Responding to the Complaint

AuthorKenneth L. Dorsney
chapter 9
Responding to the Complaint
I. Introduction to Responses in the
Hatch-Waxman Litigation Context
Understanding the options for responding to a complaint in the context
of Hatch-Waxman litigation, whether as the generic defendant accused of
infringement under 35 U.S.C. § 271(e)(2) or as the patentee in response to a
declaratory judgment action, is necessary for strategic considerations on both
sides. Considerations under the Hatch-Waxman Act, including the require-
ment that the patentee sue the generic Abbreviated New Drug Application
(ANDA) filer within 45 days of receiving a paragraph IV notice letter and the
relative priorities of multiple generic ANDA filers, uniquely affect strategies
for responding to a complaint, whether by motion or in an answer. While the
facts of each specific case may dictate different options and outcomes, this
chapter addresses key considerations for responding to a complaint that all
parties should bear in mind in developing their litigation strategies.
II. Pre-answer Motions
A. Motions to Dismiss
Instead of or before answering a complaint, the defendant may move to
dismiss the claims for any of several reasons under Rule 12(b) of the Fed-
eral Rules of Civil Procedure.1 Importantly, some of these bases for dis-
missal, such as personal jurisdiction, are waived if not made either before
Mark J. Feldstein, Ph.D., Jonathan R. Davies, Ph.D., and Yoonhee Kim, Finnegan,
Henderson, Farabow, Garrett & Dunner LLP
1. See
12(b) (“(1) lack of subject-matter jurisdiction; (2) lack of personal
jurisdiction; (3) improper venue; (4) insufficient process; (5) insufficient service of process;
(6) failure to state a claim upon which relief can be granted; and (7) failure to join a party
under Rule 19.”).
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or at the time of answering; others, such as subject-matter jurisdiction,
can be raised at any time. While all the bases for dismissal under Rule 12
are technically available in a Hatch-Waxman case, some are more common
due to considerations unique to these cases and their strategy.
Dismissals under Rule 12(b) are most commonly—but not always2
ordered without prejudice.3 Obtaining a dismissal without prejudice can
generally be used by a defendant to, for example, avoid an inconvenient
or otherwise undesirable venue. It may, however, only delay an inevitable
action if the defect—such as lack of personal jurisdiction—is curable by,
for instance, refiling in another district. In contrast, in the ANDA context,
obtaining a dismissal even without prejudice can have further significance
given the statutory requirement that the patentee sue within 45 days of
receipt of the notice letter. Specifically, some have argued that the impact
of dismissal of an action after the expiration of the 45-day window bars a
patentee from refiling its case.4 For this reason, many patentees concur-
rently file a so-called “protective suit” in a forum where the defendant has
admitted to or will concede to jurisdiction.
For this reason, it is important for the patentee to be particularly cog-
nizant of the potential bases for dismissal from the start. Likewise, given
the potential—but as yet undecided—value of undermining the 45-day
Hatch-Waxman filing requirement, consideration of potential bases to dis-
miss is significant for the generic company.
In the ANDA context, the most common bases for a Rule 12 motion to
dismiss are (b)(1) lack of subject-matter jurisdiction, (b)(2) lack of personal
jurisdiction, (b)(3) improper venue, (b)(6) failure to state a claim upon
which relief can be granted, and (b)(7) failure to join a party under Rule
19. These are addressed, in turn, below.5
1. Lack of Subject-Matter Jurisdiction
The district court must have subject-matter jurisdiction over the case;
otherwise, the case should be dismissed under Rule 12(b)(1) on the court’s
own initiative.6 For patent cases, subject-matter jurisdiction is conferred
2. See, e.g., AstraZeneca AB v. Mylan Labs. Inc., Nos. 00 Civ. 6749, 03 Civ. 6057,
2010 WL 2079722, at *1 (S.D.N.Y. May 19, 2010) (granting motion to dismiss antitrust
counterclaims with prejudice).
3. See, e.g., In re Cyclobenzaprine Patent Litig., 693 F. Supp. 2d 409, 418 (D. Del. 2010).
4. See, e.g., Pfizer Inc. v. Apotex, Inc., No. 08-cv-00948-LDD, 2009 WL 2843288, at *3
n.4 (D. Del. Aug. 13, 2009) (discussing the filing of protective suits and acknowledging
uncertainty surrounding the effect of a dismissal for lack of personal jurisdiction after the
45-day statutory window in which to file suit).
5. Rules 12(b)(4) and (5) relate to dismissal for insufficient process and insufficient
service of process, respectively. Dismissals under these rules are not specifically addressed
in this chapter as they are rare and not specific to ANDA cases.
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II. Pre-answer Motions 177
upon the district courts by section 1338(a) of Title 28, which provides
exclusive jurisdiction for civil actions “arising under any Act of Congress
relating to patents, plant variety protection, copyrights and trade-marks.”7
The principal act of Congress for Hatch-Waxman suits by the patentee is
35 U.S.C. § 271(e)(2).8 The Declaratory Judgment Act, 22 U.S.C. § 2201, is
similarly relevant for claims brought by the generic and some additional
claims brought by the patentee.
There are two primary Rule 12(b)(1) attacks on subject-matter juris-
diction for Hatch-Waxman cases: (1) whether the plaintiff has standing to
assert the patent and (2) whether there is a cause of action under § 271(e)(2).
For declaratory judgment counts, questions of subject-matter jurisdiction
have arisen for (1) claims brought by generics against an unasserted patent
and (2) claims for infringement brought by the patentee under provisions
other than §271(e)(2).
a. Patent Ownership Issues
A threshold requirement for subject-matter jurisdiction in patent infringe-
ment actions is that each plaintiff have standing to sue.9 For patent cases,
the patentee has standing to sue.10 Issues of standing potentially chal-
lengeable under Rule 12(b)(1) may arise, however, where ownership of the
patent is in question. Moreover, because the burden is on the plaintiff to
plead standing,11 the failure to aver sufficient status as the sole owner or
exclusive licensee may create the opportunity for moving to dismiss under
7. 28 U.S.C. § 1338(a).
8. 35 U.S.C. § 271(e)(2) (“It shall be an act of infringement to submit—(A) an
application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described
in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed
in a patent, or (B) an application under section 512 of such Act or under the Act of March 4,
1913 (21 U.S.C. 151—158) for a drug or veterinary biological product which is not primarily
manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other
processes involving site specific genetic manipulation techniques and which is claimed in
a patent or the use of which is claimed in a patent, if the purpose of such submission is to
obtain approval under such Act to engage in the commercial manufacture, use, or sale of a
drug or veterinary biological product claimed in a patent or the use of which is claimed in a
patent before the expiration of such patent.”).
9. Sicom Sys., Ltd. v. Agilent Techs., Inc., 427 F.3d 971, 975–76 (Fed. Cir. 2005)
(“Standing to sue is a threshold requirement in every federal action. Standing must be
present at the time suit is brought. The party bringing the action bears the burden of
establishing that it has standing.”) (citations omitted).
10. 35 U.S.C. § 281 (“A patentee shall have remedy by civil action for infringement of
his patent.”).
11. Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1364 (Fed. Cir. 2010) (“[I]n
a patent infringement action, ‘the plaintiff must demonstrate that it held enforceable title to
the patent at the inception of the lawsuit’ to assert standing.” (quoting Paradise Creations,
Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309–10 (Fed. Cir. 2003))); but see SiRF Tech., Inc.
v. Int’l Trade Comm’n, 601 F.3d 1319, 1328–29 (Fed. Cir. 2010) (recordation of assignment
with PTO creates presumption of ownership).
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