[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Notices]
[Pages 36813-36814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17504]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0075]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LAMICTAL
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 LAMICTAL 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 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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human 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 a human drug 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 drug product
LAMICTAL (lamotrigine). LAMICTAL is indicated as
adjunctive therapy in the treatment of partial seizures in adults with
epilepsy. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for LAMICTAL
(U.S. Patent No. 4,602,017) from Burroughs Wellcome Co., 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 12, 1995, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of LAMICTAL 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
LAMICTAL is 3,703 days. Of this time, 2,693 days occurred
during the testing phase of the regulatory review period, while 1,010
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: November 8,
1984. The applicant claims March 14, 1984, as the date the
investigational new drug application (IND) for LAMICTAL (IND
23,793) was submitted. However, FDA records indicate that IND 23,793
was placed on clinical hold on April 12, 1984, and removed from hold by
a letter dated November 8, 1984, which is the IND effective date.
2. The date the human drug was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: March 23, 1992. The applicant claims March 20, 1992,
as the date the new drug application (NDA) for LAMICTAL (NDA
20-241) was initially submitted. However, FDA records indicate that NDA
20-241 was submitted on March 23, 1992.
3. The date the application was approved: December 27, 1994. FDA
has verified the applicant's claim that NDA 20-241 was approved on
December 27, 1994.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension.
[[Page 36814]]
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 September 18, 1995, 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 January 15, 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.
Dated: June 30, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-17504 Filed 7-17-95; 8:45 am]
BILLING CODE 4160-01-F
