[Federal Register: April 30, 1999 (Volume 64, Number 83)]
[Notices]               
[Page 23339-23340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap99-98]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0846]

 
Determination of Regulatory Review Period for Purposes of Patent 
Extension; Apligraf<SUP>TM</SUP>

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 Apligraf<SUP>TM</SUP> 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 
Commissioner of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that medical device.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 
Apligraf<SUP>TM</SUP>. Apligraf<SUP>TM</SUP> is indicated for use with 
standard therapeutic compression in the treatment of uninfected partial 
and/or full-thickness skin loss ulcers due to venous insufficiency of 
greater than 1 month duration and which have not adequately responded 
to conventional ulcer therapy. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
Apligraf<SUP>TM</SUP> (U.S. Patent No. 4,485,096) from Organogenesis, 
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 16, 1998, FDA advised the Patent and Trademark 
Office that this medical device had undergone a regulatory review 
period and that the approval of Apligraf<SUP>TM</SUP> 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 
Apligraf<SUP>TM</SUP> is 4,013 days. Of this time, 3,051 days occurred 
during the testing phase of the regulatory review period, while 962 
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: May 29, 1987. The applicant claims that 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 on July 2, 1987. However, FDA records 
indicate that the IDE was determined substantially complete for 
clinical studies to have begun on May 29, 1987, which represents the 
IDE effective date.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): October 4, 
1995. FDA has verified the applicant's claim that the

[[Page 23340]]

premarket approval application (PMA) for Apligraf<SUP>TM</SUP> (PMA 
P950032) was initially submitted on October 4, 1995.
    3. The date the application was approved: May 22, 1998. FDA has 
verified the applicant's claim that PMA P950032 was approved on May 22, 
1998.
    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 1,826 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before June 29, 1999, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before October 27, 1999, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. 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 (address above) in three copies (except that 
individuals may submit single copies) and 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 20, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-10795 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F