[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51159-51160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0057]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; EMEND FOR INJECTION

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 EMEND FOR INJECTION 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 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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 drug 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 EMEND 
FOR INJECTION (fosaprepitant meglumine). EMEND FOR INJECTION, in 
combination with other antiemetic agents, is indicated for the 
prevention of acute and delayed nausea and vomiting associated with 
initial and repeat courses of highly emetogenic cancer chemotherapy 
including high-dose cisplatin, and for prevention of nausea and 
vomiting associated with initial and repeat courses of moderately 
emetogenic cancer chemotherapy. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
EMEND FOR INJECTION (U.S. Patent No. 5,691,336) from Merck & Co., Inc., 
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 26, 2009, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of EMEND FOR INJECTION represented the 
first permitted commercial marketing or use of the product. 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 
EMEND FOR INJECTION is 4,473 days. Of this time, 3,810 days occurred 
during the testing phase of the regulatory review period, while 663 
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: 
October 29, 1995. The applicant claims October 28, 1995, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was October 
29, 1995, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: April 3, 2006. 
The applicant claims March 31, 2006, as the date the new drug 
application (NDA) for Emend for Injection (NDA 22-023) was initially 
submitted. However, FDA records indicate that NDA 22-023 was submitted 
on April 3, 2006.
    3. The date the application was approved: January 25, 2008. FDA has 
verified the applicant's claim that NDA 22-023 was approved on January 
25, 2008.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and

[[Page 51160]]

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 are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by December 4, 2009. 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 April 
5, 2010. 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-23900 Filed 10-2-09; 8:45 am]
BILLING CODE 4160-01-S