[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Rules and Regulations]
[Pages 63268-63269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 85N-0214]


Policy on 180-Day Marketing Exclusivity for Drugs Marketed Under 
Abbreviated New Drug Applications; Clarification

AGENCY: Food and Drug Administration, HHS.

ACTION: Clarification.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food 
and Drug Administration (FDA) is publishing this document to clarify 
the status of its practices governing 180 days of marketing exclusivity 
for generic drugs and the approval of abbreviated new drug applications 
(ANDA's) subject to patent litigation. This document is being published 
due to recent court decisions interpreting provisions of the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments).

FOR FURTHER INFORMATION CONTACT:  Jerry Phillips, Center for Drug 
Evaluation and

[[Page 63269]]

Research (HFD-605), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-5846.

SUPPLEMENTARY INFORMATION:

I. Background

    The 1984 amendments included a provision, codified under section 
505(j)(4)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 355(j)(4)(B)(iv)), granting 180 days of marketing 
exclusivity to the first applicant to submit an ANDA containing a 
challenge to a listed patent. Regulations interpreting this provision 
were proposed in 1989 (54 FR 28872, July 10, 1989), and made final in 
1994 (59 FR 50338, October 3, 1994). These regulations are codified 
under Sec. 314.107(c) (21 CFR 314.107(c)).
    The regulations state that for a generic drug to qualify for 180 
days of marketing exclusivity, the first ANDA applicant submitting a 
certification under section 505(j)(2)(A)(vii)(IV) of the act (paragraph 
IV certification) to the listed patent must, in addition to submitting 
the certification, be sued for patent infringement and successfully 
defend that suit (Sec. 314.107(c)). This interpretation has been the 
subject of legal action 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. et al. v. Shalala et al., No. 5:97-CV-485-
BO(1)(E.D.N.C. July 3, 1997). Both the Inwood and Mova courts 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. The Mova 
decision has been appealed to the U.S. Court of Appeals for the 
District of Columbia Circuit.
    Following the Mova decision, in June 1997, the Office of Generic 
Drugs notified applicants with ANDA's for ranitidine hydrochloride 
(HCl) that the agency would acquiesce to the court's holding in Mova, 
pending an appellate decision. The agency determined that temporarily 
acquiescing to the court's holding in Mova would promote administrative 
uniformity in the application of section 505(j)(4)(B)(iv) of the act 
and would prevent forum shopping among disappointed ANDA applicants. 
Subsequently, the U.S. District Court for the Eastern District of North 
Carolina addressed the validity of Sec. 314.107(c) in Granutec v. 
Shalala, and, in a holding contrary to the earlier Mova decision, 
ordered FDA to follow its regulations in approving ANDA's for 
ranitidine HCl. The Granutec decision was stayed and is on expedited 
appeal to the U.S. Court of Appeals for the 4th Circuit.
    Because the uncertain state of the law makes it difficult for the 
industry to make business plans and other arrangements, CDER wishes to 
clarify its policy with respect to these exclusivity issues, pending 
their final resolution by the courts.

II. 180-Day Marketing Exclusivity

    It is the agency's position that, given the uncertainty created by 
the conflict among the courts, the most reasonable policy is to apply 
the 180-day exclusivity provisions of the statute as set forth in 
Sec. 314.107(c) to all ANDA's to which the regulation would, on its 
face, apply, whether they were submitted before or after the Mova 
decision. The only ANDA's to which the agency applied the Mova 
analysis, other than those ANDA's directly involved in the Mova 
litigation, were those for ranitidine HCl.
    The regulations in Sec. 314.107(c) were issued through notice and 
comment rulemaking with the active participation of the pharmaceutical 
industry and consumer groups. They are the product of careful 
consideration by the agency of the complex factors at issue in granting 
a period of exclusivity to generic drug applicants and in ensuring that 
the statute is implemented in a manner most consistent with its 
original purpose. These regulations will be applied until such time as 
the appellate courts complete their analyses of the agency's 
interpretation.

III. Approval of ANDA's After Judgment in the District Courts

    The agency does not intend to acquiesce to the court's decision in 
Torpharm v. Shalala, Civil Action No. 97-1925 (JR) (D.D.C. Sept. 15, 
1997), in which the court, finding that the term ``the court'' in 
section 505(j)(4)(B)(iii) of the act means district court, ordered FDA 
to approve an ANDA after the applicant had prevailed in patent 
infringement litigation in the district court, but before either the 
appeal was resolved or the 30-month stay had lapsed. The U.S. Court of 
Appeals for the District of Columbia has granted the appeal of Torpharm 
an expedited review. While Torpharm is pending on appeal, FDA will 
continue to interpret the statute as described in Sec. 314.107(e), 
which defines ``the court'' as ``the court that enters final judgment 
from which no appeal can be or has been taken.''

    Dated: November 7, 1997.
Roger Williams,
Deputy Center Director for Pharmaceutical Science.
[FR Doc. 97-31150 Filed 11-26-97; 8:45 am]
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