[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Pages 38170-38171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10408]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0396]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TAXUS EXPRESS Paclitaxel-Eluting Coronary Stent System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TAXUS EXPRESS Paclitaxel-Eluting Coronary 
Stent 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 written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 TAXUS 
EXPRESS Paclitaxel-Eluting Coronary Stent System. TAXUS EXPRESS 
Paclitaxel-Eluting Coronary Stent System is indicated for improving 
luminal diameter for the treatment of de novo lesions <=28 mm in length 
in native coronary arteries >=2.5 to <=3.75 mm in diameter. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for TAXUS EXPRESS Paclitaxel-Eluting 
Coronary Stent System (U.S. Patent No. 5,716,981) from Angiotech 
Phamaceuticals, 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 24, 2006, FDA advised the 
Patent and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of TAXUS EXPRESS 
Paclitaxel-Eluting Coronary Stent System represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
Patent and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
TAXUS EXPRESS Paclitaxel-Eluting Coronary Stent System is 716 days. Of 
this time, 456 days occurred during the testing phase of the regulatory 
review period, while 260 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 involving this device became effective: March 
21, 2002. The applicant claims that the investigational device 
exemption (IDE) required under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) for human tests to 
begin became effective on October 25, 2001. However, FDA records 
indicate that the IDE was determined substantially complete for 
clinical studies to have begun on March 21, 2002, which represents the 
IDE effective date.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): June 19, 
2003. The applicant claims February 25, 2003, as the date the premarket 
approval application (PMA) for TAXUS EXPRESS Paclitaxel-Eluting 
Coronary Stent System (PMA P030025) was initially submitted. However, 
FDA records indicate that PMA P030025 was submitted in modules and was 
not substantially complete until the final submission of clinical data 
on June 19, 2003.
    3. The date the application was approved: March 4, 2004. FDA has 
verified the applicant's claim that PMA P030025 was approved on March 
4, 2004.
    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 807 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may

[[Page 38171]]

submit to the Division of Dockets Management (see ADDRESSES) written or 
electronic comments and ask for a redetermination by September 5, 2006. 
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 January 2, 2006. 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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 13, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-10408 Filed 7-3-06; 8:45 am]
BILLING CODE 4160-01-S