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 Industry
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.
                                                
1This 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).
1 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).
2 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).
3 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).
4 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.
5