Document ID: FDA-2008-E-0315-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: Fusilev (Levoleucovorin)
Posted Date: 2011-06-23T04:00Z

[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36927-36928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0315]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; Fusilev, Levoleucovorin

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 Fusilev (Levoleucovorin) 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 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. 6222, 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 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 Fusilev 
(levoleucovorin calcium), a folate analog. Levoleucovorin rescue is 
indicated after high-dose methotrexate therapy in osteosarcoma and is 
also indicated to diminish the toxicity and counteract the effects of 
impaired methotrexate elimination and/or inadvertent overdosage of 
folic acid antagonists. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
Fusilev (U.S. Patent No. 6,500,829) from the University of Strathclyde, 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration and 
that FDA determine the product's regulatory review period. In a letter 
dated June 1, 2011, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of Fusilev represented the first permitted commercial 
marketing or use of the product.
    FDA has determined that the applicable regulatory review period for 
Fusilev is 6,993 days. Of this time, 703 days occurred during the 
testing phase of the regulatory review period, while 6,290 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: January 15, 1989. The applicant claims December 15, 1988, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was January 15, 1989, 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 505(b) of the FD&C Act: December 
18, 1990. The applicant claims December 14, 1990, as the date the new 
drug application (NDA) for FUSILEV (NDA 20-140) was initially 
submitted. However, FDA records indicate that NDA 20-140 was submitted 
on December 18, 1990.
    3. The date the application was approved: March 7, 2008. FDA has 
verified the applicant's claim that NDA 20-140 was approved on March 7, 
2008.
    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 797 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) either electronic or written comments and ask for a 
redetermination by August 22, 2011. 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 December 20, 2011. 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

[[Page 36928]]

ADDRESSES) electronic or written comments and written petitions. It is 
only necessary to send one set of comments. It is no longer necessary 
to send three copies of mailed 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://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-15689 Filed 6-22-11; 8:45 am]
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