Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc.

Vimovo® (naproxen and esomeprazole magnesium)

February 17, 2021

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc., No. 15-3324 (SRC), 2021 WL 616067 (D.N.J. Feb. 17, 2021) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen and esomeprazole magnesium); U.S. Patents Nos. 8,858,996 (“the ’996 patent”) and 9,161,920 (“the ’920 patent”)

Nature of the Case and Issue(s) Presented: Plaintiffs were the owner and licensee of patents that covered the drug Vimovo. Defendants were pharmaceutical companies that filed ANDA applications for approval to market generic versions of Vimovo. The first round of litigation between the parties resulted in the court’s invalidating two patents for failure to meet the written-description requirement. During that case, nine additional patents covering Vimovo were listed in the FDA’s Orange Book, including the two patents-in-suit. DRL moved for summary judgment of invalidity of the asserted claims in the ‘996 and ‘920 patents for lack of adequate written description. Relying on the first litigation, DRL argued that the claims were invalid under the doctrine of issue preclusion, or, in the alternative, the court’s claim construction warranted a grant of judgment of invalidity as a matter of law. The court denied DRL’s motion

Why Plaintiffs Prevailed: DRL did not prove one of the requirements for establishing issue preclusion, namely, that the identical issue was adjudicated previously. The court found that DRL’s contention that the court had construed the patents-in-suit to require the same effective uncoated esomeprazole limitation as the patents from the prior litigation “has no basis in reality.” “The claim-construction decision has no discussion about uncoated anything, because that was not the issue. No issues about ‘coating’ were ever considered or determined: in this Court's claim construction Opinion and Order, filed August 14, 2020, the word ‘uncoated’ appears only in a quote from [the first litigation’s opinion].”

DRL also argued for identity of issues by asserting that any differences in claim language between the claims here and those in the prior litigation were “immaterial.” The court also took issue with this characterization. The differences in the wording of the claims merited, at least, some inquiry into the impact on the written-description determination. For example, claim 11 of the ‘920 patent and claim 12 of the ‘996 patent both expressly required the esomeprazole layer to have a coating, while the prior litigation focused on uncoated proton pump inhibitors (“PPI”). DRL did not present an analysis of the differences in claim language, or show that the differences had no impact on the written-description inquiry. Instead, DRL relied on Federal Circuit case law, which the court distinguished.

DRL next argued that, in the alternative, DRL was entitled to judgment as a matter of law because there were no genuine issues of material fact, given the outcome of the prior litigation, concerning what the common specification described—or didn’t describe—about “effective” uncoated PPI. The court held that DRL “had not even attempted” to meet its burden of proof of invalidity by clear and convincing evidence. DRL had not affirmatively shown the absence of a genuine issue of material fact, and the court rejected this argument.

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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