[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Notices]
[Pages 39752-39753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19060]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95E-0047]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Allergen Patch Test (Thin-layer Rapid Use Epicutaneous 
(T.R.U.E.) TestTM)

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 Allergen Patch Test (Thin-layer Rapid Use 
Epicutaneous (T.R.U.E.) TestTM) 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 biologic 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) 

[[Page 39753]]
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 biologic product, 
Allergen Patch Test (Thin-layer Rapid Use Epicutaneous (T.R.U.E.) 
TestTM) (multiple allergen test). T.R.U.E. TestTM is 
indicated primarily as an aid in the diagnosis of allergic dermatitis 
in patients whose histories suggest sensitivity to one or more of 
substances included on the T.R.U.E. TestTM panels. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for T.R.U.E. TestTM (U.S. Patent No. 
4,836,217) from Pharmacia AB, and the Patent and Trademark Office 
requested FDA's assistance in determining the patent's eligibility for 
patent term restoration. In a letter dated June 21, 1995, FDA advised 
the Patent and Trademark Office that this human biologic product had 
undergone a regulatory review period and that the approval of T.R.U.E. 
TestTM 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 
T.R.U.E. TestTM is 2,966 days. Of this time, 1,601 days occurred 
during the testing phase of the regulatory review period, while 1,365 
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: October 10, 1986. FDA has 
verified the applicant's claim that the date the investigational new 
drug application (IND) became effective was on October 10, 1986.
    2. The date application was initially submitted with respect to the 
human biological product under section 351 of the Public Health Service 
Act: February 26, 1991. The applicant claims July 16, 1986, as the date 
the product license application (PLA) for T.R.U.E. TestTM (PLA 91-
0118) was initially submitted. However, FDA records indicate that the 
two-panel test kit for the product that was ultimately approved was 
submitted on February 26, 1991. Therefore, the PLA was submitted on 
February 26, 1991.
    3. The date the application was approved: November 21, 1994. FDA 
has verified the applicant's claim that PLA 91-0118 was approved on 
November 21, 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, the applicant seeks 898 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 2, 1995, 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 January 30, 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: July 26, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-19060 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-01-F