80 FR 26277 - Determination of Regulatory Review Period for Purposes of Patent Extension; OSENI
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 88 (May 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 88 (May 7, 2015)
| Page Range | 26277-26278 | |
| FR Document | 2015-11002 |
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)] [Notices] [Pages 26277-26278] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11002] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0155] Determination of Regulatory Review Period for Purposes of Patent Extension; OSENI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for OSENI 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 Bldg., 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 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 [[Page 26278]] 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 OSENI (alogliptin benzoate and pioglitazone hydrochloride). OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the USPTO received a patent term restoration application for OSENI (U.S. Patent No. 6,329,404) from Takeda Pharmaceutical Company Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 2, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of OSENI 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 OSENI is 2,482 days. Of this time, 895 days occurred during the testing phase of the regulatory review period, while 1,587 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: April 12, 2006. The applicant claims April 13, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was April 12, 2006, 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: September 22, 2008. FDA has verified the applicant's claim that the new drug application (NDA) for OSENI (NDA 22-426) was submitted on September 22, 2008. 3. The date the application was approved: January 25, 2013. FDA has verified the applicant's claim that NDA 22-426 was approved on January 25, 2013. 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 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) 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. 2015-11002 Filed 5-6-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26277
with the initial submission of an 200677 was approved on December 14, SUMMARY: The Food and Drug
application to market the human drug 2012. Administration (FDA) has determined
product and continues until FDA grants This determination of the regulatory the regulatory review period for OSENI
permission to market the drug product. review period establishes the maximum and is publishing this notice of that
Although only a portion of a regulatory potential length of a patent extension. determination as required by law. FDA
review period may count toward the However, the USPTO applies several has made the determination because of
actual amount of extension that the statutory limitations in its calculations the submission of an application to the
Director of USPTO may award (for of the actual period for patent extension. Director of the U.S. Patent and
example, half the testing phase must be In its application for patent extension, Trademark Office (USPTO), Department
subtracted as well as any time that may this applicant seeks 503 days of patent of Commerce, for the extension of a
have occurred before the patent was term extension. patent which claims that human drug
issued), FDA’s determination of the Anyone with knowledge that any of product.
length of a regulatory review period for the dates as published are incorrect may
a human drug product will include all submit to the Division of Dockets ADDRESSES: Submit electronic
of the testing phase and approval phase Management (see ADDRESSES) either comments to http://
as specified in 35 U.S.C. 156(g)(1)(B). electronic or written comments and ask www.regulations.gov. Submit written
FDA has approved for marketing the for a redetermination by July 6, 2015. petitions (two copies are required) and
human drug product SIGNIFOR Furthermore, any interested person may written comments to the Division of
(pasireotide diaspartate). SIGNIFOR is petition FDA for a determination Dockets Management (HFA–305), Food
indicated for treatment of adult patients regarding whether the applicant for and Drug Administration, 5630 Fishers
with Cushing’s disease for whom extension acted with due diligence Lane, Rm. 1061, Rockville, MD 20852.
pituitary surgery is not an option or has during the regulatory review period by Submit petitions electronically to
not been curative. Subsequent to this November 3, 2015. To meet its burden, http://www.regulations.gov at Docket
approval, the USPTO received a patent the petition must contain sufficient facts No. FDA–2013–S–0610.
term restoration application for to merit an FDA investigation. (See H. FOR FURTHER INFORMATION CONTACT:
SIGNIFOR (U.S. Patent No. 7,473,761) Rept. 857, part 1, 98th Cong., 2d sess., Beverly Friedman, Office of
from Novartis AG, and the USPTO pp. 41–42, 1984.) Petitions should be in Management, Food and Drug
requested FDA’s assistance in the format specified in 21 CFR 10.30. Administration, 10001 New Hampshire
determining this patent’s eligibility for Interested persons may submit to the Ave., Hillandale Bldg., Rm. 3180, Silver
patent term restoration. In a letter dated Division of Dockets Management (see Spring, MD 20993, 301–796–7900.
March 26, 2014, FDA advised the ADDRESSES) electronic or written
SUPPLEMENTARY INFORMATION: The Drug
USPTO that this human drug product comments and written or electronic Price Competition and Patent Term
had undergone a regulatory review petitions. It is only necessary to send Restoration Act of 1984 (Pub. L. 98–417)
period and that the approval of one set of comments. Identify comments and the Generic Animal Drug and Patent
SIGNIFOR represented the first with the docket number found in Term Restoration Act (Pub. L. 100–670)
permitted commercial marketing or use brackets in the heading of this generally provide that a patent may be
of the product. Thereafter, the USPTO document. If you submit a written extended for a period of up to 5 years
requested that FDA determine the petition, two copies are required. A so long as the patented item (human
product’s regulatory review period. petition submitted electronically must
FDA has determined that the drug product, animal drug product,
be submitted to http:// medical device, food additive, or color
applicable regulatory review period for www.regulations.gov, Docket No. FDA–
SIGNIFOR is 3,440 days. Of this time, additive) was subject to regulatory
2013–S–0610. review by FDA before the item was
3,138 days occurred during the testing Comments and petitions that have not
phase of the regulatory review period, marketed. Under these acts, a product’s
been made publicly available on
while 302 days occurred during the regulatory review period forms the basis
http://www.regulations.gov may be
approval phase. These periods of time for determining the amount of extension
viewed in the Division of Dockets
were derived from the following dates: an applicant may receive.
Management between 9 a.m. and 4 p.m.,
1. The date an exemption under Monday through Friday. A regulatory review period consists of
section 505(i) of the Federal Food, Drug, two periods of time: A testing phase and
Dated: May 1, 2015. an approval phase. For human drug
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: July 17, Leslie Kux, products, the testing phase begins when
2003. The applicant claims July 16, Associate Commissioner for Policy. the exemption to permit the clinical
2003, as the date the investigational new [FR Doc. 2015–10994 Filed 5–6–15; 8:45 am] investigations of the drug becomes
drug application (IND) became effective. BILLING CODE 4164–01–P effective and runs until the approval
However, FDA records indicate that the phase begins. The approval phase starts
IND effective date was July 17, 2003, with the initial submission of an
which was 30 days after FDA receipt of DEPARTMENT OF HEALTH AND application to market the human drug
the IND. HUMAN SERVICES product and continues until FDA grants
2. The date the application was permission to market the drug product.
initially submitted with respect to the Food and Drug Administration Although only a portion of a regulatory
human drug product under section [Docket No. FDA–2014–E–0155] review period may count toward the
mstockstill on DSK4VPTVN1PROD with NOTICES
505(b) of the FD&C Act: February 17, actual amount of extension that the
2012. FDA has verified the applicant’s Determination of Regulatory Review Director of USPTO may award (for
claim that the new drug application Period for Purposes of Patent example, half the testing phase must be
(NDA) for SIGNIFOR (NDA 200677) was Extension; OSENI subtracted as well as any time that may
submitted on February 17, 2012. AGENCY: Food and Drug Administration, have occurred before the patent was
3. The date the application was HHS. issued), FDA’s determination of the
approved: December 14, 2012. FDA has length of a regulatory review period for
ACTION: Notice.
verified the applicant’s claim that NDA a human drug product will include all
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![26278 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
of the testing phase and approval phase Management (see ADDRESSES) either information, and to allow 60 days for
as specified in 35 U.S.C. 156(g)(1)(B). electronic or written comments and ask public comment in response to the
FDA has approved for marketing the for a redetermination by July 6, 2015. notice. This notice solicits comments on
human drug product OSENI (alogliptin Furthermore, any interested person may medical device reporting (MDR);
benzoate and pioglitazone petition FDA for a determination manufacturer, importer, user facility,
hydrochloride). OSENI is indicated as regarding whether the applicant for and distributor reporting.
an adjunct to diet and exercise to extension acted with due diligence DATES: Submit either electronic or
improve glycemic control in adults with during the regulatory review period by written comments on the collection of
type 2 diabetes mellitus. Subsequent to November 3, 2015. To meet its burden, information by July 6, 2015.
this approval, the USPTO received a the petition must contain sufficient facts ADDRESSES: Submit electronic
patent term restoration application for to merit an FDA investigation. (See H. comments on the collection of
OSENI (U.S. Patent No. 6,329,404) from Rept. 857, part 1, 98th Cong., 2d sess., information to http://
Takeda Pharmaceutical Company pp. 41–42, 1984.) Petitions should be in www.regulations.gov. Submit written
Limited, and the USPTO requested the format specified in 21 CFR 10.30. comments on the collection of
FDA’s assistance in determining this Interested persons may submit to the information to the Division of Dockets
patent’s eligibility for patent term Division of Dockets Management (see Management (HFA–305), Food and Drug
restoration. In a letter dated May 2, ADDRESSES) electronic or written Administration, 5630 Fishers Lane, Rm.
2014, FDA advised the USPTO that this comments and written or electronic 1061, Rockville, MD 20852. All
human drug product had undergone a petitions. It is only necessary to send comments should be identified with the
regulatory review period and that the one set of comments. Identify comments docket number found in brackets in the
approval of OSENI represented the first with the docket number found in heading of this document.
permitted commercial marketing or use brackets in the heading of this FOR FURTHER INFORMATION CONTACT: FDA
of the product. Thereafter, the USPTO document. If you submit a written PRA Staff, Office of Operations, Food
requested that FDA determine the petition, two copies are required. A and Drug Administration, 8455
product’s regulatory review period. petition submitted electronically must Colesville Rd., COLE–14526, Silver
FDA has determined that the be submitted to http:// Spring, MD 20993–0002, PRAStaff@
applicable regulatory review period for www.regulations.gov, Docket No. FDA– fda.hhs.gov.
OSENI is 2,482 days. Of this time, 895 2013–S–0610.
days occurred during the testing phase SUPPLEMENTARY INFORMATION: Under the
Comments and petitions that have not PRA (44 U.S.C. 3501–3520), Federal
of the regulatory review period, while been made publicly available on
1,587 days occurred during the approval Agencies must obtain approval from the
http://www.regulations.gov may be Office of Management and Budget
phase. These periods of time were viewed in the Division of Dockets
derived from the following dates: (OMB) for each collection of
Management between 9 a.m. and 4 p.m., information they conduct or sponsor.
1. The date an exemption under
Monday through Friday. ‘‘Collection of information’’ is defined
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 Dated: May 1, 2015. in 44 U.S.C. 3502(3) and 5 CFR
U.S.C. 355(i)) became effective: April Leslie Kux, 1320.3(c) and includes Agency requests
12, 2006. The applicant claims April 13, Associate Commissioner for Policy. or requirements that members of the
2006, as the date the investigational new [FR Doc. 2015–11002 Filed 5–6–15; 8:45 am] public submit reports, keep records, or
drug application (IND) became effective. BILLING CODE 4164–01–P
provide information to a third party.
However, FDA records indicate that the Section 3506(c)(2)(A) of the PRA (44
IND effective date was April 12, 2006, U.S.C. 3506(c)(2)(A)) requires Federal
which was 30 days after FDA receipt of DEPARTMENT OF HEALTH AND Agencies to provide a 60-day notice in
the IND. HUMAN SERVICES the Federal Register concerning each
2. The date the application was proposed collection of information,
initially submitted with respect to the Food and Drug Administration including each proposed extension of an
human drug product under section existing collection of information,
[Docket No. FDA–2012–N–0110]
505(b) of the FD&C Act: September 22, before submitting the collection to OMB
2008. FDA has verified the applicant’s Agency Information Collection for approval. To comply with this
claim that the new drug application Activities; Proposed Collection; requirement, FDA is publishing notice
(NDA) for OSENI (NDA 22–426) was Comment Request; Medical Device of the proposed collection of
submitted on September 22, 2008. Reporting: Manufacturer, Importer, information set forth in this document.
3. The date the application was With respect to the following
User Facility, and Distributor Reporting
approved: January 25, 2013. FDA has collection of information, FDA invites
verified the applicant’s claim that NDA AGENCY: Food and Drug Administration, comments on these topics: (1) Whether
22–426 was approved on January 25, HHS. the proposed collection of information
2013. ACTION: Notice. is necessary for the proper performance
This determination of the regulatory of FDA’s functions, including whether
review period establishes the maximum SUMMARY: The Food and Drug the information will have practical
potential length of a patent extension. Administration (FDA) is announcing an utility; (2) the accuracy of FDA’s
However, the USPTO applies several opportunity for public comment on the estimate of the burden of the proposed
mstockstill on DSK4VPTVN1PROD with NOTICES
statutory limitations in its calculations proposed collection of certain collection of information, including the
of the actual period for patent extension. information by the Agency. Under the validity of the methodology and
In its application for patent extension, Paperwork Reduction Act of 1995 (the assumptions used; (3) ways to enhance
this applicant seeks 1,826 days of patent PRA), Federal Agencies are required to the quality, utility, and clarity of the
term extension. publish notice in the Federal Register information to be collected; and (4)
Anyone with knowledge that any of concerning each proposed collection of ways to minimize the burden of the
the dates as published are incorrect may information, including each proposed collection of information on
submit to the Division of Dockets extension of an existing collection of respondents, including through the use
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Document Created: 2015-12-16 07:50:28
Document Modified: 2015-12-16 07:50:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993, 301-796-7900. | |
| FR Citation | 80 FR 26277 |
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