Impax Labs., Inc. v. Actavis Labs. FL, Inc.

Case Name: Impax Labs., Inc. v. Actavis Labs. FL, Inc., Civ. No. 15-6934, 2018 U.S. Dist. LEXIS 38623 (D.N.J. Mar. 8, 2018) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Rytary® (levodopa/carbidopa); U.S. Patents Nos. 8,557,283 (“the ’283 patent”), 9,089,608 (“the ’608 patent”), 9,463,246 (“the ’246 patent”), and 9,553,046 (“the ’046 patent”)

Nature of the Case and Issue(s) Presented: Rytary is approved for the treatment of Parkinson’s Disease. Impax sued Actavis alleging patent infringement based on the filing of an ANDA for a generic version of Rytary. Actavis moved for summary judgment of non-infringement of all asserted patents, which the court granted for purposes of literal infringement and denied for purposes of infringement under the doctrine of equivalents.

Why Actavis Partially Prevailed: The 37 asserted claims fell into two general categories: (i) formulation structure claims and (ii) pharmacokinetic (“PK”) profile claims. Infringement of the formulation structure claims turned on whether the carboxylic acid component was in a distinct bead. The pharmacokinetic profile claims turned on whether the method resulted in a levodopa plasma concentration profile with certain characteristics.

Formulation Structure Claims: The asserted formulation structure claims contained the 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).” Actavis moved for summary judgment of no literal infringement because the beads in its formulation containing tartaric acid, a carboxylic acid, also contained levodopa (“LD”) and a decarboxylase inhibitor (“CD”).

Impax did not dispute that fact. Instead, Impax argued that the claim term “in a distinct bead” did not mean that the carboxylic acid must be in a bead with no CD or LD. The court stated “[t]his is a ‘sky is green’ argument,” and held that the claims plainly required carboxylic acid to be in a bead with no CD or LD. The court therefore granted summary judgment of no literal infringement.

Actavis also moved for no infringement under the doctrine of equivalents, arguing that prosecution history estoppel barred Impax from recapturing claim scope it surrendered during prosecution. The court noted that Actavis’s prosecution history estoppel argument was too cursory, stating “Actavis has given the court a few dots outlining the trail of a possible future argument, and this Court will not sua sponte fill in the missing sections to create a complete path.” The court therefore denied Actavis’s motion with respect to prosecution history estoppel.

Pharmacokinetic Profile Claims: The PK profile claims fell into two sub-categories: (i) the maximum concentration claims and (ii) the 40% fluctuation claims.

With respect to the 40% fluctuation claims, the court found that Actavis’s summary judgment argument relied on a non-infringement theory that it did not disclose in its non-infringement contentions. The court held that Actavis was barred from making the undisclosed argument, and denied the motion for summary judgment.

With respect to the maximum concentration claims, the parties agreed that the term “maximum concentration” should have its plain and ordinary meaning. Impax argued, however, that Actavis misapplied that construction and Impax went on to set forth an analytical procedure for determining infringement. The court found Impax’s argument that it should follow a special analytical procedure unpersuasive and unsupported by law. The court viewed it as a meritless attempt to preclude summary judgment by turning the issue into a battle of the experts. The evidence showed that if Impax’s proposed analytical procedure was not followed, then there was no genuine dispute that Actavis’s product did not infringe. The court therefore granted summary judgment of no literal infringement.    

Finally, the court addressed Actavis’s motion with regard to indirect infringement of the PK profile claims. The court found that a reasonable fact finder could conclude that Actavis’s label instructs physicians to perform the infringing steps, and that the label and circumstantial evidence showed specific intent to induce infringement. Thus, the court denied summary judgment of no inducement. Similarly, the court found a material factual dispute regarding whether the Actavis product was suitable for a substantial non-infringing use. Thus, the court denied summary judgment of no contributory infringement.