[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77879-77880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0037 and FDA-2010-E-0038]


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

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 SAMSCA 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 Patents 
and Trademarks, Department of Commerce, for the extension of patents 
which claim that human drug product.

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

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 (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.

[[Page 77880]]

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 SAMSCA 
(tolvaptan). SAMSCA is indicated for the treatment of clinically 
significant hypervolemic and euvolemic hyponatremia, including patients 
with heart failure, cirrhosis, and Syndrome of Inappropriate 
Antidiuretic Hormone. Subsequent to this approval, the Patent and 
Trademark Office received patent term restoration applications for 
SAMSCA (U.S. Patent Nos. 5,258,510 and 5,753,677) from Otsuka 
Pharmaceutical Co., Ltd., and the Patent and Trademark Office requested 
FDA's assistance in determining these patents' eligibility for patent 
term restoration. In a letter dated March 3, 2010, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of SAMSCA represented 
the first permitted commercial marketing or use of the product. 
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 
SAMSCA is 4,722 days. Of this time, 4,147 days occurred during the 
testing phase of the regulatory review period, while 575 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: June 16, 1996. The applicant claims October 23, 1997, as the 
date the investigational new drug application (IND) became effective. 
However, according to FDA records, this IND was not the first IND 
received for this active ingredient. In general, FDA has used the first 
IND of the active ingredient of the drug product as the beginning of 
the testing phase, if information derived from this first IND was or 
could have been relied on or was relevant for approval to market the 
drug product. FDA records indicate that the effective date of the first 
IND for tolvaptan was June 16, 1996, which was 30 days after FDA 
receipt of this first 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: October 
23, 2007. FDA has verified the applicant's claim that the new drug 
application (NDA) for SAMSCA (NDA 22-275) was submitted on October 23, 
2007.
    3. The date the application was approved: May 19, 2009. FDA has 
verified the applicant's claim that NDA 22-275 was approved on May 19, 
2009.
    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 
applications for patent extension, this applicant seeks 1,826 days or 
1,827 days respectively 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 February 14, 2011. 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 June 13, 2011. 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 petitions. 
It is only necessary to send one set of comments. It is no longer 
necessary to send three copies of mailed comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31298 Filed 12-13-10; 8:45 am]
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