[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Notices]
[Pages 4982-4983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0854]


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

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 Bapten 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 animal 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-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 on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360b(j)) became effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal 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 an animal drug product will include all of the testing phase 
and approval phase as specified in 35 U.S.C. 156(g)(4)(B).
    FDA recently approved for marketing the animal drug product 
Bapten (beta-aminopropionitrile fumarate). Bapten 
is indicated for the treatment of tendinitis of the superficial digital 
flexor tendon in the adult horse where there is sonographic evidence of 
fiber tearing. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
Bapten (U.S. Patent No. 4,485,088) from Alaco, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated April 29, 1999, FDA advised the Patent and Trademark Office that 
this animal drug product had undergone a regulatory review period and 
that the approval of Bapten 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 
Bapten is 5,845 days. Of this time, 5,734 days occurred 
during the testing phase of the regulatory review period, while 111 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date an exemption under section 512(j) of the act became 
effective: June 11, 1982. The applicant claims May 27, 1982, as the 
date the investigational new animal drug application (INAD) became 
effective. However, FDA records indicate that the date of FDA's letter 
assigning a number to the INAD was June 11, 1982, which

[[Page 4983]]

is considered to be the effective date for the INAD.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the act: February 20, 
1998. The applicant claims February 17, 1998, as the date the new 
animal drug application (NADA) for Bapten (NADA 141-107) was 
initially submitted. However, a review of FDA records reveals that the 
date of FDA's official acknowledgement letter assigning a number to 
NADA 141-107 was February 20, 1998, which is considered to be the 
initially submitted date for NADA 141-107.
    3. The date the application was approved: June 10, 1998. FDA has 
verified the applicant's claim that NADA 141-107 was approved on June 
10, 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 1,825 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. 00-2149 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F