[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]
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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.
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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