[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14120-14121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0046]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ONYX LES

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 ONYX LES 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 
tohttp://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

[[Page 14121]]

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 ONYX LES. 
ONYX LES is indicated for presurgical embolization of brain 
arteriovenous malformations. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
ONYX LES (U.S. Patent No. 5,667,767) from Micro Therapeutics, Inc., and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated June 14, 2006, FDA advised the Patent and Trademark Office 
that this medical device had undergone a regulatory review period and 
that the approval of ONYX LES 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 
ONYX LES is 1,682 days. Of this time, 825 days occurred during the 
testing phase of the regulatory review period, while 857 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: December 14, 2000. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the act for human tests to begin 
became effective December 14, 2000.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): March 18, 
2003. The applicant claims March 12, 2003, as the date the premarket 
approval application (PMA) for ONYX LES (PMA P030004) was initially 
submitted. However, FDA records indicate that PMA P030004 was submitted 
on March 18, 2003.
    3. The date the application was approved: July 21, 2005. FDA has 
verified the applicant's claim that PMA P030004 was approved on July 
21, 2005.
    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 1,271 days of 
patent term extension.
    Anyone with knowledge that any of the dates are published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by May 25, 2007. 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 September 24, 
2007. 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.

    Dated: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5444 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S