Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

GLAXO GROUP LIMITED v. KALI LABORATORIES

June 10, 2005.

GLAXO GROUP LIMITED, and SMITHKLINE BEECHAM CORPORATION, Plaintiffs,
v.
KALI LABORATORIES, INCORPORATED, Defendant.



The opinion of the court was delivered by: JOSE LINARES, District Judge

OPINION

INTRODUCTION

This matter is before the Court on the motion of defendant for partial summary judgment of patent invalidity under 35 U.S.C. § 102(e). The Court has considered the submissions in support of and in opposition to the motion. There was no oral argument. See Fed.R.Civ.P. 78. For the reasons set forth below, defendant's motion is DENIED.

  BACKGROUND

  This action concerns plaintiffs' patented drug ondansetron, sold under the tradename Zofran, which combats nausea and vomiting. Defendant filed an Abbreviated New Drug Application (ANDA) on September 30, 2002, seeking to sell a generic version of Zofran. This action for patent infringement ensued. There are three patents at issue: the first and second "TYERS" patents, i.e., the patents-insuit; and the "COATES" patent, which defendant contends anticipates the TYERS patents. The Court will now describe the relevant portions of these.*fn1

  In September 1987, a patent was issued to Ian H. Coates and others for certain compounds "useful in the treatment of migraine and psychotic disorders such as schizophrenia." See U.S. Patent No. 4,695,578, abstract (issued Sept. 22, 1987) [hereinafter "`578 patent" or "COATES"]. These compounds, one of which is ondansetron, are antagonists which bind with certain receptors found on nerves to block serotonin, a process which relieves migraine pain and helps treat conditions such as schizophrenia and other psychotic disorders, as well as anxiety, obesity, and mania. `578 patent, cols. 1:19-25, 4:6-21. Of central import to this motion, the COATES patent's specification states: "The compunds [sic] of the invention may, if desired, be administered in combination with one or more other therapeutic agents, such as anti-nauseants." `578 patent, col. 6:18-21.

  In June 1988, a patent was issued to Michael B. Tyers and others for certain compounds used "for the relief of nausea and vomiting. . . ." See U.S. Patent No. 4,753,789, abstract (issued June 28, 1988) [hereinafter "`789 patent" or "TYERS I"]. Ondansetron is one of these compounds, and TYERS I "relates to a new medical use" for it. `789 patent, col. 1:5. The claims at issue here are these:
1. A method of treatment for the relief of nausea and vomiting which comprises administering to a human or animal subject in need thereof an effective amount for treatment for the relief of nausea and vomiting of [ondansetron] or a physiologically acceptable salt or solvate thereof. 2. A method according to claim 1 wherein the [ondansetron] is in the form of its hydrochloride.
3. A method according to claim 1 wherein the [ondansetron] is in the form of its hydrochloride dihydrate.
`789 patent, claims 1-3.
  In November 1996, a patent was issued to Dr. Tyers and others, again for ondansetron and other compounds "for the relief of nausea and vomiting. . . ." See U.S. Patent No. 5,578,628, abstract (issued Nov. 26, 1996) [hereinafter "`628 patent" or "TYERS II"]. The only relevant claim at issue here is this:
1. A method of treatment of nausea and vomiting which comprises administering to a human or animal subject in need thereof an effective amount for the treatment of nausea and vomiting of [ondansetron].
`628 patent, claim 1.

  Defendant now moves for summary judgment, arguing that TYERS I and II are invalid. Specifically, defendant argues that the particular teaching in COATES pertaining to nausea — "The compunds [sic] of the invention may, if desired, be administered in combination with one or more other therapeutic agents, such as anti-nauseants," `578 patent, col. 6:18-21 — inherently anticipates the claimed invention set forth in TYERS I and II. "Clearly," defendant submits, "one would only administer an anti-nauseant to one suffering from nausea and vomiting. It is a natural and inevitable result that ondansetron, when administered in the amounts and in the manner disclosed by COATES, would treat such symptomatic nausea and vomiting." (Def.'s Br. at 3 (emphasis in original).) The dosages or effective amounts of ondansetron in all three patents, according to defendant, are virtually the same, and it is not in dispute that TYERS I and II merely relate to a different use of the same drug claimed in COATES. Plaintiffs oppose the motion. They argue that the teaching in COATES concerning administering ondansetron with anti-nauseants does not "necessarily" disclose all the elements of TYERS I and II, because, inter alia, not all patients taking ondansetron per COATES' teaching actually suffer from nausea. Plaintiffs contend that TYERS I and II claim valid new medical uses for ondansetron.

  DISCUSSION

  I. Summary Judgment Standard

  A party is entitled to summary judgment when it demonstrates that there is no genuine issue of material fact and that the evidence establishes its entitlement to judgment as a matter of law. Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Orson, Inc. v. Mirimax Film Corp., 79 F.3d 1358, 1366 (3d Cir. 1996). Put another way, summary judgment will be granted when the evidence on the record "is so one-sided that one party must prevail as a matter of law." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251-52 (1986).

  The movant carries the initial burden of supporting its motion, but once the movant has satisfied this burden, the opposing party must then "produce specific facts" sufficient to "create a fair doubt" over whether the movant should prevail. Jersey Cent. Power & Light Co. v. Lacey Township, 772 F.2d 1103, 1109 (3d Cir. 1985). The non-moving party cannot rest on mere allegations and must instead present actual evidence that creates a genuine issue as to a material fact for trial. Fed.R.Civ.P. 56(e); Siegel Transfer, Inc. v. Carrier Express, Inc., 54 F.3d 1125, 1130-31 (3d Cir. 1995). In considering a motion for summary judgment, the Court views all evidence in a light most ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.