Responding to the Complaint

• Author: Kenneth Dorsney
• Pages: 105-139

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chapter 6

Responding to the

Complaint1

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 requirement that the patentee sue the generic Abbreviated New Drug

Application (ANDA) filer within forty-five days of receiving a Paragraph

IV notice letter and the relative priorities of multiple generic ANDA fil-

ers, 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 devel-

oping their litigation strategies.

II. Pre-Answer Motions

A. Motions to Dismiss

Instead of or before answering a complaint, the defendant may move to dis-

miss the claims for any of several reasons under Rule 12(b) of the Federal

Rules of Civil Procedure.2 Importantly, some of these bases for dismissal,

1. Mark J. Feldstein, Ph.D., Jennifer A. Johnson, Ph.D., & Jonathan R. Davies, Ph.D.

Finnegan, Henderson, Farabow, Garrett & Dunner LLP.

2. 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;

CHAPTER 6

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such as personal jurisdiction, are waived if not made either before or at

the time of answering; others, such as subject-matter jurisdiction, can be

raised at any time. Even though 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 always)3

ordered without prejudice.4 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 forty-five

days of receipt of the notice letter. Specifically, the impact of dismissal of

an action after the expiration of the forty-five-day window, is uncertain,

but arguably bars a patentee from refiling its case.5 For this reason, many

patentees concurrently 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 forty-five

day Hatch-Waxman filing requirement, consideration of potential bases to

dismiss 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.6

(6) failure to state a claim upon which relief can be granted; and (7) failure to join a party

under Rule 19.”).

3. 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).

4. See, e.g., In re Cyclobenzaprine Litig., 693 F. Supp. 2d 409, 418 (D. Del. 2010).

5. 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).

6. Rule 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.

II. Pre-Answer Motions 107

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.7 For patent cases, subject-matter jurisdiction is conferred

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.”8

The principal act of Congress for Hatch-Waxman suits by the patentee is

35 U.S.C. § 271(e)(2).9 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 Section

271(e)(2). For Declaratory Judgment counts, questions of subject-matter

jurisdiction have arisen for (1) claims brought by generics against an unas-

serted patent, and (2) claims for infringement brought by the patentee

under provisions other than Section 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.10 For patent cases,

the patentee has standing to sue.11 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

7. FED. R. CIV. P. 12(h)(3).

8. 28 U.S.C. §1338(a).

9. “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.” 35 U.S.C. §271(e)(2).

10. 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.”).

11. 35 U.S.C. §281 (“A patentee shall have remedy by civil action for infringement of

his patent.”).