[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Notices]
[Page 43437]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-93]
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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