Infringement Contentions

AuthorKenneth L. Dorsney
Pages739-740
Infringement Contentions
IN THE UNITED STATES DISTRICT COURT
[Name of District]
[DISTRICT COURT CAPTION]
CONFIDENTIAL—
OUTSIDE COUNSEL EYES ONLY
PLAINTIFF’S INFRINGEMENT CONTENTIONS
Pursuant to Local Rule __ and the [Date] Scheduling Order, Plaintiff, [Name
of Plaintiff], hereby submits its Initial Claim Chart on Infringement by Defendant
[Name of Defendant] regarding U.S. Patent No. 1 (“the ’001 Patent”) with respect to
Defendant’s Abbreviated New Drug Application (“ANDA”) No. 00-001 for generic
versions of BrandX.
Defendant’s ANDA No. 00-001 seeks approval to commercially manufacture,
use, and sell 15, 30, and 45 mg [active ingredient] tablets (“Defendant’s Generic
Product”). Defendant’s Generic Product is a pharmaceutical composition containing
the active pharmaceutical ingredient (“API”) [name of active ingredient] for treating
patients with [name of medical problem]. At a minimum, Defendant infringes, or will
infringe, literally or under the doctrine of equivalents, the asserted claims of the ’001
Patent under 35 U.S.C. §§ 271(a), (b), (c), and/or (e)(2)(A).
Further details on how Defendant’s Generic Product infringes or will infringe
each of the asserted claims of the ’001 Patent are provided in the chart below.
Because discovery is ongoing at this time, Plaintiff makes this Initial Claim Chart
based on information presently known to Plaintiff. Plaintiff reserves the right to
supplement and/or amend the Initial Claim Chart pursuant to the ____ Order [Cite]
and to the extent permitted by the Court based on information discovered during
litigation. In addition, the Court has not yet entered a claim construction order in this
case. Plaintiff reserves the right to supplement and/or amend this disclosure based on
a claim construction order entered by the Court.
If Defendant’s Generic Product is granted final approval by the U.S. Food &
Drug Administration (“FDA”) and marketed in the United States, it will infringe
claims of the ’001 Patent as set forth in the chart below under §§ 271(e)(2) and/or
271(a).
Additionally, the use of Defendant’s Generic Product by patients and/or
healthcare providers will infringe the method claims of the ’001 Patent. Plaintiff will
establish through and during discovery that Defendant has knowledge of the ’001
Patent and knows and intends that physicians and/or patients using its Generic
Product in accordance with the instructions and/or label provided by Defendant will
739
A-11
dor54588_24_app_663–914.indd 739 5/5/16 5:05 PM

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