[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12330-12331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0196]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SAPIEN TRANSCATHETER 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 SAPIEN TRANSCATHETER 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 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. 6284, 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 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, SAPIEN 
TRANSCATHETER HEART VALVE. SAPIEN TRANSCATHETER HEART VALVE is 
indicated for transfemoral delivery in patients with severe symptomatic 
native aortic valve stenosis who have been determined by a cardiac 
surgeon to be inoperable for open aortic valve replacement and in whom 
existing comorbidities would not preclude the expected benefit from 
correction of the aortic stenosis. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for SAPIEN TRANSCATHETER HEART VALVE (U.S. Patent No. 
5,411,552) from Edwards Lifesciences AG and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated July 10, 
2012, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of SAPIEN TRANSCATHETER HEART VALVE represented the first permitted 
commercial marketing or use of the product. Thereafter, the Patent and 
Trademark Office requested that the

[[Page 12331]]

FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
SAPIEN TRANSCATHETER HEART VALVE is 2,473 days. Of this time, 2,106 
days occurred during the testing phase of the regulatory review period, 
while 367 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 FD&C Act) (21 U.S.C. 360j(g)) involving 
this device became effective: January 26, 2005. The applicant claims 
that the investigational device exemption (IDE) required under section 
520(g) of the FD&C Act for human tests to begin became effective on 
March 24, 2003. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
January 26, 2005, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November 
1, 2010. The applicant claims October 29, 2010, as the date the 
premarket approval application (PMA) for SAPIEN Transcatheter Heart 
Valve (PMA P100041) was initially submitted. However, FDA records 
indicate that PMA P100041 was submitted on November 1, 2010.
    3. The date the application was approved: November 2, 2011. FDA has 
verified the applicant's claim that PMA P100041 was approved on 
November 2, 2011.
    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 1,757 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) either electronic or written comments and ask for a 
redetermination by April 23, 2013. 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 August 21, 2013. 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. 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 http://www.regulations.gov may be viewed in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04016 Filed 2-21-13; 8:45 am]
BILLING CODE 4160-01-P