The US District Court for the District of New Jersey granted generic manufacturer's motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Case No. 16-cv-02290 (D.N.J. Feb. 1, 2017) (Walls, J.).
Par is the New Drug Applications (NDA) holder and assignee of the two Orange Book-listed patents for Adrenalin®, 1 mg/ mL injectable epinephrine. Adrenalin® is indicated for the emergency treatment of allergic reactions and induction and maintenance of mydriasis (dilation of the pupil) during intraocular surgery. The two Orange Book patents, US Patent Nos. 9,119,876 and 9,295,657, are directed to pharmaceutical compositions comprising epinephrine and various specified excipients, and methods of treatment using such compositions.
Even though the product described in Luitpold's ANDA lacks one of the excipients (the bisulfite antioxidant) required by the claims of both Orange Book patents, Par nevertheless filed suit on April 22, 2016. Par's infringement claims were based on allegations that the product Luitpold will eventually market will infringe the Orange Book patents. In other words, Par speculated that the US Food and Drug Administration (FDA) will require Luitpold to change its formulation, and that those changes will bring Luitpold's product within the scope of the patent claims. Luitpold filed its motion for judgment on the pleadings on September 9, 2016.
Relying on the Federal Circuit's opinion in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003), the district court held that 35 USC § 271(e)(2) does not encompass speculative claims, or future acts of infringement. Because the formulation in Luitpold's ANDA falls outside the independent claims of the Orange Book patents, and Par's claim is "entirely premised on speculation that future, uncertain amendments to Luitpold's ANDA will infringe," judgment in favor of Luitpold was warranted. The court then dismissed Par's infringement claims with prejudice, and granted Luitpold's counterclaim for a declaratory judgment of non-infringement. The court noted that should Luitpold be required by Food and Drug Administration to amend its ANDA, it would then need to send a new Paragraph IV certification, giving Par the opportunity to file a second infringement action.
Notably, the court later granted attorney fees under 35 USC § 285 (a carefully calculated $207,482.50), and costs ($4,580.93) to Luitpold. Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Case no. 16-02290-WHW-CLW (DNJ Apr. 24, 2017). The court noted Par's unjustified maintenance of meritless claims and vigorous attempts to engage in overbroad discovery of highly confidential, competitive business information as the basis for finding an exceptional case.
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