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PFIZER, INC. v. MYLAN LABORATORIES

November 2, 2005.

PFIZER, INC., Plaintiff and Counterclaim Defendant,
v.
MYLAN LABORATORIES, INC. and MYLAN PHARMACEUTICALS, INC., Defendant and Counterclaim Plaintiffs.



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 be denied.

BACKGROUND

  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, 1989.

  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 besylate.

  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 Pfizer.*fn4

  At issue in the instant motion for partial summary judgment is the validity of the '909 patent.

  STANDARD OF REVIEW

  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 ...


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