University of Rochester v. G.D. Searle & Co., Inc.

• Decision Date: 13 February 2004
• Docket Number: No. 03-1304.,03-1304.
• Citation: 358 F.3d 916
• Parties: UNIVERSITY OF ROCHESTER, Plaintiff-Appellant, v. G.D. SEARLE & CO., INC., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

358 F.3d 916

UNIVERSITY OF ROCHESTER, Plaintiff-Appellant, v. G.D. SEARLE & CO., INC., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., Defendants-Appellees.

No. 03-1304.

United States Court of Appeals, Federal Circuit.

Decided February 13, 2004.

Gerald P. Dodson, Morrison & Foerster, LLP, of Palo Alto, California, argued for plaintiff-appellant. With him on the brief were Emily A. Evans, Erica D. Wilson, and Erik J. Olson. Of counsel on the brief was Jeanine Arden Ornt, Office of Counsel, University of Rochester, of Rochester, New York.

Gerald Sobel, Kaye Scholer LLP, of New York, New York, argued for defendants-appellees. With him on the brief were Richard G. Greco, Sylvia M. Becker, and Daniel L. Reisner. With him on the brief were Robert L. Baechtold, Henry J. Renk, Bruce C. Haas, and Colleen Tracy, Fitzpatrick, Cella, Harper & Scinto, of New York, New York.

Daniel J. Furniss, Townsend and Townsend and Crew LLP, of Palo Alto, California, for amici curiae The Regents of the University of California, et al. With him on the brief were Susan M. Spaeth and Madison C. Jellins.

James J. Kelley, Eli Lilly and Company, of Indianapolis, Indiana, for amicus curiae Eli Lilly and Company. With him on the brief were Steven P. Caltrider, Michael T. Bates, Robert A. Armitage, Gilbert T. Voy, and Gregory C. Cox.

Before LOURIE, BRYSON, and DYK, Circuit Judges.

LOURIE, Circuit Judge.

The University of Rochester ("Rochester") appeals from the decision of the United States District Court for the Western District of New York granting summary judgment that United States Patent 6,048,850 is invalid. Univ. of Rochester v. G.D. Searle & Co., 249 F.Supp.2d 216 (W.D.N.Y.2003). Because we conclude that the court did not err in holding the '850 patent invalid for failing to comply with the written description requirement of 35 U.S.C. § 112, ¶ 1, and in granting summary judgment on that ground, we affirm.

BACKGROUND

Traditional non-steroidal anti-inflammatory drugs ("NSAIDs") such as aspirin, ibuprofen, ketoprofen, and naproxen are believed to function by inhibiting the activity of enzymes called cyclooxygenases. Cyclooxygenases catalyze the production of a molecule called prostaglandin H₂, which is a precursor for other prostaglandins that perform various functions in the human body. Id. at 219.

In the early 1990s, scientists discovered the existence and separate functions of two distinct cyclooxygenases, referred to as "COX-1" and "COX-2."¹ COX-1 is expressed (i.e., produced biologically) in the gastrointestinal tract, where it is involved in the production of prostaglandins that serve a beneficial role by, for example, providing protection for the stomach lining. Id. COX-2 is expressed in response to inflammatory stimuli, and is thought to be responsible for the inflammation associated with diseases such as arthritis. Id. It is now known that the traditional NSAIDs inhibit both COX-1 and COX-2, and as a result they not only reduce inflammation but also can cause undesirable side effects such as stomach upset, irritation, ulcers, and bleeding. Id.

After the separate functions of COX-1 and COX-2 were discovered, it was hypothesized that it would be possible to reduce inflammation without gastrointestinal side effects if a method could be found for selectively inhibiting the activity of COX-2 (i.e., inhibiting the activity of COX-2 without inhibiting COX-1 activity). Id. To that end, Rochester scientists developed a screening assay for use in determining whether a particular drug displayed such selectivity, and filed a U.S. patent application directed to their developments in 1992. After filing a series of continuation, continuation-in-part, and divisional applications derived from that 1992 application, the scientists eventually received United States Patent 5,837,479 in 1998, covering methods "for identifying a compound that inhibits prostaglandin synthesis catalyzed by mammalian prostaglandin H synthase-2 (PGHS-2)."

From a division of the application that led to the '479 patent, the scientists also obtained, on April 11, 2000, the '850 patent. The '850 patent contains three independent claims and five dependent claims. The three independent claims read as follows:

1. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.

5. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product in a human host in need of such treatment, wherein the activity of the non-steroidal compound does not result in significant toxic side effects in the human host.

6. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product in a human host in need of such treatment, wherein the ability of the non-steroidal compound to selectively inhibit the activity of the PGHS-2 gene product is determined by:

a) contacting a genetically engineered cell that expresses human PGHS-2, and not human PGHS-1, with the compound for 30 minutes, and exposing the cell to a pre-determined-amount of arachidonic acid;

b) contacting a genetically engineered cell that expresses human PGHS-1, and not human PGHS-2, with the compound for 30 minutes, and exposing the cell to a pre-determined amount of arachidonic acid;

c) measuring the conversion of arachidonic acid to its prostaglandin metabolite; and

d) comparing the amount of the converted arachidonic acid converted by each cell exposed to the compound to the amount of the arachidonic acid converted by control cells that were not exposed to the compound, so that the compounds that inhibit PGHS-2 and not PGHS-1 activity are identified.

'850 patent, col. 71, l. 36-col. 72, l. 51. Thus, all eight claims are directed to methods "for selectively inhibiting PGHS-2 activity in a human host" by "administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to [or in] a human host in need of such treatment."

On the day the '850 patent issued, Rochester sued G.D. Searle & Co., Inc., Monsanto Co., Pharmacia Corp., and Pfizer Inc. (collectively, "Pfizer"), alleging that Pfizer's sale of its COX-2 inhibitors Celebrex® and Bextra® for treatment of inflammation infringed the '850 patent,² and seeking injunctive and monetary relief. Univ. of Rochester, 249 F.Supp.2d at 220. In May 2002, Pfizer moved for summary judgment of invalidity of the '850 patent for failure to comply with the written description and enablement requirements of 35 U.S.C. § 112, ¶ 1. Rochester opposed the motion and filed a cross-motion for summary judgment with respect to the written description issue. Id.

In evaluating the parties' motions, the district court found that, although all of the claims require the use of a "non-steroidal compound that selectively inhibits activity of the PGHS-2 gene," the '850 patent neither discloses any such compound nor provides any suggestion as to how such a compound could be made or otherwise obtained other than by trial-and-error research. Id. at 224-25, 228-29. Indeed, the court found no evidence in the '850 patent that the inventors themselves knew of any such compound at the time their patent application was filed. Id. at 228. Accordingly, the court concluded that the patent's claims are invalid for lack of written description. Id. at 224.

The district court also found that practice of the claimed methods would require "a person of ordinary skill in the art ... to engage in undue experimentation, with no assurance of success," and on that basis concluded that the claims are also invalid for lack of enablement. Id. at 232. The court considered, but rejected as conclusory, Rochester's experts' opinions that one of skill in the art would have known to start with existing NSAIDs and would have used routine methods to make structural changes to lead compounds to optimize them, citing a general failure to point to any language in the patent supporting those opinions. Id. at 233.

Finding no genuine issue of material fact concerning either written description or enablement, the district court accordingly granted Pfizer's motions for summary judgment of invalidity of the '850 patent for failure to meet the written description and enablement requirements, denied Rochester's cross-motion, and dismissed the complaint. Id. at 235-36.

Rochester now appeals. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

Rochester asserts three grounds of error on appeal. First, it argues that the district court erred by granting Pfizer's motion for summary judgment of invalidity for lack of written description. Second, it argues that the court erred by granting Pfizer's motion for summary judgment of invalidity for lack of enablement. Third, Rochester contends that the court erred by denying its cross-motion for summary judgment with regard to written description. Pfizer refutes each of those asserted grounds of error.

Summary judgment is appropriate when there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1353 (Fed.Cir.1998). We review a district court's grant of summary judgment de novo, reapplying the summary judgment standard. Conroy v. Reebok Int'l, 14 F.3d 1570, 1575 (Fed. Cir.1994). In contrast, "when a district court denies summary judgment, we review that decision with considerable deference to the court," and "will not disturb the trial court's denial ... unless we find that the court has indeed abused its discretion in so denying." SunTiger, Inc. v. Scientific Research Funding Group, 189 F.3d 1327, 1333 (Fed.Cir.1999). Addit...