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Sanofi-Aventis v. Barr Laboratories

February 20, 2009

SANOFI-AVENTIS, SANOFI-AVENTIS U.S. LLC, PLAINTIFF,
v.
BARR LABORATORIES, INC., ET AL. DEFENDANTS.



The opinion of the court was delivered by: Mark Falk United States Magistrate Judge

OPINION

This matter comes before the Court by way of Defendants' request for leave to submit a reply expert report limited to the issue of secondary considerations of non-obviousness raised by Plaintiff in its rebuttal expert report on invalidity. The Court has considered the parties submissions on the matter, namely Defendants' letter dated December 23, 2008 and Plaintiff's letter dated January 14, 2009.*fn1 No oral argument was heard. Fed. R. Civ. P. 78. For the reasons that follow, Defendants' request is denied without prejudice.

BACKGROUND

A. The '531 Patent -- Ambien CR(r)

Sanofi-Aventis, Sanofi-Aventis U.S., LLC ("Sanofi-Aventis" or "Plaintiff") is the owner of Untied States Patent No. 6,514,531 ("the '531 patent"). The '531 patent discloses a pharmaceutical controlled-release dosage form adapted to release zolpidem or a salt thereof over a predetermined time period. Ambien CR(r) is an embodiment of the '531 patent. Ambien CR(r) was approved by the Food and Drug Administration ("FDA") on September 2, 2005 for the treatment of insomnia.

B. Defendants Seek FDA Approval for Generic Version of Ambien CR(r)

Defendants, Barr Laboratories, Inc., Mutual Pharmaceutical Co., and Sandoz, Inc. ("Defendants") each respectively filed an Abbreviated New Drug Application ("ANDA") pursuant to the Hatch-Waxman Act*fn2 seeking FDA approval to sell a generic version of the zolpidem extended-release tablets prior to the expiration of the '531 patent. Each ANDA contains a paragraph IV certification. By filing a paragraph IV certification, Defendants have each taken the position that its generic drug does not infringe the '531 patent or, in the alternative, that the '531 patent is otherwise invalid. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV).

C. Sanofi-Aventis Sues Defendants for Infringement of the '531 Patent

Sanofi-Aventis responded by filing complaints against each Defendant.*fn3 This invoked an automatic stay under the Hatch-Waxman Act which prohibits the FDA from approving the generic until the earlier of: (a) the date on which the '531 patent expires, (b) the date on which the Court enters judgment in the infringement lawsuit, or (c) thirty months from the date on which Plaintiff first received notice of Defendants' respective ANDA paragraph IV filings. See 21 U.S.C. § 355(j)(5)(B)(iii); Allergan, 324 F.3d at 1327.*fn4

D. Expert Discovery

Expert discovery is scheduled to remain open through August 17, 2009. The Court has directed that all expert reports for the issues on which a party bears the burden of proof are due on April 15, 2009 and that all rebuttal expert reports are due on June 17, 2009. See CM/ECF Docket Entry No. 32. By way of letter to the Court dated December 23, 2008, Defendants request leave to submit a reply expert report on secondary considerations of non-obviousness. The Court now considers Defendants' request.

LEGAL STANDARD

Federal Rule of Civil Procedure 26(a)(2) ("Disclosure of Expert Testimony") provides that "a party must disclose to the other parties the identity of any witness it may use at trial." Fed. R. Civ. P. 26(a)(2)(A). This disclosure, unless otherwise stipulated or ordered by the court, "must be accompanied by a written report . . . if the witness is one retained or specially employed to provide expert testimony in the case." Fed. R. Civ. P. 26(a)(2)(B). The report must contain, in pertinent part, "a complete statement of all opinions the witness will express and the basis and reasons for them." Fed. R. Civ. P. 26(a)(2)(B)(i).

"The reason for requiring expert reports is 'the elimination of unfair surprise to the opposing party and the conservation of resources.' " Reed v. Binder, 165 F.R.D. 424, 429 (D.N.J. 1996) (internal quotation omitted). Nevertheless, the Third Circuit has made clear that it is unaware of any bright line rule requiring that every opinion by an expert be preliminarily stated in their expert report. See Hill v. Reederei F. Laeisz G.M.B.H., Rostock, 435 F.3d 404, 423 (3d Cir. 2006) (allowing expert's testimony, despite the fact that it exceeded the scope of his report, and noting that "the permissible scope of expert testimony is quite broad, and ...


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