[Federal Register Volume 62, Number 65 (Friday, April 4, 1997)]
[Notices]
[Pages 16166-16167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0505]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; MERETEK UBT<SUP>TM Breath Test

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 MERETEK UBT<SUP>TM Breath Test 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

[[Page 16167]]

(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 MERETEK 
UBT<SUP>TM Breath Test (urea, C-13). MERETEK UBT<SUP>TM Breath Test is 
intended for use in the qualitative detection of urease associated with 
Helicobacter pylori in the human stomach and as an aid in the diagnosis 
of H. pylori infection in adult patients. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for MERETEK UBT<SUP>TM Breath Test (U.S. Patent No. 
4,830,010) from Meretekdiagnostics, 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 February 21, 
1997, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of MERETEK UBT<SUP>TM Breath Test 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 
MERETEK UBT<SUP>TM Breath Test is 2,023 days. Of this time, 1,527 days 
occurred during the testing phase of the regulatory review period, 
while 496 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: March 7, 
1991. The applicant claims January 19, 1990, as the date the 
investigational new drug application (IND) for MERETEK UBT<SUP>TM 
Breath Test (IND 26,861) became effective. However, FDA records 
indicate that IND 26,861 was received by the agency on August 7, 1985. 
The protocol that first contained the Urea Breath Test was received by 
the agency on February 5, 1991, as part of this IND. Using February 5, 
1991, as the beginning date plus adding 30 days for the receipt date of 
the modification, results in an effective date of March 7, 1991, for 
the testing phase of the active ingredient of this product.
    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:  May 11, 1995. FDA has verified the applicant's claim 
that the new drug application (NDA) for MERETEK UBT<SUP>TM Breath Test 
(NDA 20-586) was initially submitted on May 11, 1995.
    3. The date the application was approved: September 17, 1996. FDA 
has verified the applicant's claim that NDA 20-586 was approved on 
September 17, 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 780 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 3, 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 October 1, 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: March 27, 1997.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-8625 Filed 4-3-97; 8:45 am]
BILLING CODE 4160-01-F