[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Page 43437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E-0344] (formerly Docket No. 02E-0344)


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ATS Open Pivot Bileaf Heart Valve

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 ATS Open Pivot Bileaf Heart Valve 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: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-453-6699.

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 approved for marketing the medical device ATS Open Pivot Bileaf 
Heart Valve. ATS Open Pivot Bileaf Heart Valve is indicated for the 
replacement of diseased, damaged, or malfunctioning native or 
prosthetic aortic or mitral valves. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for ATS Open Pivot Bileaf Heart Valve (U.S. Patent No. 
5,354,330) from ATS Medical, 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 December 30, 2002, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of ATS Open 
Pivot Bileaf Heart Valve 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 
ATS Open Pivot Bileaf Heart Valve is 1,418 days. Of this time, 980 days 
occurred during the testing phase of the regulatory review period, 
while 438 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 involving this device became effective: November 
27, 1996. FDA has verified the applicant's claim that the date the 
investigational device exemption (IDE) required under section 520(g) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) 
for human tests to begin became effective November 27, 1996.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): August 3, 
1999. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for ATS Open Pivot Bileaf Heart Valve (PMA 
P990046) was initially submitted August 3, 1999.
    3. The date the application was approved: October 13, 2000. FDA has 
verified the applicant's claim that PMA P990046 was approved on October 
13, 2000.
    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 505 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 September 26, 2005. 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 January 
23, 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, 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: June 29, 2005.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 05-14748 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S