Determination of Regulatory Review Period for Purposes of Patent Extension; MULTIHANCE, 39120-39121 [E6-10796]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 132 (Tuesday, July 11, 2006)]
[Notices]
[Pages 39120-39121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005E-0236]


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

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 MULTIHANCE 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 that claims that human 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 https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 human drug product 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 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 
MULTIHANCE (gadobenate dimeglumine). MULTIHANCE is indicated for 
intravenous use in magnetic resonance imaging (MRI) of the central 
nervous system in adults to visualize lesions with abnormal blood brain 
barrier or abnormal vascularity of the brain, spine, and associated 
tissues. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for MULTIHANCE (U.S. 
Patent No. 4,916,246) from Bracco International B.V., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
July 8, 2005, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of MULTIHANCE 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 
MULTIHANCE is 3,789 days. Of this time, 2,482 days occurred during the 
testing phase of the regulatory review period, while 1,307 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) became effective: July 
12, 1994. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on July 12, 
1994.
    2. The date the application was initially submitted with respect to 
the human drug product under section

[[Page 39121]]

505(b) of the act: April 27, 2001. FDA has verified the applicant's 
claim that the new drug applications (NDA) for Multihance (NDA 21-357 
and NDA 21-358) were initially submitted on April 27, 2001.
    3. The date the applications were approved: November 23, 2004. FDA 
has verified the applicant's claims that NDA 21-357 and NDA 21-358 were 
approved on November 23, 2004.
    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 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) written or electronic comments and ask for a 
redetermination by September 11, 2006. 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 January 8, 2007. 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: June 13, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-10796 Filed 7-10-06; 8:45 am]
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