80 FR 25301 - Determination of Regulatory Review Period for Purposes of Patent Extension; BOSULIF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 85 (May 4, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 85 (May 4, 2015)
| Page Range | 25301-25302 | |
| FR Document | 2015-10333 |
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)] [Notices] [Pages 25301-25302] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10333] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0074] Determination of Regulatory Review Period for Purposes of Patent Extension; BOSULIF AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for BOSULIF 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 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). [[Page 25302]] 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 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 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: 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
![Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25301
application to market the human drug This determination of the regulatory the regulatory review period for
product and continues until FDA grants review period establishes the maximum BOSULIF and is publishing this notice
permission to market the drug product. potential length of a patent extension. of that determination as required by
Although only a portion of a regulatory However, the USPTO applies several law. FDA has made the determination
review period may count toward the statutory limitations in its calculations because of the submission of an
actual amount of extension that the of the actual period for patent extension. application to the Director of the U.S.
Director of USPTO may award (for In its application for patent extension, Patent and Trademark Office (USPTO),
example, half the testing phase must be this applicant seeks 264 days of patent Department of Commerce, for the
subtracted as well as any time that may term extension. extension of a patent which claims that
have occurred before the patent was Anyone with knowledge that any of human drug product.
issued), FDA’s determination of the the dates as published are incorrect may ADDRESSES: Submit electronic
length of a regulatory review period for submit to the Division of Dockets comments to http://
a human drug product will include all Management (see ADDRESSES) either www.regulations.gov. Submit written
of the testing phase and approval phase electronic or written comments and ask petitions (two copies are required) and
as specified in 35 U.S.C. 156(g)(1)(B). for a redetermination by July 6, 2015. written comments to the Division of
FDA has approved for marketing the Furthermore, any interested person may Dockets Management (HFA–305), Food
human drug product NESINA petition FDA for a determination and Drug Administration, 5630 Fishers
(alogliptin benzoate). NESINA is regarding whether the applicant for Lane, rm. 1061, Rockville, MD 20852.
indicated as an adjunct to diet and extension acted with due diligence Submit petitions electronically to http://
exercise to improve glycemic control in during the regulatory review period by www.regulations.gov at Docket No.
adults with type 2 diabetes mellitus. November 2, 2015. To meet its burden, FDA–2013–S–0610.
Subsequent to this approval, the USPTO the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT:
received a patent term restoration to merit an FDA investigation. (See H. Beverly Friedman, Office of
application for NESINA (U.S. Patent No. Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug
8,173,663) from Takeda Pharmaceuticals pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire
U.S.A., and the USPTO requested FDA’s the format specified in 21 CFR 10.30. Ave., Hillandale Campus, Rm. 3180,
assistance in determining this patent’s Interested persons may submit to the Silver Spring, MD 20993, 301–796–
eligibility for patent term restoration. In Division of Dockets Management (see 7900.
a letter dated May 2, 2014, FDA advised ADDRESSES) electronic or written
the USPTO that this human drug SUPPLEMENTARY INFORMATION: The Drug
comments and written or electronic Price Competition and Patent Term
product had undergone a regulatory petitions. It is only necessary to send
review period and that the approval of Restoration Act of 1984 (Pub. L. 98–417)
one set of comments. Identify comments and the Generic Animal Drug and Patent
NESINA represented the first permitted with the docket number found in
commercial marketing or use of the Term Restoration Act (Pub. L. 100–670)
brackets in the heading of this generally provide that a patent may be
product. Thereafter, the USPTO document. If you submit a written
requested that FDA determine the extended for a period of up to 5 years
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– additive) was subject to regulatory
NESINA is 3,021 days. Of this time,
2013–S–0610. Comments and petitions review by FDA before the item was
1,164 days occurred during the testing
that have not been made publicly marketed. Under these acts, a product’s
phase of the regulatory review period,
while 1,857 days occurred during the available on http://www.regulations.gov regulatory review period forms the basis
approval phase. These periods of time may be viewed in the Division of for determining the amount of extension
were derived from the following dates: Dockets Management between 9 a.m. an applicant may receive.
1. The date an exemption under and 4 p.m., Monday through Friday. A regulatory review period consists of
section 505(i) of the Federal Food, Drug, Dated: April 28, 2015. two periods of time: A testing phase and
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, an approval phase. For human drug
U.S.C. 355(i)) became effective: October Associate Commissioner for Policy. products, the testing phase begins when
20, 2004. The applicant claims October [FR Doc. 2015–10337 Filed 5–1–15; 8:45 am]
the exemption to permit the clinical
19, 2004, as the date the investigational investigations of the drug becomes
BILLING CODE 4164–01–P
new drug application (IND) became effective and runs until the approval
effective. However, FDA records phase begins. The approval phase starts
indicate that the IND effective date was DEPARTMENT OF HEALTH AND with the initial submission of an
October 20, 2004, which was 30 days HUMAN SERVICES application to market the human drug
after FDA receipt of the IND. product and continues until FDA grants
2. The date the application was Food and Drug Administration permission to market the drug product.
initially submitted with respect to the Although only a portion of a regulatory
[Docket No. FDA–2014–E–0074] review period may count toward the
human drug product under section
505(b) of the FD&C Act: December 27, actual amount of extension that the
Determination of Regulatory Review
2007. FDA has verified the applicant’s Director of USPTO may award (for
Period for Purposes of Patent
mstockstill on DSK4VPTVN1PROD with NOTICES
claim that the new drug application example, half the testing phase must be
Extension; BOSULIF
(NDA) for NESINA (NDA 22–271) was subtracted as well as any time that may
submitted on December 27, 2007. 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: January 25, 2013. FDA has ACTION: Notice. length of a regulatory review period for
verified the applicant’s claim that NDA a human drug product will include all
22–271 was approved on January 25, SUMMARY: The Food and Drug of the testing phase and approval phase
2013. Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).
VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/80_FR_25386/page/1.svg)
![25302 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
FDA has approved for marketing the electronic or written comments and ask petitions (two copies are required) and
human drug product BOSULIF for a redetermination by July 6, 2015. written comments to the Division of
(bosutinib monohydrate). BOSULIF is Furthermore, any interested person may Dockets Management (HFA–305), Food
indicated for treatment of adult patients petition FDA for a determination and Drug Administration, 5630 Fishers
with chronic, accelerated, or blast phase regarding whether the applicant for Lane, rm. 1061, Rockville, MD 20852.
Ph+ chronic myelogenous leukemia extension acted with due diligence Submit petitions electronically to http://
with resistance or intolerance to prior during the regulatory review period by www.regulations.gov at Docket No.
therapy. Subsequent to this approval, November 2, 2015. To meet its burden, FDA–2013–S–0610.
the USPTO received a patent term the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT:
restoration application for BOSULIF to merit an FDA investigation. (See H. Beverly Friedman, Office of
(U.S. Patent No. RE42376) from Wyeth Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug
Holdings Corporation, and the USPTO pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire
requested FDA’s assistance in the format specified in 21 CFR 10.30. Ave., Hillandale Campus, rm. 3180,
determining this patent’s eligibility for Interested persons may submit to the Silver Spring, MD 20993, 301–796–
patent term restoration. In a letter dated Division of Dockets Management (see 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
BOSULIF represented the first permitted with the docket number found in
commercial marketing or use of the Term Restoration Act (Pub. L. 100–670)
brackets in the heading of this generally provide that a patent may be
product. Thereafter, the USPTO document. If you submit a written
requested that FDA determine the extended for a period of up to 5 years
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–
BOSULIF is 3,032 days. Of this time, additive) was subject to regulatory
2013–S–0610. Comments and petitions review by FDA before the item was
2,739 days occurred during the testing that have not been made publicly
phase of the regulatory review period, marketed. Under these acts, a product’s
available on http://www.regulations.gov regulatory review period forms the basis
while 293 days occurred during the may be viewed in the Division of
approval phase. These periods of time for determining the amount of extension
Dockets Management between 9 a.m. an applicant may receive.
were derived from the following dates: and 4 p.m., Monday through Friday.
1. The date an exemption under A regulatory review period consists of
section 505(i) of the Federal Food, Drug, Dated: April 28, 2015. two periods of time: A testing phase and
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, an approval phase. For human drug
U.S.C. 355(i)) became effective: May 19, Associate Commissioner for Policy. products, the testing phase begins when
2004. The applicant claims May 16, [FR Doc. 2015–10333 Filed 5–1–15; 8:45 am] the exemption to permit the clinical
2004, as the date the investigational new BILLING CODE 4164–01–P
investigations of the drug becomes
drug application (IND) became effective. effective and runs until the approval
However, FDA records indicate that the phase begins. The approval phase starts
IND effective date was May 19, 2004, DEPARTMENT OF HEALTH AND with the initial submission of an
which was 30 days after FDA receipt of HUMAN SERVICES application to market the human drug
the IND. product and continues until FDA grants
2. The date the application was Food and Drug Administration permission to market the drug product.
initially submitted with respect to the Although only a portion of a regulatory
[Docket No. FDA–2014–E–0156]
human drug product under section review period may count toward the
505(b) of the FD&C Act: November 17, Determination of Regulatory Review actual amount of extension that the
2011. FDA has verified the applicant’s Period for Purposes of Patent Director of USPTO may award (for
claim that the new drug application Extension; KAZANO example, half the testing phase must be
(NDA) for BOSULIF (NDA 203–341) was subtracted as well as any time that may
submitted on November 17, 2011. 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: September 4, 2012. FDA has ACTION: Notice. length of a regulatory review period for
verified the applicant’s claim that NDA a human drug product will include all
203–341 was approved on September 4, SUMMARY: The Food and Drug of the testing phase and approval phase
2012. Administration (FDA) has determined as specified in 35 U.S.C. 156(g)(1)(B).
This determination of the regulatory the regulatory review period for FDA has approved for marketing the
review period establishes the maximum KAZANO and is publishing this notice human drug product KAZANO
potential length of a patent extension. of that determination as required by (alogliptin benzoate and metformin
However, the USPTO applies several law. FDA has made the determination hydrochloride). KAZANO is indicated
statutory limitations in its calculations because of the submission of an as an adjunct to diet and exercise to
application to the Director of the U.S.
mstockstill on DSK4VPTVN1PROD with NOTICES
of the actual period for patent extension. improve glycemic control in adults with
In its application for patent extension, Patent and Trademark Office (USPTO), type 2 diabetes mellitus. Subsequent to
this applicant seeks 1,664 days of patent Department of Commerce, for the this approval, the USPTO received a
term extension. extension of a patent which claims that patent term restoration application for
Anyone with knowledge that any of human drug product. KAZANO (U.S. Patent No. 8,288,539)
the dates as published are incorrect may ADDRESSES: Submit electronic from Takeda Pharmaceutical Company
submit to the Division of Dockets comments to http:// Limited, and the USPTO requested
Management (see ADDRESSES) either www.regulations.gov. Submit written FDA’s assistance in determining this
VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/80_FR_25386/page/2.svg)
Document Created: 2018-02-21 10:22:46
Document Modified: 2018-02-21 10:22:46
| 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 Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900. | |
| FR Citation | 80 FR 25301 |
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