Document ID: FDA-2009-E-0053-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: NPLATE
Posted Date: 2009-08-11T04:00Z

[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]               
[Page 40205-40206]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au09-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0053]

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

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 NPLATE 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 or electronic 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 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 biologic product 
NPLATE (romiplostim). NPLATE is indicated for the treatment of 
thrombocytopenia in patients with chronic immune (idiopathic) 
thrombocytopenic purpura (ITP) who have had an insufficient response to 
corticosteroids, immunoglobulins, or splenectomy. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for NPLATE (U.S. Patent No. 6,835,809) from 
Amgen 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 biological product had 
undergone a regulatory review period and that the approval of NPLATE 
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 
NPLATE is 2,319 days. Of this time, 2,014 days occurred during the 
testing phase of the regulatory review period, while 305 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: April 19, 
2002. The applicant claims April 23, 2002, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was April 19, 2002, 
the date of the FDA correspondence removing the clinical hold on the 
application.
    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): October 23, 2007. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
NPLATE (BLA 125268/0) was initially submitted on October 23, 2007.
    3. The date the application was approved: August 22, 2008. FDA has 
verified the applicant's claim that BLA 125268/0 was approved on August 
22, 2008.
    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 818 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 October 13, 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 
February 8, 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

[[Page 40206]]

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 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-19233 Filed 8-10-09; 8:45 am]

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