SIMANDLE, Chief Judge:
This patent infringement action, one of twenty-six related actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 281, generally concerns Plaintiff Otsuka Pharmaceutical Co, Ltd.'s (hereinafter, "Otsuka") position that Apotex Corp.'s and Apotex Inc.'s (collectively, "Apotex") proposed generic aripiprazole product infringes one or more claims of four of the various patents covering Otsuka's Ability aripiprazole product, U.S. Patent Nos. 8,017,615 ("the '615 patent"), 8,580,796 ("the '796 patent"), 8,642,760 ("the '760
Otsuka now moves to dismiss Apotex's Ninth and Tenth Counterclaims for "Unlawful Monopolization" and for "Patent Misuse" (hereinafter, the "Counterclaims") pursuant to Federal Rule of Civil Procedure 12(b)(6) or, in the alternative, to bifurcate and stay Apotex's Counterclaims pending resolution of the primary patent infringement issues pursuant to Federal Rule of Civil Procedure 42(b). [Docket Item 102.] The Court recently addressed the viability of substantively identical, but slightly less developed, counterclaims in Otsuka Pharmaceutical Co., Ltd. v. Torrent Pharm. Ltd., Inc., 118 F.Supp.3d 646, No. 14-1078, 2015 WL 3869677 (D.N.J. June 22, 2015), and reaches substantially the same result in connection with the pending motion.
1. As this Court has summarized on numerous occasions, Otsuka holds New Drug Application (hereinafter, "NDA") No. 21-436, approved by the Food and Drug Administration (hereinafter, the "FDA"), for aripiprazole tablets, which Otsuka markets under the trade name Ability®. (See Am. Compl. at ¶¶ 1, 18, 20.) In connection with Ability®'s listing in the Orange Book, the FDA's book of drug products approved under the Food, Drug, and Cosmetic Act (hereinafter, the "Orange Book"), 21 U.S.C. § 355(j), Otsuka identifies the Patents-in-Suit, and discloses Ability®'s active ingredient as "aripiprazole," the dosage form as a "tablet" or "oral," and the strengths as 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. (Countercl. at ¶¶ 32-34.)
2. In late 2014, Apotex filed Abbreviated New Drug Application (hereinafter, "ANDA") No. 78-583 with the FDA, seeking approval to market generic 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg aripiprazole tablets in the United States, prior to expiration of the Patents-in-Suit. (See Countercl. at ¶¶ 35-37.) Apotex's ANDA filing included a "paragraph IV certification" pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), in which Torrent set forth its assertion that the Abilify® patents would not be infringed by the commercial manufacture, use, or sale of Apotex's generic aripiprazole product. (See id.)
3. On November 12, 2014, Apotex then mailed notice of its ANDA certification to Otsuka, and provided a detailed explanation of the bases for Apotex's position that its generic aripiprazole tablets would not infringe any valid or enforceable claim of the Orange Book-listed Patents-in-Suit. (Id. at ¶ 38.) In order to substantiate its non-infringement and/or invalidity positions, Apotex's notice "included an Offer of Confidential Access" to its ANDA and supporting materials. (Id.)
4. Despite Apotex's assertions, Otsuka filed an initial and Amended Complaint in this District, alleging that Apotex's proposed generic product "will, if approved and marketed," infringe at least one claim of the Patents-in-Suit. (Am. Compl. at ¶¶ 24, 34, 44, 54.) On March 23, 2015, Apotex responded to Otsuka's Amended Complaint and, as relevant here, asserted Counterclaims for "Unlawful Monopolization in Violation of the Sherman Act:
5. Apotex's "Unlawful Monopolization" Counterclaim alleges, in particular, that Otsuka "has the power to control prices and/or exclude competition in, or prevent entry into" the aripiprazole market, and claims that Otsuka has wielded that power "to monopolize" the market. (Id. at ¶¶ 80-81.) Indeed, Apotex claims that Otsuka has "engaged" in a "predatory scheme to monopolize" the aripiprazole market through its institution of "objectively baseless and sham judicial proceedings designed to continue its monopoly of aripiprazole tablets" and to prevent Apotex, among other generic companies, from competing in the aripiprazole market. (Id. at ¶¶ 86-88, 106-108.) Apotex therefore alleges that this infringement litigation amounts to "sham" and "bad faith" litigation, in violation of the Sherman and Clayton Acts, 15 U.S.C. §§ 2, 15, and 26. (Id. at ¶¶ 72-110.)
6. Apotex's patent misuse Counterclaim largely reiterates the allegations of its antitrust Counterclaim, and specifically alleges that Otsuka filed this action without "any good faith factual or legal basis" to support its infringement positions, and for purposes of delaying Apotex's entry into the marketplace for aripiprazole tablets. (Id. at ¶¶ 111-14.) Apotex further alleges that Otsuka has, in filing and prosecuting this "baseless" action, "impermissibly broadened the physical or temporal scope" of the Patents-in-Suit and asserted the patents in order "to obtain a market benefit beyond that which inheres in the statutory patent right." (Id. at ¶¶ 115-16.)
7. In moving to dismiss, Otsuka argues, as it did in connection with substantially similar counterclaims in Torrent, 118 F.Supp.3d 646, 2015 WL 3869677, that Apotex's antitrust and patent misuse Counterclaims must be dismissed, because Apotex has not alleged the "anticompetitive" or "antitrust injury" required for antitrust standing, because Apotex's "cursory conclusions" fail to plausibly overcome Otsuka's Noerr-Pennington immunity, and because Apotex's patent misuse counterclaim fails as a matter of law to state a cognizable claim for patent misuse. (See Otsuka's Br. at 5-11; Otsuka's Reply at 1-5.) In the alternative, Otsuka requests that the Court follow the "`standard practice'" of bifurcating for trial the patent issues raised in this litigation from the antitrust and/or patent misuse issues. (Otsuka's Br. at 12 (citations omitted); Otsuka's Reply at 6.)
8. Under Federal Rule of Civil Procedure 12(b)(6), the court must generally accept as true the factual allegations of the defendant's counterclaims, and construe all "reasonable inferences" in the light most favorable to the defendant. Revell v. Port Auth. of N.Y., N.J., 598 F.3d 128, 134 (3d Cir.2010); see also Fleisher v. Standard Ins. Co., 679 F.3d 116, 120 (3d Cir.2012) (same). However, "[a] pleading that offers labels and conclusions or a formulaic recitation of the elements of a cause of action" fails to suffice. Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Rather, the "well-pled factual allegations" must be sufficient to demonstrate a plausible "entitlement to relief." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)); see also Umland v. PLANCO Fin. Serv., Inc., 542 F.3d 59, 64 (3d Cir.2008).
9. As stated above, Otsuka moves to dismiss Apotex's antitrust Counterclaim for lack of standing and on immunity grounds, and moves to dismiss Apotex's patent misuse Counterclaim for failure to state a plausible claim for relief. For substantially the reasons stated in Torrent, the Court will deny Otsuka's motion to the
10. A party suing under federal antitrust laws, as here, must meet the prudential requirement of "`antitrust standing.'"
11. As stated by this Court in Torrent,
Torrent, 118 F.Supp.3d at 652-53, 2015 WL 3869677, at *4 (footnote omitted).
12. The Court rejects, at the outset, Otsuka's position that Apotex cannot, under Ethypharm S.A. France, be considered a competitor for purposes of antitrust standing, due to its lack of FDA approval. (See Otsuka's Br. at 5-6.) In Ethypharm S.A. France, the Court of Appeals for the Third Circuit found the plaintiff could not "be considered a competitor for purposes of antitrust injury," because "legal barriers particular to the pharmaceutical market" precluded the plaintiff's from marketing a competing product. 707 F.3d at 236. In so finding, however, the Third Circuit relied upon the fact that the plaintiff acted only as the foreign manufacturer of the product, and could not "directly supply the United States market" with the disputed drug. Id. Indeed, the plaintiff had specifically relinquished its right to sell and distribute the product in the United States through a third-party license agreement. Id. In other words, the Third Circuit's determination did not hinge upon the status of the plaintiff's FDA approval,
13. Moreover, if the Court accepted Otsuka's position, "antitrust standing under the Hatch-Waxman Act would be wholly contingent on the vagaries of the timing of agency action." Bristol-Myers Squibb Co. v. Ben Venue Labs., 90 F.Supp.2d 540, 545 (D.N.J.2000). This would, in turn, create an "anomalous" result, because generic defendants have "little practical incentive" to pursue final agency approval during the pendency of infringement actions, and are often "better served" by directing "their resources toward defense of the infringement action." Id. For these reasons, the Court holds that Apotex has standing as a competitor for purposes of an antitrust injury because it is an ANDA filer intending to manufacture and directly distribute generic aripiprazole in the United States market awaiting final FDA approval. The Court next addresses whether Apotex's allegations prove otherwise sufficiently plausible on the issue of antitrust injury.
14. The "hallmark" for evaluating the plausibility of an allegation of antitrust injury is whether "the actions alleged to be anticompetitive when viewed `as a whole' bear consequence for the overall market, rather than only for an individual competitor." Torrent, 118 F.Supp.3d at 653, 2015 WL 3869677, at *5 (quoting TransWeb, LLC v. 3M Innovative Props. Co., No. 10-4413, 2011 WL 2181189, at *18 (D.N.J. June 1, 2011)). Here, Apotex's antitrust Counterclaim alleges, in essence, that Otsuka has initiated meritless infringement actions and subsequently pursued preliminary injunctions against ANDA filers, in order "to prevent any and all competitors from competing in the marketplace" and to maintain its exclusive monopoly over the aripiprazole market. (Countercl. at 72-110.) Apotex further alleges that Otsuka's "exclusionary, anticompetitive and unlawful actions" have excluded "alternative source[s]" of aripiprazole tablets and have, in particular, forestalled and frustrated Apotex's ability to compete in the aripiprazole market. (Id. at ¶¶ 106-10.)
15. For largely the reasons stated in Torrent, Apotex's Counterclaim plausibly alleges the elements of an antitrust injury, namely, "an injury of the type protected by the antitrust laws, and that the injury derived, at least in part, from anti-competitive acts." Torrent, 118 F.Supp.3d at 653-55, 2015 WL 3869677, at *5-*6. Indeed, the pursuit of litigation that forestalls entry into the generic market and effectively extends a long-standing monopoly, as alleged here, constitutes precisely the type of "`anti-competitive behavior'" that the antitrust laws seek to redress.
16. As stated by this Court in Torrent,
Torrent, 118 F.Supp.3d at 655-56, 2015 WL 3869677, at *7.
17. Here, Otsuka argues, as it did in Torrent, that Apotex has failed to plead sufficient facts to trigger the sham litigation exception to Otsuka's presumptive Noerr-Pennington immunity. (See Otsuka's Br. at 7-10; Otsuka's Reply at 4-5.) Nevertheless, the Court finds Apotex's allegations even more ample than those the Court deemed sufficient in Torrent, and rejects Otsuka's argument that Apotex's Counterclaim should be dismissed on immunity grounds.
18. Critically, Apotex alleges that it provided Otsuka with the "detailed legal and factual bases" for its position on the non-infringement of Apotex's ANDA product on November 12, 2014. (Countercl. at ¶ 89.) On December 23, 2014, Apotex then provided Otsuka with supporting documentation of in excess of 13,000 pages, together with the raw materials and product samples associated with its ANDA product. (Id. at ¶¶ 90-92.) Despite this production, however, Otsuka filed this infringement action on the following day, December 24, 2014. (Id. at ¶ 93.) Apotex therefore alleges that Otsuka filed this action without regard for the contents of Apotex's production, "despite a complete lack of evidence of infringement," and without any other objective basis to buttress its claims of infringement. (Id. at ¶¶ 93-96.) Moreover, because Otsuka "initiated litigation" despite the volume of Apotex's evidence of alleged noninfringement,
19. These allegations, accepted as true for purposes of this Rule 12(b)(6) motion, set forth plausible facts sufficient to overcome Otsuka's presumptive antitrust immunity under the Noerr-Pennington doctrine.
20. For all of these reasons, the Court rejects Otsuka's argument that Apotex's Counterclaim should be dismissed on Noerr-Pennington immunity. If, however, Apotex fails to meet its burden of proof as to "sham litigation" upon litigation of the patent infringement claims and upon discovery as to Apotex's Counterclaims, Otsuka may renew its claim of Noerr-Pennington immunity.
21. The "key inquiry under the patent misuse doctrine is whether ... the patentee has "`impermissibly broaden[ed] the `physical or temporal scope' of the patent grant with an anticompetitive effect.""
22. Apotex's Counterclaim, by contrast, plainly alleges that this action amounts to an impermissible attempt to prolong the life of Otsuka's long-standing
23. The Court last addresses Otsuka's request to bifurcate and stay. Under Federal Rule of Civil Procedure 42(b), the Court may "order a separate trial of one or more separate issues, claims, cross-claims, counterclaims, or third-party claims," in order to encourage "convenience, to avoid prejudice, or to expedite and economize." FED. R. CIV. P. 42(b). In determining whether to bifurcate, courts carefully balance "considerations of convenience, avoidance of prejudice, and efficiency," and must ensure the preservation of the litigant's constitutional right to a jury. Torrent, 118 F.Supp.3d at 659, 2015 WL 3869677, at *10 (citations and internal quotations omitted).
24. Considering the various factors presented in this action, and the parties' qualified agreement,
25. For these reasons, the Court will follow the practice of separating for trial patent issues and antitrust issues. See In re Innotron Diagnostics, 800 F.2d 1077, 1084 (Fed.Cir.1986) (affirming the severance of patent and antitrust claims as in the interests of judicial economy); see also Torrent, 118 F.Supp.3d at 658-60, 2015 WL 3869677, at *9-*10 (bifurcating and staying a substantively identical antitrust counterclaim); Eurand Inc. v. Mylan Pharm. Inc., No. 08-889, 2009 WL 3172197, at *2 (D.Del. Oct. 1, 2009) (granting motion to sever and stay antitrust and patent misuse counterclaims and affirmative defenses from the patent infringement action).
26. For the reasons stated above, Otsuka's motion will be denied to the extent it seeks dismissal of Apotex's antitrust and patent misuse Counterclaims. Torrent's antitrust and patent misuse Counterclaims will, however, be bifurcated and stayed,
27. An accompanying Order will be entered.