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Bayer Schera Pharma AG v. Sandoz

September 2, 2010

BAYER SCHERA PHARMA AG AND BAYER HEALTHCARE PHARMACEUTICALS INC., PLAINTIFFS,
v.
SANDOZ, INC., WATSON PHARMACEUTICALS, INC., AND WATSON LABORATORIES, INC., DEFENDANTS.



The opinion of the court was delivered by: Paul G. Gardephe, U.S.D.J.

MEMORANDUM OPINION AND ORDER

In this action, Bayer Schera Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (collectively "Bayer") allege that Defendants' proposed generic production of Bayer's brand-name oral contraceptive Yasmin will infringe on Bayer's patent rights. Bayer initiated this litigation after Watson filed an abbreviated new drug application ("ANDA") to market a generic version of Yasmin. (See Cmplt. ¶¶ 14, 15)

Pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355, 360cc (2003); 35 U.S.C. §§ 156 (2002), 271 (2003)) (collectively the "Hatch-Waxman Act"), a thirty-month stay is currently in place preventing Defendants Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. (collectively "Watson") from obtaining final approval from the Food and Drug Administration for their marketing of a generic version of Yasmin. See 21 U.S.C. § 355(j)(5)(B)(iii). The thirty-month stay expires on September 4, 2010. (Bayer Br. 3) Before the Court is Bayer's motion to extend the statutory thirty-month stay pursuant to 21 U.S.C. § 355(j)(5)(B)(iii). (Docket No. 79)

For the reasons set forth below, Bayer's motion to extend the statutory thirty-month stay will be DENIED.

BACKGROUND

A.Procedural History

Bayer has filed multiple patent infringement suits against Watson and Sandoz in both the Southern District of New York and the District of Nevada relating to their proposed generic production of the oral contraceptive Yasmin and the related oral contraceptive Yaz.

On November 5, 2007, Bayer sued Watson in the District of Nevada for infringement of U.S. Patent No. 6,787, 531 ("the '531 patent"), U.S. Reissue Patent No. 37,564 ("the '564 patent"), and U.S. Reissue Patent No. 37, 838 ("the '838 patent"), all relating to Yaz. (Jansen Decl. ¶ 3, Id., Ex. 1 ("Nevada Yaz Cmplt.") ¶¶ 16-18)

On April 17, 2008, Bayer filed the instant action against Watson and Sandoz in the Southern District of New York for infringement of U.S. Patent No. 5,569,652 ("the '652 patent") in connection with Yasmin. (Cmplt. ¶¶ 20, 21) The case was assigned to Judge Crotty. On July 21, 2008, Watson sent a letter to the Court seeking a pre-motion conference. Watson's letter indicated that it intended to contest in personam jurisdiction. (Bayer Br., Ex. 2, July 21, 2008 Meister Ltr.) Judge Crotty held an initial conference on August 20, 2008. At that time, he informed the parties that he might be required to recuse himself. (Cooklin Decl ¶ 4) Judge Crotty subsequently recused himself, and this matter was reassigned to this Court on September 10, 2008. (Docket No. 20)

On August 1, 2008, Bayer sued Sandoz in the District of Nevada alleging infringement of the '564 patent and the '838 patent in connection with Yaz. (Jansen Decl. ¶ 4) Sandoz answered the complaint on September 19, 2008, and asserted a counterclaim for a declaratory judgment that the '652 patent is invalid. (Id.) On November 24, 2008, the Nevada District Court consolidated the two Yaz actions. (Id.; Letter from Delphine W. Knight Brown dated January 14, 2009 (Docket No. 41))

On September 18, 2008, Bayer sued Sandoz and Watson in the Southern District of New York alleging infringement of the '652 patent in connection with Yaz ("New York Yaz action"). (08 Civ. 08112 Cmplt. ¶¶ 24, 25)

On September 22, 2008, Sandoz filed a motion to transfer the instant action to the District of Nevada pursuant to 28 U.S.C. § 1404(a). (Docket No. 22) Bayer subsequently joined that motion. (See Transcript of Initial Conference dated Oct. 1, 2008 ("Oct. 1 Tr.") at 7:5-6; Sept. 25, 2008 Bensinger Ltr. (Docket No.37)) Sandoz and Bayer later requested that the New York Yaz action also be transferred to the District of Nevada. (See Oct. 1 Tr. at 4:15-17; Sept. 25, 2008 Bensinger Ltr. (Docket No. 37))

This Court held its first conference in this matter on October 1, 2008. At that conference, Bayer argued that this Court should defer consideration of Watson's proposed jurisdictional motion and resolve the transfer issue. (Oct. 1 Tr. 8:10-17, 11:14-18) The Court accepted Bayer's argument, and announced that it would address Sandoz and Bayer's motion to transfer before considering any other contemplated motions. (Id. at 30:10-14) On February 17, 2009, this Court denied the motion to transfer the instant action and the New York Yaz action to the District of Nevada. Bayer Schera Pharma AG v. Sandoz, Inc., No. 08 Civ. 03710 (PGG), 08 Civ. 08112 (PGG), 2009 WL 440381 (S.D.N.Y. Feb. 18, 2009).

After this Court's decision denying the motion to transfer, Bayer and Watson entered into a stipulation regarding jurisdictional discovery and a schedule for briefing on Watson's motion to dismiss. (Docket No. 45) On April 27, 2009, Watson filed its motion to dismiss. (Docket No. 55) Approximately three months later, on July 28, 2009, Watson withdrew its motion to dismiss. (July 28, 2009 Cooklin Ltr. (Docket No. 68; 08 Civ. 08112, Docket No. 25))

On December 21, 2009, Watson and Sandoz filed a motion for judgment on the pleadings arguing that the '652 patent is invalid. (Docket No. 78) That same day, Bayer filed the instant motion to extend the statutory thirty-month stay with respect to the FDA's ...


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