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