Reproduced with permission from BNA’s Patent, Trademark & Copyright Journal, 91 PTCJ 1505, 3/25/16. Copy-
right 姝2016 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
PATENTS
Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month
Regulatory Stay in Hatch-Waxman Litigation
BYANDREA WEISS JEFFRIES AND NANCY L.
SCHROEDER
Upon initiation of a patent infringement action be-
tween branded and generic pharmaceutical com-
panies, the Hatch-Waxman Act (21 U.S.C.
§ 355(j)) provides for an automatic 30-month stay of
Food and Drug Administration approval of the Abbrevi-
ated New Drug Application (ANDA) for the proposed
generic pharmaceutical product. As the legislative his-
tory of the Act makes clear, the purpose of the 30-
month stay is to permit resolution of the underlying pat-
ent dispute before the generic product may enter the
market.
The stay serves the interests of both parties: Prevent-
ing entry of a generic to the market forestalls signifi-
cant disruption to the market for the branded pharma-
ceutical that later removal of an infringing generic
product cannot always repair, and precludes the ge-
neric from incurring liability that can run into the hun-
dreds of millions of dollars by virtue of launching a
product later found to infringe.
Litigation under the Hatch-Waxman Act has pro-
ceeded with the 30-month stay largely serving its in-
tended purpose. However, since enactment of the
America Invents Act (AIA) in 2012, parties have sought
stays of the district court litigation during the pendency
of inter partes review (IPR) proceedings. This has
raised questions about the 30-month stay, and whether
it should be extended. Although IPRs progress rapidly,
with final written decisions for instituted IPRs issuing
within 18 months of a petition’s filing date,
1
a stay of
the district court litigation during some or all of the 18
months significantly shortens the time available for liti-
gation to resolve before the 30-month stay expires.
This article explores two recent cases that have ad-
dressed the 30-month regulatory stay in light of litiga-
tion stays pending the resolution of IPRs and identifies
considerations that can impact extensions of the regu-
latory stay.
The Regulatory Stay
Under the Hatch-Waxman Act, once a branded phar-
maceutical company has received a generic company’s
Paragraph IV certification
2
asserting that the branded
company’s Orange Book
3
listed patents covering the
Reference Listed Drug (RLD) are invalid or not in-
fringed by the generic drug’s commercialization,
4
the
branded company has 45 days to file suit in district
1
See 35 U.S.C. § 316(a)(11); 37 C.F.R. § 42.100(b).
2
3
The ‘‘Orange Book’’ refers to the FDA’s Therapeutic
Equivalence Determinations publication. Once the FDA ap-
proves the branded manufacturer’s New Drug Application
(NDA), it publishes information about patents identified in the
NDA as covering either the drug (including the active ingredi-
ent and formulation) or a method of using the drug. See 21
U.S.C. § 355(b)(1)(G); 21 C.F.R. § 314.53.
4
See 21 U.S.C. §355(b)(2)(A)(i)-(iv); id.
§ 355(j)(2)(A)(vii)(I)-(IV).
Andrea Jeffries is a partner in the Los Angeles
office of WilmerHale, with a focus on tech-
nology and intellectual property litigation.
Nancy Schroeder is a senior associate in the
IP Litigation group at WilmerHale, also in Los
Angeles.
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