[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Page 46989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0404]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CeeOn Model 911A

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 CeeOn Model 911A 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 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-007), 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 (for 
example, 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 CeeOn Model 
911A. CeeOn Model 911A is indicated for primary implantation for the 
visual correction of aphakia in persons 60 years of age or older in 
whom a cataractous lens has been removed by phacoemulsification. The 
lens is intended to be placed in the capsular bag. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for CeeOn Model 911A (U.S. Patent No. 
5,444,106) from Pharmacia AB, 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 14, 2002, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of CeeOn 
Model 911A 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 
CeeOn Model 911A is 1,594 days. Of this time, 1,101 days occurred 
during the testing phase of the regulatory review period, while 493 
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: November 25, 1996. 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 November 
25, 1996.
    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 30, 
1999. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for CeeOn Model 911A (PMA P990080) was 
initially submitted November 30, 1999.
    3. The date the application was approved: April 5, 2001. FDA has 
verified the applicant's claim that PMA P990080 was approved on April 
5, 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 956 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 
September 16, 2002. 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 13, 
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 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch. Three copies of any 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: April 17, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-17904 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S