[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Page 33762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13640]



[[Page 33762]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0383; FDA-2011-E-0386, and FDA-2011-E-0387]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Arctic Front Cryocatheter 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 Arctic Front Cryocatheter System and is 
publishing this notice of that determination as required by law. FDA 
has made the determination because of the submission of applications to 
the Director of Patents and Trademarks, Department of Commerce, for the 
extension of patents which claim 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, 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 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 has approved for marketing the medical device, Arctic Front 
Cryocatheter System. Arctic Front Cryocatheter System is indicated for 
treatment of drug refractory recurrent symptomatic paroxysmal atrial 
fibrillation. Subsequent to this approval, the Patent and Trademark 
Office received patent term restoration applications for Arctic Front 
Cryocatheter System (U.S. Patent Nos. 6,575,966; 7,648,497; and 
7,727,228) from Medtronic CryoCath LP, and the Patent and Trademark 
Office requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated March 6, 
2012, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of Arctic Front Cryocatheter System represented the first permitted 
commercial marketing or use of the product. Thereafter, the Patent and 
Trademark Office requested that FDA determine the product's regulatory 
review period.
    FDA has determined that the applicable regulatory review period for 
Arctic Front Cryocatheter System is 2,670 days. Of this time, 2,389 
days occurred during the testing phase of the regulatory review period, 
while 281 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: August 28, 2003. FDA has verified the 
applicant's claim that the date the investigational device exemption 
required under section 520(g) of the FD&C Act for human tests to begin 
became effective was August 28, 2003.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): March 12, 2010. FDA has verified the applicant's 
claim that the premarket approval application (PMA) for Arctic Front 
Cryocatheter System (PMA P100010) was initially submitted March 12, 
2010.
    3. The date the application was approved: December 17, 2010. FDA 
has verified the applicant's claim that PMA P100010 was approved on 
December 17, 2010.
    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 
applications for patent extension, this applicant seeks 200, 307, or 
1,476 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 August 11, 2014. 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 December 9, 2014. 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: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13640 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P