[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Notices]
[Pages 6549-6550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3417]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0385]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ULTIVATM
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 ULTIVATM 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
Commissioner of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that human drug product.
ADDRESSES: Written comments and petitions should be directed to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-1382.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts
[[Page 6550]]
with the initial submission of an application to market the human drug
product and continues until FDA grants permission to market the drug
product. Although only a portion of a regulatory review period may
count toward the actual amount of extension that the Commissioner 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 drug 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 drug product
ULTIVATM (remifentanil hydrochloride). ULTIVATM is indicated
for intravenous administration as follows: (1) As an analgesic agent
for use during the induction and maintenance of general anesthesia for
inpatient and outpatient procedures, and for continuation as an
analgesic into the immediate postoperative period under the direct
supervision of an anesthesia practitioner in a postoperative anesthesia
care unit or intensive care setting; and (2) as an analgesic component
of monitored anesthesia care. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
ULTIVATM (U.S. Patent No. 5,019,583) from Glaxo Wellcome, 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 November 4, 1996, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of ULTIVATM 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
ULTIVATM is 2,222 days. Of this time, 1,920 days occurred during
the testing phase of the regulatory review period, while 302 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: June 14,
1990. FDA has verified the applicant's claim that the date that the
investigational new drug application became effective was on June 14,
1990.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: September 15, 1995. FDA has verified the applicant's
claim that the new drug application (NDA) for ULTIVATM (NDA 20-
630) was initially submitted on September 15, 1995.
3. The date the human drug was approved: July 12, 1996. FDA has
verified the applicant's claim that NDA 20-630 was approved on July 12,
1996.
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 1,088 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before April 14, 1997, submit to the Dockets
Management Branch (address above) written comments and ask for a
redetermination. Furthermore, any interested person may petition FDA,
on or before May 5, 1997, for a determination regarding whether the
applicant for extension acted with due diligence during the regulatory
review period. 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 (address above) in three copies (except that
individuals may submit single copies) and 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: January 31, 1997.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-3417 Filed 2-11-97; 8:45 am]
BILLING CODE 4160-01-F
