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

March 12, 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

This action is brought pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271 (commonly referred to as the "Hatch-Waxman Act") alleging, inter alia, infringement of United States Patent No. 5,338,874 (the " '874 patent"). Presently before the Court is a motion by Fresenius Kabi Oncology plc and Dabur Pharma Limited (together "Dabur") for summary judgment of non-infringement of claims 1 and 2 of the '874 patent. Plaintiffs SanofiAventis U.S. LLC, Sanofi-Aventis, Debiopharm, S.A. (together "Sanofi") oppose the motion and have cross-moved for summary judgment of infringement. For the reasons set forth herein, Dabur's motion for summary judgment of non-infringement is denied, and Plaintiff's cross-motion for summary judgment of infringement is granted.

I. Background*fn1

A. The '874 Patent

The '874 patent relates to a chemical compound claimed as "optically pure oxaliplatin."*fn2 See '874 patent at claim 1. Sanofi-Aventis U.S. LLC holds approved new drug application 21-492 and 21-759 for ELOXATIN, an FDA approved treatment for colorectal cancer, the active ingredient of which is oxaliplatin. Debiopharm, S.A. is owner of the '874 patent, and Sanofi-Aventis is its exclusive licensee.

The '874 patent contains two claims. The first claims "optically pure [oxaliplatin]" and sets forth the compound's chemical formula. '874 Patent, claim 1, col. 8, lines 54-64. As explained in more detail in the Court's June 18th Opinion, "optical purity" refers to the ratio of the amount of a desired enantiomer*fn3 in a compound to the amount of an undesired enantiomer in that compound. The second claim of the '874 patent refers to oxaliplatin "as claimed in claim 1" and adds the limitation of a melting point between 198o C and 292o C. Id., claim 2, col. 8, lines 65-68.

B. Defendants' Oxaliplatin Product

Dabur is a generic drug manufacturer that filed with the United States Food and Drug Administration ("FDA") Abbreviated New Drug Applications ("ANDA") 78-810 and 78-811which concern a new drug product containing oxaliplatin. Dabur submitted a Drug Master File ("DMF") to the FDA in which it described the oxaliplatin it will use in its proposed product. The DMF specifies that the level of the d-OHP enantiomer (the undesired enantiomer) in Dabur's product as being not less than 0.02% and not more than 0.10%. Declaration of Claude Hariton ("Hariton Dec."), Ex. 1. The ANDAs include the same specification for the level of the d-OHP enantiomer. Id., Exs. 2 and 3.

C. The Present Motion

As issue in the present motion is the construction of the term "optically pure" as used in claim 1 of the '874 patent. Dabur argues that the term as used in the '874 patent should be construed to mean oxaliplatin that contains no d-OHP enantiomer. Def. Brf. at 9. Should the Court adopt Dabur's construction, there appears to be no dispute between the parties that Dabur would be entitled to summary judgment of non-infringement, as it is uncontested that its oxaliplatin product contains a measurable amount of the d-OHP enantiomer.

Plaintiffs, on the other hand, propose that the claim term "optically pure" should be interpreted as oxaliplatin having an optical purity of 99.95% or better. Should the Court adopt Plaintiffs' construction, there appears to be no dispute that Plaintiffs would be entitled to summary judgment of infringement, as it is uncontested that Dabur's oxaliplatin product has an optical purity that is 99.95% or better.

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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