Document ID: FDA-2013-E-0476-0005
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; TUDORZA PRESSAIR
Posted Date: 2015-05-04T04:00Z

[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25303-25304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0476 and FDA-2013-E-0654]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; TUDORZA PRESSAIR

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 TUDORZA PRESSAIR 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 the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
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 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 drug product TUDORZA 
PRESSAIR (aclidinium bromide). TUDORZA PRESSAIR is indicated for the 
long-term maintenance treatment of bronchospasm associated with chronic 
obstructive pulmonary disease, including chronic bronchitis and 
emphysema. Subsequent to this approval, the USPTO received patent term 
restoration applications for TUDORZA PRESSAIR (U.S. Patent Nos. 
6,750,226 and 7,078,412) from Almiral, S.A., and the USPTO requested 
FDA's assistance in determining the patents eligibilities for patent 
term restoration. In a letter dated July 16, 2013, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of TUDORZA PRESSAIR represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO

[[Page 25304]]

requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
TUDORZA PRESSAIR is 3,136 days. Of this time, 2,739 days occurred 
during the testing phase of the regulatory review period, while 397 
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: December 24, 2003. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on December 24, 2003.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: June 23, 
2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for TUDORZA PRESSAIR (NDA 202-450) was submitted on 
June 23, 2011.
    3. The date the application was approved: July 23, 2012. FDA has 
verified the applicant's claim that NDA 202-450 was approved on July 
23, 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 applications for patent extension, 
this applicant seeks 1,679 or 1,298 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 6, 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 November 2, 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 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10336 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P