[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Notices]
[Pages 28978-28979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0260]


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

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 ORENCIA 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

[[Page 28979]]

which claims that human biological product.

ADDRESSES:  Submit written comments and petitions to the Division of 
Dockets 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-007), 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 recently approved for marketing the human biological product 
ORENCIA (abatacept). ORENCIA is indicated for reducing signs and 
symptoms, inducing major clinical response, slowing the progression of 
structural damage, and improving physical function in adult patients 
with moderately to severely active rheumatoid arthritis who have had an 
inadequate response to one or more disease modifying anti-rheumatic 
drugs, such as methotrexate or TNF antagonists. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for ORENCIA (U.S. Patent No. 5,851,795) from 
Bristol-Myers Squibb Company, and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated September 5, 2006, FDA 
advised the Patent and Trademark Office that this human biological 
product had undergone a regulatory review period and that the approval 
of ORENCIA 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 
ORENCIA is 3,803 days. Of this time, 3,536 days occurred during the 
testing phase of the regulatory review period, while 267 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 28, 
1995. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on July 28, 
1995.
    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): April 1, 2005. The applicant claims March 
31, 2005, as the date the biologics license application (BLA) for 
ORENCIA (BLA 125118) was submitted. However, FDA records indicate that 
BLA 125118 was received on April 1, 2005.
    3. The date the application was approved: December 23, 2005. FDA 
has verified the applicant's claim that BLA 125118 was approved on 
December 23, 2005.
    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 1,414 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by July 23, 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 November 19, 
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: May 2, 2007
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-9945 Filed 5-22-07; 8:45 am]
BILLING CODE 4160-01-S