[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Pages 76739-76740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30992]



Food and Drug Administration

[Docket No. FDA-2010-E-0047]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ILARIS 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 biological 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.

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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 biological 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 biologic product 
ILARIS (canakinumab). ILARIS is indicated for the treatment of 
Cryopyrin Associated Periodic Syndromes in adults and children 4 years 
of age and older including Familial Cold Autoinflammatory Syndrome and 
Muckle-Wells Syndrome. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
ILARIS (U.S. Patent No. 7,446,175) from Novartis AG, 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 24, 2010, FDA advised the Patent and Trademark Office that this 
human biological product had undergone a regulatory review period and 
that the approval of ILARIS 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 
    FDA has determined that the applicable regulatory review period for 
ILARIS is 1,072 days. Of this time, 889 days occurred during the 
testing phase of the regulatory review period, while 183 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 (21 U.S.C. 355(i)) became effective: July 13, 
2006. The applicant claims July 12, 2006, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 13, 2006, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262: December 17, 2008. The applicant claims 
December 15, 2008, as the date the biologics license application (BLA) 
for ILARIS (BLA 125319) was initially submitted. However, FDA records 
indicate that BLA 125319 was submitted on December 17, 2008.
    3. The date the application was approved: June 17, 2009. FDA has 
verified the applicant's claim that BLA 125319 was approved on June 17, 
    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 177 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 7, 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 7, 2011. To meet its burden, the petition must contain 
sufficient facts to merit an FDA

[[Page 76740]]

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. 2010-30992 Filed 12-8-10; 8:45 am]