[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Pages 13651-13652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7135]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket Nos. 96E-0289, 96E-0286, and 96E-0288]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for DAUNOXOME 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.


[[Page 13652]]


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 
DAUNOXOME (daunorubicin citrate). DAUNOXOME is 
indicated as a first line cytotoxic therapy for advanced human 
immunodeficiency virus (HIV)-associated Kaposi's sarcoma. 
DAUNOXOME is not recommended in patients with less than 
advanced HIV-related Kaposi's sarcoma. Subsequent to this approval, the 
Patent and Trademark Office received patent term restoration 
applications for DAUNOXOME (U.S. Patent Nos. 5,435,989; 
5,441,745; and 5,019,369) from NeXstar Pharmaceuticals, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
these patent's eligibilities for patent term restoration. In letters 
dated December 2, 1996, FDA advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of DAUNOXOME 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 
DAUNOXOME is 2,771 days. Of this time, 1,629 days occurred 
during the testing phase of the regulatory review period, while 1,142 
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: September 
8, 1988. The applicant claims September 29, 1988, as the date the 
investigational new drug application (IND) for DAUNOXOME (IND 
31,927) became effective. However, FDA records indicate that the 
effective date for IND 31,927 was September 8, 1988, which was 30 days 
after FDA received the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 507 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357): February 22, 1993. The applicant claims 
February 18, 1993, as the date the new drug application (NDA) for 
DAUNOXOME (NDA 50-704) was initially submitted. However, FDA 
records indicate that NDA 50-704 was submitted on February 22, 1993.
    3. The date the application was approved: April 8, 1996. FDA has 
verified the applicant's claim that NDA 50-704 was approved on April 8, 
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 258 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before May 20, 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 September 17, 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 12, 1997.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 97-7135 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F