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Pfizer Inc. v. Teva Pharmaceuticals USA

October 25, 2006

PFIZER INC., PHARMACIA CORP., PHARMACIA & UPJOHN INC., PHARMACIA & UPJOHN COMPANY, G.D. SEARLE & CO, G.D. SEARLE LLC, SEARLE LLC DELAWARE AND SEARLE LLC (NEVADA) PLAINTIFFS,
v.
TEVA PHARMACEUTICALS USA, INC. DEFENDANT.



The opinion of the court was delivered by: Lifland, District Judge

OPINION

Teva's In Limine Motion No. 1

This case arises out of Teva Pharmaceuticals U.S.A., Inc.'s ("Teva" or "Defendant") alleged infringement of U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068 (the "patents-in-suit"), which are held by Pfizer, Inc., Pharmacia Corp., Pharmacia & Upjohn Inc., Pharmacia & Upjohn Company, G.D. Searle & Co., G.D. Searle LLC, Searle LLC (Delaware), and Searle LLC (Nevada) (collectively "Pfizer" or "Plaintiffs"). The patents-in-suit are directed toward celecoxib, the active ingredient in Celebrex, and a broad genus of compounds that includes celecoxib, pharmaceutical compositions including such compounds, and methods of using such compounds.

Before the Court is Teva's in limine motion No. 1, which contains three separate but related arguments. The Court rendered a decision on Teva's first argument in an Opinion and Order dated October 13, 2006. This Opinion deals exclusively with Teva's second and third arguments, both of which involve Pfizer's intention to submit evidence aimed at disqualifying the Merck U.S. patent No. 5,474,995 (the "Merck '995 patent") as a prior art reference.

Since fairly early in this litigation, Teva has indicated that it plans to rely on the Merck '995 patent as a prior art reference to demonstrate the obviousness of the patents-in-suit. Based on the general information the parties have provided to the Court thus far, Teva's theory of obviousness (in somewhat simplified terms) seems to be that a hypothetical person with ordinary skill in the relevant art could construct a hypothetical pharmacophore based on the Merck '995 patent and the Fujisawa European application No. 055, 829 (the "Fujisawa '829 application"), and then use the Fujisawa '829 application to select twelve compounds embraced by the pharmacophore, including celecoxib.

In a September 8, 2006 draft of the Pre-Trial Order ("PTO"), Pfizer indicated for the first time that it planned to argue that the Merck '995 patent should not be considered prior art. In the next draft of the PTO, dated September 15, 2006, Pfizer expanded on this idea. Pfizer wrote:

1. Pfizer conceived of and synthesized numerous diphenyl heterocycle compounds, including compounds containing either a paramethylsulfonyl [or] para-sulfamyl on a phynel ring prior to June 24, 1993, and worked with reasonable diligence continuously until filing for patent protection; and

2. The Merck '995 patent is not entitled to the June 24, 1993 filing date of the Merck '196 application because the applicant added substantial new matter required to support the claims that issued in the '995 patent. (Declaration of Michael E. Patunas in Support of Teva's Motion in Limine No. 1 (hereinafter, "Petunas Decl."), Ex. G.)

Teva sent a letter to Pfizer seeking more information on these positions. In its September 28, 2006 response to Teva's request, Pfizer indicated that the Merck '995 patent should be disqualified because Pfizer "was in prior possession of compounds sufficient (under Teva's reasoning) to put it in possession of the alleged pharmacophore" prior to the earliest possible filing date for the Merck '995 patent. With respect to its second argument, Pfizer declared its intent to argue that the Merck '995 patent is not entitled to the June 24, 1993 filing date of the Merck application serial number 08/082,186 (the "Merck '196 application") because the Merck '196 application does not enable the claims of the Merck '995 patent and/or does not provide adequate written description support for those claims under 35 U.S.C. § 112. (See Id., Ex. C.)

In the instant motion, Teva argues that Pfizer should be precluded from offering evidence in support of these arguments.

I.

Pfizer's first argument-as articulated in the September 15 draft of the PTO and the September 28 letter to Teva-was essentially as follows. The earliest possible filing date for the Merck '995 patent is June 24, 1993.*fn1 By that date, Pfizer had already invented compounds "sufficient to teach" the hypothetical pharmacophone, which Teva asserts was obvious based on the Merck '995 patent. The Merck '995 patent, Pfizer concluded, should therefore be disqualified as a prior art reference.

In its opposition papers to the instant motion, however, Pfizer appears to have altered its position. Pfizer now argues that both the Merck '995 patent and the Fujisawa '829 application should be disqualified as prior art references. Specifically, Pfizer now claims that by June 24, 1993, Pfizer "had recognized at least as much about potentially GI-sparing [Non Steroidal Anti-Inflammatory Drugs] as was disclosed by the combination of the '995 patent and the '829 application," and had invented numerous compounds that-under Teva's obviousness reasoning-would render the patents-in-suit obvious. (Pfizer's Opposition to Teva's in Limine Motion No. 1, at 8 (emphasis added).)

Teva argues that the Court should preclude Pfizer from offering evidence regarding prior possession of sufficient information to disqualify the Merck '995 patent (the "prior possession argument") because: (1) Pfizer's late disclosure of its prior possession argument will cause Teva to suffer "great prejudice" ; (2) the evidence in support of the argument is irrelevant; and (3) the evidence is insufficient to demonstrate that Pfizer was, in fact, in ...


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