[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26554-26555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0113]


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

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 GILENYA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an

[[Page 26555]]

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:[sol][sol]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. 6284, 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 GILENYA 
(fingolimod). GILENYA is indicated for treatment of patients with 
relapsing forms of multiple sclerosis to reduce the frequency of 
clinical exacerbations and to delay the accumulation of physical 
disability. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for GILENYA (U.S. 
Patent No. 5,604,229) from Novartis Pharmaceuticals Corp., and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated April 25, 2011, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of GILENYA 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 
GILENYA is 4,296 days. Of this time, 4,021 days occurred during the 
testing phase of the regulatory review period, while 275 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: December 19, 1998. The applicant claims December 25, 1998, 
as the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was December 19, 1998, 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 
21, 2009. The applicant claims December 18, 2009, as the date the new 
drug application (NDA) for GILENYA (NDA 22-527) was initially 
submitted. However, FDA records indicate that NDA 22-527 was submitted 
on December 21, 2009.
    3. The date the application was approved: September 21, 2010. FDA 
has verified the applicant's claim that NDA 22-527 was approved on 
September 21, 2010.
    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) either electronic or written comments and ask for a 
redetermination by July 3, 2012. 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 October 31, 2012. 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. 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:[sol][sol]www.regulations.gov may be viewed in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10819 Filed 5-3-12; 8:45 am]
BILLING CODE 4160-01-P