[Federal Register Volume 60, Number 146 (Monday, July 31, 1995)]
[Notices]
[Pages 39000-39001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18687]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0093]


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

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 NISOCOR 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 

[[Page 39001]]
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 NISOCOR 
(nisoldipine). NISOCOR is indicated for the treatment of hypertension. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for NISOCOR (U.S. Patent No. 
4,154,839) from Bayer AG, and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated May 22, 1995, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of NISOCOR 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 
NISOCOR is 4,965 days. Of this time, 4,292 days occurred during the 
testing phase of the regulatory review period, while 673 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 2, 
1981. The applicant claims May 22, 1989, as the date the 
investigational new drug application (IND) became effective, based on 
IND 33,244. However, FDA records indicate that the effective date for 
the first IND submitted for NISOCOR, IND 18,813, was July 2, 1981, 
which was 30 days after FDA receipt of the IND.
    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: April 1, 1993. The applicant claims March 31, 1993, 
as the date the new drug application (NDA) for NISOCOR (NDA 20-356) was 
initially submitted. However, FDA records indicate that NDA 20-356 was 
submitted on April 1, 1993.
    3. The date the application was approved: February 2, 1995. FDA has 
verified the applicant's claim that NDA 20-356 was approved on February 
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 1,377 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before September 29, 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 29, 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: July 19, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affiars.
[FR Doc. 95-18687 Filed 7-28-95; 8:45 am]
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