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

Case Name: Horizon Meds. LLC v. Dr. Reddy’s Labs., Inc., Civil Action No. 15-3324 (SRC), 2019 U.S. Dist. LEXIS 218330 (D.N.J. Dec. 18, 2019) (Chesler, J) 

Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen/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 to District Court: Vimovo is an oral drug formulation used to treat symptoms of osteoarthritis, rheumatoid arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. The patents-in-suit all cover a method to achieve pain-and-symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions, and hemorrhages. Plaintiffs sought a preliminary injunction to prevent Dr. Reddy’s from launching its ANDA product. The court denied the motion for a preliminary injunction, as plaintiffs failed to show a likelihood of success on the merits against Dr. Reddy’s challenges to the patents-in-suit’s validity and enforceability.

Why Dr. Reddy’s Prevailed: In its opposition, Dr. Reddy’s challenged the validity of the patents-in-suit, arguing that the asserted claims lacked adequate written description. Dr. Reddy based this argument on Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc., 923 F.3d 1368, 1371 (Fed. Cir. 2019), in which the Federal Circuit invalidated U.S. Patent No. 6,926,907, which shares a parent application with the patents-in-suit. Specifically, Dr. Reddy’s contended that, as in Nuvo, the court should construe the asserted claims to require effective uncoated esomeprazole, and as construed, the asserted claims fail to meet the written-description requirement. Plaintiffs contended that the all claim language should have its ordinary meaning.

The court noted that, as to the likelihood of success on the merits, the dispute turned on the question of how the asserted claims should be construed in the preliminary-injunction context, and that the court need not reach a conclusive resolution of the issue. The Federal Circuit has called this a “rolling claim construction.” Because Dr. Reddy’s raised a substantial question of patent invalidity at the preliminary-injunction stage, which the Plaintiffs did not show lacked substantial merit, the court denied plaintiffs motion for injunctive relief. Relying on Nuvo, the court noted, “it is a common-sense proposition that, if [Plaintiffs] were unable to persuade the Federal Circuit that the shared specification—shared with the ’996 and ’920 patents, the parties agreed—provides adequate written description support for a claim limitation of effective uncoated PPI, they are unlikely to succeed in defeating the same validity challenge in this case.”