Dey, L.P. v. Teva Parental Medicines, Inc.

Case Name: Dey, L.P. v. Teva Parental Medicines, Inc., Civ. No.1:09–cv-87, 2013 U.S. Dist. LEXIS 101500 (N.D.W.V. July 17, 2013) (Keeley, J.)

Drug Product and Patent(s)-in-Suit: Perforomist® (formoterol); U.S. Patent Nos. 6,667,344 (“the ’344 patent”), 6,814,953 (“the ’953 patent”), 7,348,362 (“the ’362 patent”), and 7,462,645 (“the ’645 patent”)

Nature of the Case and Issue(s) Presented: After claim construction, Plaintiffs moved for summary judgment that Teva’s ANDA product infringed at least two claims of the ‘344 patent. Teva argued that there was a genuine issue of material fact that at least two claim elements were not present in its proposed ANDA product.

First, Teva argued that the formoterol fumerate solution in its proposed ANDA product, when not covered to prevent exposure to sunlight, degraded such that it was not “stable during long-term storage.” Teva argued that the claim construction for this term required the pharmaceutical composition to have a stable shelf life. Plaintiffs argued that the claim construction provided no such requirement, and that the specification did not teach exposure to sunlight as part of the meaning of “stable during long-term storage.”

Second, Teva argued that plaintiffs were bound to the construction of the term “label” that was made in another proceeding. Because plaintiffs litigated a claim construction and lost, issue preclusion should apply and hold plaintiffs to the construction determined in the other litigation. Plaintiffs argued that issue preclusion should not apply because the construction of the term “label” in the present litigation was not disputed. Further, the other litigation ended in a consent judgment, which cannot form the basis for issue preclusion.

The district court granted plaintiffs’ motion for summary judgment that Teva’s proposed ANDA product will infringe two claims of the ’344 patent.

Why Plaintiffs Prevailed: The court rejected Teva’s first argument as an attempt to read in a limitation that was not present in the claim construction of “stable for long-term storage.” Moreover, the claim did not address photostability, so reading that limitation into the claim would be improper. The court noted that Teva appeared to be resurrecting an argument that the court had already rejected during claim construction.

The court also rejected Teva’s issue preclusion argument because Teva was not able to show the necessary elements. In particular, Teva was unable to prove that the issue had previously been litigated, that the issue was critical and necessary, and that there was a judgment in the prior proceeding. The court focused on the fact that the construction for the term “label” had been stipulated to by Dey and Teva. Moreover, the court construed the term more than one year before the construction in the other litigation. Nevertheless, the court found that Teva’s ANDA product satisfied this limitation under the either construction.