[Federal Register Volume 64, Number 41 (Wednesday, March 3, 1999)]
[Notices]
[Pages 10304-10305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0843]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Singulair

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 Singulair 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, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

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 
Singulair (montelukast sodium). Singulair is 
indicated for the prophylaxis and chronic treatment of asthma in adults 
and pediatric patients 6 years of age and older. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for Singulair (U.S. Patent No. 
5,565,473) from Merck & 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 December 16, 1998, FDA 
advised the Patent and Trademark Office that this human drug product 
had undergone a regulatory review period and that the approval of 
Singulair 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 Singulair is 2,090 days. Of this time, 1,725 days occurred during 
the testing phase of the regulatory review period, while 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 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: June 
3, 1992. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on June 3, 
1992.
     2.  The date the application was initially submitted with respect 
to the human drug product under section 505

[[Page 10305]]

of the act: February 21, 1997. FDA has verified the applicant's claim 
that the new drug application (NDA) for Singulair (NDA 20-
829) was initially submitted on February 21, 1997.
     3.  The date the application was approved: February 20, 1998. FDA 
has verified the applicant's claim that NDA 20-829 was approved on 
February 20, 1998.
     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 428 days of 
patent term extension.
     Anyone with knowledge that any of the dates as published is 
incorrect may, on or before May 3, 1999, 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 August 30, 1999 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: February 16, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-5132 Filed 3-2-99; 8:45 am]
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