GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2021)
In 2020, the Federal Circuit issued an odd decision in this ANDA case. The patent on the drug at issue (carvedilol) has expired, but GSK holds a patent on using the drug for treatment of congestive heart failure. Teva began selling the drug for other approved uses, such as hypertension and ensured that congestive heart failure was not part of its product label. Of course, its generic product is still prescribed for that purpose. AND, in 2011 the FDA required Teva to list congestive heart failure as one of the drug treatments — since Teva’s approval was based on GSK’s original new drug application the FDA required a label that was identical-in-content. The result — $234 million in lost profit damages for inducing infringement. That damage award included pre-2011 acts even with the label carveout since Teva had (accurately) described its product as the generic equivalent of GSK’s product. On appeal, the Federal Circuit affirmed (split decision).
At that point Teva petitioned for rehearing, and the original merits panel of Chief Judge Prost and Judges Newman and Moore have agreed to rehear the appeal on the merits on the following question:
Whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011. We find all other issues to be sufficiently briefed.
Although there is no evidence that Teva really encouraged folks to buy and use its product for an infringing purpose, I can just imagine Teva’s confused CEO “where did this extra $200 million come from, I thought the non-infringing market wasn’t this big…”
The Court has not asked for new briefs and will be holding oral arguments later this month. The case has already generated substantial amici support.
Update – I thought my $200m comment above was funny. But, the damage award here is not actually excess Teva revenue. Rather, it is GSK’s lost profits. Judge Prost wrote in her opinion that the Teva’s total revenue from its sales was $75 million — and the jury was told that 17.1% of the sales were for infringing uses. So, we’re talking here about $13 million in revenue to Teva.