Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, Civ. No. 13-2088-GMS, 2016 U.S. Dist. LEXIS 114419 (D. Del. Aug 26, 2016) (Sleet, J.)

Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel / ethinyl estradiol); U.S. Patent No. 5,989,581 (“the ’581 patent”)

Nature of the Case and Issue(s) Presented: The issue here centered on Warner’s defense that the ’581 patent was invalid based on anticipation and obviousness. For anticipation, Warner asserted that four different claim elements were inherently disclosed in a prior-art patent application that shared one of the same inventors of the ’581 patent. Warner further argued that those limitations, if not inherently disclosed, would have been obvious in light of the knowledge of one of skill in the art.

Merck argued that the ’581 patent was not anticipated because it was not inherent that all of the claim limitations were disclosed in the prior art. Further, it would not have been obvious to one of skill in the art because the prior-art reference taught away from the claimed limitations. Lastly, Merck asserted that secondary considerations of non-obviousness demonstrated that the patent was not obvious. The court held that the ’581 patent was not anticipated, but the patent was invalid as obvious.

Why Warner Prevailed: The district court found the ’581 patent was not anticipated because several of the claimed limitations were not disclosed in the prior-art reference.  In particular, the court found that there was no clear and convincing evidence that two of the claim elements were explicitly or inherently disclosed in the prior art.

As to obviousness, the court found that these two limitations were obvious in light of the knowledge of one of skill in the art. The court rejected Merck’s argument that the prior art taught away from the claim limitations. Indeed, for one of the elements, the inventor of the ’581 patent admitted he relied on the knowledge of doctors regarding the release-timing claim limitation.

Lastly, the court rejected Merck’s argument that secondary considerations evidenced the non-obviousness of the patent-in-suit. The court found that there was no commercial success because NuvaRing was the fifth most popular contraceptive. Moreover, effective contraception was not the novel feature of the ’581 patent. Thus, the commercial success of NuvaRing was not relevant. Likewise, Merck’s allegations of copying were unfounded because of the ANDA legal framework. Lastly, Merck did not establish a nexus between long-felt need or industry recognition and the patented features.