Document ID: FDA-2014-E-0126-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; FLUCELVAX
Posted Date: 2015-05-22T04:00Z

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29724-29725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0126]

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

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 FLUCELVAX 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 U.S. 
Patent and Trademark Office (USPTO), 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, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, 
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 USPTO 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 FLUCELVAX 
(A/Brisbane/10/2010 (wild type), A/California 7/2009-like virus (H1N1), 
A/Victoria/361/2011 virus IVR-165(H3N2, B/Wisconsin/1/2010 (wildtype) B 
Yamagata lineage)). FLUCELVAX is indicated for active immunization for 
the prevention of influenza disease caused by influenza virus subtypes 
A and type B contained in the vaccine. Subsequent to this approval, the 
USPTO received a patent term restoration application for FLUCELVAX 
(U.S. Patent No. 6,656,720) from Novartis AG, and the USPTO requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated May 22, 2014, FDA advised the USPTO 
that this human biological product had undergone a regulatory review 
period and that the approval of FLUCELVAX represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
FLUCELVAX is 2,589 days. Of this time, 2,224 days occurred during the 
testing phase of the regulatory review period, while 365 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 21, 
2005. The applicant claims March 31, 2004, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was October 21, 2005, 
which was the date the IND was removed from clinical hold.
    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): November 22, 2011. The applicant claims 
October 31, 2011, as the date the biologics license application (BLA) 
for FLUCELVAX (BLA 125408) was initially submitted. However, FDA 
records indicate that BLA 125408 was submitted on November 22, 2011.
    3. The date the application was approved: November 20, 2012. FDA 
has verified the applicant's claim that BLA 125408 was approved on 
November 20, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,773 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 21, 2015. Furthermore, any interested person 
may petition FDA for a determination regarding whether the applicant 
for

[[Page 29725]]

extension acted with due diligence during the regulatory review period 
by November 18, 2015. 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 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12397 Filed 5-21-15; 8:45 am]
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