Initiating Litigation

AuthorKenneth L. Dorsney
chapter 5
Initiating Litigation
I. Parties
A. Proper Plaintiffs
A “patentee” has a right to seek remedy by civil action for patent infringe-
ment.1 In general, only a patent owner or an exclusive licensee has stand-
ing to bring a patent infringement suit.2 The Federal Circuit has identified
three general categories of plaintiffs in analyzing the standing issue in
patent suits:
1. Plaintiffs that hold all legal rights to the patent (in general,
owners and assignees). These plaintiffs can sue in their own
2. Plaintiffs that hold patent exclusionary rights and interests,
but not all substantial rights to the patent (in general, exclusive
licensees). These plaintiffs can sue, but only if the patent owner
is joined as a plaintiff.
3. Plaintiffs that hold less than all substantial rights to the pat-
ent and lack exclusionary rights under the patent statutes (in
general, nonexclusive licensees). These plaintiffs lack standing
to sue.3
John L. Abramic and Katherine H. Johnson, Steptoe & Johnson LLP; Kevin A. O’Connor,
Neal, Gerber & Eisenberg LLP; and Aaron F. Barkoff, McAndrews, Held & Malloy, Ltd.
2. Mars, Inc. v. Coin Acceptors, Inc., 527 F.3d 1359, 1367 (Fed. Cir. 2008).
3. Morrow v. Microsoft Corp., 499 F.3d 1332, 1339–40 (Fed. Cir. 2007); Takeda Pharm.
Co., LTD v. Handa Pharms., LLC, No. 11-00840, 2013 U.S. Dist. LEXIS 187604, at *194–98
(N.D. Cal. Oct. 17, 2013).
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The traditional standing analysis for patent cases applies to Hatch-
Waxman patent suits.4 Accordingly, where a drug maker does not own the
patent or does not hold all substantial rights to the patent, it lacks stand-
ing to sue for infringement.5
II. Proper Defendants
It is an act of infringement to submit an application under section 505(j)
or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.6 Accordingly,
the person submitting the Abbreviated New Drug Application (ANDA) is
a proper defendant. Under Food and Drug Administration (FDA) regula-
tions, the name and address of the ANDA applicant (i.e., “any person who
submits an application”) must be included in the application.7 In the event
that the applicant is a foreign corporation, the application must be coun-
tersigned by an agent who “resides or maintains a place of business within
the United States.”8
Courts have held that parties that were actively involved in preparing
an ANDA may be proper defendants:
Parties “actively involved” in preparing the ANDA are deemed to
have “submit[ted]” the ANDA, regardless of whether they are the
4. In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 399 (D. Del. 2010).
5. Pfizer Inc. v. Elan Pharm. Res. Corp., 812 F. Supp. 1352, 1374 (D. Del. 1993). In In re
Rosuvastatin Calcium Patent Litigation, the court was asked to decide whether the standing
analysis for Hatch-Waxman patent suits differs from the traditional standing analysis. 719
F. Supp. at 398–99. One of the plaintiffs in the case did not own substantial rights in the
patent-in-suit, but asserted that it had standing because (1) it served as the exclusive agent
of the New Drug Application (NDA) owner, (2) it submitted the subject NDA to the FDA,
and (3) it was the licensed marketer of the drug of the subject NDA. The plaintiff conceded
that under that traditional analysis, it would not have standing, but argued that a different
conclusion was warranted because “the text, structure, and legislative history of the Hatch-
Waxman Act supports standing for an NDA holder in the first instance and for the agent
of an NDA holder under agency principles.” Id. at 398. The court rejected the plaintiff’s
arguments, stating that the traditional standing analysis applied to Hatch-Waxman patent
suits, and dismissed the plaintiff for lack of standing. Id. at 399.
7. 21 C.F.R. §§ 314.3(b) & 314.50(a)(1) & 314.94(a)(1).
8. 21 C.F.R. § 314.50(a)(5). In In re Rosuvastatin Calcium Patent Litigation, the court
held that a subsidiary of a foreign ANDA applicant that signs an ANDA and intends to
benefit directly from the ANDA, is subject “to suit under § 271(e) as one who has ‘submitted’
an ANDA.” 2008 U.S. Dist. LEXIS 96289, 2008 WL 5046424, at *10 (D. Del. Nov. 24, 2008);
see also In re Rosuvastatin Calcium Patent Litig. v. Aurobindo Pharma Ltd., 703 F.3d 511,
528 (Fed. Cir. 2012) (applying same).
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