[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26276-26277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-E-0100]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SIGNIFOR
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 SIGNIFOR 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 the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 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
[[Page 26277]]
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 USPTO
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 has approved for marketing the human drug product SIGNIFOR
(pasireotide diaspartate). SIGNIFOR is indicated for treatment of adult
patients with Cushing's disease for whom pituitary surgery is not an
option or has not been curative. Subsequent to this approval, the USPTO
received a patent term restoration application for SIGNIFOR (U.S.
Patent No. 7,473,761) from Novartis AG, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated March 26, 2014, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of SIGNIFOR represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
SIGNIFOR is 3,440 days. Of this time, 3,138 days occurred during the
testing phase of the regulatory review period, while 302 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 FD&C Act) (21 U.S.C. 355(i)) became
effective: July 17, 2003. The applicant claims July 16, 2003, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was July 17,
2003, 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 FD&C Act: February
17, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for SIGNIFOR (NDA 200677) was submitted on February
17, 2012.
3. The date the application was approved: December 14, 2012. FDA
has verified the applicant's claim that NDA 200677 was approved on
December 14, 2012.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 503 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) either electronic or written comments and ask for a
redetermination by July 6, 2015. 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 3, 2015. 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610.
Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10994 Filed 5-6-15; 8:45 am]
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