Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment jurisdiction exists to overcome motion to dismiss.)
Drug Product and Patent(s)-in-Suit: DDAVP® (desmopressin acetate); U.S. Pat. No. 7,002,340 (“the ’340 patent”)
Nature of the Case and Issue(s) Presented: Glenmark, who was not the first ANDA filer, was attempting to obtain FDA approval to market a generic version of drug claimed by the ’340 patent. Ferring is the owner of the ’340 patent and initially caused it to be listed in the Orange Book. Sanofi holds the approved NDA for DDAVP. Before Glenmark filed suit, Ferring disclaimed the ’340 patent and requested that the FDA delist it from the Orange Book. The FDA, however, had yet to delist the patent from the Orange Book. Consequently, the FDA had not given final approval for Glenmark’s ANDA, and to enable such approval, Glenmark sought a declaratory judgment that Ferring’s disclaimed patent was unenforceable.
Ferring moved to dismiss Glenmark’s complaint on the basis that there was no justiciable dispute as to the statutorily disclaimed ’340 patent. Glenmark disagreed, arguing that an Article III case or controversy supported a judgment as to the ’340 patent because, despite Ferring’s request to delist, the patent remained listed in the Orange Book, preventing Glenmark from selling its tentatively approved competing generic version of desmopressin acetate. The Court denied Ferring’s motion.
Why Glenmark Prevailed: To have standing, Glenmark must show an alleged injury-in-fact, causation by defendant, and redressability. The alleged injury-in-fact stems from Glenmark’s inability to market its competing generic version of desmopressin acetate, as it lacks final approval from the FDA. “Of equal importance is that Glenmark’s injury is fairly traceable to Ferring’s actions.” Ferring held an exclusive license to the ’340 patent that is listed in connection with Sanofi’s NDA for DDAVP tablets. The statutory disclaimer by Ferring of the ’340 patent, that Glenmark admits renders the patent legally nonexistent, does not eliminate Ferring’s patent from obstructing the FDA’s approval of Glenmark’s ANDA. Finally a declaratory judgment from the Court could redress Glenmark’s alleged injury, as it could remove the ’340 patent’s effect of excluding the generic drug from the market. Glenmark has standing.
Moreover, the Court found that the issue was ripe for judicial review. Glenmark had a complete generic drug product that had been submitted to the FDA for approval, and no additional facts were required to determine whether the product infringes the ’340 patent. “In essence, if Glenmark’s drug does not infringe the ’340 patent, then delaying court consideration of Glenmark’s declaratory judgment action on the ’340 patent delays the date the FDA may approve Glenmark’s ANDA.”
Next, the Court found that the action was not moot. Ferring’s statutory disclaimer did not affect the FDA’s authority to approve the ANDA because Glenmark’s inability to enter the market was directly attributable to the ’340 patent’s being listed in the Orange Book. In particular, the disclaimer did not obviate the necessity of a final judgment to trigger forfeiture of the first filer’s exclusivity period, thus allowing the FDA to approve the subsequent, i.e., Glenmark’s, Paragraph IV ANDA thereafter.
Finally, after finding that it may appropriately exercise jurisdiction, the Court found no persuasive reason to decline to do so. “Exercising jurisdiction in this matter will not merely serve a useful purpose in settling the legal relations at issue and affording relief from the underlying controversy, but is essential to doing so.”
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