The Eastern District of Virginia recently allowed a subsequent ANDA filer to proceed with a declaratory judgment action seeking a declaration of unenforceability of a patent that remained listed in the Orange Book after the patentee disclaimed it and requested its delisting from the Orange Book.

Glenmark Generics Ltd. v. Ferring B.V., Civ. No. 3:14-CV-422-HEH (E.D. Va.) is the second declaratory judgment action between Ferring and Glenmark involving Glenmark’s ANDA seeking FDA approval to market a generic version of Sanofi’s DDAVP tablets (desmopressin acetate), which act on the kidneys to reduce the amount of urine produced.  Ferring’s U.S. Patent No. 7,002,340 is listed in the Orange Book for Sanofi’s DDAVP.   Glenmark filed a first declaratory judgment action for non-infringement and invalidity after Glenmark was not sued within 45 days of sending its notice letter.  Glenmark asked Ferring to enter into a consent decree of non-infringement, but Ferring refused.  Instead, Ferring disclaimed the ’340 patent and requested the FDA delist it from the Orange Book.   Despite Ferring’s request, the ’340 patent remains listed in the Orange Book.

The FDA tentatively approved Glenmark’s ANDA but could not give final approval because another generic company, who was the first to file a paragraph IV certification for the ’340 patent and whose ANDA was not approved, had 180-day exclusivity. In an effort to trigger the first-filer’s 180-day exclusivity period, Glenmark filed a second action seeking a declaratory judgment that the ’340 patent is unenforceable based on Ferring’s disclaimer.  Ferring moved to dismiss Glenmark’s case, arguing that the court lacks subject matter jurisdiction because Ferring has already requested delisting of its patent.

A declaratory judgment action is justiciable where the plaintiff has standing, the issues presented are ripe for judicial review, and the case will not be rendered moot at any stage of the litigation. The court found all three requirements satisfied.  As the court pointed out, it is settled law that the Hatch-Waxman Act recognizes standing, an injury-in-fact, for a generic drug company that cannot market its non-infringing drug because of an Orange Book listing.  Ripeness is similarly settled in the ANDA context.  Glenmark has a complete generic drug that has been submitted to the FDA for approval and Glenmark claims there are no additional facts required to determine whether its product infringes the ‘340 patent.

On mootness, the court extended the reasoning found in Caraco Pharm. Labs., Ltd. v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008), to Glenmark’s situation.  In Caraco, the Federal Circuit found an Orange Book listing prevented a subsequent ANDA filer from entering the market despite the patent holder’s covenant not to sue on the patent.  Since the listing in the Orange Book was the barrier to the generic drug company obtaining FDA approval to market its version, the covenant not to sue did not solve the problem with the listing in the Orange Book.  In addition, the covenant not to sue did not trigger the first filer’s exclusivity period.  The Eastern District of Virginia found Glenmark faced a comparable problem.  The ’340 patent remained listed in the Orange Book, despite Ferring’s request for delisting, and the FDA would not approve the subsequent filer’s ANDA.

Thus, this case suggests that non-first-filers who find their ANDAs held in limbo because of an unapproved first-filer and a patentee who disclaims an Orange Book patent have a path to trigger exclusivity and get their product on the market.