[Federal Register Volume 74, Number 47 (Thursday, March 12, 2009)]
[Pages 10744-10745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5374]



Food and Drug Administration

[Docket No. FDA-2007-E-0228]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for PROFENDER 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 Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that animal drug product.

ADDRESSES:  Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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

[[Page 10745]]

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 (the 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 Director 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 
PROFENDER (emodepside, praziquantel). PROFENDER is indicated for the 
treatment and control of hookworm infections caused by Ancylostoma 
tubaeforme (adults, immature adults, and fourth stage larvae), 
roundworm infections caused by Toxocara cati (adults and fourth stage 
larvae), and tapeworm infections caused by Dipylidium caninum (adults) 
and Taenia taeniaeformis (adults) in cats. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for PROFENDER (U.S. Patent No. 5,514,773) from Astellas 
Pharma Inc., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated June 10, 2008, FDA advised the Patent 
and Trademark Office that this animal drug product had undergone a 
regulatory review period and that the approval of PROFENDER 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 
PROFENDER is 1,585 days. Of this time, 1,542 days occurred during the 
testing phase of the regulatory review period, while 43 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 act (21 U.S.C. 
360b(j)) became effective: February 27, 2003. The applicant claims June 
2, 2000, as the date the investigational new animal drug application 
(INAD) became effective. However, the date that a major health or 
environmental effects test is begun or the date on which the agency 
acknowledges the filing of a notice of claimed investigational 
exemption for a new animal drug, whichever is earlier, is the effective 
date for the INAD. According to FDA records, February 27, 2003, is the 
effective date for the INAD.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the act: May 18, 2007. The 
applicant claims May 15, 2007, as the date the new animal drug 
application (NADA) for PROFENDER (NADA 141-275) was initially 
submitted. However, a review of FDA records reveals that NADA 141-275 
was initially submitted on May 18, 2007.
    3. The date the application was approved: June 29, 2007. FDA has 
verified the applicant's claim that NADA 141-275 was approved on June 
29, 2007.
    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 1,314 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by May 11, 2009. Furthermore, any interested person may petition FDA 
for a determination regarding whether the applicant for extension acted 
with due diligence during the regulatory review period by September 8, 
2009. 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 Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 24, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-5374 Filed 3-11-09; 8:45 am]