[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Notices]
[Pages 21696-21697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0048] (formerly Docket No. 2007E-0445)


Determination of Regulatory Review Period for Purposes of Patent 
Extension; NEUPRO TRANSDERMAL SYSTEM

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 NEUPRO TRANSDERMAL SYSTEM 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 written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 human drug product 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 NEUPRO 
TRANSDERMAL SYSTEM (rotigotine). NEUPRO TRANSDERMAL SYSTEM is indicated 
for the treatment of the signs and symptoms of early-stage idiopathic 
Parkinson's disease. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
NEUPRO TRANSDERMAL SYSTEM (U.S. Patent No. 6,884,434) from Schwarz 
Pharma Limited, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated April 28, 2008, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of NEUPRO TRANSDERMAL 
SYSTEM represented the first permitted commercial marketing or use of 
the product. Shortly 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 
NEUPRO TRANSDERMAL SYSTEM is 4,367 days. Of this time, 3,535 days 
occurred during the testing phase of the regulatory review period, 
while 832 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 act) (21 U.S.C. 355(i)) became effective: 
May 27, 1995. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on May 27, 
1995.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: January 28, 
2005. The applicant claims January 19, 2005, as the date the new drug 
application (NDA) for NEUPRO TRANSDERMAL SYSTEM (NDA 21-829) was 
initially submitted. However, FDA records indicate that NDA 21-829 was 
initially submitted on January 28, 2005, the date of receipt by the 
Agency of a resubmission following a refusal to file.
    3. The date the application was approved: May 9, 2007. FDA has 
verified the applicant's claim that NDA 21-829 was approved on May 9, 
2007.
    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 744 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) written or electronic comments and ask for a redetermination 
by July 7, 2009. 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 4, 
2009. 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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.


[[Page 21697]]


    Dated: April 6, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-10818 Filed 5-7-09; 8:45 am]
BILLING CODE 4160-01-S