Guidance for Industry

Court Decisions, ANDA Approvals, and

180-Day Exclusivity Under

the Hatch-Waxman Amendments to the

Federal Food, Drug, and Cosmetic Act

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Procedural

March 2000
Guidance for Industry

Court Decisions, ANDA Approvals, and

180-Day Exclusivity Under

the Hatch-Waxman Amendments to the

Federal Food, Drug, and Cosmetic Act

Comments and suggestions regarding this document should be submitted within 90 days of publication in

the Federal Register of the notice announcing the availability of the guidance. All comments should be

identified with the docket number provided at the beginning of the notice. Submit comments to the

Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.

1-23, Rockville, MD 20857. 

After the comment period closes, comments should be provided in writing to the Center for Drug

Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 

20857.

Additional copies of this Guidance are available from:

 Office of Training and Communications

 Division of Communications Management

Drug Information Branch, HFD-210

Center for Drug Evaluation and Research

Food and Drug Administration

 5600 Fishers Lane, Rockville, MD 20857

(Phone 301-827-4573)

Internet: http://www.fda.gov/cder/guidance/index.htm.
TABLE OF CONTENTS

I. WHY IS FDA ISSUING THIS GUIDANCE?.....................................................................................................................1

II. STATUTORY AND REGULATORY BACKGROUND..................................................................................................2

A. ANDA APPROVALS AND COURT DECISION .................................................................................................................... 2

B. 180-DAY EXCLUSIVITY AND DECISION OF A COURT........................................................................................................ 2

III. LITIGATION, CURRENT ISSUES, AND AGENCY POSITION..................................................................................2

IV. EFFECT ON ANDA APPROVALS AND 180-DAY EXCLUSIVITY......................................................................4

A. NEW DEFINITION OF COURT .............................................................................................................................................. 4

B. IMPLEMENTATION OF NEW DEFINITION OF COURT ......................................................................................................... 4
1

Guidance for Industry1

Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under

the Hatch-Waxman Amendments to

the Federal Food, Drug, and Cosmetic Act

I. WHY IS FDA ISSUING THIS GUIDANCE?

This guidance is being issued in response to recent litigation and is intended to provide guidance to

the pharmaceutical industry regarding (1) the timing of approval of abbreviated new drug

applications (ANDAs) following an unsuccessful patent infringement action by the patent owner or

new drug application (NDA) holder and (2) the start of 180 days of generic drug exclusivity.

FDA's interpretation of two provisions of the Federal Food, Drug, and Cosmetic Act (the Act)

have been affected by recent court decisions interpreting the phrase "decision of a court" or "court

decision." Section 505(j)(5)(B)(iii) of the Act governs the approval of ANDAs when the patent

owner or NDA holder has brought a timely patent infringement action in response to the ANDA

applicant's notice of filing of a paragraph IV certification to a listed patent. Section 505(j)(5)(B)(iv)

of the Act governs the eligibility for and timing of 180-day exclusivity. The regulations

implementing these statutory provisions are found at 21 CFR 314.107. Certain aspects of these

regulations have been successfully challenged in TorPharm, Inc. v. Shalala and Mylan

Pharmaceuticals, Inc. v. Shalala.

2

 This guidance describes the Agency's response to those court

decisions.

 

1

This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and

Research (CDER) at the Food and Drug Administration. This guidance represents the Agency=s current

thinking on sections 505(j)(5)(B)(iii)(I) and (iv) of the Act. It does not create or confer any rights for or on any

person and does not operate to bind FDA or the public. An alternative approach may be used if such approach

satisfies the requirements of the applicable statutes, regulations, or both.

2

TorPharm, Inc. v. Shalala, No. 97-1925, 1997 U.S. Dist. LEXIS 21983 (D.D.C. Sep. 15, 1997), appeal withdrawn and

remanded, 1998 U.S. App. LEXIS 4681 (D.C. Cir. Feb. 5, 1998); vacated No. 97-1925 (D.D.C. Apr. 9, 1998); Mylan

Pharmaceuticals, Inc. v. Shalala, No. 99-2995, slip op. (D.D.C. Jan. 4, 2000).
2

II. STATUTORY AND REGULATORY BACKGROUND

A. ANDA Approvals and Court Decision

The concept of a court decision is used in two important places in section 505(j) of the Act — in the

provision governing the timing of ANDA approvals and in the 180-day exclusivity provision. There is a

30-month statutory bar to approval of an ANDA that is the subject of patent infringement litigation

except if "before the expiration of such period the court decides that such patent is invalid or not

infringed, the approval will be made effective on the date of the court decision" (section

505(j)(5)(B)(iii)(I) (emphasis added)). In implementing this provision, FDA interpreted court to mean

"the court that enters final judgment from which no appeal can be or has been taken" (21 CFR

314.107(e)(1) (1999)). The Agency's reasons for adopting this interpretation are discussed in the

preambles to the proposed and final rules implementing the 1984 Drug Price Competition and Patent

Term Restoration Act.3

B. 180-Day Exclusivity and Decision of a Court

Certain court decisions are also important for 180-day generic drug exclusivity. FDA's interpretation of

court in the court decision described in Section 505(j)(5)(B)(iii)(I) was influenced by the role such a

decision plays in 180-day exclusivity. The 180-day period of exclusivity can begin on either (1) the

date of first commercial marketing or (2) Athe date of a decision of a court ... holding the patent which

is the subject of the [paragraph IV] certification to be invalid, or not infringed, whichever is earlier@

(section 505(j)(5)(B)(iv) (emphasis added)). As described in the preambles to the implementing

regulations, FDA believed that for the 180-day exclusivity to have real meaning for the eligible ANDA

applicant, the court decision triggering the exclusivity must be the one that finally resolves the patent

infringement litigation related to the ANDA.4 Therefore, for purposes of section 505(j)(5)(B)(iv), FDA

determined that court means "the court that enters final judgment from which no appeal can be or has

been taken" (21 CFR 314.107(e)(1) (1999)).

III. LITIGATION, CURRENT ISSUES, AND AGENCY POSITION

FDA=s interpretation of the term court has been successfully challenged in the context of both the timing

of ANDA approvals and the commencement of 180-day exclusivity. In TorPharm v. Shalala, the

D.C. District Court found the FDA=s interpretation not supported by the statute and directed FDA to

approve an ANDA upon a decision of the district court finding a patent invalid, unenforceable, or not

infringed. When the case became moot, FDA's appeal of that decision was withdrawn, and the district

 

3

 54 FR 28872, 28893-95 (July 10, 1989); 59 FR 50338, 50352-54 (October 3, 1994).

4

 54 FR 28893-95 (July 10, 1989); 59 FR 50352-54 (October 3, 1994).
3

court opinion was vacated. In the period since the TorPharm decision, FDA has continued to apply

the definition of court set out at 314.107(e).5

Recently, in Mylan Pharmaceuticals, Inc. v. Shalala., the D.C. District Court found FDA=s

interpretation of court as used in the 180-day exclusivity context inconsistent with the statute=s plain

meaning. However, the court also determined that the applicant who relied in good faith on FDA=s

interpretation of the 180-day exclusivity provision should not be punished by losing its exclusivity. The

court therefore refused to order FDA to begin the running of 180-day exclusivity upon the decision of

the district court in the patent litigation at issue.

These recent decisions add considerable uncertainty to FDA=s implementation of the ANDA approval

and 180-day generic drug exclusivity programs. These regulatory programs already have been disrupted

by the changes in eligibility for 180-day exclusivity necessitated by Mova Pharmaceutical Corp. v.

Shalala and Granutec, Inc. v. Shalala.

6

 Therefore, in determining its response to the TorPharm and

Mylan decisions, a primary concern for the Agency has been to identify an approach that will minimize

further disruption and provide the regulated industry with reasonable guidance for making future

business decisions. 

The government has decided not to appeal the Mylan decision and will follow that court=s interpretation

of the statute in approving ANDAs and calculating the commencement of 180 days of exclusivity. 

Although the Agency believes that the statutory provisions at issue may properly be interpreted as FDA

sets out in § 314.107(e), the Agency nonetheless has determined that it is in the interest of the regulated

industry and the Agency to accept the interpretation of the TorPharm and Mylan courts. Therefore,

the Agency will not apply the definition of the court found at § 314.107(e) (1) and (2) (i)-(iii).7 The

Agency intends to formally remove the relevant sections of § 314.107(e), and will incorporate the

TorPharm and Mylan courts= interpretation of the statute into the final rule implementing the changes in

180-day exclusivity.8 As described in section IV, FDA will implement the new interpretation of the

term "court" prospectively, in a manner consistent with the court=s approach in Mylan.

 

5

 Guidance for industry 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal

Food, Drug, and Cosmetic Act, June 1998, p. 2, n. 3.

6 Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 (D.C.Cir. 1998); Granutec, Inc. v. Shalala, 46 U.S.P.Q.2d 1398

(4th Cir. 1998).

7

 Applicants will still be required to submit a copy of the relevant order or judgment to the Office of Generic Drugs

under § 314.107(e)(2)(iv).

8

 64 FR 42873 (August 6, 1999).
4

IV. EFFECT ON ANDA APPROVALS AND 180-DAY EXCLUSIVITY

A. New Definition of Court

FDA will interpret the term court as found in section 505(j)(5)(B)(iii)(I) and 505(j)(5)(B)(iv) to mean

the first court that renders a decision finding the patent at issue invalid, unenforceable, or not infringed. 

When it is the district court that renders such a decision, FDA may approve the ANDA as of the date

the district court enters its decision. For eligible applicants, 180-day exclusivity will also begin to run on

that date, unless it has already begun with commercial marketing. If the district court finds the patent is

infringed, but that decision is reversed on appeal, the Agency may approve the ANDA on the date the

district court issues a judgment that the patent is invalid, unenforceable, or not infringed pursuant to a

mandate issued by a court of appeals.9

Neither a stay nor a reversal of a district court decision finding the patent invalid, unenforceable, or not

infringed will have an effect on the approval of the ANDA or on the beginning, or continued running, of

exclusivity. Should the NDA holder or patent owner wish to prevent an applicant with an approved

ANDA from marketing its product during the course of an appeal, it must obtain an injunction from the

court. If there is an injunction barring marketing of an approved drug, the ANDA applicant and NDA

holder are asked to notify FDA, and the Agency will move the drug to the discontinued section of

Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), so as to

minimize confusion in the marketplace. Once the injunction is lifted or expires and if the ANDA

applicant notifies the Agency it has begun marketing its product, the drug will be moved back to the

active section of the Orange Book. The 180-day exclusivity period will continue to run during the

pendency of a stay or injunction.

B. Implementation of New Definition of Court

The new definition of court will apply to certain ANDAs submitted after the publication of this

guidance. Specifically, the new definition will be used for approval and exclusivity determinations for

ANDAs containing a paragraph IV certification where the ANDA cites a reference listed drug for which

no other ANDA containing a paragraph IV certification has been submitted.

This new interpretation of the statute may substantially change the value of the 180-day exclusivity. As

Judge Roberts recognizes in the Mylan opinion, applicants who have made certain business decisions

in good faith reliance upon an FDA regulation should not be penalized for their actions. For example,

the potential change in the value of exclusivity may have considerable effect upon an ANDA applicant=s

willingness to file a paragraph IV certification to a patent and to undertake the effort and expense of

litigating a patent infringement suit. This may be particularly true for patent challenges that are seen as

risky, but for which the possible award of a full exclusivity was an adequate incentive. Judge Roberts

also noted that based upon FDA=s interpretation of the statute, ANDA applicants have held products

off the market even after a victory in the district court.

 

9 This is the same process as described in current § 314.107(e)(2)(iii).
5

The Agency believes that an implementation plan for the new definition of court that

recognizes the industry=s reliance on the previous definition and establishes a bright line for

ANDAs affected by the new definition will minimize the disruption to the ANDA approval and

180-day exclusivity programs. Moreover, the Agency believes that this approach will lessen the

likelihood that ANDA applicants will sue the Agency alleging that they, like Geneva in the Mylan

case, relied in good faith on the Agency=s regulation and would be irreparably injured by

application of the new interpretation to pending ANDAs.