Brief in Opposition to Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) and (6)

AuthorKenneth L. Dorsney
Pages729-732
Brief in Opposition to Motion to Dismiss Pursuant to Fed. R.
Civ. P. 12(b)(1) and (6)
IN THE UNITED STATES DISTRICT COURT
[Name of District]
[DISTRICT COURT CAPTION]
BRI EF IN OPP OSI TI ON TO D EFE ND AN T’S MOT ION T O D ISM IS S
FOR L ACK OF SU BJE CT MAT TER J URI SD IC TIO N U ND ER FED .
R. C IV. P. 12 (B) (1) AN D FOR FA ILU RE TO ST ATE A CL AIM
UN DE R F ED. R . C IV . P. 12 (B) (6)
[Insert Table of Contents for Brief]
[Insert Table of Authorities for Brief]
I. NATURE AND STAGE OF THE PROCEEDINGS
Defendant [Name of Defendant] moved for dismissal of Plaintiff’s [Name of
Plaintiff] [Date] Complaint alleging infringement of U.S. Patent No. 1 (“the ’001
patent”). For the reasons set forth herein, Defendant’s motions are without merit and
should be denied.
Defendant has submitted Abbreviated New Drug Applications (“ANDAs”) under
21 U.S.C. § 355(j) seeking approval from the FDA to commercially market generic
versions of Plaintiff’s patented drug BrandX indicated for the treatment of [name of
medical problem] using [active ingredient]. Plaintiff’s Complaint alleges that Defendant
seeks approval to engage in the commercial manufacture, use, or sale of a drug product
claimed in Plaintiff’s U.S. Patent No. 2 (“the ’002 patent”), and the commercial
manufacture, use, or sale of a drug product the use of which is claimed in the ’001 patent,
and has committed an act of infringement under 35 U.S.C. § 271(e)(2)(A). Defendant
brings this instant Motion to Dismiss for lack of subject matter jurisdiction under FED. R.
CIV. P. 12(b)(1), and for failure to state a claim upon which relief can be granted under
FED. R. CIV. P. 12(b)(6) (“Motion”).
II. SUMMARY OF ARGUMENT
This Court has subject matter jurisdiction over Plaintiff’s allegations under 28
U.S.C. § 1338, and Plaintiff has stated a claim for patent infringement under the language
of 35 U.S.C. § 271(e)(2)(A). The Federal Circuit has ruled that a Paragraph IV
certification is not a requirement as a matter of law for subject matter jurisdiction or for
the court to reach the merits of a claim under § 271(e)(2)(A). AstraZeneca Pharm. LP v.
Apotex Corp., 669 F.3d 1370, 1376–77 (Fed. Cir. 2012); see also Res. Found. of State
Univ. of N.Y. v. Mylan Pharm. Inc., 2012 WL 1901267, at *4–5 (D. Del. May 25, 2012)
729
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dor54588_24_app_663–914.indd 729 5/5/16 5:05 PM

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