[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26558-26559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0661 and FDA-2010-E-0662]


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

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 JEVTANA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human drug product.

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

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

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

[[Page 26559]]

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 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 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 JEVTANA 
(cabazitaxel). JEVTANA, in combination with prednisone, is indicated 
for treatment of patients with hormone-refractory metastatic prostate 
cancer previously treated with a docetaxel-containing treatment 
regimen. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for JEVTANA (U.S. Patent 
Nos. 5,847,170 and 6,331,635) from Aventis Pharma S.A., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
February 11, 2011, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of JEVTANA represented the first permitted commercial 
marketing or use of the product. 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 
JEVTANA is 4,250 days. Of this time, 4,171 days occurred during the 
testing phase of the regulatory review period, while 79 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: October 30, 1998. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on October 30, 1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: March 31, 
2010. FDA has verified the applicant's claim that the new drug 
application (NDA) for JEVTANA (NDA 201023) was submitted on March 31, 
2010.
    3. The date the application was approved: June 17, 2010. FDA has 
verified the applicant's claim that NDA 201023 was approved on June 17, 
2010.
    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 
applications for patent extension, this applicant seeks 1,591 days and 
5 years 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) either electronic or written comments and ask for a 
redetermination by July 3, 2012. 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 October 31, 2012. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on http:[sol][sol]www.regulations.gov may be viewed in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10828 Filed 5-3-12; 8:45 am]
BILLING CODE 4160-01-P