Effectiveness of Section viii carve-outs

In GSK v. Teva, CAFC limited the effectiveness of Section viii carve-outs & reinstated a $235 million jury verdict against Teva, concluding that substantial evidence supported the jury’s finding of induced infringement.

Teva’s omission of the CHF indication from its label did not help as CAFC found “ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe.”

Interestingly Court found Teva liable for all of GSK’s lost profits, even though Teva was only one of at least eight generic drugs for Coreg® that had entered the market.

This is possibly a big threat for any generic considering entering the market with skinny labelling.

A potential pathway could be to modify any promotional materials and communications to the doctors, to specify that the generic product is not indicated or encouraged for treatment of the claimed indication.

Hopefully Teva will petition for rehearing and en banc review.

#carveout #sectionviii #skinnylabel #inducedinfringement

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