April 26, 2017
Case Name: Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civ. No. 14-1203-LPS, 2017 U.S. Dist. LEXIS 31985 (D. Del. Mar. 6, 2017) (Stark, J.)
Drug Product and Patent(s)-in-Suit: Mucinex® DM (dextromethorphan hydrobromide / 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: Plaintiff Reckitt Benckiser (“RB”) sued Aurobindo after Aurobindo submitted to the FDA an ANDA to market generic Mucinex DM. The patents-in-suit claim controlled-release formulations of the drug guaifenesin, which contains both immediate-release and sustained-release portions or quantities. The court issued a claim construction opinion, and in view of that opinion, Aurobindo filed a motion for summary judgment of non-infringement and a motion to exclude certain expert testimony. The court denied Aurobindo’s motion to exclude and granted its motion for summary judgment of non-infringement.
Why Aurobindo Prevailed: The court first addressed Aurobindo’s motion to exclude. Aurobindo moved to exclude the expert opinions of Mario A. Gonzalez, Ph.D., FCP, concerning: (i) the structure or physical make-up of Aurobindo’s product; and (ii) the obviousness of the patents in suit. It argued that Dr. Gonzalez was not qualified to opine on drug formulation science and that his opinions were neither reliable nor fit the issues in the case. The court disagreed. Although there was some disagreement as to the definition of a skilled artisan, the court found that Dr. Gonzalez met both sides’ definitions. While not a formulator, he has had experience working in research and development of specialized drug-delivery systems, including immediate-release and modified-release dosage forms. Moreover, the court found that Dr. Gonzalez articulated his reasoning supporting the conclusions that he drew from the data presented to him.
RB’s theory of infringement was based on its assertion that the ANDA product behaved as if it contained two distinct formulations. RB contended that the dissolution profile of the ANDA product released guaifenesin at two different rates, and any product with two release rates must have two formulations, like Mucinex DM, which has a two-rate dissolution profile and undisputedly contained two formulations.
RB did not analyze the ingredient list in the ANDA; it did not offer any evidence about the excipients that made up the alleged two formulations; it did not discuss the composition of the ANDA product; it did not provide evidence regarding the physical structure of Aurobindo’s product to demonstrate that it included more than a single formulation; it did not provide evidence about the physical structure of Aurobindo’s tablets; and it did not take any fact or expert depositions. RB’s entire theory relies solely on its expert. The court found that RB was unable to point to anything that indicated that Aurobindo’s ANDA product was going to contain two distinct formulations, one IR and one SR. To the contrary, Aurobindo sought FDA approval of a single-formulation, extended-release product. The ANDA explained that Aurobindo’s proposed product avoids the claims of RB’s patents because it contained a single layer. Thus, RB had failed to provide any direct evidence that Aurobindo’s ANDA product would meet the modified release drug product, quantity, and portion limitations of the asserted claims.
Moreover, the court found the circumstantial evidence RB relied on—the similarities between the dissolution profile of Mucinex DM and the dissolution profile of Aurobindo’s ANDA product—did not provide an adequate basis on which a reasonable factfinder could find infringement. The court did not credit Dr. Gonzalez’s opinions on this issue, finding that he admitted that two tablets with the same dissolution profile nevertheless could have different formulations, indicating that the ANDA product’s similarities to Mucinex DM did not mean that their formulations, or the number of formulations, must have been the same. In addition to being unsupported by evidence, the court found that RB’s infringement position was also inconsistent with the court’s claim construction. Ultimately, the court found that RB’s infringement proof came down to bioequivalence. But bioequivalence is not the test for infringement.