[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Notices]
[Pages 15264-15265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8474]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96E-0033]


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

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 OPTIMMUNE 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: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., 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 animal drug products, the 
testing phase begins 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 (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 
OPTIMMUNE (cyclosporine). OPTIMMUNE is indicated 
for treatment of chronic keratoconjunctivitis sicca in dogs. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for OPTIMMUNE (U.S. Patent No. 
4,839,342) from Schering 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 February 8, 1996, FDA 
advised the Patent and Trademark Office that this animal drug product 
had undergone a regulatory review period and that the approval of 
OPTIMMUNE represented the first commercial marketing of the 
product. Shortly thereafter, the Patent and Trademark Office requested 
that FDA determine the products's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
OPTIMMUNE is 1,898 days. Of this time, 1,668 days occurred 
during the testing phase of the regulatory review period, while 230 
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 Federal Food, 
Drug, and Cosmetic Act became effective: May 24, 1990. The applicant 
claims May 10, 1990, as the date the investigational new animal drug 
application (INAD) became effective. However, FDA records indicate that 
the date of FDA's official acknowledgement letter assigning a number to 
the INAD was May 24, 1990, which 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 Federal Food, Drug, 
and Cosmetic Act: December 16, 1994. The applicant claims December 14, 
1994, as the date the new animal drug application (NADA) for 
OPTIMMUNE (NADA 141-052) was initially submitted. However, 
FDA records indicate that the date of FDA's official acknowledgement 
letter assigning a number to the NADA was December 16, 1994, which is 
considered to be the NADA initially submitted date.
    3. The date the application was approved: August 2, 1995. FDA has 
verified the applicant's claim that NADA 141-052 was approved on August 
2, 1995.
    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 698 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 4, 1996, 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 October 2, 1996, 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.


[[Page 15265]]

    Dated: March 28, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-8474 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F