[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16061-16062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02E-0150]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; GYNECARE INTERGEL

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 GYNECARE INTERGEL 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-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

[[Page 16062]]


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 GYNECARE 
INTERGEL. GYNECARE INTERGEL is indicated for use in patients undergoing 
open, conservative gynecologic surgery as an adjunct to good surgical 
technique to reduce postsurgical adhesions. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for GYNECARE INTERGEL (U.S. Patent No. 
5,532,221) from Lifecore Medical, 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, 
2001, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of GYNECARE INTERGEL 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 
GYNECARE INTERGEL is 2,438 days. Of this time, 1,453 days occurred 
during the testing phase of the regulatory review period, while 985 
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: March 17, 1995. 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 March 17, 1995.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): March 8, 
1999. The applicant claims March 5, 1999, as the date the premarket 
approval application (PMA) FOR GYNECARE INTERGEL (PMA P990015) was 
initially submitted. However, FDA records indicate that PMA P990015 was 
submitted on March 8, 1999.
    3. The date the application was approved: November 16, 2001. FDA 
has verified the applicant's claim that PMA P990015 was approved on 
November 16, 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 867 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 2, 
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 Septemebr 29, 
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: February 6, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-7819 Filed 4-1-03; 8:45 am]
BILLING CODE 4160-01-S