[Federal Register Volume 67, Number 136 (Tuesday, July 16, 2002)]
[Notices]
[Pages 46680-46681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17783]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0366]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; PEG-Intron

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for PEG-Intron 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 human biological product.

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 human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological product. 
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 human biological product will include all of the testing 
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biological product 
PEG-Intron (peginterferon-alfa-2b). PEG-Intron is indicated for 
treatment of chronic hepatitis C in patients not previously treated 
with interferon alfa who have compensated liver disease and are at 
least 18 years of age. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
PEG-Intron (U.S. Patent No. 5,951,974) from Schering Corp., 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 human biological product had undergone a regulatory review 
period and that the approval of PEG-Intron 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 
PEG-Intron is 1,271 days. Of this time, 877 days occurred during the 
testing phase of the regulatory review period, while 394 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 30, 
1997. The applicant claims July 29, 1997, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 30, 1997, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act: December 23, 1999. The applicant claims December 22, 1999, 
as the date the product license application (BLA) for PEG-Intron (BLA 
99-1488) was initially submitted. However, FDA records indicate that 
BLA 99-1488 was submitted on December 23, 1999.
    3. The date the application was approved: January 19, 2001. FDA has 
verified the applicant's claim that BLA 99-1488 was approved on January 
19, 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 435 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

[[Page 46681]]

Branch. Three copies of any information are to be submitted, except 
that individuals may submit a single 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 22, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-17783 Filed 7-15-02; 8:45 am]
BILLING CODE 4160-01-S