[Federal Register Volume 65, Number 18 (Thursday, January 27, 2000)]
[Notices]
[Pages 4432-4433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0853]


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

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 GlucaGen 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:  Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Claudia V. Grillo, Regulatory Policy 
Staff (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION:  The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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

[[Page 4433]]

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 
GlucaGen (glucagon (rDNA origin)). GlucaGen is 
indicated for the treatment of hypoglycemia. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for GlucaGen (U.S. Patent No. 
4,826,763) from Novo Nordisk A/S, and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated May 27, 1999, FDA advised 
the Patent and Trademark Office that this human drug product had 
undergone a regulatory review period and that the approval of 
GlucaGen 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 
GlucaGen is 2,569 days. Of this time, 2,296 days occurred 
during the testing phase of the regulatory review period, while 273 
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 
12, 1991. The applicant claims June 13, 1991, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was June 12, 1991, 
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 of the act: September 23, 
1997. The applicant claims September 18, 1997, as the date the new drug 
application (NDA) for GlucaGen (NDA 20-918) was initially 
submitted. However, FDA records indicate that NDA 20-918 was submitted 
on September 23, 1997.
    3. The date the application was approved: June 22, 1998. FDA has 
verified the applicant's claim that NDA 20-918 was approved on June 22, 
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 1,423 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before March 21, 2000, 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 July 25, 2000, 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: December 23, 1999.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 00-1872 Filed 1-26-00; 8:45 am]
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