Levodopa & Carbidopa – USA

On Apr. 18, 2018, U.S. District Judge STANLEY R. CHESLER, of District of New Jersey granted in part & denied in part Actavis’ motion for summary judgment of non-infringement in Rytary®(carbidopa and levodopa) Extended-release Capsules.

This matter came before this Court on the motion for summary judgment, pursuant to Federal Rule of Civil Procedure 56, by Defendants Actavis Laboratories FL, Inc. and Actavis Pharma Inc. (collectively, “Actavis”). Plaintiff Impax Laboratories, Inc. (“Impax”) has opposed the motion. The Court heard oral argument on this motion on February 27, 2018. This is a Hatch-Waxman case involving a patent dispute regarding pharmaceuticals: the Complaint alleges that Actavis seeks to make and sell a generic version of Plaintiff’s Rytary® (levodopa/carbidopa) capsules prior to the expiration of the relevant patents. This consolidated case now involves four patents. Actavis moves for summary judgment that its proposed generic product will not infringe 37 claims in U.S. Patent Nos. 8,557,283 (“the ’283 patent”), 9,089,608 (“the ’608 patent”), 9,463,246 (“the ’246 patent”), and 9,533,046 (“the ’046 patent”).

I. Infringement of claims requiring a particular formulation structure:

For purposes of this motion, the parties have grouped together claims in the ’283 and ’608 patents that contain this phrase: “(a) levodopa; (b) a decarboxylase inhibitor; and (c) a carboxylic acid that is not (a) or (b); wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b).” While Actavis makes a number of arguments, the heart of its non-infringement case for these claims is the contention that its proposed product does not meet this limitation, and thus cannot literally infringe. Specifically, Actavis contends that, the bead with tartaric acid, a carboxylic acid, also contains levodopa (“LD”) and a decarboxylase inhibitor (“CD.”). As a result, the proposed product does not contain the claim limitation at issue: the carboxylic acid is not in a distinct bead from the levodopa and decarboxylase inhibitor.

Court after hearing both the parties held that Impax has failed to defeat Actavis’ motion as to these claims, and thus granted motion for summary judgment of non-infringement, as to literal infringement of the Formulation Structure Claims.

II. Infringement of claims requiring a particular PK profile:

For purposes of this motion, the parties have grouped together method of use claims in the ’246, ’046, and ’608 patents that require pharmacokinetic profiles with certain characteristics. In brief, one subset of claims contains claim limitations involving “maximum concentration” (“the ‘maximum concentration’ claims”) while the other subset of claims contains claim limitations with the term, “the levodopa blood plasma levels do not fluctuate more than 40% between 0.5 hours and six hours after administration” (“the ‘40% fluctuation’ claims). Actavis moved for summary judgment of literal non-infringement on all such claims on the ground that its proposed product does not meet these limitations.

Court held that Impax has failed to defeat the motion for summary judgment of non-infringement on the method of use claims that contain “maximum concentration” limitations. As to the issue of literal infringement, in regard to the counts based on the method of use claims that contain “maximum concentration” limitations, the motion for summary judgment will be granted. See Intellectual Ventures I LLC v. Motorola Mobility LLC, 870 F.3d 1320, 1331 (Fed. Cir. 2017) (“a finding of direct infringement is predicate to any finding of indirect infringement”).

Court thus granted Actavis’ motion for summary judgment of non-infringement under literal theory & denied motion for summary judgment of non-infringement under DOE theory.