Impax Labs. V. Zydus Pharms. USA, Inc.

Case Name: Impax Labs. V. Zydus Pharms. USA, Inc., C.A. No. 17-13476, 2018 U.S. Dist. LEXIS 202879 (D.N.J. Nov. 29, 2018) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Rytary® (carbidopa/levodopa extended-release capsules); U.S. Patent No. 9,089,608 (“the ’608 patent”)

Nature of Case and Issue(s) Presented: Zydus’s ANDA contained paragraph IV certifications that its proposed product would not infringe any valid claim of the six Orange Book-listed patents. After receipt of this information, Impax sued Zydus for infringing only the ’608 patent. Zydus filed an Amended Answer to the Complaint that included six counterclaims seeking declaratory judgments of non-infringement for each of the six Orange Book-listed patents. In its answer to Zydus’s counterclaim concerning the ’608 patent, Impax denied the counterclaim alleging non-infringement.

In the counterclaim for declaratory judgment for each of the other four patents, Zydus alleged that the manufacture and sale of its proposed product would not and will not directly or indirectly infringe, either literally or under the doctrine of equivalents, any valid claim of that particular patent. Impax answered as follows, “As of this date, based on the current proposed products that are the subject of ANDA No. 210911, Plaintiff admits the allegations of paragraph [X] as stated in the counterclaims.”

Zydus moved for judgment on the pleadings on the ground that, as to the Orange Book-listed patents that were not the ’608 patent, Impax’s statements in the Answer to the counterclaims constituted statements conceding non-infringement. And the court agreed.

Why Zydus Prevailed: Zydus relied on District of New Jersey precedent in support of its arguments, particularly, the decision in Par Pharm., Inc. v. Luitpold Pharm., 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017). In Par, defendant Luitpold moved for judgment on the pleadings, seeking judgment on its declaratory judgment counterclaims that the product proposed in its ANDA submissions did not infringe the applicable patents. In opposition, plaintiff Par argued that the product Luitpold intended to eventually sell, rather than the product specified in the ANDA, would infringe. In a filing, however, Par conceded that the formulations stated in the ANDA did not have the same or equivalent formulation required by the patents-in-suit. The court rejected Par’s argument opposing the motion on the basis that it was speculative.

Impax attempted to distinguish Par by arguing that it was not here relying on speculation, but on actual concerns the FDA had voiced about the Zydus ANDA product. The court did not find this persuasive. Impax had speculated that, sometime in the future, and in some unknown way, Zydus will change its ANDA formulation from one that did not infringe to one that did. This was essentially the same argument that Par made, and that the court rejected. Impax had conceded that the product that was the subject of the ANDA as of June 1, 2018, did not infringe. That was the product that Zydus wpuld likely market if ANDA No. 210911, as it stood on June 1, 2018, were approved. “The argument that Zydus might market something different from what was in its ANDA on June 1, 2018 has no relevance to the question of whether the product that is the subject of ANDA No. 210911, as of June 1, 2018, infringes.” Impax pointed to nothing that raised a material factual question: there was no question that Impax filed the counterclaim Answer containing the concession statements. Nor had Impax pointed to anything that challenged the entitlement of Zydus to judgment as a matter of law.