[Federal Register: April 17, 2003 (Volume 68, Number 74)]
[Page 18990-18991]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02E-0021]

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 HYPERION LTK 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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

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 HYPERION LTK 
SYSTEM. HYPERION LTK SYSTEM is indicated for temporary reduction of 
hyperopia in patients with +0.75 to +2.5 diopters of manifest 
refraction spherical equivalent at the spectacle plane (with cylinder 
less than or equal to +0.75 diopters) who are 40 years of age or older 
with documented stability of refraction for the prior 6 months, as 
demonstrated by a change of less than or equal to 0.50D in spherical 
and cylindrical components of the manifest refraction. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for HYPERION LTK SYSTEM (U.S. Patent No. 
4,976,709) from Sunrise Technologies International, 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 October 31, 2002, FDA advised the Patent and Trademark Office 
that this medical device had undergone a regulatory review period and 
that the approval of HYPERION LTK SYSTEM 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 
HYPERION LTK SYSTEM is 3,047 days. Of this time, 2,806 days occurred 
during the testing phase of the regulatory review period, while 241 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date a clinical investigation involving this device was 
begun: February 28, 1992. FDA has verified the applicant's claim that 
the date 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 February 
28, 1992.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): November 3, 
1999. The applicant claims November 1, 1999, as the date the premarket 
approval application (PMA) for HYPERION LTK SYSTEM (PMA P990078) was 
initially submitted. However, FDA records

[[Page 18991]]

indicate that PMA P990078 was submitted on November 3, 1999.
    3. The date the application was approved: June 30, 2000. FDA has 
verified the applicant's claim that PMA P990078 was approved on June 
30, 2000.
    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 1,644 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments and ask for a redetermination by June 
16, 2003. 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 October 14, 2003. 
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 
    Comments and petitions should be submitted to the Dockets 
Management Branch (see ADDRESSES). 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-9535 Filed 4-16-03; 8:45 am]