[Federal Register Volume 59, Number 178 (Thursday, September 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22760]
[[Page Unknown]]
[Federal Register: September 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94E-0234]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZemuronTM Injection
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 ZemuronTM Injection 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, rm.
1-23, 12420 Parklawn Dr., 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 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
ZemuronTM Injection. ZemuronTM Injection (rocuronium bromide)
is indicated for inpatients and outpatients as an adjunct to general
anesthesia to facilitate both rapid sequence and routine tracheal
intubation, and to provide skeletal muscle relaxation during surgery or
mechanical ventilation. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
ZemuronTM Injection (U.S. Patent No. 4,894,369) from Akzo Nobel,
N.V., and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. FDA,
in a letter dated July 6, 1994, advised the Patent and Trademark Office
that this human drug product had undergone a regulatory review period
and that the approval of ZemuronTM Injection 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
ZemuronTM Injection is 1,889 days. Of this time, 1,627 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 became effective: January 15, 1994. The
applicant claims January 14, 1989, as the date the investigational new
drug application (IND) became effective. However, FDA records indicate
that the IND effective date was January 15, 1994, which was 30 days
after FDA receipt of the IND.
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: June 29, 1993. FDA has verified the applicant's claim
that the new drug application (NDA) for ZemuronTM Injection (NDA
20-214) was initially submitted on June 29, 1993.
3. The date the application was approved: March 17, 1994. FDA has
verified the applicant's claim that NDA 20-214 was approved on March
17, 1994.
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 427 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before November 14, 1994, 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 March 14, 1995, 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: August 31, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-22760 Filed 9-14-94; 8:45 am]
BILLING CODE 4160-01-F
