May 1, 2018

Case Name: Valeant Pharms. Int’l v. Mylan Pharms., Civ. No. 15-8180 (SRC), 2018 U.S. Dist. LEXIS 73069 (D.N.J. May 1, 2018) (Chesler, J.) 

Drug Product and Patent(s)-in-Suit: Relistor® (methylnaltrexone bromide); U.S. Patent No. 8,552,025 (“the “’025 patent”)

Nature of the Case and Issue(s) Presented: Plaintiffs moved for partial judgment concerning non-obviousness. Specifically, Plaintiffs argued that Defendants could not prove that claim 8 of the ’025 patent was invalid in light of the prior art. Plaintiffs provided three reasons to support their argument: (i) Defendants failed to identify any motivation to modify prior-art methylnaltrexone products; (ii) Defendants could not establish that the “stable for storage for 24 months” element was taught by the prior art; and (iii) the modifications to prior-art products would not be obvious to try. The court agreed with Plaintiffs’ last two points and granted partial summary judgment.

Why Valeant Prevailed: After surveying the prior art, the court determined that, at the time of invention, one skilled in the art was not able to formulate an injectable pharmaceutical solution that was stable for 24 months. While the prior art did suggest that a methylnaltrexone solution with a pH called for by claim 8 of the ’025 patent would have some stability, Defendants provided no evidence that one of ordinary skill in the art would have expected such a solution to be stable for 24 months. Because Defendants could not bridge the gap between the general idea of improved stability, and a solution that remained stable for 24 months, no reasonable fact finder would conclude that the ’025 patent was obvious. Thus, the court granted partial summary judgment of non-obviousness.