[Federal Register Volume 66, Number 9 (Friday, January 12, 2001)]
[Notices]
[Pages 2910-2911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0490]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Synvisc Hylan G-F 20 (5,099,013)

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 Synvisc Hylan G-F 20 (5,099,013) 
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

[[Page 2911]]

Commissioner 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.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Regulatory Policy 
Staff (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

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 Commissioner 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 Synvisc 
Hylan G-F 20 (5,099,013). Synvisc Hylan G-F 20 
(5,099,013) is indicated for the treatment of pain in 
osteoarthritis of the knee in patients who have failed to respond 
adequately to conservative nonpharmacologic therapy and to simple 
analgesics (e.g., acetaminophen). Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for Synvisc Hylan G-F 20 (5,099,013) (U.S. Patent 
No. 5,099,013) from Biomatrix, 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 December 11, 
1998, FDA advised the Patent and Trademark Office that this medical 
device had undergone a regulatory review period and that the approval 
of Synvisc Hylan G-F 20 (5,099,013) 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 
Synvisc Hylan G-F 20 (5,099,013) is 2,949 days. Of this time, 
1,783 days occurred during the testing phase of the regulatory review 
period, while 1,166 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: July 14, 1989. 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 July 14, 1989.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): May 31, 1994. 
FDA has verified the applicant's claim that the premarket approval 
application (PMA) for Synvisc Hylan G-F 20 (5,099,013) (PMA 
P940015) was initially submitted May 31, 1994.
    3. The date the application was approved: August 8, 1997. FDA has 
verified the applicant's claim that PMA P940015 was approved on August 
8, 1997.
    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 396 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Dockets Management Branch (address above) 
written comments and ask for a redetermination by March 13, 2001. 
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 July 11, 2001. 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: December 20, 2000.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug evaluation and Research.
[FR Doc. 01-974 Filed 1-11-01; 8:45 am]
BILLING CODE 4160-01-F