[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Page 79382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0042]


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

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 LIVALO 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 LIVALO 
(pitavastatin calcium). LIVALO is indicated for patients with primary 
hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet 
to reduce elevated total cholesterol, low-density lipoprotein 
cholesterol, apolipoprotein B, and triglycerides, and to increase high-
density lipoprotein cholesterol. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for LIVALO (U.S. Patent No. 5,856,336) from Nissan Chemical 
Industries, Ltd., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 3, 2010, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of LIVALO 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 
LIVALO is 3,341 days. Of this time, 3,036 days occurred during the 
testing phase of the regulatory review period, while 305 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: June 12, 2000. The applicant claims June 9, 2000, as the 
date the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was June 12, 
2000, 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: October 3, 
2008. The applicant claims October 1, 2008, as the date the new drug 
application (NDA) for LIVALO (NDA 22-363) was initially submitted. 
However, FDA records indicate that NDA 22-363 was submitted on October 
3, 2008.
    3. The date the application was approved: August 3, 2009. FDA has 
verified the applicant's claim that NDA 22-363 was approved on August 
3, 2009.
    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 1,826 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 February 18, 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 June 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 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 regulations.gov may be viewed in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31847 Filed 12-17-10; 8:45 am]
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