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Aktiebolag v. Andrx Pharmaceuticals, Inc.

United States District Court, Second Circuit

August 5, 2013

ASTRA AKTIEBOLAG, et al., Plaintiffs,

Errol B. Taylor, Fredrick M. Zullow, Suraj K. Balusu, MILBANK, TWEED, HADLEY & McCLOY LLP, New York, NY, for plaintiffs.

Richard F. Lawler, Lori Van Auken, WINSTON & STRAWN LLP, New York, NY, Michael K. Nutter, Peter J. Slawniak, WINSTON & STRAWN LLP, Chicago, IL, Peter E. Perkowski, WINSTON & STRAWN LLP, Los Angeles, CA, for defendant.


DENISE COTE, District Judge.

Plaintiffs Astra Aktiebolag, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP (collectively, "Astra") filed this action against Andrx Pharmaceuticals, Inc. ("Andrx") in 1999, alleging patent infringement in connection with Andrx's efforts to manufacture and sell a generic form of omeprazole, popularly known by its trade name, Prilosec. Before the Court is Andrx's March 8, 2013, motion for summary judgment. For the following reasons, the motion is denied.


A more detailed factual history of this long-running dispute can be found in the Court's prior Opinions and will not be recited here beyond what is necessary to put the current dispute in context. This suit concerns the filing by Andrx and other generic manufacturers of Abbreviated New Drug Applications (or "ANDAs") for generic omeprazole. Several such cases were consolidated before The Hon. Barbara S. Jones, [1] and trial was divided into four phases. The first phase, which dealt with infringement and validity of certain of the patents at issue, began in December 2001. On October 16, 2002, Judge Jones issued an Opinion finding, inter alia, that the claims at issue were valid and had been infringed by Andrx. Astra Aktiebolag v. Andrx Pharmaceuticals, Inc. , 222 F.Supp.2d 423 (S.D.N.Y. 2002). On October 30, Judge Jones entered a final judgment, which found in favor of Astra with regard to infringement and enjoined Andrx from manufacturing its omeprazole formulation. Andrx appealed the October 16 Opinion, and the Federal Circuit affirmed. 84 Fed.App'x 76 (Fed. Cir. 2003).

Immediately before the commencement of the trial in 2001, Astra discovered that Andrx had begun manufacturing batches of omeprazole (the "validation batches"). At the time, Andrx's CFO acknowledged on a conference call with investors that the company had produced $41 million "at cost of generic Prilosec, " which he speculated could generate "$650 million of net sales." After consulting with the parties, Judge Jones asked Andrx whether it wished to delay the trial so that Astra could be provided with discovery concerning the validation batches. Andrx indicated that it preferred to proceed to trial and have the issue of infringement litigated solely on the basis of its ANDA, and not the omeprazole that had been produced. In July 2007, after the Federal Circuit affirmed another of the District Court's Opinions regarding certain other patents at issue, see In re Omeprazole Patent Litig. , 438 F.3d 1364 (Fed. Cir. 2007), Astra informed Andrx and Judge Jones that it viewed the issue of damages in connection with Andrx's manufacture of the validation batches as outstanding.

On November 21, 2008, Astra filed a motion for leave to file a supplemental complaint alleging additional facts with regard to its claim for damages. Andrx opposed this request, arguing (1) that the final judgment barred the addition of the damages theory, (2) that supplementation would be futile because it would be untimely and because Astra was not legally entitled to damages for Andrx's manufacture of the validation batches, and finally (3) that Astra had unduly delayed in seeking supplementation and that Andrx would be prejudiced by that delay. In an Opinion of February 2, 2010, Judge Jones rejected these arguments and granted Astra's motion, allowing it to add the damages remedy. 695 F.Supp.2d 21 (S.D.N.Y. 2010). Astra filed its Second Supplemental Complaint on February 8, 2010, and on February 16 Andrx filed a motion for reconsideration of Judge Jones's February 2 Opinion, which she denied in an Order of April 5, 2010.

On March 8, 2013, Andrx filed a motion for summary judgment, which was fully submitted on April 5. Trial in this action is scheduled to begin on September 30.


In seeking summary judgment, Andrx makes two principal arguments, both of which were presented to Judge Jones in connection with Andrx's opposition to Astra's motion to supplement its complaint, and neither of which has merit. First, Andrx argues that it is undisputed that it never sold any of the omeprazole it manufactured in 2001 and that, as a matter of statutory interpretation, Astra is therefore not entitled to damages for "commercial manufacture" under the Hatch-Waxman Act, 35 U.S.C. ยง 271(e)(4)(C). Second, Andrx argues that Judge Jones's entry of a final judgment granting an injunction in 2002 bars Astra from seeking monetary damages. Neither of these arguments entitles Andrx to summary judgment, both because they were already resolved and are therefore barred under the law of the case doctrine and because they lack merit.

Summary judgment may not be granted unless the submissions of the parties taken together "show that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). The moving party bears the burden of demonstrating the absence of a dispute as to a material fact, and in making this determination the court must view all facts in the light most favorable to the non-moving party. Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 247 (1986); Celotex Corp. v. Catrett , 477 U.S. 317, 323 (1986). When the moving party has asserted facts showing that the non-movant's claims cannot be sustained, the opposing party must "set forth specific facts showing that there is a genuine issue for trial, " and cannot rest on mere "allegations or denial" of the movant's pleadings. Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 587 (1986); Hicks v. Baines , 593 F.3d 159, 166 (2d Cir. 2010).

Under the law of the case doctrine, "a court should not reopen issues decided in earlier stages of the same litigation." Agostini v. Felton , 521 U.S. 203, 236 (1997). While it is not mandatory, the law of the case doctrine "counsels a court against revisiting its prior rulings in subsequent stages of the same case absent cogent and compelling reasons such as an intervening change of controlling law, the availability of new evidence, or the need to ...

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