GSK responds to Teva’s ‘skinny’ label rehearing petition
Following a substantial push from generics companies to reverse the GSK v Teva “skinny” label ruling, GlaxoSmithKilne (GSK) has added its response to the petition to rehear the case yet again.
The US Court of Appeals for the Federal Circuit has so far twice ruled that Teva Pharmaceutical’s variant of GSK’s heart disease medication Coreg (carvedilol) infringed on key patents.
The split court opinion held that drugmakers were free to sell generic treatments, as long as they don’t promote uses for the drug that were pioneered by the original manufacturer.
Teva petitioned the Federal Circuit to reconsider its decision yet again in October, reiterating its argument that the court’s February ruling would lead to a “wave of lawsuits” against generic drug manufacturers that exclude patent-protected indications from their generic labels—a process known as “carving out”
Now, GSK has submitted a brief claiming that there exists no “exceptional circumstances or contrary precedents” to warrant an en banc review of the ruling.
“As before, this appeal involves review of a jury’s verdict for substantial evidence, not a sea change in the law of induced infringement or a death knell for the ‘skinny’ label,” claimed GSK in the response
Addressing the fears of generic companies that the ruling will set a new precedent that will be used to rule against generic companies eliminating indications in their drugs going forward, GSK said:
“Simply put, the majority’s decision is limited to the facts of this case and does not bind any future panel from coming to a different conclusion in a carve-out case with different facts.”
The brief concluded: “Teva’s suggestion that the majority’s decision creates an unworkable regime for the Food and Drug Administration (FDA) is similarly flawed. Teva blames GSK for its failure to fully carve out the patented use from its partial label, based on the use codes GSK submitted to FDA.”
Split vote
While the circuit ruled in favour of GSK, holding that Teva’s generic had infringed despite carving out the indications as it was still prescribed for infringing purposes, the decision was split.
Federal Circuit chief judge Sharron Prost claimed that the ruling “creat[ed] infringement liability for any generic entering the market with a skinny label” and permitted liability for labels that “did not actually cause any direct infringement”.
Prost also held that the other Circuit judges had wrongly claimed that the case was analogous to prior cases Vanda and Sanofi where a brand manufacturer alleged patent infringement based on a “virtually identical label” as Teva had excluded the indications.
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