Document ID: FDA-2012-E-0489-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; EYLEA
Posted Date: 2014-04-02T04:00Z

[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18566-18567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07333]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-E-0487; FDA-2012-E-0488; and FDA-2012-E-0489]

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

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 EYLEA 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 (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6284, Silver 
Spring, MD 20993-0002, 301-796-3602.

[[Page 18567]]

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 has approved for marketing the human biological product EYLEA 
(aflibercept). EYLEA is indicated for the treatment of patients with 
neovascular (Wet) Age-Related Macular Degeneration (AMD). Subsequent to 
this approval, the U.S. Patent and Trademark Office received patent 
term restoration applications for EYLEA (U.S. Patent Nos.: 7,070,959; 
7,374,757; and 7,374,758) from Regeneron Pharmaceuticals, Inc., and the 
Patent and Trademark Office requested FDA's assistance in determining 
these patents' eligibility for patent term restoration. In a letter 
dated August 7, 2012, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of EYLEA 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 
EYLEA is 2,349 days. Of this time, 2,075 days occurred during the 
testing phase of the regulatory review period, while 274 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 15, 2005. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on June 15, 2005.
    2. The date the application was initially submitted with respect to 
the human drug product under section 352 of the Public Health Service 
Act (42 U.S.C. 262): February 18, 2011. The applicant claims February 
17, 2011, as the date the biologics license application (BLA) for EYLEA 
(BLA 125387/0) was initially submitted. However, FDA records indicate 
that BLA 125387/0 was submitted on February 18, 2011.
    3. The date the application was approved: November 18, 2011. FDA 
has verified the applicant's claim that BLA 125387/0 was approved on 
November 18, 2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the Patent and 
Trademark Office applies several statutory limitations in its 
calculations of the actual period for patent extension. In its 
applications for patent extension, this applicant seeks either 775 or 
1,118 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 June 2, 2014. 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 September 29, 2014. 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 electronic or 
written petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07333 Filed 4-1-14; 8:45 am]
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