[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14818-14819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1997E-0013]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; RETEVASE

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 RETEVASE 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 Division of 
Dockets

[[Page 14819]]

Management (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: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 product 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 approved for marketing the human biological product RETEVASE 
(reteplase). RETEVASE is indicated in the management of acute 
myocardial infarction (AMI) in adults for the improvement of 
ventricular function following AMI, the reduction of the incidence of 
congestive heart failure and the reduction of mortality associated with 
AMI. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for RETEVASE (U.S. 
Patent No. 5,223,256) from Boehringer Mannheim GmbH, 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 6, 1997, FDA advised the Patent and Trademark Office that this 
human biological product had undergone a regulatory review period and 
that the approval of RETEVASE represented the first permitted 
commercial marketing or use of the product. On September 14, 2006, 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 
RETEVASE is 1,919 days. Of this time, 1,430 days occurred during the 
testing phase of the regulatory review period, while 489 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: August 1, 
1991. The applicant claims July 1, 1991, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 1, 1991, 
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 (42 U.S.C. 262): June 30, 1995. FDA has verified the 
applicant's claim that the product license application (PLA) for 
Retevase (PLA 95-1167) was initially submitted on June 30, 1995. The 
PLA was renumbered as biologics license application (BLA) 103632/0.
    3. The date the application was approved: October 30, 1996. The 
applicant claims October 29, 1996, as the date the PLA was approved. 
However, FDA records indicate that PLA 95-1167 (BLA 103632/0) was 
approved on October 30, 1996.
    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 123 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by May 29, 2007. 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 September 25, 
2007. 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 Division of 
Dockets Management. Three copies of any mailed 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5736 Filed 3-28-07; 8:45 am]
BILLING CODE 4160-01-S