Reckitt Benckiser LLC v. Amneal Pharms. LLC

Case Name: Reckitt Benckiser LLC v. Amneal Pharms. LLC, No. 15-2155-RMB-JS, 2019 U.S. Dist. LEXIS 184628 (D.N.J. Oct. 25, 2019) (Bumb, J.) 

Drug Product and Patent(s)-in-Suit: Mucinex® (guaifenesin); U.S. Patents Nos. 6,372,252 (“the ’252 patent”), 6,955,821 (“the ’821 patent”), and 7,838,032 (“the ’032 patent”)

Nature of the Case and Issue(s) Presented: Reckitt Benckiser (“RB”) alleged that Amneal and co-defendant Dr. Reddy’s ANDA products would infringe the patents-in-suit. After the filing of its complaints, RB dismissed its claims under the ’252 patent as to all defendants and its claims under the ’821 patent against Dr. Reddy’s. The principle dispute concerned whether defendants’ ANDA products had distinct formulations: an immediate-release (“IR”) formulation and a sustained-release (“SR”) formulation. RB contended that they did. Defendants argued that that their ANDA products were single-formulation-matrix tablets. The court agreed with defendants, and the Federal Circuit affirmed.

That case was not RB’s first challenge against a generic manufacturer of Mucinex; in fact, RB brought at least three others (against Watson, Perrigo, and Aurobindo). In Watson and Perrigo, the district courts concluded that a single-formulation-matrix tablet, like the tablets manufactured by the Amneal and Dr. Reddy’s in this case, contained only one single portion of guaifenesin. In Aurobindo, the court construed the claims of the same patents at issue here as requiring two “distinct” structural formulations of guaifenesin. Because Aurobindo’s product did not contain two distinct formulations, the court granted summary judgment as to the defendant.

Here, Amneal and Dr. Reddy’s moved for attorney fees under 35 U.S.C. § 285, contending that this case was “exceptional” based on RB’s conduct throughout litigation. The court denied defendants’ motion.

Why RB Prevailed: Defendants conceded that there is no basis for an exceptional case ruling prior to this court’s adoption of the Aurobindo claim construction, and so, the court began its exceptional case analysis from that point.

The court found that there were factors that supported “exceptionality.” First, defendants were the “prevailing party” within the meaning of the statute. The court in Watson construed the term “portion” as requiring two distinct formulations and found that the defendant’s product did not infringe because it did not have two structural portions. Based on these existing findings, the Aurobindo Court noted, “the fact that the Federal Circuit had already ruled on a patent in this family is relevant to assessing subsequent actions by RB. RB—the same patentee and plaintiff here as in Watson—was surely aware of that case and proceeded here with knowledge of the Federal Circuit’s decision on the issues presented there.” The Aurobindo decision itself also tended to support a finding of exceptionality because the summary judgment found that the defendant’s product likewise did not contain two distinct formulations.

But the court also found that there were factors weighing against “exceptionality.” The Watson decision was not a dispositive decision because it involved a different ANDA product and the ’252 patent, which RB had withdrawn. Additionally, RB persuaded the court that it had additional structural data available to it that the Aurobindo court did not have before ruling. For that reason, the court permitted RB to: (i) present limited testimony of RB’s expert on the dissolution and pharmacokinetic profiles of defendants’ ANDA products to prove infringement; and (ii) introduce testimony of a second RB expert on infringement. Though the court found the latter testimony “flawed” and “unreliable,” it was not prepared to find that his testimony was offered in bad faith.

While a “close call,” the court denied defendants’ motion, but warned RB: “further ‘bites at the apple,’ through future litigation over the same patents, will likely be viewed as unreasonable or abusive by any court, subjecting RB to fees under Section 285.”