Remedies

• Author: Kenneth Dorsney
• Pages: 321-356

321

chapter 14

Remedies

I. Introduction

The remedies available in Hatch-Waxman cases in principle track the

equitable and compensatory 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 Hatch-Waxman litigation. Compensatory damages are not typical in

Hatch-Waxman cases because the generic drug has, most often, not yet

been made, used, or sold commercially. Damages may be trebled for willful

infringement, and attorneys’ fees are available in exceptional cases.

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 35 U.S.C. § 285 attorneys’ fees, the Hatch-

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

(C) of section 271(e)(4). Those provisions 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,

Kenneth L. Dorsney, Morris James LLP; Gurpreet Singh Walia, M.B., B.S., M.D., Cohen &

Gresser LLP; David S. Bloch, Winston & Strawn LLP; Thomas J. Vetter, Lucas & Mercanti

LLP.

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CHAPTER 14

322

(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

This chapter discusses the remedies available in Hatch-Waxman 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 Hatch-Waxman 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) requires relief in Hatch-Waxman

cases in addition to the relief available by an injunction or an award

of money damages.2 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 infringement.3 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.4 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.5 This amounts to a “de facto injunction.”6 An exception to this

rule appears in SmithKline Beecham Corp. v. Apotex Corp.7 The court in

that case reasoned that “[a]s a form of patent injunction, the delay order

1. 35 U.S.C. §271(e)(4)(A)–(C).

2. 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.C.A.N. 2647, 2679).

3. Id.

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

5. Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349, 1367 (Fed. Cir. 2014) (“while

the injunction remedy rests within the discretion of the district court, the order to delay the

approval of the ANDA until patent expiration is not discretionary”) (Moore, J., dissenting).

6. Id.

7. 247 F. Supp. 2d 1011 (N.D. Ill. 2003); overturned on other grounds, 403 F.3d 1331

(Fed. Cir. 2005).

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II. Section 271(e)(4)(A)—FDA Preclusion Orders 323

is subject to the principles that govern such injunctions, although only in

a very unusual case will those principles counsel for withholding relief.”8

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.9 The case is notable though for the court’s navigation of the man-

datory “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 ordinar-

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

nature, is not formally an injunction.10 Section 271(e)(4)(A) is concerned

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

finding infringement[,]”11 though ordering a later date for FDA approval

has substantially the same effect as an injunction. Therefore, with the

exception of the minority view in SmithKline, principles of equity 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 below,

provides a basis for an equitable injunction in Hatch-Waxman cases using

permissive language.12 This section, in turn, requires consideration of tra-

ditional 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 Hatch-Waxman

litigation.13

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.”14 If the FDA did not approve an ANDA before the court’s infringe-

ment finding, the court’s section 271(e)(4)(A) order will set a specific date

for ANDA approval.15 In most cases, the date set will be the date of patent

expiration.16 Several courts have held though that patent owners may also

capture the six-month period of pediatric exclusivity17 as part of a section

8. Id. at 1050.

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

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

11. Id.

12. See 35 U.S.C. § 271(e)(4)(B).

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

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

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

§ 271(e)(4)(A)).

16. Id. at 1368; but see SmithKline, 247 F. Supp. 2d at 1050–51 (denying relief after

infringement finding).

17. See 21 U.S.C. § 355a.

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