[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27878-27879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0711; FDA-2011-E-0712; FDA-2011-E-0715]


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

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 BENLYSTA 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 a patent 
which claims that human biological product.

ADDRESSES: 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. 6257, Silver 
Spring, MD 20993-0002, 301-796-7900.

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 has approved for marketing the human biologic product, BENLYSTA 
(belimumab). BENLYSTA is indicated for treatment of adult patients with 
active, autoantibody-positive, systemic lupus erythematosus who are 
receiving standard therapy. Subsequent to this approval, the Patent and 
Trademark Office received patent term restoration applications for 
BENLYSTA (U.S. Patent Nos. 6,403,770; 7,138,501; and 7,879,328) from 
Human Genome Sciences Inc., and the Patent and Trademark Office 
requested FDA's assistance in determining the patents' eligibility for 
patent term restoration. In a letter dated July 2, 2012, FDA advised 
the Patent and Trademark Office that this human biological product had 
undergone a regulatory review period and that the approval of BENLYSTA 
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 
BENLYSTA is 3,426 days. Of this time, 3,152 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 (21 U.S.C. 355(i)) became effective: October 23, 
2001. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on October 
23, 2001.
    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): June 9, 2010. The applicant claims June 
10, 2010, as the date the biologics license application (BLA) for 
BENLYSTA (BLA 125370/0) was initially submitted. However, FDA records 
indicate that BLA 125370/0 was submitted on June 9, 2010.
    3. The date the application was approved: March 9, 2011. FDA has 
verified the applicant's claim that BLA 125370/0 was approved on March 
9, 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 1,733 days or 
610 days or 37 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 July 14, 2014. Furthermore, any interested person 
may

[[Page 27879]]

petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period 
by November 12, 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 written or 
electronic 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.
    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: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11176 Filed 5-14-14; 8:45 am]
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