AuthorKenneth L. Dorsney
chapter 14
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
dor54588_14_ch14_321–356.indd 321 5/5/16 5:44 PM
(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
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).
dor54588_14_ch14_321–356.indd 322 5/5/16 5:44 PM
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
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
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).
dor54588_14_ch14_321–356.indd 323 5/5/16 5:44 PM

To continue reading

Request your trial