[Federal Register: September 28, 2004 (Volume 69, Number 187)]
[Notices]
[Page 57938-57939]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se04-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002E-0065]
Determination of Regulatory Review Period for Purposes of Patent
Extension; KINERET
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for KINERET and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.
ADDRESSES: Submit written or electronic comments and petitions to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6699.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a biological product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing the human biologic product
KINERET (anakinra). KINERET is indicated for the reduction of signs and
symptoms of moderately to severely active rheumatoid arthritis, in
patients 18 years or older who have failed 1 or more disease modifying
antirheumatic drugs (DMARDs). Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
Kineret (U.S. Patent No. 5,075,222) from Amgen, Inc., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
December 30, 2002, FDA advised the Patent and Trademark Office that
this human biologic product had undergone a regulatory review period
and that the approval of KINERET represented the first permitted
commercial marketing or use of the product. Shortly thereafter, the
Patent and Trademark Office
[[Page 57939]]
requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
KINERET is 4,101 days. Of this time, 3,413 days occurred during the
testing phase of the regulatory review period, while 688 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 25,
1990. The applicant claims August 23, 1990, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 25, 1990,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 28, 1999. The applicant claims
December 27, 1999, as the date the product license application (BLA)
for KINERET (BLA 103950) was initially submitted. However, FDA records
indicate that BLA 103950 was submitted on December 28, 1999.
3. The date the application was approved: November 14, 2001. FDA
has verified the applicant's claim that BLA 103950 was approved on
November 14, 2001.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,825 days of
patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by November 29, 2004. Furthermore, any interested person may petition
FDA for a determination regarding whether the applicant for extension
acted with due diligence during the regulatory review period by March
28, 2005. To meet its burden, the petition must contain sufficient
facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information 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. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 30, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-21675 Filed 9-27-04; 8:45 am]
BILLING CODE 4160-01-S