[Federal Register Volume 61, Number 171 (Tuesday, September 3, 1996)]
[Notices]
[Pages 46465-46466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0102]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CEDAX Capsules

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 CEDAX capsules 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, 
12420 Parklawn Dr., rm. 1-23, 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

[[Page 46466]]

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 
CEDAX capsules (ceftibuten dihydrate). CEDAX 
capsules is indicated for the treatment of individuals with mild-to-
moderate infections caused by susceptible strains of the designated 
microorganisms in the specific conditions: Acute Bacterial 
Exacerbations of Chronic Bronchitis due to Haemophilus influenzae 
(including B-lactamase-producing strains), Moraxella catarrhalis 
(including B-lactamase producing strains) or Streptoccocus pneumoniae 
(penicillin-susceptible strains only), Acute Bacterial Otitis Media due 
to H. influenzae (including B-lactamase producing strains), M. 
catarrhalis (including B-lactamase producing strains), or S. pyogenes, 
or Pharyngitis and Tonsillitis due to S. pyogenes. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for CEDAX capsules (U.S. Patent No. 
4, 634,697) from Schering-Plough 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 April 10, 
1996, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of CEDAX capsules 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 
CEDAX capsules is 3,065 days. Of this time, 1,603 days 
occurred during the testing phase of the regulatory review period, 
while 1,462 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: August 1, 
1987. The applicant claims August 2, 1987, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 1, 1987, 
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 507 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357): December 20, 1991. FDA has verified the 
applicant's claim that the new drug application (NDA) for 
CEDAX capsules (NDA 20-685) was initially submitted on 
December 20, 1991.
    3. The date the application was approved: December 20, 1995. FDA 
has verified the applicant's claim that NDA 20-685 was approved on 
December 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 1,826 days of 
patent term restoration.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before November 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 March 3, 1997, 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: August 16, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-22285 Filed 8-30-96; 8:45 am]
BILLING CODE 4160-01-F