Summary Judgment

AuthorKenneth Dorsney
chapter 13
Summary Judgment
In prior chapters the statutory and regulatory scheme of the Hatch-
Waxman Act has been reviewed. Topics discussed have included proce-
dural and substantive requirements for filing an Abbreviated New Drug
Application (ANDA), and issues arising in patent litigation based on a
filed ANDA having a paragraph IVcertification.1
One of the primary objectives of the Hatch-Waxman legislative scheme
is the encouragement of generic drug manufacturers to bring generic drugs
to market at the earliest date practical, by complying with Food and Drug
Administration (FDA) requirements for approval of ANDAs, and by over-
coming all impediments based on patents for the corresponding branded
drug listed in the FDA’s Orange Book as of the filing of the ANDA.2
This chapter focuses on “summary judgment,” a specific procedure
available to litigants in U.S. district courts for obtaining an early adju-
dication of issues in the case. The summary judgment procedure is
available prior to a trial and prior to some or all of the most costly and
time-consuming aspects of a lawsuit, including fact and expert discovery,
pretrial preparations, and the conduct of the trial itself.3 Not all patent
issues in all cases can be resolved by the summary judgment procedure,
Gregory S. Gewirtz, Arnold I. Rady, and Daniel P. Laine, Lerner David Littenberg Krumholz
& Mentlik LLP.
1. Food, Drug, and Cosmetic Act §505, 21U.S.C. § 355(j)(2)(A)(vii) (2010).
2. See
98-857, pt. II (1984) [hereinafter
]. The Hatch-
Waxman provisions, as amended, bring FDA approval and resolution of the patent issues
together. For example, if the patent owner brings a patent infringement action based on a
listed patent within the prescribed 45-day period following a patent owner’s receipt of the
notice (21U.S.C. § 355(j)(2)(B)) of the ANDA and paragraph IV certification (id. § 355(j)
(2)(A)(vii)) therein, then FDA approval of the ANDA is suspended or stayed for 30 months
after the date of receipt of the notice of certification by the patent owner, unless the listed
patent expires or a court judgment is entered in favor of the paragraphIV certification,
i.e., that listed patents are invalid or not infringed or unenforceable. Id. § 355(j)(5)(B)(iii);
21C.F.R. §314.107(b)(3) (2009).
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but because of the unique circumstances existing in Hatch-Waxman pat-
ent litigation, it has become an effective and frequently used tool, espe-
cially for ANDA applicants. An early resolution of the patent litigation
can potentially terminate the stay precluding FDA approval of the ANDA
and lead to the prompt commercial launch of the generic product.
I. The Ideal Adjudication for a Hatch-Waxman Case
A. Objectives of the Hatch-Waxman Act Include
Early Resolution of Patent Issues
The Drug Price Competition and Patent Term Restoration Act of1984,4
commonly referred to as the Hatch-Waxman Act, includes provisions
incorporated in the patent statute and in the Food, Drug, and Cosmetic
Act.5 These provisions reflect a strong public interest and public policy to
encourage companies to develop generic drugs prior to patent expiration,
to simplify and expedite the FDA’s generic drug approval process, and pro-
vide courts with jurisdiction to hear patent disputes raised by the proposed
generic drugs.6 Illustrative provisions of the Hatch-Waxman legislation
implementing these objectives include the following:
1. Section 355(j), which created the “abbreviated new drug applica-
tion” (ANDA) for seeking FDA approval of generic versions of pre-
viously approved drugs. The ANDA requires less information and
follows a more expedited review process compared to a new drug
application (NDA) for a new drug.7
2. Section 271(e)(1), which provided generic drug companies with
a limited “safe harbor,” or “immunity” from patent infringement
4. Pub. L. No. 98-417, 98 Stat. 1598 (1984).
5. 35 U.S.C. §271(e); 21U.S.C. §355(j)(5)(B)(iii); 21 C.F.R. § 314.107(b)(3)(i)(A).
6. See, e.g.,
, supra note 2
Eli Lilly & Co.v. Medtronic, Inc., 496 U.S. 661, 676 (1990);
Glaxo, Inc.v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997); accord Pliva, Inc. v.
Mensing, 131 S. Ct. 2567, 2582 (2011).
7. An ANDA does not require costly and time-consuming investigations showing the new
generic drug is “safe in use” and “effective for use” as required for a new drug application
(NDA) under 21 U.S.C.§ 355(b)(1)(A). Instead, the ANDA only requires information “to
show that the route of administration, the dosage form, and the strength of the new [generic]
drug are the same as those of the listed drug” (21U.S.C.§ 355(j)(2)(A)(iii)) and that the new
[generic] drug is the “bioequivalent” of the listed drug. 21U.S.C.§ 355(j)(2)(A)(iv).
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I. The Ideal Adjudication for a Hatch-Waxman Case 281
liability in their efforts in developing data and information in sup-
port of the filing of ANDAs prior to patent expiration.8
3. Section 355(j)(5)(B)(iv)), which encouraged generic developers
to file ANDAs promptly, to qualify as the first ANDA filer for a
generic drug associated with a branded drug and be rewarded
with 180-day exclusivity as the only generic drug permitted in the
market;9 and
4. Section 271(e)(2), which created a judicial procedure permitting
U.S. district courts to hear and resolve patent issues after an
ANDA is filed having a paragraph IV certification, and prior to
FDA approval of the subject generic drug and prior to marketing.10
Although the FDA lists the patents that pertain to NDA approved
drugs,11 it defers to the courts to resolve any related patent issues.12 The
Hatch-Waxman Act includes provisions to provide courts with a basis to
take jurisdiction of patent infringement cases upon the filing of an ANDA
with a paragraphIV certification, without waiting for FDA approval of the
generic drug or actual marketing of the generic drug product.13 The legisla-
8. “It shall not be an act of infringement to make, use, offer to sell, or sell within the
United States or import into the United States a patented invention . . . solely for uses
reasonably related to the development and submission of information under a federal law
which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
35U.S.C. § 271(e)(1) (emphasis added).
9. 21 U.S.C. § 355(j)(5)(B)(iv).
10. “It shall be an act of infringement to submit . . . an application under section 505(j)
of the Federal Food, Drug, and Cosmetic Act . . . for a drug claimed in a patent or the use
of which is claimed in a patent . . . if the purpose of such submission is to obtain approval
under such Act to engage in commercial manufacture, use or sale . . . before the expiration
of such patent.” 35U.S.C. 271(e)(2). This artificial act of infringement has been interpreted
to require the filing of an ANDA containing a paragraph IV certification, which states
the intent to market the generic drug prior to expiration of patents listed in the FDA
Orange Book (see infra note 13) and a statement that such listed patents are invalid, are
unenforceable, or will not be infringed by the generic drug of the ANDA. Eli Lilly & Co.
v. Medtronic, Inc., 496 U.S. 661, 678 (1990). The created artificial act of infringement is
intended to assure that courts have subject matter jurisdiction or a justifiable controversy
to hear the case. Id.
11. Pursuant to 21 U.S.C. § 355(b)(1) and § 355(c)(2), an NDA applicant is required to list
patents that might cover the drug and its methods of use that are the subject of the NDA,
including patents that issue after NDA approval. 21 C.F.R. §§ 314.53(b), 314.54(e). The list
of patents appears in the FDA Orange Book,
12. “The FDA has stated that it lacks the resources and the expertise to review patents
submitted with NDAs, and that it intends listing disputes to be settled privately.” Ben
Venue Labs, Inc.v. Novartis Pharm. Corp., 10 F. Supp. 2d 446, 456 (D.N.J. 1998); accord
Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1377–78 (Fed. Cir. 2002).
13. See supra note 9.
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