[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Page 58176-58177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0033]

Determination of Regulatory Review Period for Purposes of Patent 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for DERMAGRAFT 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/docket/ecomments.

Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 240-453-6699.

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. 
    FDA recently approved for marketing the medical device DERMAGRAFT. 
DERMAGRAFT is indicated for use in the treatment of full-thickness 
diabetic foot ulcers greater than 6-weeks duration, which extend 
through the dermis, but without tendon, muscle, joint capsule, or bone 
exposure. DERMAGRAFT should be used in conjunction with standard wound 
care regimens and in patients that have adequate blood supply to the 
involved foot. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for Dermagraft 
(U.S. Patent No. 4,963,489) from Advanced Tissue 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 March 10, 2003, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of DERMAGRAFT represented the first 
permitted commercial marketing or use of the product. Shortly 
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 
DERMAGRAFT is 4,050 days. Of this time, 3,650 days occurred during the 
testing phase of the regulatory review period, while 400 days occurred 
during the approval phase. These periods of

[[Page 58177]]

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: August 
29, 1990. The applicant claims that the investigational device 
exemption (IDE) required under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act for human tests to begin became effective on 
September 2, 1992. FDA records confirm that one IDE for this medical 
device did become effective on September 2, 1992. However, FDA records 
also indicate that another IDE for this medical device was determined 
substantially complete for clinical studies to have begun on August 29, 
1990, which represents the IDE effective date. Although this IDE was 
for a different indication, it is material to the approval of 
DERMAGRAFT. FDA considers all investigational exemptions for a 
particular product to be material to the approval of the product 
regardless of any difference between the indications studied and those 
ultimately approved.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): August 25, 
2000. The applicant claims August 24, 2000, as the date the premarket 
approval application (PMA) for DERMAGRAFT (PMA P00036) was initially 
submitted. However, FDA records indicate that PMA P00036 was submitted 
on August 25, 2000.
    3. The date the application was approved: September 28, 2001. FDA 
has verified the applicant's claim that PMA P00036 was approved on 
September 28, 2001.
    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 5 years of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by November 29, 2004. 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 
28, 2005. 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 and 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: August 30, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-21749 Filed 9-28-04; 8:45 am]