[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Notices]
[Page 15265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8363]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket Nos. 95E-0418 and 95E-0419]


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

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 FLOLAN 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 
FLOLAN (epoprostenol sodium). FLOLAN is indicated 
for the long-term intravenous treatment of primary pulmonary 
hypertension in New York Heart Association Class III and Class IV 
patients. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for FLOLAN 
(U.S. Patent Nos. 4,338,325 and 4,883,812) from Glaxo Wellcome Inc., 
and the Patent and Trademark Office requested FDA's assistance in 
determining these patents' eligibilities for patent term restoration. 
In letters dated February 8, 1996 (U.S. Patent No. 4,338,325), and 
February 22, 1996 (U.S. Patent No. 4,883,812), FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of FLOLAN 
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 
FLOLAN is 5,927 days. Of this time, 5,357 days occurred 
during the testing phase of the regulatory review period, while 570 
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: July 1, 
1979. The applicant claims June 29, 1979, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 1, 1979, 
which was 30 days after FDA receipt of IND 16,459 on June 1, 1979
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the Federal Food, Drug, 
and Cosmetic Act: February 28, 1994. FDA has verified the applicant's 
claim that the new drug application (NDA) for FLOLAN (NDA 20-
444) was initially submitted on February 28, 1995.
    3. The date the application was approved: September 20, 1995. FDA 
has verified the applicant's claim that NDA 20-444 was approved on 
September 20, 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 730 days (U.S. 
Patent No. 4,338,325) and 1,346 days (U.S. Patent No. 4,883,812) 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.

    Dated: March 28, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-8363 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F