[Federal Register Volume 59, Number 182 (Wednesday, September 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23276]
[[Page Unknown]]
[Federal Register: September 21, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94E-0235]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SemprexTM-D Capsules
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 SemprexTM-D Capsules 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
SemprexTM-D Capsules. SemprexTM-D Capsules (acrivastine and
pseudoephedrine hydrochloride) is indicated for relief of symptoms
associated with seasonal allergic rhinitis such as sneezing,
rhinorrhea, pruritus, lacrimation, and nasal congestion. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for SemprexTM-D Capsules (U.S. Patent No.
4,650,807) from Burroughs Wellcome Co., and the Patent and Trademark
Office requested FDA's assistance in determining this patent's
eligibility for patent term restoration. FDA, in a letter dated July 8,
1994, advised the Patent and Trademark Office that this human drug
product had undergone a regulatory review period and that the approval
of SemprexTM-D Capsules 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
SemprexTM-D Capsules is 3,489 days. Of this time, 1,210 days
occurred during the testing phase of the regulatory review period,
while 2,279 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: September 6, 1984. The
Applicant claims August 13, 1984, as the date the investigational new
drug application (IND) became effective. However, FDA records indicate
that the IND effective date was September 6, 1984, which was 30 days
after FDA receipt of the IND.
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: December 29, 1987. FDA has verified the applicant's
claim that the New Drug Application (NDA) for SemprexTM-D Capsules
(NDA 19-806) was initially submitted on December 29, 1987.
3. The date the application was approved: March 25, 1994. FDA has
verified the applicant's claim that NDA 19-806 was approved on March
25, 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, this applicant seeks 1,469 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before November 21, 1994, 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 March 20, 1994, 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: September 12, 1994.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 94-23276 Filed 9-20-94; 8:45 am]
BILLING CODE 4160-01-F
