Document ID: FDA-2009-E-0165-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: ABLAVAR
Posted Date: 2010-06-08T04:00Z

[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]               
[Page 32479-32480]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn10-104]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0165 and FDA-2009-E-0169]

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

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 ABLAVAR (previously the trade name of the 
product was VASOVIST) 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 the 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.

[[Page 32480]]

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 
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 ABLAVAR 
(gadofosveset trisodium). ABLAVAR is indicated for use as a contrast 
agent in magnetic resonance angiography to evaluate aortoiliac 
occlusive disease in adults with known or suspected peripheral vascular 
disease. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for ABLAVAR (U.S. Patent 
Nos. 6,676,929 and 7,060,250) from Epix Pharmaceuticals, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
the patents' eligibility for patent term restoration. In a letter dated 
September 29, 2009, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of ABLAVAR 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 
ABLAVAR is 4,508 days. Of this time, 2,673 days occurred during the 
testing phase of the regulatory review period, while 1,835 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 act) (21 U.S.C. 355(i)) became effective: 
August 21, 1996. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on August 
21, 1996.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: December 15, 
2003. FDA has verified the applicant's claim that the new drug 
application (NDA) 21-711 was submitted on December 15, 2003.
    3. The date the application was approved: December 22, 2008. FDA 
has verified the applicant's claim that NDA 21-711 was approved on 
December 22, 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 
applications for patent extension, this applicant seeks 1,806 days of 
patent term extension for U.S. Patent No. 6,676,929 and 924 days of 
patent term extension for U.S. Patent No. 7,060,250.
    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 9, 2010. 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 6, 2010. 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: April 23, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-13655 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S