Apotex, Inc. v. Daiichi Sankyo Co.

Case Name: Apotex, Inc. v. Daiichi Sankyo Co., No. 12-cv-9295, 2014 U.S. Dist. LEXIS 3156 (N.D. Ill. Jan. 9, 2014) (Coleman, J.)

Drug Product and Patent(s)-in-Suit: Benicar® (olmesartan medoxomil); U.S. Patents Nos. 6,878,703 (“the ’703 patent”) and 5,616,599 (“the ’599 patent”)

Nature of the Case and Issue(s) Presented: Daiichi Sankyo holds an approved NDA for Benicar and listed the ’599 and ’703 patents in the FDA’s Orange Book in connection with its NDA. As against those patents, Mylan was the first to file an ANDA including a paragraph IV certification. Accordingly, Mylan is entitled to 180 days of market exclusivity regardless of whether it established that the Orange Book patents were invalid or not. The start of the 180-day exclusivity period can only be triggered by Mylan’s marketing of its generic drug (21 U.S.C. § 355(j)(5)(B)(iv))—or if a subsequent filer obtains a qualifying final judgment of invalidity or non-infringement, Mylan must begin marketing within 75 days or forfeit its exclusivity period (21 U.S.C. § 355(j)(5)(D)(i)(I)(bb)(AA)).

Prior to suing Mylan on the ’599 patent, Daiichi Sankyo statutorily disclaimed every claim of the ’703 patent pursuant to 35 U.S.C. § 253. Eventually the district court found that the ’599 patent was valid and that Mylan infringed it. Mylan never brought a declaratory judgment action regarding the disclaimed ’703 patent. Here, Apotex seeks a final judgment of invalidity or non-infringement regarding the ’703 patent in the hopes of compelling Mylan to begin marketing within 75 days or forfeiting its exclusivity period. Daiichi Sankyo moved to dismiss Apotex’s complaint for lack of subject-matter jurisdiction. The court granted Daiichi Sankyo’s motion.

Why Daiichi Sankyo Prevailed: Daiichi Sankyo moved to dismiss Apotex’s complaint arguing that there can be no justiciable dispute concerning a disclaimed patent. Apotex argued that because a judgment has never been entered stating that the ’703 patent is invalid, the ’703 patent prevents it from selling its competing generic version of the Benicar drug until the end of Mylan’s 180 day exclusivity period. The Federal Circuit, in interpreting the 2003 MMA Amendments has noted that “[i]f the first ANDA filer ‘parked’ its 180-day exclusivity under an agreement with the brand-name company, a subsequent ANDA filer could independently trigger the first filer’s exclusivity period through a declaratory judgment action leading to a final judgment of invalidity or non-infringement, thereby accelerating the second ANDA filer’s ability to market its drug.” But here, the court found that the ’703 does not create an independent barrier that deprives Apotex of an economic opportunity to compete. Once Daiichi Sankyo disclaimed the ’703 patent, it is as if the disclaimed claims never existed. Moreover, Daiichi Sankyo requested that the FDA de-list the ’703 patent from the FDA’s Orange Book on July 11, 2006, and it is unclear why the FDA has yet to actually remove the patent from the Orange Book. But that is not Daiichi Sankyo’s problem.

Daiichi Sankyo is not preventing the FDA from approving Apotex’s ANDA through any delay tactics or strategies similar to the NDA holder’s covenant not to sue. Moreover, all parties acknowledge that Daiichi Sankyo can never assert the ’703 patent against any ANDA filer or any entity as the patent no longer exists by virtue of its disclaimer.