[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
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 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 (valacyclovir hydrochloride). VALTREX 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 (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 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 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 (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]
BILLING CODE 4160-01-F
