[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