[Federal Register Volume 65, Number 62 (Thursday, March 30, 2000)]
[Notices]
[Pages 16922-16923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1197]


Guidance for Industry on Court Decisions, ANDA Approvals, and 
180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal 
Food, Drug, and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Court Decisions, 
ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman 
Amendments to the Federal Food, Drug, and Cosmetic Act.'' The purpose 
of this guidance is to inform the public of FDA's application of the 
abbreviated new drug application (ANDA) approval provisions and 180-day 
generic drug exclusivity provisions of the Federal Food, Drug, and 
Cosmetic Act (the act) in light of recent court decisions on these 
issues.

DATES: Submit written comments on the guidance by June 28, 2000. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of the guidance to the Drug Information 
Branch (HFD-210), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Virginia G. Beakes, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Court Decisions, ANDA Approvals, and 
180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal 
Food, Drug, and Cosmetic Act.'' This guidance is being issued in 
response to recent litigation. The guidance is intended to provide 
information to the pharmaceutical industry regarding: (1) The timing of 
approval of ANDA's 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 act have been 
successfully challenged in TorPharm, Inc. v. Shalala and Mylan 
Pharmaceuticals, Inc. v. Shalala \1\.

[[Page 16923]]

These provisions apply the concept of a court decision to the timing of 
certain ANDA approvals and to the start of 180-day exclusivity. 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) of the act (21 U.S.C. 
355(j)(5)(B)(iii)(I))). Certain court decisions are also important for 
180-day generic drug exclusivity. The 180-day period of exclusivity can 
begin on either: (1) The date of first commercial marketing, or (2) the 
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) of the act). For 
purposes of section 505(j)(5)(B)(iii)(I) and (j)(5)(B)(iv) of the act, 
FDA determined that ``court'' means ``the court that enters final 
judgment from which no appeal can be or has been taken'' 
(Sec. 314.107(e)(1) (21 CFR 314.107(e)(1)) (1999)).
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    \1\ Torpharm v. Shalala, No. 97-1925, 1997 U.S. Dist. LEXIS 
21983 (D.D.C. September 15, 1997); appeal withdrawn and remanded, 
1998 U.S. App. LEXIS 4681 (D.C. Cir. February 5, 1998); vacated No. 
97-1925 (D.D.C. April 9, 1998); Mylan Pharmaceuticals, Inc. v. 
Shalala, No. 99-2995, slip op. (D.D.C. January 4, 2000).
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    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. These recent decisions add 
considerable uncertainty to FDA's implementation of the ANDA approval 
and 180-day generic drug exclusivity programs. 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 will 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 ANDA's and 
calculating the commencement of 180 days of exclusivity. The agency 
intends to formally amend Sec. 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 (64 FR 42873, 
August 6, 1999). FDA will implement the new interpretation of the term 
``court'' prospectively.
    FDA will interpret the term ``court'' as found in section 
505(j)(5)(B)(iii)(I) and (j)(5)(B)(iv) of the act to mean the first 
court that renders a decision finding the patent at issue invalid, 
unenforceable, or not infringed. The new definition of ``court'' will 
be applied to approval and exclusivity determinations for all ANDA's 
containing a paragraph IV certification submitted after the publication 
of this guidance, where the ANDA cites a reference listed drug for 
which no other ANDA containing a paragraph IV certification has been 
submitted.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance is 
being implemented immediately without prior public comment because the 
guidance is needed to explain FDA's application of the statute in light 
of recent court decisions. However, the agency wishes to solicit 
comments from the public and is providing a 90-day comment period and 
establishing a docket for the receipt of comments.
    This guidance represents the agency's current thinking on section 
505(j)(5)(B)(iii)(I) and (j)(5)(B)(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 act.
    Interested persons may submit written comments on the guidance to 
the Dockets Management Branch (address above). Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 23, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7823 Filed 3-29-00; 8:45 am]
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