Teva fires back at GSK again over potential 'skinny' label SCOTUS case
Teva on Wednesday fired back at GSK after the UK-based drugmaker sought to squash Teva’s attempt to get its “skinny” label case overturned by the US Supreme Court.
Teva filed a reply to GSK on Wednesday, slamming the firm’s claims around these label carve-outs, which generic drugmakers use frequently to get competition on the market before all the patented indications of the reference product can be challenged.
The Israeli generic drugmaker notes that a prior federal court decision in GSK’s favor “is more than just a misapplication of settled precedent: it is an about-face, because it adopts what was previously a dissenting view and allows a jury to find active inducement in virtually any carveout case.”
GSK, meanwhile, previously claimed that SCOTUS shouldn’t hear the case, which hinges on Teva’s “skinny” label that was found to infringe on GSK’s beta-blocker Coreg after the generic firm marketed one of the unapproved indications.
Teva noted that while GSK says generic manufacturers can claim carve-outs are protected if they “fully and truly carve out” patented indications, that’s still a thorny issue.
“Under the Federal Circuit’s decision, the carve-out statute provides no protection, not even to a company that follows FDA’s directions and carves out everything the brand manufacturer identifies,” Teva’s lawyers said — adding, “That is precisely why certiorari is needed.”
The crux of GSK’s response, filed by attorneys for the UK pharma centered on the following question:
When a generic drug is doubly indicated for a patented use, and there is strong record evidence of intent and inducing conduct, can the generic manufacturer evade liability for induced patent infringement merely because it did not include on its label (i.e. ‘carved out’) one of the two indications corresponding to the patented use?
Teva also previously petitioned the high court two months ago to protect this longstanding precedent behind “skinny” labels, which is now in limbo thanks to the 2021 Federal Circuit court decision.
Harvard medical professor Aaron Kesselheim told Endpoints News at the time that the ruling, “was a problematic decision because it made it harder for generic companies to do what they’re legally allowed to do.”
But GSK claims that this case does not present threats to “generic companies who operate properly under the law of induced infringement as applied to generic drug labels — “skinny” or not. And, it concerns circumstances highly unlikely to be repeated, as well as regulations and policies FDA has changed multiple times.”