[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Notices]
[Page 58176-58177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-75]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0033]
Determination of Regulatory Review Period for Purposes of Patent
Extension; DERMAGRAFT
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.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
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.
156(g)(3)(B).
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]
BILLING CODE 4160-01-S