Court finds patent is valid and infringed after bench trial in ANDA case
Alcon, Inc. And Alcon Research, LTD. v., Teva Pharmaceuticals USA, Inc., Civ. No. 06-234-SLR, October 19, 2009.
Robinson, J. The Court finds in favor of plaintiff and against defendant on infringement and validity following bench trial.
This action arises out of the filing of an ANDA by defendant to market a generic version of the antibacterial drug VIGAMOX®, a topical ophthalmic solution comprised of the active ingredient moxifloxacin hydrochloride, which is claimed by the patent-in-suit (the”’830 patent”). Plaintiff brought this suit on April 5, 2006, alleging infringement of the ′ 830 patent. The parties agree that defendant's ANDA product contains every limitation of the ′830 patent with the exception of one point of dispute as to whether the ANDA product contains “moxifloxacin” as it is used in claim 1. The court's construction of “moxifloxacin” is dispositive of plaintiffs' infringement claim. Following a bench trial the Court construes “moxifloxacin” according to its ordinary and accustomed meaning and finds that the generic moxifloxacin product described in defendant’s ANDA infringes claim 1 of the ′830 patent.
As for defendant’s validity claim, defendant argues that the ′830 patent is invalid as anticipated by the ′942. Specifically, defendant contends that the ′942 patent discloses each limitation of claim 1 of the ′830 patent. The parties agree that the ′942 patent discloses a “topical ophthalmic pharmaceutical composition.” In light of the construction of “moxifloxacin”, the Court finds that the '942 patent also discloses “moxifloxacin or a pharmaceutically useful hydrate or salt thereof.” However, the Court finds that the defendant has failed to show that the ′942 patent discloses the relevant concentration range and the “pharmaceutically acceptable vehicle” of claim 1 and therefore the ′830 patent is not invalid for anticipation. Next, considering defendant’s obviousness arguments, the Court that the prior art consistently taught away from the use of moxifloxacin in ophthalmic treatments. Several secondary considerations of nonobviousness demonstrate that it was not obvious to incorporate moxifloxacin into such a composition. Therefore, the Court finds that defendant has failed to adduce clear and convincing evidence that the invention of the ′830 patent is obvious. Finally, defendant has failed to produce clear and convincing evidence that plaintiff violated the best mode, written description or enablement requirements of 35 U.S.C. § 112, ¶ 1.
