[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26268-26269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0397]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ISTENT TRABECULAR MICRO-BYPASS STENT

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 ISTENT TRABECULAR MICRO-BYPASS STENT 
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 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 ISTENT TRABECULAR 
MICRO-BYPASS STENT. ISTENT TRABECULAR MICRO-BYPASS STENT is indicated 
for use in conjunction with cataract surgery for the reduction of 
intraocular pressure in adult patients with mild to moderate open-angle 
glaucoma currently treated with ocular hypotensive medication. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for the ISTENT TRABECULAR MICRO-BYPASS STENT 
(U.S. Patent No. 6,626,858) from Glaukos Corporation, and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated January 30, 2014, FDA 
advised the USPTO that this medical device had undergone a regulatory 
review period and that the approval of the ISTENT TRABECULAR MICRO-
BYPASS STENT 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 
the ISTENT TRABECULAR MICRO-BYPASS STENT is 2,820 days. Of this time, 
1,535 days occurred during the testing phase of the regulatory review 
period, while 1,285 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: October 7, 2004. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the FD&C Act for human tests to 
begin became effective October 7, 2004.
    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): December 
19, 2008. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for the ISTENT TRABECULAR MICRO-BYPASS STENT 
(PMA P080030) was initially submitted December 19, 2008.
    3. The date the application was approved: June 25, 2012. FDA has 
verified the applicant's claim that PMA P080030 was approved on June 
25, 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 5 years of patent term extension.

[[Page 26269]]

    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 3, 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: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10999 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P