Pharmacia Corp. v. Par Pharmaceutical, Inc., 04-1478

• Decision Date: 10 August 2005
• Docket Number: 04-1496.,No. 04-1478,04-1478
• Citation: 417 F.3d 1369
• Parties: PHARMACIA CORPORATION, Pharmacia AB, Pharmacia Enterprises S.A., and Pharmacia & Upjohn Company, Plaintiffs-Cross Appellants, and The Trustees of Columbia University in the City of New York, Plaintiff, v. PAR PHARMACEUTICAL, INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

417 F.3d 1369

PHARMACIA CORPORATION, Pharmacia AB, Pharmacia Enterprises S.A., and Pharmacia & Upjohn Company, Plaintiffs-Cross Appellants, and The Trustees of Columbia University in the City of New York, Plaintiff, v. PAR PHARMACEUTICAL, INC., Defendant-Appellant.

Nos. 04-1478, 04-1496.

United States Court of Appeals, Federal Circuit.

August 10, 2005.

Jack B. Blumenfeld, Morris, Nichols, Arsht & Tunnell, of Wilmington, Delaware, argued for plaintiffs-cross appellants. With him on the brief were Maryellen Noreika, Rodger D. Smith, II, and Leslie A. Polizoti. Of counsel on the brief was Robert D. Rhoad, Dechert LLP, of Princeton, New Jersey.

Glenn J. Pfadenhauer, Williams & Connolly LLP, of Washington, DC, argued for defendant-appellant. With him on the brief were John G. Kester and Jessamyn S. Berniker. Of counsel was Aaron P. Maurer.

Before RADER, SCHALL, and LINN, Circuit Judges.

RADER, Circuit Judge.

Par Pharmaceutical, Inc. (Par) filed Abbreviated New Drug Application (ANDA) No. 76-218, seeking approval to market and sell a generic version of a glaucoma medication called Xalatan. Because the United States District Court for the District of New Jersey did not abuse its discretion in finding only U.S. Patent No. 5,422,368 (the '368 patent) unenforceable due to inequitable conduct, this court affirms.

I.

Glaucoma is a chronic disease manifested by an increased fluid pressure in the eye, known as intraocular pressure. Treatments include topical medications, oral medications and surgery. Xalatan treats glaucoma by topical application. The United States Food & Drug Administration's (FDA) "Orange Book," a register that provides notice of patents covering name brand drugs, shows that multiple patents cover Xalatan. Two of these patents, U.S. Patent No. 5,296,504 (the '504 patent) and the '368 patent, are collectively owned by Pharmacia Corp., Pharmacia AB, Pharmacia Enterprises S.A. and Pharmacia & Upjohn Co. (Pharmacia).

Under requirements for an ANDA, Par notified Pharmacia on November 6, 2001 of its intent to seek to market a generic version of Xalatan. In response to this notice, Pharmacia filed suit on December 21, 2001 in the U.S. District Court for the District of New Jersey, alleging infringement by virtue of Par's ANDA submission.¹

At trial, Par admitted infringement of the '368 and '504 patents, and did not assert any invalidity defenses based on prior art or 35 U.S.C. § 112. Instead, Par asserted that inequitable conduct rendered the patents unenforceable. Specifically, Par alleged that the patent applicants issued a declaration and terminal disclaimer during prosecution of the '368 patent with an intent to deceive the Patent Office on a point of material significance. After a bench trial, the district court found only the '368 patent unenforceable due to inequitable conduct. Thus, the '504 patent remained enforceable. Pharmacia Corp. v. Par Pharm., Inc., No. 01-6011 (D.N.J. July 6, 2004) (Final Judgment). As noted, Par had conceded that it infringed the '504 patent. Thus, the district court entered judgment for Pharmacia on the '504 patent and for Par on the '368 patent. Id., slip op. at 59. This appeal followed.

II.

The '368 patent and the '504 patent are siblings, filed simultaneously on December 8, 1992 as continuations of U.S. Patent Application No. 07/469,442 (the '442 application)....