Guidance for Industry
180-Day Generic Drug 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)
June 1998
Procedural Guidance 5 Guidance for Industry
180-Day Generic Drug 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, 5630 Fishers Lane, rm. 1061, 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 are available from:
The Drug Information Branch (HFD-210),Center for Drug Evaluation and Research (CDER),
5600 Fishers Lane, Rockville, MD  20857 (Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm GUIDANCE FOR INDUSTRY1
180-Day Generic Drug Exclusivity Under the Hatch-Waxman
Amendments to the Federal Food, Drug, and Cosmetic Act
I. WHY IS FDA ISSUING THIS GUIDANCE?
This guidance is intended to provide industry with information on how the Food and Drug
Administration (FDA) is applying the 180-day generic drug exclusivity provisions of the Federal
Food, Drug, and Cosmetic Act (the Act) in light of recent court decisions.  The guidance
addresses the issue of the elimination of the "successful defense" requirement, which required an
abbreviated new application (ANDA) applicant to be sued for patent infringement and to prevail
in the litigation to receive the 180-day period of marketing exclusivity.  This guidance will remain
in effect until superseded by new regulations or new guidance.
II. BACKGROUND
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. No. 98-417) (the
Hatch-Waxman Amendments) amended the Federal Food, Drug, and Cosmetic Act (the Act). 
The Hatch-Waxman Amendments created section 505(j) of the Act (21 U.S.C. 355(j)).  Section
505(j) established the abbreviated new drug application (ANDA) approval process, which allows
lower-priced generic versions of previously approved innovator drugs to be approved and brought
on the market.
Innovator drug applicants must include in a new drug application (NDA) information about
patents that claim the drug product that is the subject of the NDA.  FDA publishes this patent
information as part of the Approved Drug Products with Therapeutic Equivalence Evaluations,
which is generally known as the Orange Book.
An ANDA applicant must include in the ANDA a patent certification described in section
505(j)(2)(A)(vii) of the Act.  The certification must make one of the following statements:  (I) no
patent information on the drug product that is the subject of the ANDA has been submitted to
FDA; (II) that such patent has expired; (III) the date on which such patent expires; or (IV) that
such patent is invalid or will not be infringed by the manufacture, use, or sale of the drug product
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 document represents the Agencys current
thinking on section 505(j)(5)(B)(iv) and 180-day generic drug exclusivity.  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 statute, regulations, or both. for which the ANDA is submitted.  This last certification is known as a paragraph IV certification. 
A notice of the paragraph IV certification must be provided to each owner of the patent that is the
subject of the certification and to the holder of the approved NDA to which the ANDA refers. 
The submission of an ANDA for a drug product that is claimed in a patent is an infringing act if
the drug product that is the subject of the ANDA is intended to be marketed before the expiration
of the patent and, therefore, may be the basis for patent infringement litigation.
  
Section 505(j)(5)(B)(iv)2 of the Act provides an incentive for generic manufacturers to file
paragraph IV certifications challenging patents that may be invalid, not infringed by the product
that is the subject of the ANDA, or unenforceable, thereby possibly triggering a patent action
against them by the patent owner.  Section 505(j)(5)(B)(iv) of the Act states that
If the [ANDA] contains a [paragraph IV certification] and is for a drug for which a
previous application has been submitted under this subsection continuing [sic] such
a certification, the application shall be made effective not earlier than one hundred
and eighty days after--
(I) the date the Secretary receives notice from the applicant under the
previous [ANDA] of the first commercial marketing of the drug under the
previous [ANDA], or
(II) the date of a decision of a court in [a patent infringement action] holding the
patent which is the subject of the certification to be invalid or not infringed,
whichever is earlier.
This means that, in certain circumstances, an ANDA applicant whose ANDA contains a paragraph
IV certification is protected from competition from subsequent generic versions of the same drug
product for 180 days after either the first marketing of the first applicant's drug or a decision of a
court holding the patent that is the subject of the paragraph IV certification to be invalid or not
infringed.3  This marketing protection is commonly known as "180-day exclusivity." 
In the Federal Register of October 3, 1994 (59 FR 50338, 50367), FDA published the final rule
implementing the patent and marketing exclusivity provisions of the Hatch-Waxman
Amendments.  The regulation implementing section 505(j)(5)(B)(iv) of the Act provides:
If an abbreviated new drug application contains a certification that a relevant
2 Prior to the enactment of the Food and Drug Administration Modernization Act of 1997 (the Modernization
Act), 180-day exclusivity was described at section 505(j)(4)(B)(iv) of the Act.  The Modernization Act added new
provisions to section 505(j) that resulted in a renumbering of the sections. 
3 The Agency interprets the term court to refer to the court that enters final judgment from which no appeal can
be or has been taken  (21 CFR 314.107(e)).
2 patent is invalid, unenforceable, or will not be infringed and the application is for a
generic copy of the same listed drug for which one or more substantially complete
abbreviated new drug applications were previously submitted containing a
certification that the same patent was invalid, unenforceable, or would not be
infringed and the applicant submitting the first application has successfully
defended against a suit for patent infringement brought within 45 days of the
patent owner's receipt of notice submitted under  314.95, approval of the
subsequent abbreviated new drug application will be made effective no sooner than
180 days from whichever of the following dates is earlier:
(i) The date the applicant submitting the first application first commences
commercial marketing of its drug product; or
(ii) The date of a decision of the court holding the relevant patent invalid,
unenforceable, or not infringed.  (21 CFR 314.107(c)(1)) (emphasis added)
The proposed rule containing  314.107(c)(1), published in the Federal Register of July 10, 1989
(54 FR 28872, 28929), proposed the requirement that the first ANDA applicant submitting a
paragraph IV certification be sued for patent infringement to obtain the 180-day exclusivity.  This
interpretation was believed to be most consistent with the language of the Hatch-Waxman
Amendments and furthered the congressional intent to encourage challenges to patents that may
be invalid or unenforceable (54 FR 28872 at 28894).  In response to a comment on the proposed
rule, FDA added a requirement to the final rule that the first ANDA applicant submitting a
paragraph IV certification successfully defend a patent infringement suit to be entitled 180-day
exclusivity.  The "successful defense" requirement was established to eliminate "an incentive for
frivolous claims of patent invalidity or noninfringement because it would give ANDA applicants
exclusivity even if the applicant was unsuccessful in defending against the patent owner's lawsuit"
(59 FR 50338 at 50353).
III. DISCUSSION
FDA's "litigation" and "successful defense" requirements for 180-day exclusivity have been
challenged in the courts in Inwood Laboratories, Inc. v. Young, 723 F. Supp. 1523 (D.D.C.
1989), vacated as moot, 43 Fed. 3d 712 (D.C.Cir. 1989); Mova Pharmaceutical Corp. v.
Shalala, 955 F. Supp. 128 (D.D.C. 1997), and Granutec , Inc. v. Shalala, No. 5:97-CV-485-
BO(1) (E.D.N.C. July 3, 1997).  The district courts in both Inwood and Mova held that 180 days
of marketing exclusivity should be granted to the first ANDA applicant who files a paragraph IV
certification, regardless of whether the applicant is subsequently sued for patent infringement.
Following the Inwood decision and the initial district court decision in Mova, FDA determined
that it would be appropriate to acquiesce in the courts decisions until the issue was resolved by
the appellate courts. 
The Mova decision was upheld in the U.S. Court of Appeals for the District of Columbia Circuit,
3 Mova Pharmaceutical Corp. v. Shalala. No. 97-5082, 1998 U.S. App. Lexis 7391 (D.C. Cir.
Apr. 14, 1998).  Following the circuit court decision, on June 1, 1998, the district court in Mova
entered an order stating that the successful defense requirement of 21 CFR 314.107(c)(1) is
invalid and permanently enjoining FDA from enforcing it.  
Subsequent to the initial district court decision in Mova and FDAs acquiescence, but prior to the
Court of Appeals decision, the U.S. District Court for the Eastern District of North Carolina
addressed the validity of  314.107(c)(1) in Granutec and, in a holding contrary to the earlier
Mova district court decision, ordered FDA to follow its regulations in approving ANDAs for
ranitidine HCl.  The Granutec decision was stayed and appealed to the U.S. Court of Appeals for
the 4th Circuit, which reversed the district court's decision, Granutec, Inc. v. Shalala, No.
97-1873 and No. 97-1874, 1998 U.S. App. LEXIS 6685, (4th Cir. Apr. 3, 1998).  
Both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of
Appeals for the 4th Circuit held that FDAs interpretation of section 505(j)(5)(B)(iv) expressed in
21 CFR 314.107(c)(1) is unsupported by the Act.  FDA has decided not to appeal either decision. 
The effect of these decisions, together with the June 1, 1998, order of the district court in Mova,
is that FDA will not enforce the "successful defense" provisions of  314.107(c)(1).4
FDA intends to formally remove the "successful defense" provisions from  314.107(c)(1), but
that process is not complete.  Following withdrawal of the regulatory provision, FDA expects to
begin a rulemaking to issue new regulations under section 505(j)(5)(B)(iv).  In the meantime, the
Agency must make exclusivity decisions for ANDAs that are nearing approval. Until such time as
the rulemaking process is complete, FDA will regulate directly from the statute, and will make
decisions on 180-day generic drug exclusivity on a case-by-case basis.
This guidance is intended to provide industry with information on how FDA is applying section 
505(j)(5)(B)(iv) in light of the decisions in Mova and Granutec.  The Agency will revise this
guidance as additional interpretations are made. 
IV. WHO IS ELIGIBLE FOR 180-DAY EXCLUSIVITY WHEN THE FIRST
APPLICANT TO SUBMIT A SUBSTANTIALLY COMPLETE ANDA WITH A
PARAGRAPH IV CERTIFICATION IS NOT SUED?   
           
The first applicant to submit an ANDA with a paragraph IV certification, but who was not sued
by the patent owner or NDA sponsor, generally would receive a letter from the Office of Generic
Drugs that contains the following information:
4 In the Federal Register of November 11, 1997 (62 FR 63268), before either court of appeals decision issued,
FDA published a clarification stating that the Agency would apply  314.107(c)(1) as written, including the  "successful
defense" requirement.  In light of subsequent events described in this document, the Agency will not regulate as
described in that publication. 
4 At this time we are writing to you to clarify the issue of 180-day exclusivity with
respect to your application.  In light of the  recent court decisions in Granutec v.
Shalala, and Mova v. Shalala, including the district courts order of June 1, 1998,
in Mova declaring the successful defense requirement 21 CFR 314.107(c)(1)
invalid and directing FDA not to enforce it, FDA is reinterpreting section
505(j)(5)(B)(iv).
(Name of applicant) was the first applicant to submit a substantially complete
ANDA with a paragraph IV certification.  Although you were not sued as a result
of the notice you provided to the holder of the NDA and the patent owner, you are
nonetheless eligible for 180 days of market exclusivity.  Such exclusivity will begin
to run either from the date you begin commercial marketing or from the date of a
decision of a court finding the patent invalid or not infringed, whichever is earlier
(section 505(j)(5)(B)(iv)).  A court decision that can trigger the beginning of
exclusivity is a decision of any court in a patent infringement action resulting from
a paragraph IV certification in which the court finds that the patent is invalid or not
infringed.  In a case such as yours, where the first applicant is not sued for patent
infringement, the court decision would obviously be rendered in a case involving a
subsequent ANDA applicant.  With respect to the first commercial marketing
trigger for the commencement of exclusivity, we draw your attention to 21 CFR
314.107(c)(3) and (4).  The Agency expects that you will begin commercial
marketing of your product promptly upon approval.
If you have additional questions, please contact Mr. Jerry Phillips, Director,
Division of Labeling and Program Support, at 301-827-5846. 
An applicant whose final approval would be affected by another's 180-day exclusivity would
generally receive a letter containing the same basic information in a different format.
The text of this letter describes the Agencys application of section 505(j)(5)(B)(iv) to the 
threshold question of whether a ANDA applicant that was not sued for patent infringement as a
result of its paragraph IV certification would nonetheless be eligible for exclusivity.  There are
many additional issues related to the application of the statutory provisions that have yet to be
resolved.  This guidance will be updated as FDA interprets and applies section 505(j)(5)(B)(iv).  
As stated above, the Agency intends to undertake a rulemaking to issue new regulations to fully
implement the 180-day generic exclusivity provisions in light of recent court decisions.        
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