[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Pages 34138-34139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0308]


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

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 RESTYLANE 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 medical device.

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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041

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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. 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 (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 medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device RESTYLANE. 
RESTYLANE is indicated for mid-to-deep dermal implantation for the 
correction of moderate to severe facial wrinkles and folds, such as 
nasolabial folds. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for RESTYLANE 
(U.S. Patent No. 5,827,937) from Q-Med AB, and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated February 24, 
2006, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of RESTYLANE 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 
RESTYLANE is 1,491 days. Of this time, 949 days occurred during the 
testing phase of the regulatory review period, while 542 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this 
device became effective: November 14, 1999. The applicant claims that 
the investigational device exemption (IDE) required under section 
520(g) of the act for human tests to begin became effective on August 
4, 2000. However, FDA records indicate that the IDE was determined 
substantially complete for clinical studies to have begun on November 
14, 1999, which represents the IDE effective date.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): June 19, 
2002. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for RESTYLANE (PMA P020023) was initially 
submitted June 19, 2002.
    3. The date the application was approved: December 12, 2003. FDA 
has verified the applicant's claim that PMA P020023 was approved on 
December 12, 2003.
    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 879 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 August 14, 2006. 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 December 11, 
2006. 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,

[[Page 34139]]

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.

    Dated: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9213 Filed 6-12-06; 8:45 am]
BILLING CODE 4160-01-S