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Sanofi-Aventis U.S. LLC. v. Sandoz

March 18, 2010

SANOFI-AVENTIS U.S. LLC., ET AL., PLAINTIFFS,
v.
SANDOZ, INC, DEFENDANT.



The opinion of the court was delivered by: Pisano, District Judge.

OPINION

Presently before the Court are motions by Fresenius Kabi Oncology plc and Dabur Pharma Limited (together "Dabur") for summary judgment of noninfringement*fn1 of United States Patent No. 5,716,988 (the "'988 patent") and United States Patent No. 5,290,961 (the "'961 patent"). Plaintiffs Sanofi-Aventis U.S. LLC, Sanofi-Aventis, Debiopharm, S.A. (together "Sanofi") oppose both motions and have cross-moved for summary judgment of infringement as to the '961 patent. For the reasons set forth below, all of the motions are denied.

I. Background

The Court will presume the parties' familiarity with the background facts of this litigation and summarizes only the facts pertinent to the instant motions.

A. The '988 Patent

The '988 patent, which is entitled "Pharmaceutically Stable Preparation of Oxaliplatinum," concerns "pharmaceutically stable" preparations of oxaliplatin for administration parenterally. See '988 Patent, col. 1, lines 5-6. The stated objective of the '988 patent is to "obtain an injectable solution of oxaliplatinum which would be ready to use and which, furthermore, would remain pharmaceutically stable before use for an acceptable period of time according to recognized standards." '988 Patent, col. 2, lines 9-11.

Claim 4, which depends on claim 1,*fn2 reads as follows: [A pharmaceutically stable preparation of oxaliplatinum for the administration by the parenteral route, consisting of a solution of oxaliplatinum in water at a concentration of 1 to 5 mg/ml and having a pH of 4.5 to 6, the oxaliplatinum content in the preparation being at least 95% of the initial content and the solution remaining clear, colorless and free of precipitate after storage for a pharmaceutically acceptable duration of time] in the form of an aqueous solution of oxaliplatinum ready to be used and contained in a hermetically sealed container. '988 Patent, col. 5, lines 13-15. Claim 5 requires that the container "contain an active unit dose of 50 to 100 mg of oxaliplatinum, which can be administered by infusion." Id., lines 17-18. Claim 6 requires that "container is a glass vial for pharmaceutical use and is closed with a stopper of which, at least, the surface extending inside the vial is inert with respect to said solution." Id., lines 20-24.

At issue with respect to the instant motion is the use of the phrase "consisting of" in claim 1. According to Dabur, this phrase limits the invention to formulations that include only oxaliplatin and water, and Dabur asserts that the claims should be construed as being limited to "[f]ormulations that include oxaliplatin and water and that do not include any other components." Under this construction, because Dabur's oxaliplatin product contains oxaliplatin, water and sodium succinate,*fn3 which Dabur claims acts as a buffer, Dabur contends that its product does not infringe the '988 patent. Dabur Brf. 9-10.

B. The '961 Patent

The '961 patent, entitled "Platinum Compound and Process of Preparing Same," concerns a process for making oxaliplatin that includes a step for removing contaminants, resulting in oxaliplatin that is substantially free from impurities. Claim 1 of the '961 patent recites:

A process of preparing a cis-platinum (II) complex of a 1,2-cyclohexanediamine isomer designated by a general formula (I) (in the formula, the conformation of 1,2-cyclohexanediamine is cis, trans-d or trans-1-isomer, and R1 and R2 form with each other a circular group selected from the group consisting of the formulae (V), (VI), (VII), (VIII), (IX) and (X)) which comprises adding to a dihalogen compound of a cis-platinum (II) complex of a 1,2-cyclohexanediamine isomer designated by a general formula (II), wherein X is a halogen, a silver ion solution containing not less than two equivalents of silver in respect to the compound (II), removing silver chloride and/or silver bromide, adding to the solution sodium iodide and/or potassium iodide to convert the unreacted compound (II), the by-products of the compound (II) and an unreacted silver ion to their iodine compounds followed by the removal thereof and thereafter adding the corresponding organic dibasic acid of the formulae (V), (VI), (VII), (VIII), (IX) and (X) to the remaining platinum complex. '961 patent, Claim 1 (emphasis supplied). Dabur seeks summary judgment of noninfringement of claim 1, alleging that in producing its oxaliplatin product, at no point in the process does it add sodium iodide or potassium iodide as is done in the claimed invention. Sanofi has cross-moved for summary judgment of infringement, alleging not that Dabur literally infringes the '961 patent, but rather alleging that Dabur infringes under the doctrine of equivalents.

II. Analysis

A. Summary Judgment Standard

A court shall grant summary judgment under Rule 56(c) of the Federal Rules of Civil Procedure "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). The substantive law identifies which facts are critical or "material." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A material fact raises a "genuine" issue "if the evidence is such that a ...


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