Aktiebolag v. ANDRX PHARMACEUTICALS, INC.

695 F. Supp. 2d 21, 2010 U.S. Dist. LEXIS 33463
CourtDistrict Court, S.D. New York
DecidedApril 5, 2010
Docket99 Civ. 8926, 99 Civ. 9887. No. M-21-81 (BSJ). MDL Docket No. 1291
StatusPublished
Cited by3 cases

This text of 695 F. Supp. 2d 21 (Aktiebolag v. ANDRX PHARMACEUTICALS, INC.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Aktiebolag v. ANDRX PHARMACEUTICALS, INC., 695 F. Supp. 2d 21, 2010 U.S. Dist. LEXIS 33463 (S.D.N.Y. 2010).

Opinion

Opinion & Order

BARBARA S. JONES, District Judge.

On November 21, 2008, Plaintiffs Astra Aktiebolag, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP KBI-E, INC., KBI, INC., and Astrazeneca LP (“Plaintiffs” or “Astra”) moved for leave to file a second supplemental complaint alleging additional facts relevant to assessing damages for infringement by Andrx Pharmaceuticals, Inc. (“Andrx”) under 35 U.S.C. § 271(e)(2) and (e)(4). That same day, Andrx moved to amend and supplement its counterclaims (“Andrx’s counterclaim motion”). Andrx has also moved for an order that Astra’s claim of willful infringement is not part of this case, or, in the alternative, for judgment on the pleadings (“Andrx’s willfulness motion”). For the reasons set forth below, Astra’s motion to supplement is GRANTED, Andrx’s counterclaim motion is DENIED, and Andrx’s willfulness motion is DENIED.

BACKGROUND 1

On May 21, 1998 and July 14, 1999, Astra filed complaints in the United States District Court for the Southern District of Florida, alleging, inter alia, that Andrx’s Abbreviated New Drug Application *24 (“ANDA”) filing constituted infringement of several omeprazole patents belonging to Astra, including the formulation described in U.S. Patent Nos. 4,786,505 (the “ '505 patent”) and 4,858,230 (the “ '230 patent”). On August 12, 1999, the Judicial Panel on Multidistrict Litigation transferred the actions, along with other actions concerning Astra’s omeprazole patents, to the United States District Court for the Southern District of New York.

Shortly before and during the course of a bench trial, Astra discovered that Andrx had manufactured multiple batches of its ANDA product on a commercial scale (the “validation batches”). (Decl. of Alison Teh, Nov. 21, 2008, Exh. 8, 3245:3-16.) After consulting with the parties, the Court asked Andrx whether it wanted to delay trial to provide Astra with more discovery into the validation batches or whether it preferred to proceed with the trial limited to the ANDA product. Andrx chose the latter option, and the Court accordingly prohibited the parties from relying on evidence relating to those batches at trial. (Decl. of Alison Teh, Nov. 21, 2008, Exh. 10, 3137:18-19.)

On October 30, 2002, the Court entered a judgment finding that Andrx’s ANDA product infringed certain '505 and '230 patent claims pursuant to 35 U.S.C. § 271(e)(2) and enjoining Andrx pursuant to 35 U.S.C. § 271(e)(4)(B) from engaging in the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the omeprazole formulation described by its ANDA until on or before the expiration of the '505 and '230 patents. That same day, Andrx entered into a commercialization agreement with Kremers Urban Development Co. (“KUDCo”), pursuant to which Andrx agreed to relinquish its exclusivity rights obtained by filing the ANDA covering products infringing the '505 and '230 patents, in exchange for a share in the net profits on the sale of KUDCo’s omeprazole formulation. (Decl. of Alison Teh, Nov. 21, 2008, Exh. 12.)

Andrx appealed the Court’s judgment and on December 11, 2003, the United States Court of Appeals for the Federal Circuit affirmed the decision. See In re Omeprazole Patent Litig., 84 Fed.Appx. 76 (Fed.Cir.2003). At this point, the Court had not yet decided whether the '230 and '505 patents were unenforceable due to their connection to U.S. Patent Number 6,013,281 (the “ '281 patent”), which is also owned by Astra. On May 19, 2004, the Court issued a decision finding certain claims of the '281 patent infringed and invalid but rejecting Andrx’s arguments that the claims of the '505 and '230 patents were unenforceable due to infectious unenforceability, unclean hands or litigation misconduct. See In re Omeprazole Patent Litig., No. M-21-81 (BSJ), 2004 WL 1171254, *14, 2004 U.S. Dist. LEXIS 9447, *49 (S.D.N.Y. May 19, 2004). Andrx appealed this decision as well, and on April 23, 2007, the Federal Circuit dismissed Andrx’s appeal, rejecting Andrx’s arguments regarding the unenforceability of the '505 and '230 patents. In re Omeprazole Patent Litig., 483 F.3d 1364, 1376 (Fed.Cir.2007).

On July 25, 2007, Astra notified the Court and Andrx that because Andrx had publicly reported an inventory of generic omeprazole worth over $41 million (with an estimated sales value of over $400 million), Astra was entitled to damages. Noting that the Federal Circuit had affirmed the Court’s ruling regarding Andrx’s defenses to '505 and '230 patent infringement, Astra requested that the Court set a schedule to address pleading amendments and discovery regarding damages. (Decl. of Alison Teh, Nov. 21, 2008, Exh. 16, at 3.) In a subsequent letter dated August 7, *25 2008, Astra indicated that this issue remained outstanding. (Decl. of Alison Teh, Nov. 21, 2008, Exh. 18, at 6.) On November 21, 2008, Astra moved for leave to file a supplemental complaint alleging additional facts relating to its claim for damages against Andrx.

In Andrx’s counterclaim motion, Andrx moves to amend and supplement its counterclaims to assert that Astra violated the Lanham Act, the Sherman Act, and state deceptive and unfair trade practices laws. In its willfulness motion, Andrx requests that the Court issue an order declaring that Astra’s willfulness claim is no longer part of this case and, if Astra’s motion to supplement is denied, that this litigation will terminate upon taxation of costs.

DISCUSSION

I. Astra’s Motion to Supplement

Rule 15(d) of the Federal Rules of Civil Procedure allows a court, “[o]n motion and reasonable notice, ... [and] on just terms” to permit the pleader to serve a supplemental pleading “setting out any transaction, occurrence, or event that happened after the date of the pleading to be supplemented.” Fed.R.Civ.P. 15(d). “A supplemental pleading may ... be used to add additional facts or events relating to liability or to change the relief requested.” 3 James WM. Moore et al., Moore’s Federal Practice § 15.30 (3d ed.2009). “The same principles that support the liberal amendment of pleadings also apply to supplemental pleadings.” Id. Therefore, “[a]bsent undue delay, bad faith, dilatory tactics, undue prejudice to the party to be served with the proposed pleading, or futility, the motion should be freely granted.” Quaratino v. Tiffany & Co., 71 F.3d 58, 66 (2d Cir.1995) (citing Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962)).

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