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Pfizer Inc. v. Teva Pharmaceuticals USA

November 3, 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. 4

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. 4 to preclude evidence that Vioxx (Refocoxib) and Searle internal compounds are proper comparisons to Celebrex.

"One way for a patent [owner] to rebut a prima facie case of obviousness is to make a showing of 'unexpected results,' i.e. to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected." In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). Pfizer has stated its intention to submit evidence demonstrating the unexpected superiority of Celebrex to another non-steroidal anti-inflammatory drug, Vioxx (and its active ingredient refocoxib), and to internal compounds created by G.D. Searle & Co. (the patentee), SC-58125 and SC-58236.

Neither party has explained the nature of the alleged unexpected results, but that is not the issue in this motion. The issue is whether Vioxx and the internal compounds are proper comparators for the purpose of an unexpected results inquiry. Specifically, Teva seeks to preclude the unexpected results evidence on the ground that these products are not prior art. Teva relies on the principle that "when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art." In re Baxter Travenol Labs, 952 F.2d 388, 392 (Fed. Cir. 1991) (emphasis added); see also, e.g., Novozymes A/S v. Genencor Int'l, Inc., 2006 U.S. Dist. LEXIS 60145, 62-63 (D. Del. 2006) ("Such results must be unexpected as compared to the closest prior art.").

I. The Searle Internal Compounds

With respect to the Searle internal compounds, Pfizer's argument that the comparison to Celebrex is appropriate is twofold. First, Pfizer argues that one of the compounds-SC-58125-is prior art. Second, Pfizer contends that it can rely on comparisons to both internal compounds (even if SC-58125 is not prior art) because a direct comparison with the prior art is unnecessary, and the compounds are "as close or closer in structure to celecoxib than any of the compounds which are argued by Teva to be the closest prior art." (Pfizer's Opposition to Defendant's Motion in Limine No. 4, at 4.)

A. Prior Art Status of SC-58125

Pfizer claims that SC-58125 constitutes prior art under 35 U.S.C. § 102(g).*fn1 Section 102(g) defines prior art that may be used to demonstrate that an invention lacks novelty: "A person shall be entitled to a patent unless . . . before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it." 35 U.S.C. § 102(g)(2). According to Pfizer, SC-58125 qualifies as prior art under this section because it was synthesized months before the invention of the patent in suit by Dr. Len F. Lee, who was not an inventor of the patents-in-suit, and who did not abandon, suppress, or conceal it. In support of the factual allegation that SC-58125 was synthesized in February 1993, Pfizer cites only the following sentence from the expert report of Dr. Galbraith: "Based on my review of lab notebooks of Monsanto and G.D. Searle & Co. . . . , I understand that in February 1993, Dr. Len F. Lee synthesized a compound called SC-58125." (Declaration of Daniel Reisner in Support of Pfizer's Opposition to Teva's Motions in Limine Nos. 1-7 (hereinafter, "Reisner Decl."), Ex. 14, ¶ 10.)

If this is the only evidence bearing on the issue of SC-58125's status as prior art, the Court would conclude that the compound meets the requirements to qualify as prior art under § 102(g). Accordingly, Teva's motion to preclude comparisons of Celebrex with SC-58125 would be denied. However, the Court will revisit this decision at trial if Pfizer is unable to establish all of the § 102(g) requirements at trial-i.e. if Pfizer does not show that the compound was conceived and reduced to practice prior to the invention date of the patents-in-suit, and that the compound was not abandoned, suppressed, or concealed.

B. Indirect Comparison With SC-58236

Pfizer does not allege that SC-58236 is prior art. Pfizer argues that it is nevertheless appropriate to rely on comparisons between Celebrex and SC-58236 because direct comparison with the prior art is unnecessary, and the compound is structurally closer to celecoxib than any of the compounds which are argued by Teva to be the closest prior art.*fn2

The predecessor to the Federal Circuit has held that a direct comparison with the closest prior art is unnecessary, and has sanctioned the use of "indirect comparisons." See In re Merchant, 575 F.2d 865, 869 n.8 (C.C.P.A. 1978) (sanctioning the use of indirect comparisons); In re Fouche, 439 F.2d 1237, 1241 (C.C.P.A. 1971). These indirect comparisons take the following form: (A), the claimed invention, is unexpectedly superior to (B), which is not prior art. (B) is superior to (C), which is prior art. In this situation, courts have found that evidence comparing (A) to ...


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