Determination of Regulatory Review Period for Purposes of Patent Extension; KAZANO, 25302-25303 [2015-10335]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 25302 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices FDA has approved for marketing the human drug product BOSULIF (bosutinib monohydrate). BOSULIF is indicated for treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia with resistance or intolerance to prior therapy. Subsequent to this approval, the USPTO received a patent term restoration application for BOSULIF (U.S. Patent No. RE42376) from Wyeth Holdings Corporation, 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 BOSULIF 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 BOSULIF is 3,032 days. Of this time, 2,739 days occurred during the testing phase of the regulatory review period, while 293 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: May 19, 2004. The applicant claims May 16, 2004, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 19, 2004, 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: November 17, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for BOSULIF (NDA 203–341) was submitted on November 17, 2011. 3. The date the application was approved: September 4, 2012. FDA has verified the applicant’s claim that NDA 203–341 was approved on September 4, 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 1,664 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 VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 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 2, 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 https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10333 Filed 5–1–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–0156] Determination of Regulatory Review Period for Purposes of Patent Extension; KAZANO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for KAZANO 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 https:// www.regulations.gov. Submit written SUMMARY: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 https:// 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 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 KAZANO (alogliptin benzoate and metformin hydrochloride). KAZANO 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 KAZANO (U.S. Patent No. 8,288,539) from Takeda Pharmaceutical Company Limited, and the USPTO requested FDA’s assistance in determining this E:\FR\FM\04MYN1.SGM 04MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 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 KAZANO 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 KAZANO is 1,365 days. Of this time, 934 days occurred during the testing phase of the regulatory review period, while 431 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: May 3, 2009. The applicant claims May 4, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 3, 2009, 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: November 22, 2011. FDA has verified the applicant’s claim that the new drug application (NDA) for KAZANO (NDA 203–414) was submitted on November 22, 2011. 3. The date the application was approved: January 25, 2013. FDA has verified the applicant’s claim that NDA 203–414 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 102 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 2, 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. VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 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 https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10335 Filed 5–1–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–E–0476 and FDA– 2013–E–0654] Determination of Regulatory Review Period for Purposes of Patent Extension; TUDORZA PRESSAIR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for TUDORZA PRESSAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 https:// 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 https:// www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 25303 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 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 TUDORZA PRESSAIR (aclidinium bromide). TUDORZA PRESSAIR is indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Subsequent to this approval, the USPTO received patent term restoration applications for TUDORZA PRESSAIR (U.S. Patent Nos. 6,750,226 and 7,078,412) from Almiral, S.A., and the USPTO requested FDA’s assistance in determining the patents eligibilities for patent term restoration. In a letter dated July 16, 2013, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TUDORZA PRESSAIR represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25302-25303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10335]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0156]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for KAZANO 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 https://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 https://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 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 KAZANO 
(alogliptin benzoate and metformin hydrochloride). KAZANO 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 KAZANO (U.S. 
Patent No. 8,288,539) from Takeda Pharmaceutical Company Limited, and 
the USPTO requested FDA's assistance in determining this

[[Page 25303]]

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 KAZANO 
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 
KAZANO is 1,365 days. Of this time, 934 days occurred during the 
testing phase of the regulatory review period, while 431 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: May 3, 2009. The applicant claims May 4, 2009, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was May 3, 
2009, 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: November 
22, 2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for KAZANO (NDA 203-414) was submitted on November 
22, 2011.
    3. The date the application was approved: January 25, 2013. FDA has 
verified the applicant's claim that NDA 203-414 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 102 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 2, 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 
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10335 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P
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