Second Circuit says Takeda can’t dodge two antitrust suits
The US Court of Appeals for the Second Circuit has denied an appeal from Takeda Pharmaceuticals to shut down two antitrust suits related to its diabetes drug Actos.
The lawsuits, filed in the US District Court for the Southern District of New York, claim that Takeda had extended its exclusivity over the drug by improperly describing patents to the US Food and Drug Administration (FDA).
Takeda’s motion to dismiss the suits was denied by the district court in 2019, leading it to appeal to the Second Circuit.
The circuit judges held that Takeda had mischaracterised the patents in its representations to the FDA, and allowed both buyers and distributors of the drug to continue their antitrust suits, which accuse the drugmaker of illegally extending patent protection and attempting to monopolise the treatment.
‘Improper description’
The improper description claims relate to two “combination patents” covering Actos. These patents combined the active ingredient, pioglitazone, with other substances to yield “novel synergies”.
The active ingredient patent for pioglitazone expired in 2011, while the two combination patents both expired in 2016.
In its appeal, Takeda claimed that it had correctly characterised the combination patents as they included the active ingredient. However, the circuit ruled that the combination patent claims are broader than the scope of the drug, allowing the suits to continue.
Generic litigation
In 2004, Teva Pharmaceuticals filed for a “section viii” certification of an Actos generic—which would allow it to develop an unpatented method of using the substance following the expiration of the ingredient patent in 2011. This application would “carve out” the patent combinations to avoid infringement.
Another generic maker, Sandoz, filed a “citizens petition” with the FDA, claiming that Takeda had “improperly caused the FDA to list the [combination] patents in the Orange Book as drug product patents for Actos.”
However, Takeda claimed in its response to Sandoz that the combination patents covered the drug itself and were properly listed and could not be carved out.
According to Reuters, Takeda settled with generics makers, allowing them to launch generics of Actos in 2012, a year after the active ingredient patent expired.
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