Responding to the Complaint

• Author: Kenneth Dorsney
• Pages: 175-211

175

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

FED. R. CIV. P.

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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CHAPTER 9

176

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.

6.

FED. R. CIV. P.

12(h)(3).

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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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