Remedies

• Author: Kenneth Dorsney
• Pages: 241-276

241

chapter 11

Remedies1

I. Introduction

Hatch-Waxman remedies in principle track the equitable and compen-

satory remedies available in patent infringement cases generally, but

with certain very significant exceptions. Equitable relief in the form of

an injunction is the most commonly requested relief in ANDA litigation.

Compensatory damages are not typical because the generic drug has, most

often, not yet been made, used, or sold commercially.

The Hatch-Waxman specific remedies depart from those available

in traditional patent cases, not necessarily in the type, form, or manner

of relief available, but in the starting point for the authority to grant

the relief. With the exception of Section 285 attorneys’ fees, the Hatch-

Waxman infringement remedies are found in subparagraphs (A), (B), and

(C) of 35 U.S.C. § 271(e)(4). Those provisions2 provide:

A. The court shall order the effective date of any approval of the drug

or veterinary biological product involved in the infringement to be

a date which is not earlier than the date of the expiration of the

patent which has been infringed,

B. Injunctive relief may be granted against an infringer to prevent

the commercial manufacture, use, offer to sell, or sale within the

United States or importation into the United States of an approved

drug, veterinary biological product, or biological product,

C. Damages or other monetary relief may be awarded against an

infringer only if there has been commercial manufacture, use, offer

to sell, or sale within the United States or importation into the

United States of an approved drug, veterinary biological product,

or biological product[.]

1. Kenneth L. Dorsney and Mary B. Matterer, Morris James LLP.

2. 35 U.S.C. § 271(e)(4)(A)-(C).

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This chapter discusses the remedies available in ANDA cases pursuant

to Section 271(e)(4). Equitable remedies generally available to all patent

litigants are also briefly discussed. Although not authorized by Section

271(e)(4)(B), these other equitable remedies play an important role in

ANDA litigation. Money damages pursuant to Section 271(e)(4)(C), along

with treble damages for willfulness and attorneys’ fees for exceptional

conduct, are discussed at the end of the chapter.

II. Section 271(e)(4)(A)—FDA Preclusion Orders

A. ANDA Approval Date

Subparagraph (A) of Section 271(e)(4) authorizes relief in ANDA cases in

addition to the relief available by an injunction or an award of money dam-

ages.3 Courts have authority pursuant to this section to direct the Food

and Drug Administration (FDA) to withhold or withdraw Abbreviated

New Drug Application (ANDA) approval following a finding of infringe-

ment.4 The section provides, in pertinent part, that “the court shall order

the effective date” of the ANDA to be no earlier than the date of patent

expiration.5 Courts appear to uniformly apply the mandatory “shall” of

Section 271(e)(4)(A) as requiring issuance of an order directing the FDA

to withhold or withdraw ANDA approval once infringement is established.

An exception to this rule appears in SmithKline Beecham Corp. v. Apotex

Corp.6 The court in that case reasoned that “[a]s a form of patent injunc-

tion, the delay order is subject to the principles that govern such injunc-

tions, although only in a very unusual case will those principles counsel

for withholding relief.”7

SmithKline represents a minority position regarding the application

of Section 271(e)(4)(A), and was later overturned on appeal on the issue of

validity.8 The case is notable for the court’s navigation of the mandatory

“shall” of Section 271(e)(4)(A) and its reference to principles of equity in

denying the relief. Application of Section 271(e)(4)(A) does not ordinarily

3. In re Omeprazole Patent Litig., 536 F.3d 1361, 1367 (Fed. Cir. 2008); see also Pfizer

Inc. v. Apotex Inc., 731 F. Supp. 2d 754, 761 (N.D. Ill. 2010) (citing H.R. REP. No. 98-857,

pt. 1, at 46 (1984), reprinted in 1984 U.S.C.A.N. 2647, 2679) (additional relief available in

addition to an injunction)).

4. Id.

5. 35 U.S.C. § 271(e)(4)(A) (emphasis added).

6. 247 F. Supp. 2d 1011 (N.D. Ill. 2003); overturned on other grounds, 403 F.3d 1331

(Fed. Cir. 2005).

7. Id. at 1050.

8. SmithKline Beecham Corp. v. Apotex Corp.,403 F.3d 1331, 1364 (Fed. Cir. 2005).

II. Section 271(e)(4)(A)—FDA Preclusion Orders 243

involve equitable considerations. The remedy, even if injunctive-like in

nature, is not formally an injunction.9 Section 271(e)(4)(A) is concerned only

with “the date of approval a court orders for an infringing drug after finding

infringement[,]”10 though ordering a later date for FDA approval has sub-

stantially the same effect as an injunction. Therefore, with the exception of

the minority view in SmithKline, principles of equity should play no role in

the decision to grant or deny the relief or in the date set for FDA approval.

In contrast, Section 271(e)(4)(B), discussed in greater length infra,

provides a basis for an equitable injunction in ANDA cases using permis-

sive language.11 This section, in turn, requires consideration of traditional

equity principles. The two sections, although both delay entry of a generic

drug to market, are distinct and do not operate together to provide patent

owners with an automatic permanent injunction in ANDA litigation.12

B. Approved and Unapproved ANDAs

A court’s application of Section 271(e)(4)(A) should “not differentiate between

unapproved ANDAs that are pending FDA action and approved ANDAs.”13

If the FDA did not approve an ANDA before the court’s infringement find-

ing, the court’s Section 271(e)(4)(A) order will set a specific date for ANDA

approval.14 In most cases, the date set will be the date of patent expiration.15

Several courts have held though that patent owners may also capture the six-

month period of pediatric exclusivity16 as part of a Section 271(e)(4)(A) order,17

although the statute governing pediatric exclusivity does not expressly grant

such authority.18

9. Pfizer Inc. v. Apotex Inc., 731 F. Supp. 2d 754, 760–61 (N.D. Ill. 2010).

10. Id.

11. See 35 U.S.C. § 271(e)(4)(B).

12. Pfizer, 731 F. Supp. 2d at 760–61.

13. Mylan Labs., Inc. v. Thompson, 332 F. Supp. 2d 106, 112 (D.D.C. 2004) .

14. In re Omeprazole Patent Litig., 536 F.3d 1361, 1367 (Fed. Cir. 2008) (citing 35

U.S.C. § 271(e)(4)(A)).

15. Id. at 1368; but see SmithKline, 247 F. Supp. 2d at 1050-1051 (denying relief after

infringement finding).

16. See 21 U.S.C. § 355a.

17. Altana Pharma AG v. Teva Pharms. USA Inc., 2010 WL 3211126, at *3–4 (D.N.J.

Aug. 13 2010) (not for publication); (citing Alcon, Inc. v. Teva Pharms. USA, Inc., 2010 WL

3081327, at *1 (D. Del. Aug. 5, 2010); Takeda Pharm. Co. Ltd. v. Teva Pharms. USA, Inc.,

2009 WL 3738738, at *1–3 (D. Del. Nov. 9, 2009); Astrazeneca AB v. Impax Laboratories,

Inc., 490 F. Supp. 2d 368, 379 (S.D.N.Y. 2007), aff’d, In re Omeprazole Patent Litigation, 536

F.3d 1361 (Fed. Cir. 2008)); Mylan Labs., Inc. v. Thompson, 332 F. Supp. 2d 106, 123–124

(D.D.C. 2004); but see Roche Palo Alto LLC v. Apotex, Inc., 526 F. Supp. 2d 985, 1000 (N.D.

Cal. 2007) (“21 U.S.C. § 355(a)(2)(B) does not provide a sufficient basis for this Court to

restrict the FDA’s approval of the ANDA beyond the expiration date of the patent.”) (citation

omitted).

18. Wyeth v. Teva, 2010 WL 3211126, at *3 (D.N.J. Aug. 13, 2010) (not for publication).