Novartis Pharma. Corp. v. Wockhardt USA LLC

Case Name: Novartis Pharma. Corp. v. Wockhardt USA LLC, Civ. No. 12-cv-3967 (SDW)(MCA), 2013 U.S. Dist. LEXIS 152141 (D.N.J. Oct. 23, 2013) (Wigenton, J.) (Motion to dismiss under Rule 12(b)(6) is appropriate if proposed ANDA product labeling does not include an indication that is covered by the patented method.)

Drug Product and Patent(s)-in-Suit: Zometa® and Reclast® (zoledronic acid); U.S. Pat. Nos. 7,982,241 (“the ’241 patent”), 8,052,987 (“the ’987 patent”), and 8,324,189 (“the ’189 patent”) 

Nature of the Case and Issue(s) Presented:  Plaintiffs commenced this lawsuit on February 20, 2013 and filed an amended complaint on March 15, 2013 asserting infringement of the ’241 patent, the ’987 patent, and the ’189 patent against various generic drug company defendants. Then each defendant filed a motion to dismiss. Before the Court were defendants’ motions to dismiss Count II relating to infringement of the ’987 patent pursuant to Fed. R. Civ. P. 12(b)(6) and Apotex’s motion for judicial notice of the FDA’s Response to plaintiffs’ Citizen Petition.

The court granted, in part, the motions to dismiss Count II with respect to 35 U.S.C. §§ 271(e)(2) and (b), and denied, in part, with respect to 35 U.S.C. § 271(c). The court also granted Apotex’s motion to dismiss with respect to Count III. The court also granted Apotex’s motion for Judicial Notice.

Why Defendants Prevailed:  Defendants prevailed in dismissing Count II (infringement of the ’987 patent) because the court determined that plaintiffs failed to plead facts showing how certain defendants could infringe the patent when their proposed ANDA product labeling would not include an indication for osteoporosis—the patented use. The ’987 patent claims a method of using zoledronic acid to treat osteoporosis. Certain defendants filed Section viii certifications asserting that their proposed labels will not indicate osteoporosis—the patented use for Reclast. Plaintiffs did not demonstrate how certain defendants’ section viii certifications were misleading or improper. The court took judicial notice of the FDA’s response to Plaintiffs’ Citizen Petition since it was a matter of public record that was not available during the briefing stage. Pointing to the FDA’s Response, the court noted that the response supports the defendants’ position that the section viii certifications are not misleading. Thus, the court dismissed plaintiffs’ §271(e)(2) infringement claim.

The court also dismissed plaintiffs’ §271(b) infringement claim, since plaintiffs could not identify any explicit direction or instruction by certain defendants to infringe the asserted claims. The defendants’ proposed ANDA product labeling did not include the patented osteoporosis indication and the court was not persuaded by the plaintiffs’ allegations that “market realities” would lead physicians to prescribe the proposed generic for osteoporosis. The court found that plaintiffs sufficiently pled contributory infringement and denied the defendants’ motion relating to the §271(c) claim. Plaintiffs argued that the defendants were seeking an indication, treatment of Paget’s disease, which was only occasional and could not be deemed a substantial non-infringing use. Defendants’ countered that an FDA approved indication is necessarily substantial. The court determined that whether or not the treatment of Paget’s disease is “substantial” cannot be done at the pleading stage. Thus, the motion was denied.