[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
