October 20, 2017

Case Name: Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., 11-2317 (MLC) (DEA), 2017 U.S. Dist. LEXIS 107707 (D.N.J. July 12, 2017) (Cooper, J.) 

Drug Product and Patent(s)-in-Suit: Vimovo® (naproxen / esomeprazole magnesium); U.S. Patents Nos. 6,926,907 (“the ’907 patent”) and 8,557,285 (“the ’285 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claimed dosage forms of Vimovo, a drug used to reduce arthritis pain. Defendants stipulated that all but one ANDA product (DRL ANDA II) infringed the patents-in-suit. At summary judgement, the court concluded that the DRL ANDA II formulation did not infringe the ’907 patent. The parties thus disputed the validity of both patents-in-suit and whether the DRL ANDA II formulation were to infringe the ’285 patent. The court concluded that the DRL ANDA II formulation infringed the ’285 patent and that the asserted claims of both patents were valid.

Why Plaintiffs Prevailed: Defendants argued that, because the ’285 patent claimed uncoated naproxen, and because the specification discussed formulations that suggested a preference for coated naproxen, the claims were inadequately described. The court disagreed. Though the specification discussed a preference for coated naproxen, nothing in the specification precluded the use of uncoated naproxen. Thus, the use of uncoated naproxen was adequately described. To hold otherwise, the court reasoned, would improperly limit the claims to the preferred embodiments in the specification. The court also rejected the Defendants’ argument that the use of the word “inhibits” in the claims expanded the scope of the claim to encompass undescribed sustained-release formulations, rendering the claims invalid. The court noted that this argument had already been rejected by the PTAB and concluded that it did not pass muster in the present litigation. “Inhibits” did not refer to sustained-release formulations, but instead referred to the use of certain coatings to inhibit the release of NSAIDs in the formulation.

Defendants next argued that both patents-in-suit were obvious in light of the prior art. After reviewing the relevant art, the court determined that the claimed invention differed in two key ways: (i) the invention utilized a proton-pump inhibitor instead of a prostaglandin to prevent NSAID-related ulcers; and (ii) the proton-pump inhibitor used was uncoated. One of ordinary skill, the court reasoned, would not identify these elements in the prior art. Since Defendant stipulated that its formulations, other than the DRL ANDA II formulation, infringed the patents-in-suit, Defendants were liable for infringement of Plaintiffs’ patents.

Having lost its validity arguments, Defendants’ arguments relating to non-infringement of the ’285 patent also failed. The Court pointed to unrebutted testimony that the DRL ANDA II formulation contained each claim element in the ’285 patent. Accordingly, the ’285 patent was both valid and infringed.