Document ID: FDA-2012-E-0456-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; DALIRESP
Posted Date: 2014-01-23T05:00Z

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3831-3832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01306]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0456]

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

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 DALIRESP 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 drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions (two copies are necessary) 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, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6284, 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 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 recently approved for marketing the human drug product DALIRESP 
(roflumilast). DALIRESP is indicated as a treatment to reduce the risk 
of chronic obstructive pulmonary disease (COPD) exacerbations in 
patients with severe COPD associated with chronic bronchitis and a 
history of exacerbations. Subsequent to this approval, the U.S. Patent 
and Trademark Office received a patent term restoration application for 
DALIRESP (U.S. Patent No. 5,712,298) from Nycomed GmbH, and the U.S. 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated August 7, 2012, FDA advised the U.S. Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of DALIRESP represented the first permitted 
commercial marketing or use of the product. Thereafter, the U.S. Patent 
and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
DALIRESP is 4,237 days. Of this time, 3,645 days occurred during the 
testing phase of the regulatory review period, while 592 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: July 26, 1999. The applicant claims December 19, 1999, as 
the date the investigational

[[Page 3832]]

new drug application (IND) became effective. However, FDA records 
indicate that the IND effective date was July 26, 1999, when clinical 
trials were allowed to proceed.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: July 17, 
2009. FDA has verified the applicant's claim that the new drug 
application (NDA) for DALIRESP (NDA 22-522) was submitted on July 17, 
2009.
    3. The date the application was approved: February 28, 2011. FDA 
has verified the applicant's claim that NDA 22-522 was approved on 
February 28, 2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,826 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 March 24, 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 July 22, 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, you must 
submit two copies of the written petition. 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: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01306 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P