Monopolization Claims Move Forward in Actos Litigation

In a pair of recent decisions, United States District Judge Ronnie Abrams held that classes of purchaser plaintiffs stated monopolization claims for overcharge damages by plausibly alleging that Takeda misrepresented its patents to the FDA to delay generic entry.  The cases are In re Actos Direct Purchaser Antitrust Litigation, No. 1:15-cv-03278, ECF No. 131 (S.D.N.Y. Oct. 8, 2019) and In re Actos End Payer Antitrust Litig., No. 13-cv-9244, ECF No. 272 (S.D.N.Y. Sept. 30, 2019).  Direct Purchaser and End Payer Plaintiffs will therefore move forward on their monopolization claims against Takeda, the brand manufacturer of the diabetes drug, Actos.   

Plaintiffs alleged that, facing expiration of the Actos compound and method-of-use patent for use of Actos as a monotherapy, Takeda listed in the FDA’s Orange Book two new method-of-use patents for use of Actos in combination therapy with other drug products (metformin or an insulin secretion enhancer), representing to the FDA that these patents also covered the Actos compound.  These two combination use patents, however, did not actually cover the Actos compound or its use as a monotherapy; the old, expiring patent did that.  Sponsors of Abbreviation New Drug Applications who sought FDA approval for a generic Actos product for use as a monotherapy were nevertheless forced by Takeda’s improper listing of these two combination use patents to take various actions, the effect of which, Plaintiffs alleged, delayed generic competition.

As a result of the judge’s decision, the Actos cases will now proceed with discovery after having been stayed since May 27, 2016, pending resolution of a related appeal, which the Second Circuit resolved on February 8, 2017, and sent back to the district court for further proceedings. See In re Actos End-Payor Antitrust Litig., 848 F.3d 89 (2d Cir. 2017).