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

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]

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