[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26273-26274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0296]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; COFLEX INTERLAMINAR TECHNOLOGY

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 COFLEX INTERLAMINAR TECHNOLOGY 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. Patents and Trademarks 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, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, 
Silver Spring, MD 20993-0002, 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 COFLEX 
INTERLAMINAR TECHNOLOGY. COFLEX INTERLAMINAR TECHNOLOGY is indicated 
for use in one- or two-level lumbar stenosis from L1-L5 in skeletally 
mature patients with at least moderate impairment in function, who 
experience relief in flexion from their symptoms of leg/buttocks/groin 
pain, with or without back pain, and who have undergone at least 6 
months of non-operative treatment. Subsequent to this approval, USPTO 
received a patent term restoration application for COFLEX INTERLAMINAR 
TECHNOLOGY (U.S. Patent No. 5,645,599) from Paradigm Spine, LLC, and 
the USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated December 24, 
2013, FDA advised the USPTO that this medical device had undergone a 
regulatory review period and that the approval of COFLEX INTERLAMINAR 
TECHNOLOGY represented the first permitted commercial marketing or use 
of the product. Thereafter, the USPTO requested that the FDA determine 
the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
COFLEX INTERLAMINAR TECHNOLOGY is 2,382 days. Of this time, 1,787 days 
occurred during the testing phase of the regulatory review period, 
while 595 days occurred during the approval phase. These periods of 
time were derived from the following dates:

[[Page 26274]]

    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: April 12, 2006. 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 10, 2006. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
April 12, 2006, 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): March 3, 
2011. The applicant claims March 4, 2011, as the date the premarket 
approval application (PMA) for COFLEX INTERLAMINAR TECHNOLOGY (PMA 
P110008) was initially submitted. However, FDA records indicate that 
PMA P110008 was submitted on March 3, 2011.
    3. The date the application was approved: October 17, 2012. FDA has 
verified the applicant's claim that PMA P110008 was approved on October 
17, 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 1,503 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 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. 2015-10998 Filed 5-6-15; 8:45 am]
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