[Federal Register: June 1, 2007 (Volume 72, Number 105)]
[Notices]
[Page 30597-30598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn07-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0282]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PHAKIC INTRAOCULAR LENSES
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 PHAKIC INTRAOCULAR LENSES 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/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 approved for marketing the medical device, PHAKIC INTRAOCULAR
LENSES. PHAKIC INTRAOCULAR LENSES is indicated for: (1) The reduction
or elimination of myopia in adults with myopia ranging from -5 to -20
diopters with less than or equal to 2.5 diopters of astigmatism at the
spectacle plane and whose eyes have an anterior chamber depth greater
than or equal to 3.2 millimeters; and (2) patients with documented
stability of refraction for the prior 6 months, as demonstrated by
spherical equivalent change of less than or equal to 0.50 diopters.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration
[[Page 30598]]
application for PHAKIC INTRAOCULAR LENSES (U.S. Patent No. 5,192,319)
from Ophtec USA, Inc., subsidiary of Ophtec B.V., and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
September 5, 2006, FDA advised the Patent and Trademark Office that
this medical device had undergone a regulatory review period and that
the approval of PHAKIC INTRAOCULAR LENSES 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
PHAKIC INTRAOCULAR LENSES is 2,545 days. Of this time, 2,107 days
occurred during the testing phase of the regulatory review period,
while 438 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: September 24, 1997. 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 September 24, 1997.
2. The date the application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): July 1, 2003.
FDA has verified the applicant's claim that the premarket approval
application (PMA) for PHAKIC INTRAOCULAR LENSES (PMA P030028) was
initially submitted July 1, 2003.
3. The date the application was approved: September 10, 2004. FDA
has verified the applicant's claim that PMA P030028 was approved on
September 10, 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 1,484 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) written or electronic comments and ask for a redetermination
by July 31, 2007. 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 November 28,
2007. 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: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-10631 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S