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Belcher Pharmaceuticals, LLC v. International Medication Systems, Ltd

United States District Court, D. Delaware

March 31, 2019


          Stephen B. Brauerman, BAYARD, P.A., Wilmington, DE, Stefan V. Stein, Cole Carlson, and William Stein, GrayRobinson, P.A., Tampa, FL Attorneys for Plaintiff

          Melanie K. Sharp, James L. Higgins, and Michelle M. Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE Douglas H. Carsten, Joshua A. Mack, WILSON SONSINI GOODRICH & ROSATL San Diego, CA Attorneys for Defendant



         Plaintiff Belcher Pharmaceuticals, LLC ("Plaintiff or "Belcher") asserts in its June 28, 2018 Complaint that Defendant International Medication Systems, LLC ("Defendant" or "IMS") infringes Plaintiffs U.S. Patent No. 9, 283, 197 ("the '197 patent"). (D.I. 1) ("Complaint" or "Compl.") Defendant "filed a NDA [New Drug Application] under 21 U.S.C. § 355(b)(2) of the Hatch-Waxman Act (making it a '505(b)(2) application'), for 0.1 mg/mL epinephrine injections ('IMS's NDA')," which Plaintiff asserts is an artificial act of infringement under 35 U.S.C. § 271(e)(2). (D.I. 9 at 2) Pending before the Court is Defendant's motion to dismiss under Federal Rule of Civil Procedure 12(b)(6). (D.I. 8) After considering the parties' briefing and supplemental briefing (D.I. 9, 15, 19, 27, 28), the Court will deny Defendant's motion.

         I. BACKGROUND

         U.S. Patent Application No. 14/460, 845 was filed on August 15, 2014, and the '197 patent issued as a result on March 15, 2016. (D.I. 1-1 at 1) The '197 patent was issued to Jugal K. Taneja and assigned to Plaintiff. (D.I. 15 at 4) Of the three independent and four dependent claims, only Claims 6 and 7 are asserted, which the Complaint alleges are infringed by Defendant's NDA product.

         IMS filed its paper NDA in February, 2018 for 0.1 mg/mL epinephrine injections, (D.I. 9 at 2) This filing was made pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), specifically 21 U.S.C. § 355(b)(2), which covers "drug[s] for which the investigations . .. relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted."[1] Pursuant to § 355(b)(2)(A)(iv) ("Paragraph IV"), a § 355(b)(2) applicant must submit to the U.S. Food and Drug Administration ("FDA") "a certification, in the opinion of the applicant.. . with respect to each patent which claims the drug for which such investigations were conducted . . . that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted," Defendant submitted a Paragraph IV certification with respect to the '197 patent, a patent which is listed in the publication Approved Drug Products with Therapeutic Equivalence Evaluations ("Orange Book"). (D.I. 9 at 2)

         Plaintiff alleges Defendant's NDA filing was an act of infringement under 21 U.S.C. § 271(e)(2)(A), which provides: "It shall be an act of infringement to submit an application under .. . section 505(b)(2) of [the Food, Drug, and Cosmetic Act] for a drug claimed in a patent or the use of which is claimed in a patent," Defendant sent notice of its Paragraph IV certification to Plaintiff on May 16, 2018, which opened a 45-day window in which Plaintiff could, by filing suit, obtain an automatic 30-month stay of FDA approval of Defendant's NDA. See 21 C.F.R. § 314.107(b)(3)(i)(A). The parties negotiated an offer of confidential access ("OCA") by Plaintiff to IMS's NDA, pursuant to which Defendant produced a copy of its entire NDA submission to Plaintiff on June 7, 2018, three weeks prior to the 45-day deadline. (D.I. 9 at 3) Plaintiff filed its Complaint on June 28, 2018.


         Evaluating a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) requires the Court to accept as true all material allegations of a complaint, See Spruill v. Gillis, 372 F.3d 218, 223 (3d Cir. 2004). "The issue is not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claims." In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1420 (3d Cir. 1997) (internal quotation marks omitted). Thus, the Court may grant such a motion to dismiss only if, after "accepting all well-pleaded allegations in the complaint as true, and viewing them in the light most favorable to plaintiff, plaintiff is not entitled to relief." Maio v. Aetna, Inc., 221 F.3d 472, 481-82 (3d Cir. 2000) (internal quotation marks omitted).

         A well-pleaded complaint must contain more than mere labels and conclusions. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Ail. Corp. v. Twombly, 550 U.S. 544, 555 (2007). A plaintiff must plead facts sufficient to show that a claim has substantive plausibility. See Johnson v. City of Shelby, 135 S.Ct. 346, 347 (2014). A complaint may not be dismissed, however, for imperfect statements of the legal theory supporting the claim asserted. See Id. at 346.

         "To survive a motion to dismiss, a civil plaintiff must allege facts that 'raise a right to relief above the speculative level on the assumption that the allegations in the complaint are true (even if doubtful in fact)."' Victaulic Co. v. Tieman, 499 F.3d 227, 234 (3d Cir. 2007) (quoting Twombly, 550 U.S. at 555). A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678. At bottom, "[t]he complaint must state enough facts to raise a reasonable expectation that discovery will reveal evidence of [each] necessary element" of a plaintiff s claim. Wilkerson v. New Media Tech. Charter Sch. Inc., 522 F.3d 315, 321 (3d Cir. 2008) (internal quotation marks omitted).

         The Court is not obligated to accept as true "bald assertions," Morse v. Lower Merion Sch. Dist, 132 F.3d 902, 906 (3d Cir. 1997) (internal quotation marks omitted), "unsupported conclusions and unwarranted inferences," Schuylkill Energy Res., Inc. v. Pa. Power & Light Co., 113 F.3d 405, 417 (3d Cir. 1997), or allegations that are "self-evidently false," Nami v. Fauver, 82 F.3d 63, 69 (3d Cir. 1996).

         III. ...

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