[Federal Register Volume 61, Number 155 (Friday, August 9, 1996)]
[Notices]
[Pages 41635-41636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20339]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0101]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CEDAX
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 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
[[Page 41636]]
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 (ceftibuten dihydrate). CEDAX 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
influenzae (including B-lactamase producing strains), Moraxella
catarrhalis (including B-lactamase producing strains) or Streptococcus
pyogenes, or Pharyngitis and Tonsillitus due to Streptococcus pyogenes.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for CEDAX (U.S. Patent
No. 4,812,561) 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 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 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.
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 (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 902 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before October 8, 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 6, 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: July 26, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-20339 Filed 8-8-96; 8:45 am]
BILLING CODE 4160-01-F
