A Sufficient Controversy Exists When A Second ANDA Filer Seeks DJ Of Noninfringement Of An Orange-Book-Listed Patent Owned But Disclaimed By Brand Name Manufacturer

In Apotex Inc. v. Daiichi Sankyo, Inc., Nos. 14-1282, -1291 (Fed. Cir. Mar. 31, 2015), the Federal Circuit reversed the district court's dismissal of Apotex, Inc.'s ("Apotex") complaint for DJ that Apotex will not infringe an Orange-Book-listed patent owned but disclaimed by Daiichi Sankyo, Inc. and Daiichi Sankyo Co., Ltd. (collectively "Daiichi") if Apotex manufactures or sells a generic drug bioequivalent of Daiichi's Benicar®. The Federal Circuit also reversed the district court's denial of Mylan Pharmaceuticals, Inc.'s ("Mylan") motion to intervene.

Daiichi listed two patents in the Orange Book to cover Benicar®. The first, U.S. Patent No. 5,616,599 ("the '599 patent"), covers the active ingredient of the drug, olmesartan medoxomil, and expires on April 25, 2016. Daiichi's second listed patent, U.S. Patent No. 6,878,703 ("the '703 patent"), covers methods of treatment and expires on November 19, 2021.

Mylan filed an ANDA in April 2006, certifying that both patents were invalid or would not be infringed by Mylan's proposed drug. Thereafter, Daiichi disclaimed all claims of the '703 patent and asked the FDA to remove the '703 patent from the Orange Book. The FDA did not remove the '703 patent from the Orange Book. Daiichi sued Mylan for infringing the '599 patent. The district court in that case upheld the validity of the '599 patent and entered judgment of infringement against Mylan. As such, Mylan's earliest date of market entry is October 25, 2016, six months after the expiration date of the '599 patent.

After the litigation was over, Apotex filed its own ANDA and two certifications under 21 U.S.C. § 355(j)(2)(A)(vii): (1) a Paragraph III certification accepting the result of the prior Mylan litigation with respect to the '599 patent; and (2) a Paragraph IV certification stating that Apotex's product would not infringe the '703 patent. Daiichi did not sue Apotex for infringing the '703 patent. Apotex brought a DJ action, seeking a declaration that its product would not infringe the disclaimed, but still listed, '703 patent. Mylan moved to intervene, and both it and Daiichi moved to dismiss Apotex's complaint. The district court granted Daiichi's motion to dismiss and denied Mylan's motion to intervene as moot. Apotex appealed, and Mylan cross-appealed the denial of its motion to intervene.

On appeal, the Federal Circuit first confirmed Mylan's right to intervene. To the Court, Apotex seeks to cause a forfeiture of Mylan's presumed...