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

January 28, 2011


The opinion of the court was delivered by: Falk,u.s.m.j.


Before the Court is an application by Plaintiffs Sanofi-Aventis and Sanofi-Aventis U.S. LLC (collectively "Plaintiffs" or "Sanofi") to compel the deposition of a witness from Defendant Sandoz, Inc. on activities performed by Lek Pharmaceuticals d.d. ("Lek"), an "affiliate" of Sandoz, Inc., pursuant to Federal Rule of Civil Procedure 30(b)(6). Defendant Sandoz, Inc. opposes. For the reasons set forth below, Plaintiffs‟ request is granted.

I. Background

A. Procedural History

Sanofi-Aventis is the owner of United States Patent No. 6,514,531 ("the "531 patent"). The "531 patent covers a pharmaceutical controlled-release dosage form adapted to release zolpidem, which is sold by Sanofi-Aventis U.S. LLC as Ambien CR®. The Food and Drug Administration ("FDA") approved Ambien CR® for insomnia treatment on September 2, 2005.

Defendant Sandoz filed an abbreviated new drug application ("ANDA") with the FDA pursuant to the Hatch-Waxman Act, 21 U.S.C. § 355(j)(1), in which it sought approval to manufacture generic zolpidem tartrate extended-release tablets prior to the expiration of the "531 patent. As part of its ANDA, Sandoz asserts that its generic does not infringe on the "531 patent or, alternatively, that the "531 patent is invalid. Id. § 355(j)(2)(A)(vii). Sandoz had Lek, a Slovenian pharmaceutical company, develop and manufacture its ANDA product. Lek is a wholly-owned subsidiary of Novartis, the parent company of Sandoz. Thus, Sandoz and Lek may be referred to as "sister" companies.

Sanofi filed suit against Sandoz, Inc. under 35 U.S.C. § 271(e)(2) for infringing on its "531 patent. That suit was then consolidated with similar cases under the above-captioned docket number [CM/ECF No. 9]. After the close of fact discovery, the FDA changed its criteria for evaluating the bioequivalency of generic copies of zolpidem tartrate controlled release tablets. See Draft Guidances for Industry Describing Product-Specific Bioequivalency Recommendations; Availability, 74 Fed. Reg. 62,793 (Dec. 1, 2009) (announcing availability of new bioequivalency guidelines for "zolpidem").*fn1 Soon thereafter, the FDA informed Sandoz that certain aspects of its ANDA did not meet the revised bioequivalency parameters. Sandoz then had Lek manufacture new sample generic tablets for supplemental testing under the new bioequivalency standards. At Plaintiffs‟ request, fact discovery was re-opened so that Sanofi could investigate the new samples made by Lek.

B. The Discovery Dispute

As part of its fact discovery, Sanofi noticed a 30(b)(6) deposition of Defendant Sandoz, Inc. on a range of nineteen (19) topics related to the supplemental bioequivalency testing of its new ANDA product. Sandoz objected to all but three (3) discrete topics primarily because it claimed to have no witness to designate with knowledge of matters performed by a "third-party." After engaging new counsel, Sandoz instead offered to provide two Lek witnesses in a 30(b)(1) capacity to cover twelve (12) of the noticed topics. Without waiving its position that it was entitled to 30(b)(6) testimony on all topics, Sanofi held a 30(b)(1) deposition of one Lek scientist. The witness testified on four (4) topics but apparently was not fully responsive to all questions due to a lack of personal knowledge. After further negotiations, Sandoz changed its position and offered to provide one 30(b)(6) witness on all information known to Sandoz-not Lek-on sixteen (16) of the nineteen (19) topics. Sanofi now seeks one fully-responsive 30(b)(6) witness on all topics.

Since the outset of this evolving dispute, Sanofi has urged that the knowledge required of a 30(b)(6) witness extends beyond the information in the current possession of its principal. Indeed, it argues that the rule itself provides for all information "known or reasonably available to the organization." Fed. R. Civ. P. 30(b)(6). Sanofi points out that Sandoz has regularly called on Lek for information in response to FDA requests and has even produced Lek witnesses in this case when it was advantageous to do so. Sanofi further argues that the parties agreed over two years ago that Sandoz would provide discovery from Lek "as though it [were] a party."

Sandoz opposes principally on the ground that a 30(b)(6) deponent must have "control" over a corporate affiliate to establish that information in its possession is reasonably available. Sandoz states that it does not own Lek, and its ability to occasionally obtain information from Lek does not in any way alter its status as a distinct legal entity. It also disputes the accuracy of the agreement reached between the parties. Initially, Sandoz took the position that it only agreed to produce "certain" documents and deponents from Lek "as an accommodation to Sanofi." It later conceded that Sandoz agreed that "it would not withhold Lek documents on the grounds that Lek is a third-party."

II. Discussion

A. Rule 30(b)(6) of the Federal Rules of Civil Procedure

Rule 30(b)(6) permits a party to name a "public or private corporation . . . or other entity" as a deponent so long as the notice describes the matters for examination "with reasonable particularity." To the extent the notice describes matters that are relevant under the broad scope of discovery, Fed. R. Civ. P. 26(b)(1), the entity must designate one or more individuals to testify on its behalf. Fed. R. Civ. P. 30(b)(6). As a representative of the named deponent, the testimony of a 30(b)(6) witness is binding on the entity. Harris v. New Jersey, 259 F.R.D. 89, 92 (D.N.J. ...

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