[Federal Register Volume 60, Number 235 (Thursday, December 7, 1995)]
[Notices]
[Pages 62868-62869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29809]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0311 ]


Determination of Regulatory Review Period for Purposes of Patent 
- Extension; VALTREX<Register>

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 VALTREX<Register> 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: 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) 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 
VALTREX<Register> (valacyclovir hydrochloride). VALTREX<Register> is 
indicated for the treatment of herpes zoster (shingles) in 
immunocompetent adults. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
VALTREX<Register> (U.S. Patent No. 4,957,924) from Burroughs Wellcome 
Co., and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated October 5, 1995, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of VALTREX<Register> 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 VALTREX<Register> is 1,907 days. Of this time, 1,541 days occurred 
during the testing phase of the regulatory review period, while 366 
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: April 5, 
1990. The applicant claims March 6, 1990, as the date the 
investigational new drug application (IND) became effective. The 
applicant claims that FDA waived the 30-day post-submission review 
period and the effective date of the IND relates back to the date of 
submission, March 6, 1990. According to FDA records, a safety meeting 
was held on March 23, 1990, for IND 34,526. The meeting is held within 
30 days of receipt of an IND to determine its safety in humans. At the 
meeting it was agreed by the reviewing disciplines that the study was 
reasonably safe to proceed. There is no record of any waiver for this 
IND. If a waiver had been issued, there would have been no need to have 
the safety review meeting. Therefore, the correct IND effective date 
for IND 34,526 is April 5, 1990, 30 days after agency receipt of IND 
34,526.
    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: June 23, 1994. FDA has 

[[Page 62869]]
verified the applicant's claim that the new drug application (NDA) for 
VALTREX<Register> (NDA 20-487) was initially submitted on June 23, 
1994.
    3. The date the human drug was approved: June 23, 1995. FDA has 
verified the applicant's claim that NDA 20-487 was approved on June 23, 
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 1,052 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, 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. 95-29809 Filed 12-6-95; 8:45 am]
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