Apotex, Inc. v. Daiichi Sankyo, Inc.

Apotex, Inc. v. Daiichi Sankyo, Inc.

E.D. Ill. (2014)

Fitzpatrick Successfully Obtains Dismissal For Declaratory Judgment Action On Disclaimed Patent

On January 9, 2014, Judge Coleman of the district court for the Northern District of Illinois ruled in favor of Fitzpatrick client Daiichi Sankyo by dismissing Apotex’s complaint for a declaratory judgment of invalidity of a disclaimed patent that was still listed in the Orange Book. As a result of an earlier Paragraph IV certification, third-party Mylan was potentially entitled to 180 days of exclusivity once another patent expired. Apotex’s declaratory judgment action was intended to cause Mylan to forfeit its exclusivity by inducing a judgment on the disclaimed patent at a time when Mylan could not launch. The district court dismissed Apotex’s complaint because there was no dispute between Daiichi Sankyo and the Apotex about the disclaimed patent. The court reasoned that the patent “does not create an independent barrier that deprives Apotex of an economic opportunity to compete.” The court also noted that Daiichi Sankyo “is not preventing the FDA from approving Apotex’s ANDA through any delay tactics or strategies.”