The opinion of the court was delivered by: TERRENCE McVERRY, District Judge
MEMORANDUM OPINION AND ORDER OF COURT
Presently before the Court for disposition is the MOTION FOR
PARTIAL SUMMARY JUDGMENT ON INVALIDITY OF CLAIMS 1-11 OF U.S.
PATENT NO. 4,572,909, with brief in support filed by Defendants
Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc.
(collectively referred to as "Mylan") (Document Nos. 78 and
79), the Memorandum in Opposition filed by Pfizer, Inc.
(Document No. 106), and the Reply Brief filed by Mylan (Sealed
Document No. 118). For the reasons that follow, the Motion will
Plaintiff Pfizer, Inc. ("Pfizer") is a pharmaceutical company
whose two patents cover an amlodipine besylate product sold under
the trade name, Norvasc®. The active chemical compound in
Norvasc® is amlodipine, a compound of the class known as
1,4-dihydropyridines. The amlodipine compound in Norvasc® is a
salt, amlodipine besylate.
Amlodipine is protected by United States Patent No. 4,572,909
("the '909 patent"), which covers a genus of compounds, including
a specific claim (claim 8) to amlodipine, pharmaceutical formulations of the claimed compounds, and methods
of treating humans for cardiovascular disease by administering
the claimed compounds. The application for the '909 patent was
filed originally on March 11, 1982, in Great Britain by Pfizer's
British subsidiary. On February 3, 1983, the parent application
for the '909 patent was filed in the United States claiming the
UK filing date of March 11, 1982, as its priority date under
35 U.S.C. § 119. On February 3, 1984, a continuation-in-part
application was filed in the United States, and that application
issued as the '909 patent on February 26, 1986.
The second patented invention utilized in Norvasc® is the
besylate salt of amlodipine, and specific pharmaceutical
formulations of the besylate salt of amlodipine. Amlodipine
besyalte salt is protected by United States Patent No. 4,879,303
("the '303 patent"). A patent application for amlodipine besylate
salt was filed in the UK on April 4, 1986, and filed in the
United States on March 25, 1987. A continuation application was
filed on October 13, 1988, and the patent issued on November 7,
Pursuant to the Patent Term Restoration Act, 35 U.S.C. § 156,
the term of the '909 patent was extended by the Patent and
Trademark Office ("PTO") to July 31, 2006, to restore the time
lost from the patent term while the drug was undergoing FDA
trials and approval. In addition, pursuant to 21 U.S.C. § 355(a),
Pfizer conducted pediatric trials and Norvasc® was awarded six
months "pediatric exclusivity." Thus, the expiration date of the
'909 patent is January 31, 2007. Due to a similar six-month
pediatric exclusivity period, the '303 patent will expire on
September 28, 2007.
On May 22, 2002, Mylan filed an Abbreviated New Drug
Application ("ANDA") in which it sought approval to sell generic
amlodipine besylate. By letter dated July 23, 2002, Mylan certified pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4)
(hereinafter referred to as a "paragraph IV certification") that
it was seeking approval to market its generic copy of Norvasc®
prior to the expiration of the '909 and '303 patents. The
application stated that to the best of Mylan's knowledge neither
the '909 nor the '303 patents would be infringed by the
manufacture, use or sale of the proposed generic amlodipine
On September 20, 2002, Pfizer filed this patent infringement
action pursuant to 35 U.S.C. § 271(e), which makes it an act of
infringement to file an ANDA for a drug claimed in a patent.
Mylan's defenses and counterclaims include, inter alia, the
allegation that the '909 patent is invalid based on double
patenting. Specifically, Mylan claims that certain claims of the
'909 patent are invalid for double-patenting over U.S. Patent
4,430,333 (the "'333 patent"), an earlier patent issued to
At issue in the instant motion for partial summary judgment is
the validity of the '909 patent.
The general standard for summary judgment applies in a patent
case. See Brown v. 3M, 265 F.3d 1349, 1350 (Fed. Cir. 2001)
(general summary judgment standard applies to invalidity).
Accordingly, the burden is on the moving party to establish that
there are no genuine issues of material fact in dispute and that
it is entitled to judgment as a matter of law. See
Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256
(1986). A court must grant summary judgment if the pleadings, depositions,
answers to interrogatories, and admissions on file, together with
affidavits, if any, show that there is no genuine issue as to any
material fact. Celotex Corp v. Catrett, 477 U.S. 317, 325
(1986). A dispute regarding a material fact is genuine "if the
evidence is such that a reasonable jury could return a verdict
for the nonmoving party." Anderson, 477 U.S. at 248.
When a party challenges a patent's validity, the court begins
with the statutory presumption of validity. 35 U.S.C. § 282 ("A
patent shall be presumed valid."). Accordingly, "the burden of
establishing invalidity of a patent or any claim thereof shall
rest on the party asserting such invalidity." Id. Invalidity
must be shown by clear and convincing evidence. Robotic Vision
Sys. v. View Eng'g, Inc., 189 F.3d 1370, 1377 (Fed. Cir. 1999).
This presumption of validity is never weakened, and the burden of
proving invalidity does not shift from the party asserting
invalidity. Imperial Chemical Industries, PLC v. Danbury
Pharmacal, Inc., 745 F. Supp. 998, 1004 (D. Del. 1990) (citing
ACS Hospital Systems, Inc. v. Montefiore Hospital,
732 F.2d 1572, 1574-75 (Fed. Cir. 1984) (other citations omitted)). The
burden of going forward with evidence rebutting invalidity may
shift to the patentee only after the party asserting invalidity
has demonstrated a legally sufficient prima facie case of
invalidity. Ashland Oil, Inc. v. Delta Resins & Refractories,
Inc., 776 F.2d 281, 291 (Fed. Cir. 1985). If the party ...