Reckitt Benckiser LLC v. Amneal Pharms. LLC

Case Name: Reckitt Benckiser LLC v. Amneal Pharms. LLC, Nos. 15-2155 (RMB/JS), 15-4524 (RMB/JS), 2017 U.S. Dist. LEXIS 133998 (D.N.J. Aug. 22 2017) (Bumb, J.)

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

Nature of the Case and Issue(s) Presented:  Reckitt Benckiser’s (“RB”) Mucinex product is an expectorant that thins and loosens mucus and relieves chest congestion. At issue was whether Amneal’s generic guaifenesin sustained-release tablets (“Amneal’s ANDA products”) and Dr. Reddy’s (“DRL”) generic guaifenesin and pseudoephedrine hydrochloride sustained-release tablets (“DRL’s ANDA Products”) infringed the patents-in-suit.

More specifically, Amneal stipulated that its ANDA products satisfy every limitation of the asserted claims of the ’821 patent except for the elements: “modified release drug product;” “first quantity of guaifenesin in an immediate release formulation;” and “second quantity of guaifenesin in a sustained release form/release-delaying matrix.”

With respect to the ’032 patent, DRL and Amneal stipulated that their respective ANDA products satisfy every limitation of the relevant claims except for the following claim elements directed to the drug product having two portions of guaifenesin: “a first portion comprises guaifenesin in an immediate release form;” and “a second portion comprises guaifenesin in a sustained release form.”

Defendants’ invalidity claims were stayed pending the outcome of the infringement trial. The court found that neither Amneal’s ANDA products nor DRL’s ANDA Products infringed the patents-in-suit.

Why Defendants Prevailed: The court construed the claims to require the presence of two distinct formulations. Illustratively, for the ’032 patent, the court construed “portion” to mean “a distinct formulation,” in accord with the construction in Reckitt v. Aurobindo Pharma Ltd. 2016 U.S. Dist. LEXIS 152337 (D. Del. Nov. 3, 2016). This construction, and a similar one for the ’821 patent, proved dispositive. The court found all asserted claims non-infringed.

RB’s expert attempted, by performing Raman spectroscopy on thin layers cut from the products with a microtome, to demonstrate that each of the accused products had two formulations. The defendants offered a litany of criticisms to the expert’s opinions, and the court generally agreed. One criticism was the expert’s inability to identify half of the ingredients in one tablet. Another one, and the “most troubling” one, in the court’s opinion, was that using the expert’s methodology, “an SR formulation could be transformed into an IR formulation simply by cutting off the original surface of the tablets. No matter how many times the tablet was cut, the outer layer would transform into the IR formulation even though it had been the SR formulation.”

The court summarized its view of RB’s expert opinion by stating:

In the end, the Court finds that Defendants’ criticisms of [the expert’s] Raman analyses were well-placed and called into question the reliability of [his] opinion. However, as alluded to above, [his] interpretations [of] the maps created by those analyses present a greater issue. [His] testimony leads this Court to the conclusion that, with some creative thinking, one could define any region of a tablet as having a distinct formulation.

The court buttressed its conclusion that the accused products did not infringe by reviewing the evidence of defendants’ efforts to create a tablet having only a single formulation. Reckitt, the court found, failed to identify any step in the process that could result in the creation of two distinct formulations.