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GLAXO WELLCOME, INC. v. IMPAX LABORATORIES

August 21, 2002

GLAXO WELLCOME, INC., PLAINTIFF,
V.
IMPAX LABORATORIES, INC., DEFENDANT.



The opinion of the court was delivered by: Patel, Chief Judge.

MEMORANDUM AND ORDER

On September 28, 2000, Glaxo Wellcome, Inc. filed this patent infringement action against IMPAX Laboratories, Inc. Plaintiff seeks preliminary and final injunctions enjoining further infringement. Now before the court is defendant's motion for summary judgment and plaintiffs motion for sua sponte summary judgment. Having considered the parties' arguments and for the reasons set forth below, the court enters the following memorandum and order.

BACKGROUND

Plaintiff Glaxo Wellcome ("Glaxo") is a pharmaceutical company based in Research Triangle Park, North Carolina. Glaxo is the owner of U.S. Patent No. 4,523,798 ("the '798 patent") covering sustained release Wellbutrin® and Zyban®, bupropion hydrochloride tablets marketed to treat depression and aid smoking cessation. Glaxo has marketed an instant release form of these products since 1989. The '798 patent was awarded, however, in recognition of the sustained-release element (hydroxypropyl methylcellulose, "HPMC") that Glaxo had added to the formulas, allowing users to reduce daily intake to two tablets.

1. A controlled sustained release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose [HPMC], the amount of hydroxypropyl methylcellulose to one part of bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to volume ratio of 3:1 to 25:1 cm -1 and said tablet having a shelf life of at least one year at 59 degrees to 77 F. and 35 to 60% relative humidity[.], said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent in 8 hours.
14. A controlled sustained release tablet comprising an admixture of 100 mg of bupropion hydrochloride and hydroxypropyl methylcellulose [and means for providing a shelf life of at least one year and] which after oral administration of a single one of said tablets in adult men produces plasma levels of bupropion as free base ranging [substantially] between the minimum and maximum levels as shown in Fig. 5 over twenty four hours.
18. A sustained release tablet containing a mixture of (a) 100 mg of bupropion hydrochloride and (b) means for releasing between about 25 and 45% of bupropion hydrochloride in one hour, between 60 and 85% in 4 hours and not less than 80% in eight hours in distilled water said means comprising hydroxypropyl methylcellulose.

Defendant IMPAX, a manufacturer of generic pharmaceuticals based in Hayward, California, has submitted an Abbreviated New Drug Application ("ANDA") to authorize release of generic versions of Wellbutrin® and Zyban®. The generic product does not contain HPMC. Rather, the IMPAX product uses hydroxypropyl cellulose ("HPC") as the extended drug-release agent. Like HPMC, HPC is a popular stabilizing and suspending agent in pharmaceuticals. See Berman Dec., Exhs. 2 & 4 (excerpts from the Handbook of Pharmaceutical Excipients). The substitution of HPC for HPMC appears to be the sole distinction between the two products. All active ingredients and other properties are identical. See Lowman Dec. ¶¶ 11-16.

Plaintiff filed suit on September 28, 2000, alleging that defendant's generic product is substantially equivalent to the '798 patent, and is consequently unallowable under United States patent laws, 35 U.S.C. § 271 et seq. and 21 U.S.C. § 355. Defendant moves for summary judgment dismissing plaintiffs action as a matter of law. Plaintiff also moves this court for sua sponte summary judgment. These motions are now before the court.

LEGAL STANDARD

Summary judgment shall be granted when there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(c). The moving party bears the initial burden of identifying those portions of the record that demonstrate the absence of a genuine issue of material fact. The burden then shifts to the nonmoving party to "go beyond the pleadings, and by her own affidavits, or by the `depositions, answers to interrogatories, and admissions on file,' designate `specific facts showing that there is a genuine issue for trial.'" Celotex Corp. v. Catrett, 477 U.S. 317, 324, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (citations omitted). A dispute about a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The moving party discharges its burden by showing that the nonmoving party has not disclosed the existence of any "significant probative evidence tending to support the complaint." First Nat'l Bank v. Cities Serv. Co., 391 U.S. 253, 290, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968). The court does not make credibility determinations in considering a motion for summary judgment. See Anderson, 477 U.S. at 249, 106 S.Ct. 2505. Rather, it views the inferences drawn from the facts in the light most favorable to the party opposing the motion. See T.W. Elec. Serv., Inc. v. Pacific Elec. Contractor's Ass'n, 809 F.2d 626, 631 (9th Cir. 1987).

The same standard is applied by the Federal Circuit. See, e.g., Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed.Cir. 1995); Barmag Barmer Maschinenfabrik AG v. Murata Machinery, Ltd., 731 F.2d 831, 835 (Fed.Cir. 1984). Summary judgment is not uncommon in patent actions. See e.g., Wang Lab. v. Mitsubishi Elec. Am., Inc., 103 F.3d 1571 (Fed.Cir. 1997) (prosecution history estoppel precluded finding of infringement); Mark I Mktg. Corp. v. ...


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