[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25298-25299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10338]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0785]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

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 the RELAY THORACIC STENT-GRAFT WITH PLUS 
DELIVERY SYSTEM 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 the U.S. Patent and 
Trademark Office (USPTO), 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 (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.

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

[[Page 25299]]

granted. Although only a portion of a regulatory review period may 
count toward the actual amount of extension that the Director of USPTO 
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 has approved for marketing the medical device RELAY THORACIC 
STENT-GRAFT WITH PLUS DELIVERY SYSTEM. RELAY THORACIC STENT-GRAFT WITH 
PLUS DELIVERY SYSTEM is indicated for the endovascular repair of 
fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic 
ulcers in the descending thoracic aorta in patients having appropriate 
anatomy. Subsequent to this approval, the USPTO received a patent term 
restoration application for the RELAY THORACIC STENT-GRAFT WITH PLUS 
DELIVERY SYSTEM (U.S. Patent No. 8,062,345 B2) from Bolton Medical 
Inc., and the USPTO requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
March 18, 2014, FDA advised the USPTO that this medical device had 
undergone a regulatory review period and that the approval of the RELAY 
THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM is 2,852 days. Of 
this time, 2,529 days occurred during the testing phase of the 
regulatory review period, while 323 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: December 2, 2004. 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 
December 3, 2004. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
December 2, 2004, 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 
4, 2011. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for the RELAY THORACIC STENT-GRAFT WITH PLUS 
DELIVERY SYSTEM (PMA P110038) was initially submitted November 4, 2011.
    3. The date the application was approved: September 21, 2012. FDA 
has verified the applicant's claim that PMA P110038 was approved on 
September 21, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 225 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 July 6, 2015. 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 November 2, 2015. 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 or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. 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: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10338 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P