Piramal Healthcare US Ltd. v. Novartis Pharms. Corp.

Once the first-filer ANDA applicant launched its product, it could no longer forfeit its 180-day exclusivity, thereby rendering the subsequent ANDA filer Plaintiff’s declaratory-judgment claim moot.

March 05, 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Piramal Healthcare US Ltd. v. Novartis Pharms. Corp., No. 19-12651 (SRC), 2020 U.S. Dist. LEXIS 38849 (D.N.J. Mar. 5, 2020) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Jadenu® (deferasirox); U.S. Patent No. 9,283,209 (“the ’209 patent”)

Nature of the Case and Issue(s) Presented: On Oct. 16, 2019, the court denied Novartis’s first Rule 12(b)(1) motion to dismiss, finding that: (i) the amended complaint set forth sufficient facts to support Piramal’s claim of having sustained a blocking injury under the Hatch-Waxman Act’s “failure to market” provision; and (ii) Novartis’s argument lacked sufficient evidence to refute Piramal’s prima facie demonstration of standing.

Piramal sought a declaratory judgment of non-infringement and to trigger forfeiture of the first ANDA filer’s statutory 180-day exclusivity period. Under the Hatch-Waxman Act, a subsequent ANDA filer could not receive final approval for its generic drug product until the first-filer’s exclusivity period was expired or forfeited. One way a first-filer could forfeit its exclusivity was by failing to market the drug product 75 days after a court were to enter a final judgment of non-infringement related to a subsequent filer’s ANDA product. This forfeiture provision—according to Piramal—gave rise to its claim of entitlement to a judgment of non-infringement, which would remedy the complained-of blocking injury by forcing the first ANDA filer to enter the market or forfeit its exclusivity period. The court granted Novartis’s motion to dismiss for lack of subject matter jurisdiction pursuant to Fed. R. Civ. P. 12(b)(1 ).

Why Novartis Prevailed: Novartis argued that Piramal’s declaratory judgment claim had become moot because the first ANDA filer had entered the market and Piramal’s asserted blocking injury was no longer redressable because: (i) Actavis was the first filer; (ii) Actavis commenced commercial marketing on Dec. 17, 2019, thereby initiating its 180-day exclusivity; and (iii) Piramal’s ANDA was therefore not indefinitely blocked from FDA approval. Thus, according to Novartis, Piramal’s claimed injury was no longer capable of remedy by the court, and the court agreed.

Novartis proffered “clear evidence” of the aforementioned facts. Piramal had proffered no proof that controverts those facts. A judgment of non-infringement could provide no redress because the exclusivity period could not be forfeited. Therefore, Piramal’s claim was moot. When the action was initiated, Piramal presented a live controversy between the parties, relying on the fact that its ANDA was blocked from receiving FDA approval because Actavis had failed to launch its ANDA product. The circumstances had changed, and a forfeiture based on failure to market was now an impossibility.

Piramal argued that its claim for attorneys’ fees under 35 U.S.C. § 285 preserved the court’s subject-matter jurisdiction because: (i) Section 285 authorized the court to award fees to the “prevailing party” in “exceptional cases” and (ii) Piramal’s claim for a judgment of non-infringement therefore remained live because a decision on that claim must be made to resolve the question of whether Piramal was entitled to fees as the “prevailing party.” Piramal also argued that its non-infringement claim was still capable of resolving the legal relationship between Piramal and Novartis as to the ’209 patent because “a decision would provide certainty to Piramal regarding its exposure to an infringement action.”

The court dismissed both arguments handily. Section 285 authorized the court to grant attorneys’ fees to a prevailing party in patent litigation; it did not provide an independent basis for a “case or controversy” where none otherwise existed. As for certainty, Novartis had already given Piramal a covenant not to sue to enforce the ’209 patent. Generally, such a covenant divested a court of Article Ill jurisdiction in the context of a declaratory judgment action for patent non-infringement.

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