Epinephrine - USA

On Apr 24, 2017, Judge William H. Walls of District of New Jersey granted defendants' motion for attorney fees under 35 U.S.C. § 285 because plaintiffs' infringement claim against defendant's operative ANDA and plaintiff's claim for a declaration of infringement by possible future products were baseless.

This case arises out of a patent dispute between Plaintiffs Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (collectively, “Par” or “Plaintiffs”), and Defendants Luitpold Pharmaceuticals, Inc., Daiichi Sankyo, Inc., and Daiichi Sankyo Co., Ltd (“Defendants”). Par is the assignee of several patents for Adrenalin®, a product containing 1 mg of the active ingredient epinephrine, which is used primarily to treat allergic reactions. In early 2016, Defendant Luitpold filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (“FDA”), which sought approval to market a generic version of Par’s Adrenalin® product.

Par then initiated this suit under the Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”), asserting that Luitpold’s ANDA submission constituted an act of infringement of their patents and seeking a declaration that Luitpold’s Future Generic Product — the drug to be marketed and sold after FDA approval — would infringe Par’s patents. Luitpold sought declaratory relief that it had not and was not infringing Par’s Adrenalin® patents; that the Patents-in-suit were invalid under 35 U.S.C. § 101; that Luitpold was entitled to a defense to infringement based on earlier commercial use, and that the case was exceptional under 35 U.S.C. § 285.

On September 9, 2016, Luitpold filed a motion for judgment on the pleadings, which the Court granted on January 18, 2017. The Court dismissed Plaintiffs’ patent infringement claims with prejudice and granted Luitpold’s counterclaim seeking a declaratory judgment of non-infringement because, as Par admits, Luitpold’s current ANDA formulations do not infringe Par’s Adrenalin® patents. The Court also dismissed Par’s claims under the Declaratory Judgment Act without prejudice as unripe, finding they were “premised on speculation that future, uncertain amendments to Luitpold’s ANDA will infringe Par’s patents.”

Defendants moved for attorney fees under 35 U.S.C. § 285 on February 21, 2017. Defendants argue that they are prevailing parties under 35 U.S.C. § 285, that the case should be considered exceptional, and that the Court should exercise its discretion to award fees because (1) “Par asserted an objectively baseless theory of infringement”; (2) “Par knew its allegations were false before filing suit”; (3) The Complaint improperly joined the Daiichi $ankyo Defendants” (4) Par abused discovery to attempt to monitor Defendants’ competitive activities”; and (5) the case “violates public policy favoring prompt resolution of Hatch-Waxman cases.

CONCLUSION: Defendants’ Motion for Attorney fees, is granted in the reduced amount of $207,482.50 in fees and $4,580.93 in costs.