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,
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,
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. § 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.
Under the law of the case doctrine, "a court should not reopen issues decided in earlier stages of the same litigation."
The Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585, commonly known as the Hatch-Waxman Act, allows a generic manufacturer of an already approved brand-name drug to obtain expedited approval to market that drug by filing an ANDA.
Andrx's principal argument in this summary judgment motion is that because it never sold the omeprazole it manufactured in 2001, Astra is barred from receiving damages under § 271(e)(4)(C), since Andrx's mere manufacture, without sale, does not qualify as "commercial manufacture" within the meaning of the statute. Andrx made this very argument, citing several of the same cases, to Judge Jones in opposing Astra's motion for leave to file a supplemental complaint. In her February 2, 2010 Opinion, Judge Jones addressed and rejected this argument, finding that "commercial manufacture alone suffices" and distinguishing two of the cases on which Andrx again relies in this briefing. 695 F. Supp. 2d at 29. The Court sees no reason to revisit Judge Jones's conclusions on this point.
Even addressing the matter
Andrx next argues that allowing Astra to pursue damages would be improper "double recovery," since Astra has already obtained a final judgment granting injunctive relief on the same claims. Once again, this argument was made to Judge Jones in 2010. Judge Jones rejected it, observing that the entry of final judgment as to infringement liability did not "preclude the possibility of additional remedies for that infringement." 651 F. Supp. 2d at 26. Andrx has presented no compelling reason why this prior ruling should be revisited.
Even on the merits, Andrx's argument fails. As an initial matter, the statute provides both injunctive relief and damages as available remedies. 35 U.S.C. § 271(e)(4). Moreover, the final judgment entered in 2002 enjoined Andrx from manufacturing omeprazole until the patents at issue expired. It did not resolve the issue of whether Astra might be entitled to damages based on prior acts of infringement by Andrx. That Andrx was enjoined from infringing the patents going forward does not render any damages award for past infringement "double recovery." The cases cited by Andrx are inapposite.
Andrx's March 8, 2013 motion for summary judgment is denied.
SO ORDERED.