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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 Start Printed Page 4983is 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.

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Dated: December 23, 1999.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug Evaluation and Research.

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[FR Doc. 00-2149 Filed 2-1-00; 8:45 am]

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