[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Pages 62869-62870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29808]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0302]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ULTANE<SUP>TM

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 ULTANE<SUP>TM 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: Brain 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 
ULTANE<SUP>TM (sevoflurane). ULTANE<SUP>TM is indicated for induction 
and maintenance of general anesthesia in adult and pediatric patients 
for inpatient and outpatient surgery. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for ULTANE<SUP>TM (U.S. Patent No. 4,250,334) from Baxter 
International, 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 September 25, 1995, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of ULTANE<SUP>TM 
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 
ULTANE<SUP>TM is 3,418 days. Of this time, 3,086 days occurred during 
the testing phase of the regulatory review period, while 332 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: January 29, 
1986. The applicant claims January 10, 1986, as the date the 
investigational new drug (IND) became effective. However, FDA records 
indicate that the correct IND effective date was January 29, 1985, 
which was 30 days after FDA receipt of IND 27,645 on December 30, 1985.
    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: July 11, 1994. The applicant claims July 8, 1994, as 
the date the new drug application (NDA) for ULTANE<SUP>TM (NDA 20-478) 
was initially submitted. However, FDA records indicate that the 
applicant submitted NDA 20-478 on July 8, 1994, and the agency received 
the NDA on July 11, 1994, which is considered to be the NDA initially 
submitted date.
    3. The date the application was approved: June 7, 1995. FDA has 
verified the applicant's claim that NDA 20-478 was approved on June 7, 
1995.
    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 1,826 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before February 5, 1996, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, 

[[Page 62870]]
any interested person may petition FDA, on or before June 5, 1996, 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: November 30, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-29808 Filed 12-6-95; 8:45 am]
BILLING CODE 4160-01-F