Document ID: FDA-2014-E-0130-0012
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; FLUBLOK
Posted Date: 2015-04-24T04:00Z

[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 23034-23035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09521]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0130]

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

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 FLUBLOK 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 the 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, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 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

[[Page 23035]]

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 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 
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 FLUBLOK 
(A/California/7/2009(h1N1), A/Victoria/361/2011(H3N2), B/Wisconsin/1/
2010). FLUBLOK is a vaccine indicated for active immunization against 
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 FLUBLOK (U.S. Patent No. 5,762,939) 
from Protein Sciences Corporation, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 26, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of FLUBLOK 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 
FLUBLOK is 3,010 days. Of this time, 1,275 days occurred during the 
testing phase of the regulatory review period, while 1,735 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: October 22, 2004. The applicant claims September 23, 2004, 
as the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was October 22, 2004, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: April 18, 
2008. FDA has verified the applicant's claim that the biologics license 
application (BLA) for FLUBLOK (BLA 125285/0) was submitted on April 18, 
2008.
    3. The date the application was approved: January 16, 2013. FDA has 
verified the applicant's claim that BLA 125285/0 was approved on 
January 16, 2013.
    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 5 years 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 23, 2015. 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 October 21, 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.

    Dated: April 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09521 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P