Document ID: FDA-2007-E-0461-0003
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS
Posted Date: 2008-05-29T04:00Z

[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Notices]               
[Page 30949-30950]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my08-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2007-E-0461 (formerly Docket No. 2007E-0424), FDA-
2007-E-0165 (formerly Docket No. 2007E-0425), FDA-2007-E-0459 (formerly 
Docket No. 2007E-0146)]

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

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 LUCENTIS 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 patents 
which claim that human biological product.

ADDRESSES:  Submit written or electronic 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 http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Center for Drug 
Evaluation and Research, 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 (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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological product becomes effective

[[Page 30950]]

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 
LUCENTIS (ranibizumab). LUCENTIS is indicated for the treatment of 
patients with neovascular (wet) age-related macular degeneration. 
Subsequent to this approval, the Patent and Trademark Office received 
patent term restoration applications for LUCENTIS (U.S. Patent Nos. 
6,407,213; 6,884,879; and 7,060,269) from Genentech, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In letters dated 
July 24, 2007, and November 21, 2007, FDA advised the Patent and 
Trademark Office that this human biological product had undergone a 
regulatory review period and that the approval of LUCENTIS represented 
the first permitted commercial marketing or use of the product. Shortly 
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 
LUCENTIS is 2,430 days. Of this time, 2,247 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: November 6, 
1999. The applicant claims October 7, 1999, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was November 6, 1999, 
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 30, 2005. The applicant claims 
December 29, 2005, as the date the biologics license application (BLA) 
for LUCENTIS (BLA 125156/0) was initially submitted. However, FDA 
records indicate that BLA 125156/0 was submitted on December 30, 2005.
    3. The date the application was approved: June 30, 2006. FDA has 
verified the applicant's claim that BLA 125156/0 was approved on June 
30, 2006.
    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 for U.S. Patent Nos. 6,407,213; 
6,884,879; and 7,060,269, this applicant seeks 378 days; 307 days or 17 
days, respectively, 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 July 28, 2008. 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 November 25, 
2008. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 8, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-12007 Filed 5-28-08; 8:45 am]

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