Orange Book Listing On Its Own Does Not Create A Barrier to Entry

In the Northern District of Illinois, Judge Sharon Coleman recently dismissed for lack of subject matter jurisdiction Apotex’s declaratory judgment action alleging invalidity or non-infringement of U.S. Patent 6,878,703 directed toward the treatment of hypertension with a chemical compound.  Apotex, Inc. v. Daiichi Sankyo, No. 12-9295, 2014 U.S. Dist. LEXIS 3156 (N.D. Ill. Jan. 9, 2014).  Apotex filed the suit in an attempt to force Mylan, the first ANDA applicant, to forfeit its exclusivity period.  Though the ʼ703 patent still was listed in the Orange Book, the claims previously had been disclaimed, leading Judge Coleman to hold that no case or controversy existed.

Daiichi holds an approved New Drug Application (NDA) for Benicar, a drug used to treat high blood pressure.  As part of filing its NDA, Daiichi listed the ʼ703 patent and U.S. Patent 5,616,599 in the Orange Book.  Mylan was the first company to file an ANDA.  Significantly for this case, Daiichi disclaimed the ʼ703 patent prior to suing Mylan for infringement.  Daiichi also requested that the FDA remove the ʼ703 patent from the Orange Book, though for some reason this was never done.  A district court eventually found that Mylan infringed the ʼ599 patent.  Mylan never brought a declaratory judgment action related to the disclaimed ʼ703 patent.

Because Mylan was the first generic drug maker to file an ANDA it normally would be entitled to 180 days of market exclusivity.  However, under the 2003 Medicare Prescription Drug, Improvement, and Modernization Act, a subsequent ANDA filer can obtain a final judgment of invalidity and force the first ANDA filer either to begin marketing within 75 days or forfeit its exclusivity period.  Apotex attempted to take advantage of this provision with regard to Mylan by attempting to get the ʼ703 patent declared invalid.

Daiichi moved to dismiss Apotex’s suit alleging a lack of subject matter jurisdiction, because no case or controversy existed.  Apotex conceded that Daiichi disclaimed the ʼ703 patent, but argued that because it still was listed in the Orange Book and no judgment had been entered finding it invalid, the patent continues to exclude competition in the market.  Judge Coleman, however, was not convinced: “The mere fact that the FDA has failed for some reason to delist Patent ʼ703 . . . does not create a case or controversy.”

This is in contrast to Seattle Children’s Hospital v. Akorn, Inc. (N.D. Ill. 2011), in which a case or controversy was found to exist because of continued listing of the patent at issue in the Orange  Book, despite a unilateral covenant not to sue by the NDA holder.  There, the patent claims had not been disclaimed and actually served as an independent barrier to competition.  Here, the disclaimed ʼ703 patent is treated as if it never existed.  Thus, a listing in the Orange Book to a patent that no longer exists is insufficient to create a case or controversy.