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Availability of infringing generic alternatives is not a proper consideration for pharmaceutical lost profits

Availability of infringing generic alternatives is not a proper consideration for pharmaceutical lost profits

GlaxoSmithKline v. Teva was decided on October 2, 2020, on appeal from the District of Delaware. The jury found that Defendant Teva induced infringement of Plaintiff GSK’s patent, awarded GSK “$234,110,000 based on lost profits, plus royalty payments of $1,400,000,” and found that the infringement was willful. The district court granted Teva’s motion for JMOL, stating that the verdict of induced infringement was not supported by substantial evidence. GSK appealed.

The Federal Circuit vacated the grant of JMOL of non-infringement and reinstated the jury verdicts.

The jury verdicts are supported by substantial evidence. Teva did “not challenge quantum, but argue[d] that, on correct instructions, Teva would have incurred no damages, or at most only a reasonable royalty.” Regarding lost profits, Teva argued “that the jury should have been instructed that GSK must prove that, for every infringing sale made by Teva, the direct infringer would have purchased the prescribed [medicine] as GSK’s … branded product, and not from another generic producer.”

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“It is undisputed that, at all times relevant to the lost profits analysis, there were generic [versions] available from at least eight different generic manufacturers that were approved by the FDA.” The district court correctly held that “it doesn’t matter whether the sales by other generic suppliers would be non-infringing, because the ultimate use of those products by doctors would be infringing and thus not a permissible consideration.” A lost profits analysis “must be based on a world in which infringement of the asserted patent does not exist, and therefore it does not allow for infringing alternatives to be available in the hypothetical ‘but for’ world.”

Chief Judge Prost dissented, arguing that no evidence established that Teva actually caused the doctors’ infringement.