WOLFSON, United States District Judge:
This matter comes before the Court on the Motion of Plaintiffs Takeda Pharmaceutical Company Limited ("Takeda Japan"), Takeda Pharmaceuticals U.S.A., Inc. ("Takeda U.S.A."), and Takeda Pharmaceuticals America, Inc. ("Takeda America") (cumulatively, "Plaintiffs" or "Takeda") to dismiss the antitrust claims of Defendants Zydus Pharmaceuticals Inc. ("Zydus") and Cadila Healthcare Limited's ("Cadilla") (cumulatively, "Defendants" or "Zydus"), pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons set forth below, Plaintiffs' Motion is
Plaintiffs are pharmaceutical companies which research, develop, as well as market pharmaceutical products, including lansoprazole orally digestible tablets. Plaintiffs own the following patents which claim the formulation for the drug Prevacid® SoluTab™: (a) U.S. Patent No. 6,328,994, (the "'994 Patent"); (b) U.S. Patent No. 7,431,942 (the "'942 Patent"); (c) U.S. Patent Number No. 7,875,292 (the "'292 Patent"); and (d) U.S. Patent No. 7,399,485 (the "'485 Patent") (collectively, the "patents-in-suit"). Defs.' Counterclaims ("Defs.' Countercl."), ¶¶ 18-21, 33-36. Defendants are pharmaceutical companies which manufacture, sell, as well as market generic copies of pharmaceutical products throughout the United States, that seek to produce a generic version of Prevacid® SoluTab™. Id. ¶ 22.
On August 30, 2002, the Food & Drug Administration ("FDA") approved New Drug Application ("NDA") No 21-248 for lansoprazole orally digestible tablets ("ODT") that Takeda sells under the name Prevacid® SoluTab™. Id. ¶ 30. Prescription Lansoprazole ODT is used to treat gastroesophageal reflux disease ("GERD") "in a specific subset of patients for whom other treatments are not a practical option[]" and its ODT "formulation allows the tablet to disintegrate in a patient's mouth leaving behind thousands of coated granules, which are then swallowed and released into the bloodstream." Id. ¶ 30 As Zydus alleges, "[t]his feature distinguishes Prescription Lansoprazole ODT from other GERD treatments, including other products containing the active ingredient lansoprazole, and is especially important for patients who cannot easily swallow pills in tablet form." Id. ¶ 30.
In February 2010, Zydus filed an Abbreviated New Drug Application ("ANDA") No. 200816 with the FDA, seeking to obtain regulatory approval for a generic version of lansoprazole ODT. Id. ¶ 37. Zydus subsequently submitted a letter to Takeda, wherein it provided notice of ANDA No. 200816 and included a Paragraph IV Certification.
Trial ensued, at which the parties disputed the proper claim construction of the term "fine granules," as defined in the '994 Patent. Id. ¶ 42. Ultimately, on appeal of the District Court's decision in favor of Takeda on claim construction, the Federal Circuit Court of Appeals construed that term to mean "fine granules having an average particle diameter of precisely 400 μ or less," as opposed to a deviation of ± 10%. Id.; Takeda Pharm. Co. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014). In that regard, because Zydus's ANDA product was measured to have an average particle size of 412.28 μ, the Court of Appeals ruled that "there can be no dispute that Zydus' ANDA product does not literally infringe ... the '994 patent," reversed the decision below, and judgment was entered in favor of Zydus. Id.
Subsequently, Zydus filed an amended ANDA No. 200816 with the FDA, which allegedly contains only one minor difference from the previously submitted ANDA No. 200816: "[an] immaterial addition of inactive substances ("excipients") to the formulation ... added to address certain issues raised by the FDA regarding administration of the product." Id. ¶ 45. In that regard, the FDA allegedly "indicated to Zydus that it was prepared to approve Zydus's ANDA No. 200816, as amended," following which, on January 3, 2018, Zydus submitted a letter to Takeda notifying Takeda of the amended ANDA No. 200818. Id. ¶ 46. The letter included another Paragraph IV Certification and "detailed some of the reasons why there could be no infringement of the patents-in-suit," such as: "because Zydus' product has fine granules having an average particle diameter of greater than 400 μ, the basis for the Federal Circuit's determination that Zydus' product does not infringe applies with equal force to all four patents-in-suit." Id. ¶ 47 (emphasis in original).
Following the submission of its January 3, 2018 letter, Zydus allegedly attempted to provide Takeda with the amended ANDA for its review, "no less than eight times[.]" Id. ¶ 48. However, despite also making "[s]everal telephone calls[,]" Zydus's efforts were unsuccessful. Id.
On February 12, 2018, Takeda brought the instant action against Zydus, alleging that Zydus directly infringed the '994 Patent, '942 Patent, '292 Patent, and '485 Patent by filing amended ANDA No. 200818 with the FDA, which, according to Zydus, is alleged to be "in every material respect, identical to [the] 2012 Lawsuit[.]" Id. ¶ 50. On March 29, 2018, Zydus filed counterclaims against Takeda, alleging, among other things, violations of: (1) the Sherman Act, 15 U.S.C. § 2; and
Currently, Takeda moves to dismiss those counterclaims pursuant to Federal Rule of Civil Procedure 12(b)(6), on the basis of Noerr-Pennington immunity.
Federal Rule of Civil Procedure 12(b)(6) provides that a court may dismiss a claim "for failure to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6). When reviewing a motion to dismiss, courts must first separate the factual and legal elements of the claims, and accept all of the well-pleaded facts as true. See Fowler v. UPMC Shadyside, 578 F.3d 203, 210-11 (3d Cir. 2009). All reasonable inferences must be made in the plaintiff's favor. See In re Ins. Brokerage Antitrust Litig., 618 F.3d 300, 314 (3d Cir. 2010). In order to survive a motion to dismiss, the plaintiff must provide "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This standard requires the plaintiff to show "more than a sheer possibility that a defendant has acted unlawfully," but does not create as high of a standard as to be a "probability requirement." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).
The Third Circuit has required a three-step analysis to meet the plausibility standard mandated by Twombly and Iqbal. First, the court should "outline the elements a plaintiff must plead to a state a claim for relief." Bistrian v. Levi, 696 F.3d 352, 365 (3d Cir. 2012). Next, the court should "peel away" legal conclusions that are not entitled to the assumption of truth. Id.; see also Iqbal, 556 U.S. at 678-79, 129 S.Ct. 1937 ("While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations."). It is well-established that a proper complaint "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (internal quotations and citations omitted). Finally, the court should assume the veracity of all well-pled factual allegations, and then "determine whether they plausibly give rise to an entitlement to relief." Bistrian, 696 F.3d at 365 (quoting Iqbal, 556 U.S. at 679, 129 S.Ct. 1937). A claim is facially plausible when there is sufficient factual content to draw a "reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. The third
In the context of antitrust litigation, the Noerr-Pennington doctrine "provides broad immunity from liability to those who petition the government, including administrative agencies and courts, for redress of their grievances." Hanover 3201 Realty, LLC v. Vill. Supermarkets, Inc., 806 F.3d 162, 179 (3d Cir. 2015) (citation omitted). Nevertheless, immunity under Noerr-Pennington is not absolute; indeed, its protections do not extend to the activities of those who engage in "sham litigation." Noerr-Pennington. Prof'l Real Estate Investors v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60-61, 113 S.Ct. 1920, 123 L.Ed.2d 611 (1993); Hanover 3201 Realty, LLC, 806 F.3d at 178; Otsuka Pharm. Co, 118 F.Supp.3d 646, 656 (D.N.J. 2015).
The "sham litigation" exception under Noerr-Pennington requires a two-pronged showing: "first, `the lawsuit must be objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits' ... [s]econd, `the baseless lawsuit [must] conceal[] an attempt to interfere directly with the business relationships of a competitor,' rather than reflect a legitimate effort to obtain judicial review." Otsuka Pharm. Co, 118 F.Supp.3d at 656 (quoting Noerr-Pennington. Prof'l Real Estate Investors, 508 U.S. at 60-61, 113 S.Ct. 1920); In re Lipitor Antitrust Litig., 868 F.3d 231, 272 (3d Cir. 2017). The latter inquiry, therefore, requires an examination of an alleged wrongdoer's "subjective intent." ADP, LLC v. Ultimate Software Grp., Inc., No. 16-8664, 2018 WL 1151713, at *4, 2018 U.S. Dist. LEXIS 35240, at *10 (D.N.J. March 5, 2018). A successful showing of both subjective and objective baselessness will preclude a party from invoking immunity under Noerr-Pennington.
Notably, district courts within this Circuit have routinely prohibited parties from invoking the protections of Noerr-Pennington at the dismissal stage of a case in the context of patent suits, at which time the factual record remains undeveloped and insufficient for the purpose of determining whether a "sham litigation" has been filed. FTC v. Shire ViroPharma, Inc., No. 17-131, 2018 WL 1401329, at *7, 2018 U.S. Dist. LEXIS 45727, at *18 (D. Del. March 20, 2018) ("[W]hether [the patent holder's] activity was in fact a sham under either standard is a factual inquiry, which cannot be resolved at the motion to dismiss stage."); Otsuka Pharm. Co., 118 F.Supp.3d at 657 ("Moreover, even assuming the allegations proved insufficient, the inquiry into whether [the plaintiff-counter-defendant] maintains in this action `objectively and subjectively baseless' infringement claims turns upon issues of reasonableness and intent—issues which are premature to consider upon the present record."); S3 Graphics Co. v. ATI Techs. ULC, No. 11-1298, 2014 WL 573358, at *3, 2014 U.S. Dist. LEXIS 16928, at *9 (D.N.J. Feb. 11, 2014) (holding that the issue of Noerr-Pennington immunity is "not proper before discovery"); Shionogi Pharma, Inc. v. Mylan, Inc., No. 10-1077, 2011 WL 3860680, at *6, 2011 U.S. Dist. LEXIS 98547, at *6 (D. Del. Aug. 31, 2011) ("Whether the underlying litigation is baseless is a factual issue not to be determined on a motion to dismiss."); In re Metoprolol Succinate Direct Purchaser Antitrust Litig., No. 06-52, 2010 WL 1485328, at *10, 2010 U.S. Dist. LEXIS 36303, at *34 (D. Del. April 13, 2010)
In the instant matter, Takeda argues that its decision to bring suit is per se reasonable, because it was filed in response to a paragraph IV certification. Memorandum of Law in Support of Motion to Dismiss Defendants' Antitrust Counterclaims, ("Pls.' Support Brief"), at 2. According to Takeda, Zydus's amended filing, in of itself, constitutes an act of infringement thereby providing Takeda with "a statutory right to sue." Id. at 18-19. Indeed, Takeda contends that Zydus's Paragraph IV Certification included an "assertion[] of noninfringement," to which a reasonable party could have disagreed. Id. at 20. Thus, because "Zydus's Paragraph IV Certification allowed Takeda to `have perceived some likelihood' of success when it sued, the sham-litigation claim should be dismissed." Id. That possibility, Takeda argues, is sufficient for the purpose of invoking Noerr-Pennington immunity. Id. However, I disagree with Takeda's position, as the circumstances here are not different from the general practice of denying Noerr-Pennington immunity on a factually undeveloped record.
Takeda's arguments are confined to the issue of filing suit in response to a paragraph IV certification, the submission of which creates a "technical act of constructive infringement necessary" for a patent holder to bring an action for infringement. Otsuka Pharm. Co., 118 F.Supp.3d at 656 n.10. Indeed, Takeda does not challenge the sufficiency of Zydus's allegations, in of themselves, but instead maintains that the protections of Noerr-Pennington automatically extend to this case, because Takeda filed suit in response to Zydus's Paragraph IV Certification. Therefore, Takeda's request for relief on this motion rises and falls on that limited inquiry.
I note at the outset that, Takeda does not support its position with, nor is this Court aware of, any statutory authority or case law from which to find that an infringement action filed in response to a paragraph IV certification is per se reasonable, such that immunity automatically applies. To the contrary, Takeda's exact argument was rejected in Otsuka Pharm. Co., wherein the defendant asserted counterclaims against the plaintiff patent holder pursuant to the Sherman Act's prohibition of anticompetitive conduct. Specifically, the court, there, held that the defendant's submission of a paragraph IV certification did not automatically trigger the invocation of Noerr-Pennington immunity at the dismissal stage of litigation, reasoning:
Otsuka Pharm. Co., 118 F.Supp.3d at 656 n.10. Moreover, the Otsuka court distinguished the same cases upon which Takeda relies here to invoke Noerr-Pennington immunity, including AstraZeneca AB v. Mylan Labs., Inc., a non-binding out-of-circuit decision, and Celgene Corp. v. Barr Labs., Inc.:
Id.; see also Shionogi Pharma, Inc., 2011 WL 3860680, at *6, 2011 U.S. Dist. LEXIS 98547, at *19 ("Thus, the procedural posture of AstraZeneca permitted the court to make factual findings that this Court cannot make here."). Accordingly, the plaintiff patent holder in Otsuka could not rely on the protections of Noerr-Pennington prior to the development of a factual record, even though the dispute stemmed from the submission of a paragraph IV certification, because the defendant's certifications with respect to the non-infringement of its ANDA product were sufficient for the purpose of alleging the sham litigation exception. This Court similarly finds that Zydus has adequately pled facts to state a claim for sham litigation.
Like Otsuka, the Court, here, lacks a factually developed record from which to conduct a sufficient Noerr-Pennington analysis, because this case remains in its procedural infancy. Furthermore, Zydus has sufficiently alleged facts to show that Takeda's "petition[ing]" activity constitutes sham litigation. Hanover 3201 Realty, LLC, 806 F.3d at 179. Indeed, Zydus's Paragraph IV Certification provided "Takeda with a detailed statement explaining why [its] amended ANDA and its lansoprazole [ODT] tablets do not infringe the patents-in-suit," in addition to a letter further articulating "numerous reasons why there could be no infringement, including how the ANDA changes ... applied to inactive ingredients having nothing to do with the patents-in-suit[.]" Defendants' Opposition to Plaintiffs' Motion to Dismiss ("Defs.' Opp. Brief"), at 18-19; Countercls. ¶¶ 46, 63. While these allegations, standing alone, are sufficient to meet the sham litigation exception, Zydus also relies on the parties' prior litigation history to demonstrate that Takeda is not entitled to invoke Noerr-Pennington immunity at this early stage of the proceedings.
In that regard, the parties previously litigated the patents-in-suit in 2010, and the issue of infringement turned on the construction of the term "fine granules," as defined in the '994 Patent. See Takeda Pharm. Co. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014). The Federal
In addition to its submission of detailed letters explaining the basis for non-infringement, here, Zydus asserts that the contents of the amended ANDA support the allegation of a sham litigation because its generic drug does not literally infringe on Takeda's product. Countercls. ¶ 48. Indeed, the Federal Circuit already determined a "hard cut-off" of precisely 400 μ above which there can be no infringement, and Zydus alleges that its amended ANDA pertains only to "inactive substances" which do not relate to granule size. Id. ¶¶ 42, 45. In that regard, because the generic product was previously determined to have an average particle size of 412.28 μ Zydus alleges that Takeda lacked a legitimate basis to bring suit, but, nevertheless, filed the instant action wherein it asserts infringement claims which have already been "litigated and fully resolved in Zydus' favor by October 2014."
Accordingly, I find that the allegations in Zydus's Counterclaims are sufficient to meet the sham litigation exception at this early juncture of the case. Indeed, the Court may infer that Takeda's decision to file this suit is objectively and subjectively baseless, as well as motivated by anticompetitive purposes. Moreover, although Takeda argues that it was proper to bring this action in response to Zydus's Paragraph IV Certification, that factual dispute must be resolved at a later stage of the litigation. Accordingly, Takeda's invocation of Noerr-Pennington fails.
Despite the sufficiency of the pleadings, Takeda maintains that the requirement of but-for causation is not satisfied, because "Zydus has been free of the patents-in-suit since 2014 but never received FDA approval." Pls.' Support Brief, at 29. Therefore, according to Takeda, "Zydus could have never launched even in the absence of the 30-month stay," constituting an independent basis to dismiss Zydus's counterclaims. Id. at 30. However, this Court disagrees with Takeda's position.
The Third Circuit has held that "`[a] plaintiff who defeats the defendant's claim to Noerr immunity ... must still prove a substantive antitrust violation.'" In re Wellbutrin XL Antitrust Litig., 868 F.3d 132, 149 (3d Cir. 2017) (quoting Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49, 56-57, 113 S.Ct. 1920, 123 L.Ed.2d 611 (1993)). That requirement "includes proving the challenged lawsuit is `causally linked' to an antitrust injury." Id. (citing Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 489, 97 S.Ct. 690, 50 L.Ed.2d 701 (1977)).
Here, the Court finds that Zydus's allegations are sufficient for the purpose of pleading an antitrust injury at the dismissal stage. Indeed, as alleged in its Counterclaims, "[o]n January 3, 2018 ... the FDA indicated to Zydus that it was prepared to approve Zydus' ANDA, as amended[,]" which would have occurred "promptly after the 45-day notice period had concluded, "[b]ut for [Takeda's] anticompetitive conduct," i.e., filing this patent infringement action. See Countercls. ¶¶ 6, 46. Thus, the Court finds that these allegations adequately demonstrate a "casual link" between the alleged anticompetitive purpose of Takeda's lawsuit, as pled, and the antitrust injury which allegedly flowed therefrom.
Nonetheless, Takeda maintains that Zydus has failed to obtain regulatory or tentative FDA approval, and therefore, its alleged injuries actually stem from the Hatch-Waxman's statutory framework as opposed to the instant dispute. However, Takeda's arguments require a factually intensive analysis which this Court cannot perform, because this case is still in its procedural infancy. Brader v. Allegheny Gen. Hosp., 64 F.3d 869, 876 (3d Cir. 1995) ("[T]he existence of an `antitrust injury' is not typically resolved through motions to dismiss."); see, e.g., Atlantic Richfield Co. v. USA Petroleum Co., 495 U.S. 328, 346, 110 S.Ct. 1884, 109 L.Ed.2d 333 (1990); Town Sound & Custom Tops, Inc. v. Chrysler Motors Corp., 959 F.2d 468, 495 (3d Cir. 1992); Tunis Bros. Co. v. Ford Motor Co., 952 F.2d 715, 727-28 (3d Cir. 1991).
Indeed, various district courts within this Circuit have declined to hold that the absence of FDA approval creates a barrier to establishing the element of causation in a patent antitrust suit. See, e.g., In re Metoprolol Succinate Direct Purchaser Antitrust Litig., No. 06-71, 2010 WL 1485328, at *7, 2010 U.S. Dist. LEXIS 36303, at *23, (D. Del. April 13, 2010) ("The positioning of tentative FDA approval as the dispositive factor in patent antitrust cases, however, is questionable in view of case law in the Third Circuit and elsewhere."); In re Wellbutrin SR/Zyban Antitrust Litig., 281 F.Supp.2d 751, 757 (E.D. Pa. 2003) ("Defendants' ability to pose a plausible and legally permissible version of events that explains why generic manufacturers of [the brand drug] have not yet entered the market does not compel this Court to grant their Motion."); see also Bristol-Meyer-Squibb Co. v. Ben Venue Labs., 90 F.Supp.2d 540, 545 (D.N.J. 2000) ("There is no dispute that by suing the generic defendants under the Hatch-Waxman
For the foregoing reasons, Takeda's Motion to dismiss Zydus's anticompetitive counterclaims is
