[Federal Register Volume 67, Number 212 (Friday, November 1, 2002)]
[Proposed Rules]
[Pages 66593-66594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 85N-0214]


180-Day Generic Drug Exclusivity for Abbreviated New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a proposed rule published in the Federal Register of 
August 6, 1999 (64 FR 42873) (the August 1999 proposed rule). FDA 
proposed to amend its regulations governing 180-day exclusivity and the 
timing of certain abbreviated new drug application (ANDA) approvals 
under the Federal Food, Drug, and Cosmetic Act (the act). The proposed 
amendments to the regulations were made in response to court decisions 
that affected the agency's previous interpretation of relevant 
provisions of the act. Since the proposed rule was published, there 
have been additional court decisions that address FDA's interpretation 
of the act, including the interpretation described in portions of the 
proposed rule. In light of these decisions, FDA is withdrawing the 
August 1999 proposed rule and will reevaluate its interpretation of the 
act. FDA will continue to regulate directly from the statute and 
applicable regulations and make regulatory decisions on an issue-by-
issue basis.

DATES: The proposed rule is withdrawn November 1, 2002.

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

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 6, 1999 (64 FR 42873), FDA 
proposed to amend its regulations governing 180-day generic drug 
exclusivity under the act. The August 1999 proposed rule was an effort 
to clarify existing eligibility requirements for 180-day generic drug 
exclusivity and to describe new eligibility requirements for ANDA 
sponsors. The August 1999 proposed rule described a number of 
challenges to FDA's previous interpretations of relevant statutory 
provisions and proposed a new approach to implementing 180-day generic 
drug exclusivity. The publication of the proposed amendments was FDA's 
response to then-recent court decisions affecting portions of its 
regulations. (See Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 
(D.C. Cir. 1998), and Granutec, Inc. v. Shalala, 139 F.3d 889, 1998 WL 
153410 (4th Cir. Apr. 3, 1998)).
    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Public Law 98-417) (the Hatch-Waxman Amendments) created section 
505(j) of the act (21 U.S.C. 355(j)). The ANDA approval program 
established by section 505(j) of the act permits a generic version of a 
previously approved innovator drug to be approved without submission of 
a full new drug application (NDA). An ANDA references a previously 
approved drug product (the ``listed drug'') and relies on the agency's 
prior finding of safety and effectiveness for that drug product.
    Applicants seeking approval for an NDA must include in their NDA 
information about patents for the drug that is the subject of the NDA. 
FDA publishes this patent information as part of the agency's 
publication ``Approved Drug Products with Therapeutic Equivalence 
Evaluations'' (the Orange Book).
    Under section 505(j)(2)(A)(vii) of the act, generic drug applicants 
must include in an ANDA a patent certification for each patent listed 
in the Orange Book for the listed drug. The applicant must certify to 
one of the following for each listed patent: (1) That no patent 
information on the listed drug has been submitted to FDA; (2) that such 
patent has expired; (3) the date on which such patent will expire; or 
(4) that such patent is invalid, unenforceable, or will not be 
infringed by the manufacture, use, or sale of the drug product for 
which the ANDA is submitted. These certifications are referred to as 
``paragraph I,'' ``paragraph II,'' ``paragraph III,'' and ``paragraph 
IV'' certifications, respectively. The ANDA applicant must also provide 
notice of a paragraph IV certification 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.
    Section 505(j)(5)(B)(iv) of the act provides an incentive for ANDA 
applicants to file paragraph IV certifications challenging patents that 
may be invalid, unenforceable, or not infringed by the drug product 
that is the subject of the ANDA. In certain circumstances, the first 
ANDA applicant with a paragraph IV certification is granted 180-day 
exclusivity. The 180-day exclusivity gives the first ANDA applicant 
protection from market competition by subsequent generic versions of 
the same drug product for a 180-day period from either the date the 
first ANDA applicant begins commercially marketing its drug product or 
from the date of a court decision holding the patent that is the 
subject of the paragraph IV certification invalid, unenforceable, or 
not infringed.
    In 1994, FDA issued its final rule implementing the patent and 
marketing exclusivity provisions of the Hatch-Waxman Amendments. The 
requirements for 180-day exclusivity are contained in Sec.  
314.107(c)(1) (21 CFR 314.107(c)(1)).
    In 1998, two appellate courts found that FDA's interpretation of 
section 505(j)(5)(B)(iv) of the act as expressed in Sec.  314.107(c)(1) 
was not supported by the act (Mova, 140 F.3d at 1077; Granutec, 139 
F.3d at 889). The Mova and Granutec courts concluded that the 
``successful defense'' requirement imposed by Sec.  314.107(c)(1) which 
required an ANDA applicant to be sued for patent infringement and to 
win before it could qualify for 180-day exclusivity was invalid. They 
held that 180 days of marketing exclusivity should be granted to the 
first ANDA applicant that files a paragraph IV certification, 
regardless of whether the applicant is subsequently sued for patent 
infringement.
    Shortly after these decisions, the agency published a guidance for 
industry entitled ``180-Day Generic Drug Exclusivity Under the Hatch-
Waxman Amendments to the Federal

[[Page 66594]]

Food, Drug, and Cosmetic Act'' (June 1998) (63 FR 37890, July 14, 
1998), detailing its new approach to 180-day exclusivity in response to 
the Mova and Granutec court decisions. The agency also published an 
interim rule revoking the ``successful defense'' requirement of Sec.  
314.107(c)(1) (63 FR 59710, November 5, 1998). Since that time, the 
agency has regulated directly from the statute on issues not 
specifically addressed by the remaining regulations governing 180-day 
exclusivity.
    In the August 1999 proposed rule, the agency described a new 
approach to implementing the 180-day generic drug exclusivity 
consistent with the act. The August 1999 proposed rule addressed the 
issues resulting from the Mova and Granutec court decisions and 
responded to other 180-day exclusivity issues not currently addressed 
by the regulations.
    Since publication of the August 1999 proposed rule, there has been 
extensive litigation of issues relating to ANDA approvals and 180-day 
exclusivity. Among these litigated issues was whether 180-day 
exclusivity would begin to run with the first district or other court 
decision finding the patent invalid, unenforceable, or not infringed or 
with a final court decision from which no appeal has been or can be 
taken.
    FDA's interpretation of the words ``the court'' contained in 
section 505(j)(5)(B)(iii) of the act was initially challenged and 
reviewed by the court in 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). This provision of the act governs 
the approval of ANDAs when the NDA holder has brought a timely patent 
infringement action in response to the ANDA applicant's notice of 
filing a paragraph IV certification to a listed patent. The district 
court found that ``the court,'' as stated in section 505(j)(5)(B)(iii) 
of the act, refers to the first court that decides that the patent is 
invalid or not infringed. Hence, the court found that under the act, 
the agency must make the ANDA approval effective on the date of the 
first relevant court decision, regardless of appeal status.
    In another case decided after the proposed rule was published, the 
agency's interpretation of the phrase ``a decision of a court'' 
contained in section 505(j)(5)(B)(iv) of the act was successfully 
challenged in Mylan Pharmaceuticals, Inc. v. Shalala, 81 F. Supp.2d 30 
(D.D.C. Jan. 4, 2000) (Mylan I). Section 505(j)(5)(B)(iv) of the act 
governs the eligibility for and timing of 180-day exclusivity. In the 
regulations in Sec.  314.107 implementing this provision of the act, 
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 Mylan I court found that this interpretation was not 
consistent with the plain language of the act, and concluded that 
``court'' in the phrase ``a decision of a court'' means the first court 
that renders a decision finding the patent which is the subject of the 
certification to be invalid, unenforceable, or not infringed.
    In response to the litigation and in an effort to provide guidance 
to the pharmaceutical industry regarding the timing of approval of 
ANDAs following an unsuccessful patent infringement action by the NDA 
holder and the start of 180-day generic drug exclusivity, the agency 
issued 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'' (March 2000) (the March 2000 
guidance for industry). FDA announced that it would 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. FDA also 
announced that it would apply the new guidance policy prospectively. In 
the case of a district court decision, FDA may approve the ANDA as of 
the date the district court enters its decision. Also, for eligible 
applicants, 180-day exclusivity will begin to run on that date.
    After the March 2000 guidance for industry was issued, the agency's 
interpretation of the meaning of ``court decision'' was again litigated 
in a consolidated case, Mylan Pharmaceuticals, Inc. v. Henney, 94 
F.Supp.2d. 36 (D.D.C. 2000) (Mylan II). The court in Mylan II found 
that ``a decision of a court'' contained in section 
505(j)(5)(B)(iv)(II) of the act means all court decisions, whether 
subsequently vacated, settled, appealed, or otherwise mooted. Id. at 
54.
    In the Federal Register of July 13, 2000 (65 FR 43233), FDA issued 
an interim rule to amend its regulations governing the definition of 
``court decision'' as detailed in the March 2000 guidance for industry 
and consistent with the TorPharm and Mylan court decisions.
    The opinion of the United States Court of Appeals for the D.C. 
Circuit in Teva Pharmaceuticals, USA, Inc. v. FDA, 182 F.3d 1003 (D.C. 
Cir. 1999) also rejected the agency's interpretation of the act. The 
Teva court found that under the facts of that case, a dismissal of a 
declaratory judgment action for lack of subject matter jurisdiction was 
a court decision triggering the running of exclusivity. In Teva, the 
underlying dismissal was based on an express finding that the plaintiff 
lacked a reasonable apprehension of a patent infringement suit, and 
thus there was no case or controversy concerning infringement of the 
patent to give the court jurisdiction. Under these circumstances, the 
court held that, although the court did not opine directly on the 
question of infringement, the dismissal for lack of subject matter 
jurisdiction was a decision of a court finding the patent invalid or 
not infringed that triggered 180-day exclusivity. This holding was 
directly at odds with the approach the agency proposed in the August 
1999 proposed rule to deal with dismissals of declaratory judgment 
actions under section 505(j)(5)(B)(iii) of the act. (See 64 FR 42873 at 
42881.)

II. Comments on the Proposed Rule

    FDA received several comments on the August 1999 proposed rule. 
Comments were received from pharmaceutical companies, attorneys, trade 
associations, generic companies, the Federal Trade Commission, and 
chemical companies. The comments addressed a wide variety of issues 
described in the August 1999 proposed rule. Some comments favored and 
some opposed all or parts of the August 1999 proposed rule.

III. Withdrawal of the Proposed Rule

    After careful consideration of the comments on the August 1999 
proposed rule and the multiple court decisions affecting the agency's 
interpretation of the provisions of the act relating to 180-day 
exclusivity and ANDA approvals, FDA has concluded that it is 
appropriate to withdraw the August 1999 proposed rule at this time. The 
agency will continue to regulate directly from the statute and 
applicable FDA regulations to make 180-day exclusivity decisions on an 
issue-by-issue basis. The agency will also carefully evaluate possible 
options for future rulemaking addressing 180-day exclusivity and the 
timing of ANDA approvals.

    Dated: October 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27797 Filed 10-31-02; 8:45 am]
BILLING CODE 4160-01-S