[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9195-9196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96E-0269]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; EXCENEL<Register> Sterile 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 EXCENEL<Register> Sterile 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 animal 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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b(j)) became effective and runs until the approval 
phase begins. The approval phase starts with the initial submission of 
an application to market the animal 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA recently approved for marketing the animal drug product 
EXCENEL<Register> Sterile Suspension (ceftiofur hydrochloride). 
EXCENEL<Register> Sterile Suspension is indicated for the treatment and 
control of swine bacterial respiratory disease (swine bacterial 
pneumonia) associated with Actinobacillus (Haemophilus) 
pleuropneumoniae, Pastureruella multocida, Salmonella choleraesuis, and 
Streptococcus suis Type 2. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
EXCENEL<Register> Sterile Suspension (U.S. Patent No. 4,902,683) from 
Pharmacia & Upjohn Co. and requested FDA's assistance in determining 
the patent's eligibility for patent term restoration. In a letter dated 
November 21, 1996, FDA advised the Patent and Trademark Office that 
this animal drug product had undergone a regulatory review period and 
that the approval of EXCENEL<Register> Sterile Suspension represented 
the first

[[Page 9196]]

commercial marketing 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 
EXCENEL<Register> Sterile Suspension is 900 days. Of this time, 881 
days occurred during the testing phase of the regulatory review period, 
while 19 days occurred during the approval phase. These periods of time 
were derived from the following dates:
    1. The date an exemption under section 512(j) of the Federal Food, 
Drug, and Cosmetic Act became effective: November 10, 1993. FDA has 
verified the applicant's claim that November 10, 1993, was the date 
that the investigational new animal drug application became effective.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the Federal Food, Drug, 
and Cosmetic Act: April 8, 1996. The applicant claims April 3, 1996, as 
the date the new animal drug application (NADA) for EXCENEL<Register> 
Sterile Suspension (NADA 140-890) was initially submitted. However, a 
review of FDA records reveals that FDA's official acknowledgment that 
the NADA was sufficiently complete to begin review was a telephone call 
requesting that certain additional information be added to the NADA on 
April 8, 1996, which is considered to be the initially submitted date 
for the NADA.
    3. The date the application was approved: April 26, 1996. FDA has 
verified the applicant's claim that NADA 140-890 was approved on April 
26, 1996.
    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 1,151 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before April 29, 1997, 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 August 27, 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: February 20, 1997.
Allen B. Duncan,
Acting Associate Commissioner for Health Affairs.
[FR Doc. 97-4954 Filed 2-27-97; 8:45 am]
BILLING CODE 4160-01-F