[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25299-25300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-1299 and FDA-2013-E-1302]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CAMERON HEALTH S-ICD 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 CAMERON HEALTH S-ICD 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 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, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10001 New Hampshire Ave., Hillandale Building, 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

[[Page 25300]]

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 CAMERON HEALTH S-
ICD SYSTEM. CAMERON HEALTH S-ICD SYSTEM is indicated to provide 
defibrillation therapy for the treatment of life-threatening 
ventricular tachyarrhythmias in patients who do not have symptomatic 
bradycardia, incessant ventricular tachycardia, or spontaneous, 
frequently recurring ventricular tachycardia that is reliably 
terminated with antitachycardia pacing. Subsequent to this approval, 
the USPTO received patent term restoration applications for CAMERON 
HEALTH S-ICD SYSTEM (U.S. Patent Nos. 6,856,835 and 7,149,575) from 
Cameron Health Inc., and the USPTO requested FDA's assistance in 
determining the patents' 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 CAMERON HEALTH S-ICD SYSTEM 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 
CAMERON HEALTH S-ICD SYSTEM is 1,024 days. Of this time, 743 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: December 11, 2009. 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 December 11, 2009.
    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 
23, 2011. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for CAMERON HEALTH S-ICD SYSTEM (PMA 
P110042) was initially submitted December 23, 2011.
    3. The date the application was approved: September 28, 2012. FDA 
has verified the applicant's claim that PMA P110042 was approved on 
September 28, 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 applications for patent extension, 
this applicant seeks 651 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. 2015-10334 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P