Allergan, Inc. v. Apotex, Inc.

Case Name: Allergan, Inc. v. Apotex, Inc., Civ. Nos. 1:10-CV-68, 1:11-CV-298, 1:11-CV-650, 1:12-CV-321, 2013 U.S. Dist. LEXIS 57656 (M.D.N.C. Apr. 23, 2013) (Eagles, J.)

Drug Product and Patent(s)-in-Suit: Latisse^® (bimatoprost); U.S. Pat. Nos. 7,351,404 (“the ’404 patent”) and 7,388,029 (“the ’029 patent”)

Nature of the Case and Issue(s) Presented:  The court found the patents-in-suit valid and infringed. The court ordered the effective date of approval for each of the defendants’ ANDA’s to be no earlier than the expiration dates of the patents-in-suit. After the court’s order, plaintiffs sought a permanent injunction. In addition to opposing the motion on the merits, defendants opposed the injunction on three procedural grounds—(i) that the motions violate their due process rights since plaintiffs submitted affidavits in support of the motions; (ii) that the injunctions would violate Fed. R. Civ. P. 52(a)(1) because the court did not make factual findings or conclusions of law concerning an injunction; and (iii) plaintiffs’ motion constitutes an attempt to belatedly bifurcate the injunction remedy and plaintiffs waived such a request by not raising it in any pleading other than the complaint. The Court rejected defendants’ procedural arguments, instead finding that plaintiffs demonstrated irreparable injury, that inadequate remedies at law were available, that the balance of hardships weighs in plaintiffs’ favor, and that the public interest would not be dis-served by an injunction. The court issued permanent injunctions.

Why Allergan Prevailed:  Plaintiffs prevailed because defendants’ procedural arguments were unpersuasive. The court also found that the injunction would only prevent defendants from commercial uses of the infringing products and not developmental efforts. Plaintiffs had not waived the remedy of a permanent injunction. While plaintiffs never raised injunctive relief at the final pretrial conference, the court found that plaintiffs’ referenced injunctive relief in the pretrial brief and the complaint. Moreover, permanent injunctions are routinely granted in Hatch-Waxman cases and defendants failed to identify any evidence not offered at trial relevant to a permanent injunction. The court did strike the affidavits plaintiffs filed in support of their motions. Plaintiffs offered no reason as to why those affidavits could not have been introduced at trial. Finally, the court determined that its infringement order was not a final judgment and thus, made findings to support its granting the injunctions. The court found irreparable harm since the defendants did not dispute that they are direct competitors, and that plaintiffs will lose market share if the generics launched. The court further found that the infringement order did not sufficiently protect plaintiffs’ interests, since defendants could still enter into a licensing agreement with another company seeking FDA approval.