
[Federal Register: September 9, 2010 (Volume 75, Number 174)]
[Notices]               
[Page 54887-54888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se10-72]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0414]

 
Determination of Regulatory Review Period for Purposes of Patent 
Extension; REPEL-CV

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for REPEL-CV 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 along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 recently approved for marketing the medical device, REPEL-CV. 
REPEL-CV, a bioresorbable adhesion barrier, is indicated for reducing 
the severity of post-operative cardiac adhesions in pediatric patients 
who are likely to require reoperation via sternotomy. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for REPEL-CV (U.S. Patent No. 5,711,958) from 
SyntheMed, 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 February 17, 2010, FDA advised the 
Patent and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of REPEL-CV 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 
REPEL-CV is 4,023 days. Of this time, 3,256 days occurred during the 
testing phase of the regulatory review period, while 767 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 act) (21 U.S.C. 360j(g)) involving this 
device became effective: March 3, 1998. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the act for human tests to begin 
became effective March 3, 1998.
    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): January 30, 2007. FDA has verified the 
applicant's claim that the premarket approval application (PMA) for 
REPEL-CV (PMA P070005) was initially submitted January 30, 2007.
    3. The date the application was approved: March 6, 2009. FDA has 
verified the applicant's claim that PMA P070005 was approved on March 
6, 2009.
    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 1,742 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 November 8, 2010. 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 March 8, 2011. 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

[[Page 54888]]

ADDRESSES) electronic or written comments and written petitions. It is 
only necessary to send one set of comments. It is no longer necessary 
to send three copies of mailed comments. However, if you submit a 
written petition, you must submit three copies of the petition. 
Identify comments with the docket number found in brackets in the 
heading of this document.
    Comments and petitions that have not been made publicly available 
on regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22496 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-S

