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Notice

Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN TRANSCATHETER HEART VALVE

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 Start Printed Page 12331FDA 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.

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Dated: February 15, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-04016 Filed 2-21-13; 8:45 am]

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