United States District Court, D. Delaware
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
U.S. DISTRICT JUDGE
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.
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.
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." 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)
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.
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).
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.
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).
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).