Initiating Litigation

• Author: Kenneth Dorsney
• Pages: 89-104

89

chapter 5

Initiating Litigation1

I. Parties

A. Proper Plaintiffs

A “patentee” has a right to seek remedy by civil action for patent infringe-

ment.2 In general, only a patent owner or an exclusive licensee has stand-

ing to bring a patent infringement suit.3 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, own-

ers and assignees). These plaintiffs can sue in their own names.

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 patent

and lack exclusionary rights under the patent statutes (in general,

nonexclusive licensees). These plaintiffs lack standing to sue.4

The traditional standing analysis for patent cases applies to Hatch-

Waxman patent suits.5 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.6

1. John L. Abramic, Michael J. Fitzpatrick, & Kevin A. O’Connor, McAndrews, Held

& Malloy, Ltd.

2. 35 U.S.C. § 281.

3. Mars, Inc. v. Coin Acceptors, Inc., 527 F.3d 1359, 1367 (Fed. Cir. 2008).

4. Morrow v. Microsoft Corp., 499 F.3d 1332, 1339–40 (Fed. Cir. 2007).

5. In re Rosuvastatin Calcium Patent Litig., 719 F. Supp. 2d 388, 399 (D. Del. 2010).

6. Pfizer Inc. v. Elan Pharm. Research 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

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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 (FDCA).7 Accord-

ingly, the person submitting the Abbreviated New Drug Application

(ANDA) is a proper defendant. Under Food and Drug Administration

(FDA) regulations, the name and address of the ANDA applicant (i.e., “any

person who submits an application”) must be included in the application.8

In the event that the applicant is a foreign corporation, an agent who

“resides or maintains a place of business within the United States” must

countersign the application.9

Courts have held that parties that were actively involved in preparing

an ANDA may be proper defendants:10

Parties “actively involved” in preparing the ANDA are deemed to have

“submit[ted]” the ANDA, regardless of whether they are the named

applicant, this is especially true where the parties involved are in the

same corporate family. “Active involvement” includes “marketing and

distributing the approved generic drugs in the United States.”

In addition to suing parties actively involved in preparing the ANDA,

patent owners may also sue manufacturers or suppliers of the alleg-

edly infringing product (or the active ingredient of the product).11 Some

analysis. 719 F. Supp. 2d 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 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. 35 U.S.C. § 271(e)(2)(A).

8. 21 C.F.R. §§ 314.3(b), 314.50(a)(1), 314.94(a)(1).

9. 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).

10. Cephalon, Inc. v. Watson Pharm., Inc., 629 F. Supp. 2d 338, 349 (D. Del. 2009)

(internal citations omitted); see also Aventis Pharma Deutschland GmbH v. Lupin Ltd., 403

F. Supp. 2d 484, 494 (E.D. Va. 2005); Wyeth v. Lupin Ltd., 505 F. Supp. 2d 303, 306–07

(D. Md. 2007).

11. In situations where an ANDA product will contain ingredients supplied by parties

other than the ANDA applicant, the supplier of the ingredient may submit to the FDA a Drug

Master File (DMF), a document that typically includes information about the ingredient,

such as manufacturing, chemistry, and/or processing information. FDA regulations allow

an ANDA applicant to incorporate the supplier’s DMF by reference. 21 C.F.R. § 314.420.