Second Circuit revives competition suit against Takeda
The US Court of Appeals for the Second Circuit has partly revived a competition case against Takeda that accuses the company of delaying generic versions of its diabetes drug Actos (pioglitazone).
The decision to revive the class action, which was brought by unions and municipalities that purchase drugs, was made on Wednesday, February 8.
Takeda was accused of preventing competitors from marketing a generic version of Actos by falsely describing two patents to the Food and Drug Administration (FDA).
The plaintiffs claimed that these false patent descriptions channelled Takeda’s competitors into a generic drug approval process that granted the first-filing applicants a 180-day exclusivity period.
This, in turn, acted as a “bottleneck” to all other applicants filing at a later date, said the suing parties.
Teva was the only company out of the ten planning to market a generic version of the drug to take a different route by seeking approval via “another regulatory mechanism”.
However, Teva was “thwarted” by the FDA when it announced that all generic manufacturers would be required to take the bottleneck route.
According to the decision, the FDA’s requirement was based on Takeda’s representations that it had correctly described its patents.
Takeda settled pending patent infringement suits with the first three filing generic companies, as well as Teva, which managed to postpone them from entering the market until August 2012, said the decision.
The suing parties alleged that they were wrongfully obliged to pay monopoly prices for Actos from January 2011, when Takeda’spatent on the active ingredient in Actos expired, until most of the generics entered the market in February 2013.
In a previous decision in the case, a district court dismissed the competition claims made against Takeda because the plaintiffs had failed to plausibly allege thatTakeda’s false patent descriptions caused any delay in generic market entry.
The court reasoned that the plaintiffs had failed to “identify a viable regulatory route for generic drug approval that would have avoided the 180-day bottleneck”.
It added that even if the plaintiffs had identified a route, they failed to allege how the generic manufacturers would have avoided Takeda’s infringement lawsuits.
In the latest ruling, the Second Circuit held that the allegations by Teva should be reassessed but not the claims by the other companies.
The Second Circuit said it affirmed the district court’s decision “because plaintiffs’ theory presupposes that these applicants were aware of Takeda’s allegedly false patent descriptions when they filed their applications”.
But because the theory in relation to Teva does not require any knowledge of the false patent descriptions, the court found that the plaintiffs "plausibly alleged that Takeda delayed Teva’s market entry.”
