[Federal Register Volume 61, Number 167 (Tuesday, August 27, 1996)]
[Notices]
[Pages 44068-44069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21844]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0099]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CEDAX Oral Suspension

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 Oral Suspension 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 
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 Oral Suspension (ceftibuten dihydrate). CEDAX 
Oral Suspension 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 Haemophilis influenza (including B-lactamase producing strains), 
Moraxella catarrhalis (including B-lactamase producing strains) or 
Streptococcus pyogenes, or Pharyngitis and Tonsillitis due to 
Streptococcus pyogenes. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
CEDAX Oral Suspension (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 
Oral Suspension 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 Oral Suspension is 2,641 days. Of this time, 1,179 
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: September 
28, 1988. The applicant claims September 29, 1988, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was September 28, 
1988, which was 30 days after FDA receipt of the IND.

[[Page 44069]]

     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 Oral Suspension (NDA 50-686) 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 50-686 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 extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before Octpber 28, 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 February 24, 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. 96-21844 Filed 8-26-96; 8:45 am]
BILLING CODE 4160-01-F