Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., Case Nos. 08-627-LPS, 11-81-LPS, 09-143-LPS, 10-285-LPS, 2014 U.S. Dist. LEXIS 41865 (D. Del. Mar. 28, 2014) (Stark, J.)

Drug Product and Patent(s)-in-Suit: Actonel® (risedronate sodium); U.S. Patents Nos. 7,718,634 (“the ’634 patent”) and 7,192,938 (“the ’938 patent”)

Nature of the Case and Issue(s) Presented: Defendants moved for summary judgment that the ’634 and ’938 patents were invalid as obvious. Previously, unasserted claims of the patents-in-suit were found to be obvious in a patent infringement case in the District of New Jersey. Defendants now argued that the asserted claims in this case were obvious, for almost the same reasons in view of the prior art that was the subject of the New Jersey litigation.

Plaintiffs argued that the prior art did not disclose a monthly dosage schedule, and that there was a dispute between experts whether one of skill at the time of the invention would consider a monthly dosage schedule. Plaintiffs also argued that secondary considerations of non-obviousness, such as commercial success and long felt need, created a factual dispute. The court found that defendants had met their burden of presenting clear and convincing evidence that allowed the court to conclude that one of ordinary skill in the art would consider the patents in suit obvious.

Why Defendants Prevailed: The court found that the prior art demonstrated with clear and convincing evidence that the elements of the claims were present in the prior art.  The court noted that several prior-art references disclosed that the use of risedronate was effective for treating osteoporosis. The references also disclosed various daily and weekly dosage schedules. The court agreed with defendants that one of skill would expect a linear relationship for the dosage schedule to extend to a monthly regimen. Next, the court rejected plaintiffs’ argument that one of skill would not consider a dosage schedule greater than two weeks due to osteoclast life cycles. Rather, the court found that the prior art references showed that the industry was considering monthly, if not longer, dosage schedules despite the life cycle.

The court rejected plaintiffs’ argument that there was a battle of the experts, and thus a genuine material dispute, over whether the prior art was generally accepted. None of plaintiffs’ experts cited a study that pre-dated the prior art showing concern over longer dosage schedules that were beyond two weeks.

Lastly, the court rejected plaintiffs’ claims of secondary consideration favoring non-obviousness. The commercial-success argument was discredited because one would not enter the market given the patent protection obtained by plaintiffs. The court also rejected plaintiffs’ long-felt-need argument, because the asserted patents were filed only two years after the closest prior art. Thus, the court found that there was no genuine issue of material fact concerning a conclusion that the asserted patents were invalid as obvious.