[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32479-32480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13655]



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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