Teva hit back at GSK on Wednesday after the UK-based drugmaker sought to crush Teva’s bid to have its “skinny” label case overturned by the US Supreme Court.
Teva filed a response to GSK on Wednesday, lambasting the company’s claims about these label exclusions, which generic drug makers frequently use to gain market competition before all of the reference product’s patented indications can be released. contested.
The Israeli generic drugmaker notes that an earlier federal court ruling in favor of GSK “is more than just a misapplication of established precedent: it’s a U-turn, because it adopts what was previously a dissenting opinion and allows a jury to find active incitement to virtually any case of exclusion.
GSK, meanwhile, previously claimed SCOTUS shouldn’t hear the case, which hinges on Teva’s “skinny” label that was found to violate GSK’s Coreg beta-blocker after the generics company allegedly marketed one of the unapproved indications.
Teva noted that while GSK says generic manufacturers can claim exclusions are protected if they “fully and genuinely exclude” patented indications, this remains a thorny issue.
“Under the Federal Circuit’s decision, the exclusion law offers no protection, not even to a company that follows FDA instructions and excludes anything that the brand name manufacturer identifies,” the attorneys said. from Teva – adding, “This is precisely why certiorari is needed.”
The bulk of GSK’s response, filed by lawyers for the UK pharmaceutical industry, centered on the following question:
Where a generic drug is dual indicated for patented use and there is strong evidence of intent and inducing behavior, can the generic manufacturer escape liability for induced patent infringement simply because it does not has not included on its label (ie ‘excluded’) one of the two indications corresponding to the patented use?
Teva also asked the High Court two months ago to protect this longstanding precedent behind the “skinny” labels, which is now in limbo thanks to the 2021 federal circuit court ruling.
Aaron Kesselheim, professor of medicine at Harvard, said Terminal News at the time of the decision, “was a problematic decision because it made it more difficult for generic manufacturers to do what they were legally allowed to do”.
But GSK says this case poses no threats to “generic companies that operate properly under induced infringement law as applied to generic drug labels – ‘skinny’ or not.” And that’s for circumstances that are very unlikely to recur, as well as regulations and policies that the FDA has repeatedly changed.