AstraZeneca AB v. Dr. Reddy's Labs. Inc.
| Decision Date | 18 March 2013 |
| Docket Number | Civil Action No. 11-2317 (JAP) |
| Parties | ASTRAZENECA AB, ASTRAZENECA LP, KBI-E, INC., and POZEN INC., Plaintiffs, v. DR. REDDY'S LABORATORIES INC. And DR. REDDY'S LABORATORIES LTD., and LUPIN LTD. and LUPIN PHARMACEUTICALS INC. and ANCHEN PHARMACEUTICALS, INC. Defendants. |
| Court | U.S. District Court — District of New Jersey |
This matter comes before the Court on Plaintiffs AstraZeneca AB, AstraZeneca LP, KBI-E, Inc. (collectively, "AstraZeneca") and Pozen Inc.'s ("Pozen") Motion for Leave to Amend Responses to Defendants' Invalidity Contentions [dkt. no. 98]. Defendants Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories Ltd. (collectively, "DRL") filed Opposition [dkt. no. 116] and Plaintiffs have replied [dkt. no. 125]. The Court granted DRL leave to submit a Sur-Reply and DRL did so [dkt. no. 127]. The Court has considered all of the submissions of the Parties pursuant to FED. R. CIV. P. 78 and, for the reasons set forth below, Plaintiffs' Motion is DENIED.
This Hatch-Waxman case was commenced on April 21, 2011. Plaintiffs allege that Defendants infringed one Pozen patent (U.S. Patent 6,926,907—"the '907 patent") and five AstraZeneca patents (not at issue in the instant Motion) by filing Abbreviated New Drug Application No. 202461 ("DRL's ANDA") with the U.S. Food and Drug Administration ("FDA"). See generally Pl.'s Complaint. DRL's ANDA seeks approval to market a generic version of AstraZeneca's VIMOVO® drug prior to the expiration of Plaintiffs' patents. Id.
DRL is the first ANDA filer for any generic VIMOVO® product. Id. Lupin Ltd. and Lupin Pharmaceuticals, Inc. ("Lupin") and Achen Pharmaceuticals, Inc. ("Achen") separately filed later, discrete ANDAs for their own generic VIMOVO® products. Id. The Court has consolidated Plaintiffs' cases against DRL, Lupin and Anchen for discovery purposes only. See dkt. nos. 41 and 82.
A. The '907 Patent
Plaintiffs seek leave to amend their responses with regard to the '907 patent only. The '907 patent has 55 claims. On November 17, 2011, Plaintiffs served their Disclosure of Asserted Claims pursuant to L. Pat. R. 3.6(b). Plaintiffs asserted that DRL infringed 21 claims of the '907 patent (i.e., claims 1, 5, 9-17, 22, 23, 35, 48 and 50-55). In their November 23, 2012 Invalidity Contentions, DRL contended that each of the 21 asserted claims were invalid. DRL also addressed each of the remaining 34 claims of the '907 patent. In their January 17, 2012 Responses to DRL's Invalidity Contentions, Plaintiffs responded to DRL's contentions for six of the 21 asserted claims (i.e., claims 5, 15, and 52-55) of the '907 patent. Subsequently, Plaintiffs further narrowed their asserted claims of the '907 patent to claims 5, 15, 52, 53, and 54. DRLthereafter informed Plaintiffs they would only contest the validity of the five claims that remained and withdrew their invalidity contentions as to the other claims. See Def.'s Opp. at 8.
As a result of DRL's Opposition to the instant Motion, Plaintiffs introduced new "compromise" amended responses in their Reply. These new responses purport to address only claims 5, 15, 52, 53, and 54.1
Plaintiffs advance two primary arguments in support of their Motion. First, Plaintiffs claim they should be granted leave to amend in order to correct an "oversight" by prior counsel. Pl.'s Br. at 3; Pl.'s Reply at 3-4. According to Plaintiffs, primary responsibility for litigating each of the six patents-in-suit was previously divided between two law firms, with prior counsel taking the lead on the '907 patent. Pl.'s Br. at 3. On July 26 and 27, 2012, prior counsel withdrew. At that time, Plaintiffs' current counsel assumed primary responsibility for the '907 patent. Id. Plaintiffs now claim they should be granted leave in order to correct "omissions" and "oversights" by prior counsel in the previously submitted responses.2 Id; Pl.'s Reply at 3-4. DRL claims this argument is moot because it withdrew its invalidity contentions for all claims except those already contested and responded-to claims 5, 15, 52, 53 and 54. Def.'s Opp. at 8.
Plaintiffs also argue that they should be permitted to amend their responses to complete the "housekeeping" task of ensuring that their responses are "complete and in line with what hasalready been filed in the consolidated litigations." Pl.'s Br. at 4. For reasons more fully outlined below, DRL vehemently contests this justification. See Def.'s Opp. at 8-11.
The Local Patent Rules "exist to further the goal of full, timely discovery and provide all parties with adequate notice and information with which to litigate their cases." Computer Accelerations Corp. v. Microsoft Corp., 503 F.Supp.2d 819, 822 (E.D.Tex. 2007). The rules are designed specifically to "require parties to crystallize their theories of the case early in litigation and to adhere to those theories once they have been disclosed." Atmel Corp. v. Info. Storage Devices, Inc., 1998 WL 775115, at *2 (N.D. Cal. Nov. 5, 1998). This is "to 'prevent the 'shifting sands' approach to claim construction.'" O2 Micro Int'l Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1364 (Fed. Cir. 2006) (citing Atmel, 1998 WL 775115, at *2). As distinguished from the liberal standard for amending pleadings, "the philosophy behind amending claim charts is decidedly conservative." Atmel, 1998 WL 775115, at *2. However, Rule 3.7 "is not a straitjacket into which litigants are locked from the moment their contentions are served"; instead, "a modest degree of flexibility [exists], at least near the outset." Comcast Cable Communs. Corp. v. Finisar Corp., 2007 WL716131, at *2 (N.D. Cal. March 2, 2007). Therefore, while "preliminary infringement contentions are still preliminary" it is important to recognize that the Local Patent Rules strive to have the parties establish their contentions early on. General Atomics v. Axis-Shield ASA, 2006 WL 2329464, at *2 (N.D.Cal. Aug. 9, 2006).
Pursuant to L. Pat. R. 3.7, leave to amend responses to invalidity contentions may be granted "only by order of the Court upon a timely application and showing of good cause.''(emphasis added). Rule 3.7 provides a nonexhaustive list of circumstances that may, absent undue prejudice to the adverse party, support a finding of good cause:
by the party seeking amendment; (b) recent discovery of material prior art despite earlier diligent search; (c) recent discovery of nonpublic information about the Accused Instrumentality which was not discovered, despite diligent efforts, before the service of the Infringement Contention; (d) disclosure of an infringement contention by a Hatch- Waxman Act party asserting infringement under L. Pat. R. 3.6(g) that requires response by the adverse party because it was not previously presented or reasonably anticipated; and (e) consent by the parties in interest to the amendment and a showing that it will not lead to an enlargement of time or impact other scheduled deadlines . . .
L. Pat. R. 3.7. Good cause "considers first whether the moving party was diligent in amending its contentions and then whether the non-moving party would suffer prejudice if the motion to amend were granted." Acer, Inc. v. Tech. Prob. Ltd., 2010 WL 3618687, at *3 (N.D. Cal. Sept. 10, 2010) (citing O2 Micro, 467 F.3d 1355, 1355). Importantly, however, the Court may only consider prejudice to the non-moving party if the moving party is able to demonstrate diligence. Apple v. Samsung, 2012 U.S. Dist. LEXIS 83115, at *13 (N.D. Cal. Mar. 27, 2012) (collecting cases).
In determining whether good cause exists, courts have also considered such other factors as (1) the reason for the delay, including whether it was within the reasonable control of the party responsible for it; (2) the importance of what is to be excluded; (3) the danger of unfair prejudice; and (4) the availability of a continuance and the potential impact of a delay on judicial proceedings. See Oy Ajat, Ltd. v. Vatech Am., Inc., 2012 WL 1067900, at *20-21 (D.N.J. Mar. 29, 2012) (collecting cases); see also Computer Acceleration Corp. v. Microsoft Corp., 503 F. Supp. 2d 819, 822 (E.D. Tex. 2007) (collecting cases).
Courts have understood diligence to require a "showing that the party seeking leave to amend acted . . . promptly [in] moving to amend when new evidence is revealed in discovery." O2 Micro, 467 F. 3d 1355, 1363, 1366 (collecting cases). This requirement is consistent with L. Pat. Rule 3.7's requirement that the Motion be "timely." As with good cause in general, the burden "is on the movant to establish diligence rather than on the opposing party to establish lack of diligence." O2 Micro, 467 F. 3d 1355, 1366. For the reasons discussed below, the Court finds that Plaintiffs were not diligent in moving to amend.3
Plaintiffs argue first that withdrawal of prior counsel provides good cause to amend. This argument is not persuasive. Plaintiffs submitted their original responses on January 17, 2012— nearly seven months before filing the instant Motion to Amend. Although Plaintiffs claim, and the Court does not dispute, that the '907 patent was previously handled by prior counsel, the January 17th responses were nonetheless served by the same firm which filed the instant Motion. And Plaintiffs' 'of counsel' attorneys from three large, reputable firms also signed both the January 17th responses as well as the instant Motion. Thus, with the exception of prior counsel, the attorneys involved in Plaintiffs' original responses and Plaintiffs' current Motion to Amend are the same. Given the sophistication and number of attorneys involved, the Court is not persuaded that Plaintiffs were diligent in either discovering prior errors or omissions, or moving to amend their responses until seven months after they were first submitted. a. Oversights & Omissions
The Court would reach the same conclusion even if...
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