[Federal Register Volume 62, Number 65 (Friday, April 4, 1997)]
[Notices]
[Pages 16167-16168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97E-0014]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Astelin<Register> Nasal Spray

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 Astelin<Register> Nasal Spray 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, 
12420 Parklawn Dr., rm. 1-23, 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

[[Page 16168]]

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 
Astelin<Register> Nasal Spray (azelastine hydrochloride). 
Astelin<Register> Nasal Spray is indicated for the treatment of the 
symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, 
and nasal pruritus in adults and children 12 years and older. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Astelin<Register> Nasal Spray 
(U.S. Patent No. 5,164,194) from Astra Medica AG, and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
February 18, 1997, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of Astelin<Register> Nasal Spray 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 
Astelin<Register> Nasal Spray is 2,797 days. Of this time, 749 days 
occurred during the testing phase of the regulatory review period, 
while 2,048 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: March 8, 
1989. The applicant claims February 6, 1989, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was March 8, 1989, 
which was 30 days after FDA receipt of the IND on February 6, 1989.
    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: March 26, 1991. FDA has verified the applicant's 
claim that the new drug application (NDA) for Astelin<Register> Nasal 
Spray (NDA 20-114) was initially submitted on March 26, 1991.
    3. The date the application was approved: November 1, 1996. FDA has 
verified the applicant's claim that NDA 20-114 was approved on November 
1, 1996.
    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 349 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 3, 1997 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 October 1, 1997 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: March 27, 1997.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-8626 Filed 4-3-97; 8:45 am]
BILLING CODE 4160-01-F