[Federal Register: April 28, 2003 (Volume 68, Number 81)]
[Notices]
[Page 22389-22390]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap03-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00E-1403]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PREVNAR
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 PREVNAR 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 comments and petitions to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 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, 301-827-3460.
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 human 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
PREVNAR. PREVNAR is indicated for immunization of infants 2, 4, 6, and
12 to 15 months of age to prevent invasive pneumococcal disease.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for PREVNAR (U.S. Patent No.
5,360,897) from the University of Rochester through American Home
Products, 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 PREVNAR
represented the first permitted commercial marketing or use of the
product. Shortly thereafter, the Patent and Trademark Office requested
that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
PREVNAR is 1,910 days. Of this time, 1,648 days occurred during the
testing phase of the regulatory review period, while 262 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: November
27, 1994. The applicant claims November 25, 1994, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 27, 1994,
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: June 1, 1999. FDA has verified the applicant's claim that
the product license application (PLA) for PREVNAR (PLA 99-0279) was
initially submitted on June 1, 1999.
3. The date the application was approved: February 17, 2000. FDA
has verified the applicant's claim that PLA 99-0279 was approved on
February 17, 2000.
[[Page 22390]]
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 1,086 days of
patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Dockets Management Branch (see ADDRESSES)
written or electronic comments and ask for a redetermination by June
27, 2003. 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 October 27, 2003.
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 Dockets
Management Branch. Three copies of any 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 Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-10302 Filed 4-25-03; 8:45 am]
BILLING CODE 4160-01-S