80 FR 76696 - Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 237 (December 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76696-76697 | |
| FR Document | 2015-31096 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Pages 76696-76697] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31096] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0279] Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ELIQUIS 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. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 8, 2016. 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 June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-E-0279 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on [[Page 76697]] http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background 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 ELIQUIS (apixaban). ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Subsequent to this approval, the USPTO received a patent term restoration application for ELIQUIS (U.S. Patent No. 6,967,208) from Bristol-Myers Squibb Company, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 27, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ELIQUIS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ELIQUIS is 3,685 days. Of this time, 3,227 days occurred during the testing phase of the regulatory review period, while 458 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: November 28, 2002. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 28, 2002. 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 28, 2011. FDA has verified the applicant's claim that the new drug application (NDA) for ELIQUIS (NDA 202155) was initially submitted on September 28, 2011. 3. The date the application was approved: December 28, 2012. FDA has verified the applicant's claim that NDA 202155 was approved on December 28, 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 1,424 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). 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. To meet its burden, the petition must be timely (see DATES) and 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. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: December 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31096 Filed 12-9-15; 8:45 am] BILLING CODE 4164-01-P
![76696 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
requested that FDA determine the 305), Food and Drug Administration, comment will be made public, you are
product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your
MD 20852. Petitions that have not been comment does not include any
II. Determination of Regulatory Review
made publicly available on http:// confidential information that you or a
Period
www.regulations.gov may be viewed in third party may not wish to be posted,
FDA has determined that the the Division of Dockets Management such as medical information, your or
applicable regulatory review period for between 9 a.m. and 4 p.m., Monday anyone else’s Social Security number, or
SIRTURO is 2,213 days. Of this time, through Friday. confidential business information, such
2,030 days occurred during the testing as a manufacturing process. Please note
Dated: December 4, 2015.
phase of the regulatory review period, that if you include your name, contact
while 183 days occurred during the Leslie Kux,
information, or other information that
approval phase. These periods of time Associate Commissioner for Policy. identifies you in the body of your
were derived from the following dates: [FR Doc. 2015–31098 Filed 12–9–15; 8:45 am] comments, that information will be
1. The date an exemption under BILLING CODE 4164–01–P posted on http://www.regulations.gov.
section 505(i) of the Federal Food, Drug, • If you want to submit a comment
and Cosmetic Act (the FD&C Act) (21 with confidential information that you
U.S.C. 355(i)) became effective: DEPARTMENT OF HEALTH AND do not wish to be made available to the
December 9, 2006. The applicant claims HUMAN SERVICES public, submit the comment as a
November 9, 2006, as the date the written/paper submission and in the
investigational new drug application Food and Drug Administration manner detailed (see ‘‘Written/Paper
(IND) became effective. However, FDA [Docket No. FDA–2014–E–0279] Submissions’’ and ‘‘Instructions’’).
records indicate that the IND effective
Determination of Regulatory Review Written/Paper Submissions
date was December 9, 2006, which was
30 days after FDA receipt of the IND. Period for Purposes of Patent Submit written/paper submissions as
2. The date the application was Extension; ELIQUIS follows:
initially submitted with respect to the • Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, written/paper submissions): Division of
human drug product under section
HHS. Dockets Management (HFA–305), Food
505(b) of the FD&C Act: June 29, 2012.
FDA has verified the applicant’s claim ACTION: Notice. and Drug Administration, 5630 Fishers
that the new drug application (NDA) for Lane, Rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments
SIRTURO (NDA 204384) was initially Administration (FDA) has determined
submitted on June 29, 2012. submitted to the Division of Dockets
the regulatory review period for Management, FDA will post your
3. The date the application was
ELIQUIS and is publishing this notice of comment, as well as any attachments,
approved: December 28, 2012. FDA has
that determination as required by law. except for information submitted,
verified the applicant’s claim that NDA
FDA has made the determination marked and identified, as confidential,
204384 was approved on December 28,
because of the submission of an if submitted as detailed in
2012.
application to the Director of the U.S. ‘‘Instructions.’’
This determination of the regulatory
Patent and Trademark Office (USPTO), Instructions: All submissions received
review period establishes the maximum
Department of Commerce, for the must include the Docket No. FDA–
potential length of a patent extension.
extension of a patent which claims that 2014–E–0279 for ‘‘Determination of
However, the USPTO applies several
human drug product. Regulatory Review Period for Purposes
statutory limitations in its calculations
of the actual period for patent extension. DATES: Anyone with knowledge that any of Patent Extension; ELIQUIS.’’
In its application for patent extension, of the dates as published (in the Received comments will be placed in
this applicant seeks 741 days of patent SUPPLEMENTARY INFORMATION section) are the docket and, except for those
term extension. incorrect may submit either electronic submitted as ‘‘Confidential
or written comments and ask for a Submissions,’’ publicly viewable at
III. Petitions redetermination by February 8, 2016. http://www.regulations.gov or at the
Anyone with knowledge that any of Furthermore, any interested person may Division of Dockets Management
the dates as published are incorrect may petition FDA for a determination between 9 a.m. and 4 p.m., Monday
submit either electronic or written regarding whether the applicant for through Friday.
comments and ask for a redetermination extension acted with due diligence • Confidential Submissions—To
(see DATES). Furthermore, any during the regulatory review period by submit a comment with confidential
interested person may petition FDA for June 7, 2016. See ‘‘Petitions’’ in the information that you do not wish to be
a determination regarding whether the SUPPLEMENTARY INFORMATION section for made publicly available, submit your
applicant for extension acted with due more information. comments only as a written/paper
diligence during the regulatory review ADDRESSES: You may submit comments submission. You should submit two
period. To meet its burden, the petition as follows: copies total. One copy will include the
must be timely (see DATES) and contain information you claim to be confidential
sufficient facts to merit an FDA Electronic Submissions with a heading or cover note that states
investigation. (See H. Rept. 857, part 1, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
mstockstill on DSK4VPTVN1PROD with NOTICES
98th Cong., 2d sess., pp. 41–42, 1984.) following way: CONFIDENTIAL INFORMATION.’’ The
Petitions should be in the format • Federal eRulemaking Portal: http:// Agency will review this copy, including
specified in 21 CFR 10.30. www.regulations.gov. Follow the the claimed confidential information, in
Submit petitions electronically to instructions for submitting comments. its consideration of comments. The
http://www.regulations.gov at Docket Comments submitted electronically, second copy, which will have the
No. FDA–2013–S–0610. Submit written including attachments, to http:// claimed confidential information
petitions (two copies are required) to the www.regulations.gov will be posted to redacted/blacked out, will be available
Division of Dockets Management (HFA– the docket unchanged. Because your for public viewing and posted on
VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1](https://thefederalregister.org/doc/80_FR_76933/page/1.svg)
![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76697
http://www.regulations.gov. Submit review period may count toward the potential length of a patent extension.
both copies to the Division of Dockets actual amount of extension that the However, the USPTO applies several
Management. If you do not wish your Director of USPTO may award (for statutory limitations in its calculations
name and contact information to be example, half the testing phase must be of the actual period for patent extension.
made publicly available, you can subtracted as well as any time that may In its application for patent extension,
provide this information on the cover have occurred before the patent was this applicant seeks 1,424 days of patent
sheet and not in the body of your issued), FDA’s determination of the term extension.
comments and you must identify this length of a regulatory review period for
III. Petitions
information as ‘‘confidential.’’ Any a human drug product will include all
information marked as ‘‘confidential’’ of the testing phase and approval phase Anyone with knowledge that any of
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may
accordance with 21 CFR 10.20 and other FDA has approved for marketing the submit either electronic or written
applicable disclosure law. For more human drug product ELIQUIS comments and ask for a redetermination
information about FDA’s posting of (apixaban). ELIQUIS is indicated to (see DATES). Furthermore, any interested
comments to public dockets, see 80 FR reduce the risk of stroke and systemic person may petition FDA for a
56469, September 18, 2015, or access embolism in patients with nonvalvular determination regarding whether the
the information at: http://www.fda.gov/ atrial fibrillation. Subsequent to this applicant for extension acted with due
regulatoryinformation/dockets/ approval, the USPTO received a patent diligence during the regulatory review
default.htm. term restoration application for period. To meet its burden, the petition
Docket: For access to the docket to ELIQUIS (U.S. Patent No. 6,967,208) must be timely (see DATES) and contain
read background documents or the from Bristol-Myers Squibb Company, sufficient facts to merit an FDA
electronic and written/paper comments and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1,
received, go to http:// assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.)
www.regulations.gov and insert the eligibility for patent term restoration. In Petitions should be in the format
docket number, found in brackets in the a letter dated March 27, 2014, FDA specified in 21 CFR 10.30.
advised the USPTO that this human Submit petitions electronically to
heading of this document, into the
drug product had undergone a http://www.regulations.gov at Docket
‘‘Search’’ box and follow the prompts
regulatory review period and that the No. FDA–2013–S–0610. Submit written
and/or go to the Division of Dockets
approval of ELIQUIS represented the petitions (two copies are required) to the
Management, 5630 Fishers Lane, Rm.
first permitted commercial marketing or Division of Dockets Management (HFA–
1061, Rockville, MD 20852.
use of the product. Thereafter, the 305), Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT: 5630 Fishers Lane, Rm. 1061, Rockville,
Beverly Friedman, Office of Regulatory USPTO requested that FDA determine
the product’s regulatory review period. MD 20852. Petitions that have not been
Policy, Food and Drug Administration, made publicly available on http://
10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review www.regulations.gov may be viewed in
Rm. 6250, Silver Spring, MD 20993, Period the Division of Dockets Management
301–796–3600. FDA has determined that the between 9 a.m. and 4 p.m., Monday
SUPPLEMENTARY INFORMATION: applicable regulatory review period for through Friday.
I. Background ELIQUIS is 3,685 days. Of this time, Dated: December 4, 2015.
3,227 days occurred during the testing Leslie Kux,
The Drug Price Competition and phase of the regulatory review period,
Patent Term Restoration Act of 1984 Associate Commissioner for Policy.
while 458 days occurred during the
(Pub. L. 98–417) and the Generic [FR Doc. 2015–31096 Filed 12–9–15; 8:45 am]
approval phase. These periods of time
Animal Drug and Patent Term were derived from the following dates: BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) 1. The date an exemption under
generally provide that a patent may be section 505(i) of the Federal Food, Drug,
extended for a period of up to 5 years DEPARTMENT OF HEALTH AND
and Cosmetic Act (the FD&C Act) (21
so long as the patented item (human HUMAN SERVICES
U.S.C. 355(i)) became effective:
drug product, animal drug product, November 28, 2002. FDA has verified Food and Drug Administration
medical device, food additive, or color the applicant’s claim that the date the
additive) was subject to regulatory investigational new drug application [Docket No. FDA–2014–E–0271]
review by FDA before the item was became effective was on November 28,
marketed. Under these acts, a product’s Determination of Regulatory Review
2002.
regulatory review period forms the basis 2. The date the application was Period for Purposes of Patent
for determining the amount of extension initially submitted with respect to the Extension; ARGUS II VISUAL
an applicant may receive. human drug product under section STIMULATION SYSTEM
A regulatory review period consists of 505(b) of the FD&C Act: September 28, AGENCY: Food and Drug Administration,
two periods of time: A testing phase and 2011. FDA has verified the applicant’s HHS.
an approval phase. For human drug claim that the new drug application ACTION: Notice.
products, the testing phase begins when (NDA) for ELIQUIS (NDA 202155) was
the exemption to permit the clinical initially submitted on September 28, SUMMARY: The Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
investigations of the drug becomes 2011. Administration (FDA) has determined
effective and runs until the approval 3. The date the application was the regulatory review period for ARGUS
phase begins. The approval phase starts approved: December 28, 2012. FDA has II VISUAL STIMULATION SYSTEM
with the initial submission of an verified the applicant’s claim that NDA and is publishing this notice of that
application to market the human drug 202155 was approved on December 28, determination as required by law. FDA
product and continues until FDA grants 2012. has made the determination because of
permission to market the drug product. This determination of the regulatory the submission of an application to the
Although only a portion of a regulatory review period establishes the maximum Director of the U.S. Patent and
VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1](https://thefederalregister.org/doc/80_FR_76933/page/2.svg)
Document Created: 2015-12-14 13:28:27
Document Modified: 2015-12-14 13:28:27
| 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. | |
| Dates | Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 8, 2016. 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 June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 80 FR 76696 |
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