[Federal Register Volume 62, Number 54 (Thursday, March 20, 1997)]
[Notices]
[Pages 13387-13388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6976]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0442]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CEREBYX 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 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 
CEREBYX (fosphenytoin sodium). CEREBYX is indicated 
for short-term parenteral administration when other means of phenytoin 
administration are unavailable, inappropriate, or deemed less 
advantageous. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
CEREBYX (U.S. Patent No. 4,260,769) from Warner-Lambert 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 January 21, 1997, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of CEREBYX 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

[[Page 13388]]

CEREBYX is 3,748 days. Of this time, 3,218 days occurred 
during the testing phase of the regulatory review period, while 530 
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: May 4, 
1986. FDA has verified the applicant's claim that the date that the 
investigational new drug application became effective was on May 4, 
1986.
    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: February 23, 1995. The applicant claims July 14, 
1994, as the date the new drug application (NDA) for CEREBYX 
(NDA 20-450) was initially submitted. However, FDA records indicate 
that NDA 20-450, received by the agency on July 15, 1994, was 
incomplete. FDA refused this application and notified the applicant of 
this fact by letter dated September 12, 1994. The completed NDA was 
then received on February 23, 1995, which is considered to be the NDA 
initially submitted date.
    3. The date the application was approved: August 5, 1996. FDA has 
verified the applicant's claim that NDA 20-450 was approved on August 
5, 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 1,826 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 22, 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. 97-6976 Filed 3-19-97; 8:45 am]
BILLING CODE 4160-01-F