct. 2020 judgment vacated district court’s grant of JMOL and reinstated the jury verdicts of infringement and damages. Amici curiae raised concerns about lack of clarity of this decision when the patented uses are carved out of the FDA approved label. On February 9, 2021, Federal Circuit granted the petition for panel rehearing, and vacated the Oct., 2020 judgment.

 

Now, again on Aug. 05, 2021, Federal Circuit gave same verdict, albeit, mentioning that section viii (carve out) is still there and this decision would not be considered broadly. Basically, induced infringement was found based on following substantial evidences:

1. Teva’s label (skinny and full label)

2. Promotional materials which asked doctors to refer the label

3. Press release mentioning “AB” rated and “Bioequivalent” generic

 

Dissent by Circuit Judge Prost raised some serious concerns. She said that –

“The majority strains to prop up a jury verdict that is unsupportable. For example, based on language that remained on the skinny label after Teva’s carve-out, the majority finds it reasonable to infer that Teva intentionally encouraged infringement. It finds this reasonable even though Teva, by carving out everything that GSK said would infringe, was trying to avoid having its label encourage infringement. The majority then indulges the inference that doctors, as a class, relied on Teva’s skinny label to infringe, even though every expert cardiologist at trial said he didn’t even read the label to make prescribing decisions. And, most troubling, the majority is willing to see culpable intent behind a generic’s describing its product as the “equivalent” of a brand drug—in a system that requires generic drugs to be equivalent, and in which everyone understands that generic drugs are equivalent.” 

 

“I write in this case because far from being a disagreement among reasonable minds about the individual facts, this case signals that our law on this issue has gone awry. I am particularly concerned with three aspects of the majority’s
analysis. First, even setting aside the majority’s willingness to glean intentional encouragement from a label specifically designed to avoid encouragement, the majority further weakens the intentional-encouragement prong of inducement by effectively eliminating the demarcation between describing an infringing use and encouraging that use in a label. Second, the majority defies basic tort law by eviscerating the causation prong of inducement. The upshot of these two moves is that a plaintiff now has to show very little for a jury to speculate as to the rest. Third, the majority creates confusion for generics, leaving them in the dark about what might expose them to liability. These missteps throw a wrench into Congress’s design for enabling quick public access to generic versions of unpatented drugs with unpatented uses.”

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