Summary Judgment

• Author: Kenneth Dorsney
• Pages: 205-240

205

chapter 10

Summary Judgment1

Previous chapters have reviewed the statutory and regulatory scheme of

the Hatch-Waxman Act. Topics discussed have included procedural and

substantive requirements for filing an Abbreviated New Drug Application

(ANDA), and issues arising in patent litigation based on a filed ANDA hav-

ing a Paragraph IVcertification.2

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 the require-

ments for approval of ANDAs by the Food and Drug Administration (FDA),

and by overcoming all impediments based on patents for the correspond-

ing branded drug listed in the FDA’s Orange Book as of the filing of the

ANDA.3

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.4 Not all patent

issues in all cases can be resolved by the summary judgment procedure,

but because of the unique circumstances existing in Hatch-Waxman

1. Gregory S. Gewirtz and Arnold I. Rady, Lerner David Littenberg Krumholz &

Mentlik, LLP.

2. Federal Food Drug and Cosmetic Act §505, 21U.S.C. § 355(j)(2)(A)(vii) (2010).

3. See H.R. REP. NO. 98-857, pt. II (1984) [hereinafter HOUSE REPORT] (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

against an ANDA filer based on a listed patent within the prescribed forty-five-day period

following a patent owner’s receipt of the notice of the ANDA (21U.S.C. §355(j)(2)(B)) and

of the ParagraphIV certification (id. §355(j)(2)(A)(vii)), then FDA approval of the ANDA is

suspended or stayed for thirty 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).)

4. FED. R. CIV. P. 56.

CHAPTER 10

206

patent 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 1984,5

which is commonly referred to as the Hatch-Waxman Act, includes pro-

visions incorporated in the patent statute and in the Food, Drug, and

Cosmetic Act (FDCA).6 These provisions reflect a strong public interest

and public policy to encourage companies to develop generic drugs prior

to patent expiration, to simplify and to expedite the FDA’s generic drug

approval process, and provide courts with jurisdiction to hear patent dis-

putes raised by proposed generic drugs described in a filed ANDA.7 Illus-

trative provisions of the Hatch-Waxman legislation implementing these

objectives include:

(i) 21 U.S.C. § 355(j), which created the ANDA for seeking FDA

approval of generic versions of previously 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;8

(ii)35 U.S.C. §271(e)(1), which provided generic drug companies with

a limited “safe harbor,” or “immunity” from patent infringement liability

in their efforts in developing data and information in support of the filing

of ANDAs prior to patent expiration;9

5. Pub. L. No. 98-417, 98 Stat. 1598 (1984).

6. 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).

7. See, e.g., HOUSE REPORT, supra note 2; FTC, Generic Drug Entry Prior to Patent

Expiration: An FTC Study (2002); 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).

8. 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 “to show

that the new [generic] drug is bioequivalent to the listed drug” (21U.S.C. §355(j)(2)(A)(iv)).

9. “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).

I. The Ideal Adjudication for a Hatch-Waxman Case 207

(iii)21 U.S.C. §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;10 and

(iv)35 U.S.C. § 271(e)(2), which created a judicial procedure permit-

ting 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.11

Although the FDA lists the patents that pertain to NDA-approved

drugs,12 it defers to the courts to resolve any related patent issues.13 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.14 The legisla-

tion also encourages patent owners to commence such patent infringement

actions promptly, within forty-five days of receiving notice of the ANDA, to

trigger a stay that precludes the FDA from approving the ANDA for up to

thirty months, unless a court resolves the patent issues sooner.15

10. 21 U.S.C. § 355(j)(5)(B)(iv).

11. “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 11) 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, 496 U.S.

at 678. 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.

12. 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, electronically located at http://www

.accessdata.fda.gov/scripts/cder/ob/default.cfm.

13. “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).

14. See supra note 10.

15. The stay precludes the FDA’s approval of the ANDA until the earliest of either

the expiration of the patent, judicial resolution of the correctness of the ANDA applicant’s

certification, or thirty months from the receipt of the notice. 21U.S.C. § 355 (j)(5)(B)(iii).

To take advantage of the statutory thirty-month stay precluding the FDA from approving

an ANDA, the patent owner must commence a patent infringement suit against the ANDA

applicant within forty-five days from the date it received the ANDA filer’s required notice

of the ANDA and the Paragraph IVcertification. See Eli Lilly, 496 U.S. at 677 (if a pioneer

drug company fails to sue an ANDA filer within forty-five days of receiving the notice, the

FDA may immediately approve the ANDA). The ANDA applicant must give notice of the