Document ID: FDA-2012-E-1243-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; CARBON DIOXIDE LASER
Posted Date: 2014-10-22T04:00Z

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63132-63133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-E-1242; FDA-2012-E-1243]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; CARBON DIOXIDE LASER

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 CARBON DIOXIDE LASER 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 United States Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that food 
additive.

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 food additives, the testing 
phase begins on the date when a major health or environmental effects 
test is begun and runs until a petition relying on the test and 
requesting the issuance of a regulation for use of the additive under 
section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 348) is initially submitted to FDA. The approval phase 
begins on the date a petition requesting the issuance of a regulation 
for use of the additive under section 409 of the FD&C Act is initially 
received. The approval phase continues until the regulation for the 
additive becomes effective or until commercial marketing is permitted 
(21 CFR 60.22). Although only a portion of a regulatory review period 
may count toward the actual amount of extension that the Director of 
USPTO may award (for example, 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 food additive will include all of the testing phase and 
approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has amended the food additive regulations to provide for the 
safe use of CARBON DIOXIDE LASER for etching

[[Page 63133]]

information on the surface of fresh, intact citrus fruit for commercial 
marketing as specified in 21 CFR 179.43. Subsequent to this approval, 
USPTO received patent term restoration applications for CARBON DIOXIDE 
LASER (U.S. Patent Nos. 5,660,747 and 5,897,797) from Durant Wayland, 
Inc., and the USPTO requested FDA's assistance in determining the 
patents' eligibility for patent term restoration. In a letter dated 
February 13, 2013, FDA advised the USPTO that this product had 
undergone a regulatory review period and that FDA's granting of the 
food additive petition for CARBON DIOXIDE LASER represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
CARBON DIOXIDE LASER is 1,950 days. The applicant has not asserted a 
testing phase. All 1,950 days of the regulatory review period occurred 
during the approval phase. This period of time was derived from the 
following dates:
    1. The date a major health or environmental effects test on the 
food additive was initiated: No date claimed. The applicant has not 
asserted a testing period.
    2. The date the application was initially submitted with respect to 
the food additive under section 409 of the FD&C Act: February 9, 2007. 
FDA has determined that the food additive petition (FAP) for Carbon 
Dioxide Laser for Etching Food (FAP 7M4768) was submitted on February 
9, 2007.
    3. The date a regulation for use of the food additive became 
effective: June 11, 2012. FDA has verified the applicant's claim that 
FAP 7M4768 was granted through FDA's issuance of a responsive food 
additive regulation, effective June 11, 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 5 years 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 December 22, 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 April 20, 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: October 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25032 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P