[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Notices]
[Pages 4983-4984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99E-0116]


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

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 Rotashield 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 biological product.

ADDRESSES:  Submit written comments 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-7), 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 biological 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 biological product 
Rotashield. Rotashield is indicated for 
immunization of infants at 2, 4, and 6 months of age. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for Rotashield (U.S. Patent No. 
4,704,275) from American Home Products Corp., and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
March 16, 1999, FDA advised the Patent and Trademark Office that this 
human biological product had undergone a regulatory review period and 
that the approval of Rotashield 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 
Rotashield is 3,804 days. Of this time, 3,226 days occurred 
during the testing phase of the regulatory review period, while 578 
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: April 3, 
1988. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on April 3, 
1988.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act: January 31, 1997. FDA has verified the applicant's claim 
that the product license application (PLA) for Rotashield 
(PLA 97-0111) was initially submitted on January 31, 1997.
    3. The date the application was approved: August 31, 1998. FDA has 
verified the applicant's claim that PLA 97-0111 was approved on August 
31, 1998.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension.

[[Page 4984]]

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 April 3, 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 31, 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. 00-2243 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F