[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29334-29335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0516]


Determination of Regulatory Review Periods for Purposes of Patent 
Extension; SPRYCEL--New Drug Applications 21-986 and 22-072

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 SPRYCEL--new drug applications (NDAs) 21-
986 and 22-072 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

[[Page 29335]]

extension of a patent which claims that human drug 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 drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the human drug 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 drug product 
and continues until FDA grants permission to market the drug 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 drug 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 drug product 
SPRYCEL--NDAs 21-986 and 22-072 (dasatinib). SPRYCEL is indicated for 
the treatment of adults with chronic, accelerated, or myeloid or 
lymphoid blast phase chronic myeloid leukemia with resistance or 
intolerance to prior therapy including imatinib. It is also indicated 
for the treatment of adults with Philadelphia chromosome-positive acute 
lymphoblastic leukemia with resistance or intolerance to prior therapy. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for SPRYCEL--NDAs 21-986 and 22-072 
(U.S. Patent No. 6,596,746) 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 January 26, 2007, FDA advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of SPRYCEL--NDAs 21-986 and 22-072 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 
SPRYCEL--NDAs 21-986 and 22-072 is 1,183 days. Of this time, 1,000 days 
occurred during the testing phase of the regulatory review period, 
while 183 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 (the act) (21 U.S.C. 355(i)) became effective: 
April 4, 2003. The applicant claims April 3, 2003, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was April 4, 2003, 
which was 30 days after FDA receipt of the IND.
    2. The date the applications were initially submitted with respect 
to the human drug product under section 505(b) of the act: December 28, 
2005. FDA has verified the applicant's claim that the new drug 
applications (NDAs) for SPRYCEL (NDAs 21-986 and 22-072) were initially 
submitted on December 28, 2005.
    3. The date the applications were approved: June 28, 2006. FDA has 
verified the applicant's claim that NDAs 21-986 and 22-072 were 
approved on June 28, 2006.
    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 76 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 24, 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 21, 
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. E7-10089 Filed 5-24-07; 8:45 am]
BILLING CODE 4160-01-S