Geneva Pharmaceuticals v. Glaxosmithkline

• Citation: 349 F.3d 1373
• Decision Date: 21 November 2003
• Docket Number: No. 02-1439.,02-1439.
• Parties: GENEVA PHARMACEUTICALS, INC., Plaintiff/Counterclaim Defendant-Appellee, and Novartis Ag and Biochemie GmbH, Counterclaim Defendants, and Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited, Plaintiffs/Counterclaim Defendants-Appellees, and Teva Pharmaceuticals USA, Inc., Plaintiff/Counterclaim Defendant-Appellee, v. GLAXOSMITHKLINE PLC, SmithKline Beecham Corporation (doing business as GlaxoSmithKline Inc.), SmithKline Beecham PLC, and Beecham Group PLC, Defendants/Counterclaimants-Appellants.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

349 F.3d 1373

GENEVA PHARMACEUTICALS, INC., Plaintiff/Counterclaim Defendant-Appellee, and Novartis Ag and Biochemie GmbH, Counterclaim Defendants, and Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited, Plaintiffs/Counterclaim Defendants-Appellees, and Teva Pharmaceuticals USA, Inc., Plaintiff/Counterclaim Defendant-Appellee, v. GLAXOSMITHKLINE PLC, SmithKline Beecham Corporation (doing business as GlaxoSmithKline Inc.), SmithKline Beecham PLC, and Beecham Group PLC, Defendants/Counterclaimants-Appellants.

No. 02-1439.

United States Court of Appeals, Federal Circuit.

DECIDED: November 21, 2003.

As Amended: February 26, 2003.

Dimitrios T. Drivas, White & Case, of New York, NY, argued for plaintiff-counterclaim defendants-appellees Geneva Pharmaceuticals, Inc. Of counsel was Leslie Morioka.

Joseph F. Jennings, Knobbe, Martens, Olson & Bear, of Irvine, CA, for plaintiff/counterclaim defendants-appellees. Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited. Ranbaxy relied on the brief and the argument of Teva Pharmaceuticals USA, Inc. Of counsel were William R. Zimmerman, Christy L. Green, and Darrell L. Olson.

Thomas J. Meloro, Jr., Kenyon & Kenyon, of New York, NY, argued for plaintiffs/counterclaim defendants-appellees Teva Pharmaceuticals USA, Inc. With him on the brief were Steven J. Lee, Larissa A. Soccoli, and Robert V. Cerwinski. Of counsel on the brief was C. Kyle Musgrove, Kenyon & Kenyon, of Washington, DC.

Donald R. Dunner, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for defendants/counterclaimants-appellants. With him on the brief were Kelly A. Casey and Michael J. McCabe II, Finnegan, Henderson, etc., of Atlanta, GA.

Before MAYER, Chief Judge, RADER, and BRYSON, Circuit Judges.

RADER, Circuit Judge.

The United States District Court for the Eastern District of Virginia granted summary judgment invalidating the claims of several patents for nonstatutory double patenting. Geneva Pharms., Inc. v. Glaxosmithkline, PLC, 189 F.Supp.2d 377 (E.D.Va.2002) (Geneva I); 213 F.Supp.2d 597 (E.D.Va.2002) (Geneva II); No. 2:01cv391 (E.D.Va. July 19, 2002) (Geneva III). Because the district court correctly found that these patents are invalid, this court affirms.

I.

The invalidated patents all originated in U.S. Patent Application No. 05/569,007 (the '007 application, now abandoned) filed almost thirty years ago on April 17, 1975. The United States Patent and Trademark Office (PTO) issued a restriction requirement in the '007 application, asking the applicants to choose from one of eight distinct inventions that the PTO identified by groups of claims. This action separated the applications into two branches — one leading to patents granted in 1985, the other to patents granted in 2000/01, as shown by the table below. The record shows no terminal disclaimers in any of the patents. The appendix contains a diagram of the relationships amongst the patents and their parent applications.

                ------------------------------------------------------
                    1985 Patents*                  2000/01 Patents
                ------------------------------------------------------
                4,525,352 ('352 patent)        6,031,093 ('093 patent)
                4,529,720 ('720 patent)        6,048,977 ('977 patent)
                4,560,552 ('552 patent)        6,051,703 ('703 patent)
                                               6,218,380 ('380 patent)
                ------------------------------------------------------
                * "1985" and "2000/01" refer to the patents' issue dates
                

GlaxoSmithKline, PLC, SmithKline Beecham Corporation, SmithKline Beecham PLC, and Beecham Group PLC (collectively GSK) own the 1985 and 2000/01 patents, which relate to the antibiotic clavulanic acid and its salts. One of these salts, potassium clavulanate, is an active component of a commercially successful antibiotic that GSK markets as Augmentin®. Augmentin® contains a second active component, the antibiotic amoxycillin. Amoxycillin is the primary antibiotic in Augmentin®.

Some bacteria produce β-lactamase, a compound that deactivates some antibiotics and makes them less effective against the bacteria. While potassium clavulanate has some antibiotic activity, its main function in Augmentin® is to inhibit β-lactamase. By inhibiting β-lactamase, potassium clavulanate prevents deactivation of amoxycillin in patients with bacteria producing β-lactamase. Thus, amoxycillin and potassium clavulanate act synergistically against these bacteria to generate greater antibiotic activity.

The following are representative claims of the 1985 and 2000/01 patents:

The '352 patent (issued June 25, 1985):

1. A pharmaceutical composition useful for treating bacterial infections in humans and animals which comprises a synergistically effective amount of clavulanic acid and an antibacterially effective amount of amoxycillin, in combination with a pharmaceutically acceptable carrier.

The '720 patent (issued July 16, 1985):

1. A method of effecting β-lactamase inhibition in a human or animal in need thereof arising from a β-lactamase producing bacteria which comprises administering to said human or animal a β-lactamase inhibitory amount of clavulanic acid or a pharmaceutically acceptable salt thereof.

The '552 patent (issued Dec. 24, 1985):

1. A pharmaceutical composition for treating bacterial infections in humans and animals which comprises a synergistically effective amount of clavulanic acid, or a pharmaceutically acceptable salt thereof, and an antibacterially effective amount of a penicillin, or a pharmaceutically acceptable salt or ester thereof.

The '093 patent (issued Feb. 29, 2000):

1. A solid pharmaceutically acceptable salt of clavulanic acid.

The '977 patent (issued Apr. 11, 2000):

1. Clavulanic acid free of penicillin N,7-(5-amino-5-carboxyvaleramido)-3-carbamoyloxymethyl-3-cephem-4 — carboxylic acid and 7-(5-amino-5-carboxyvaleramido)-3-carbamoyloxymethyl-7-methoxy-3-cephem-4-carboxylic acid.

The '703 patent (issued Apr. 18, 2000):

1. Purified clavulanic acid.

7. A β-lactamase inhibitor comprising purified clavulanic acid or a pharmaceutically acceptable salt thereof.

The '380 patent (issued Apr. 17, 2001):

1. A pharmaceutical composition useful for effecting β-lactamase inhibition in humans and animals which comprises β-lactamase inhibitory amount of a pharmaceutically acceptable salt of clavulanic acid, in combination with a pharmaceutically acceptable carrier.

The appellees (collectively Geneva) are generic drug makers seeking to market generic versions of Augmentin®. Geneva applied for regulatory approval to market this compound from the Food and Drug Administration (FDA). See 21 U.S.C. § 355 (2000). That application for FDA approval constitutes infringement. See 35 U.S.C. § 271(e)(2) (2000). Thus the generic pharmaceutical companies initiated three separate lawsuits, later consolidated into this case, seeking a declaratory judgment that the 1985 and 2000/01 patents are invalid.

On February 22, 2002, a magistrate judge limited discovery in the consolidated case to the contents of Geneva's Abbreviated New Drug Applications (ANDAs). In Geneva I, the district court granted GSK's motion for partial summary judgment that the '552 patent is not invalid for nonstatutory double patenting over the '352 patent, and granted Geneva's motion for partial summary judgment that the '380 patent is invalid for nonstatutory double patenting over the '720 patent. In reaching this result, the district court found that a 1979 examiner interview (1979 interview) in the '007 application did not show that the PTO issued a restriction requirement. Therefore, 35 U.S.C. § 121 would not shield the '380 patent against invalidity over the '720 patent.

In Geneva II, the district court granted Geneva's motion for partial summary judgment that the '093, '977, and '703 patents are invalid for nonstatutory double patenting over the '720 patent. The district court concluded that the 1979 interview summary did not require the applicant to file separate patents for the relevant claims. Because the applicant could have avoided the multiple filings, the district court applied the one-way obviousness test. Accordingly, the district court ruled that the '093, '977, and '703 patents' claims are not patentably distinct from the '720 patent's claims and are thus invalid for nonstatutory double patenting.

In Geneva III, the district court ruled that the '552 and '352 patents are invalid for nonstatutory double patenting over U.S. Patent No. 4,441,609 (Crowley patent), and that the '720 patent is invalid for nonstatutory double patenting over U.S. Patent No. 4,367,175 (Fleming patent). GSK owns the Crowley and Fleming patents because GSK has merged with the original assignees of those patents, Beecham Group, Ltd. and Glaxo Laboratories, Inc. The district court heard testimony from three experts, Drs. Sanders and Benet for Geneva, and Dr. Schofield for GSK. In reaching its obviousness ruling, the district court found that Geneva's experts were more credible than GSK's expert.

GSK timely appealed the discovery order and the three decisions to this court, which has jurisdiction under 28 U.S.C. § 1295(a)(1) (2000). On appeal, GSK contends that the district court erred in Geneva I and Geneva II because 35 U.S.C. § 121 should shield the 2000/01 patents against nonstatutory double patenting over the '720 patent. GSK contends that the district court erred in Geneva III because application of double patenting in light of the Crowley and Fleming patents should not render the '352, '552, and '720 patents invalid. GSK also contends that the district court abused its discretion by limiting discovery to the ANDAs.

II.

This court reviews a grant of summary judgment without deference. Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1327 (Fed.Cir.2001). A court considering summary judgment must draw all reasonable inferences in favor of the nonmovant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106...