[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19101-19102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07657]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2012-E-0490]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; MELAFIND SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for MELAFIND 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 Patents and Trademarks, 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver 
Spring, MD 20993-0002, 301-796-3602.

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 MELAFIND SYSTEM. 
MELAFIND SYSTEM is indicated for use on clinically atypical cutaneous 
pigmented lesions with one or more clinical or historical 
characteristics of melanoma, excluding those with a clinical diagnosis 
of melanoma or likely melanoma. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
MELAFIND SYSTEM (U.S. Patent No. 6,208,749) from MELA Sciences Inc., 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated August 10, 2012, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of MELAFIND SYSTEM represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
Patent and Trademark Office requested that the FDA determine the 
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
MELAFIND SYSTEM is 3,837 days. Of this time, 2,961 days occurred during 
the testing phase of the regulatory review period, while 876 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, or, if an investigational device 
exemption (IDE) was not required, but institutional review board (IRB) 
approval is required, under section 520(g)(3) of the FD&C Act, the IRB 
approval date: May 2, 2001. The applicant claims there was no IDE 
submitted under section 520(g) of the FD&C Act and claims the date that 
IRB-required approval was effective was May 2, 2001. FDA concurs that 
no IDE was submitted and that the IRB approval action was enacted May 
2, 2001, according to the certificate of approval substantiating IRB 
approval date provided in the application for patent term extension.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the the FD&C Act (21 U.S.C. 360e): June 
9, 2009. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for MELAFIND SYSTEM (PMA P090012) was 
initially submitted June 9, 2009.
    3. The date the application was approved: November 1, 2011. FDA has 
verified the applicant's claim that PMA P090012 was approved on 
November 1, 2011.
    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 
application for patent extension, this applicant seeks 2,355 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 June 6, 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 October 6, 2014. To meet its burden, the petition must contain 
sufficient facts to

[[Page 19102]]

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: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07657 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P