80 FR 76694 - Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO
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 | 76694-76696 | |
| FR Document | 2015-31098 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Pages 76694-76696] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31098] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-0265] Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- [[Page 76695]] SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for SIRTURO 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-0265 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO''. 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 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 SIRTURO (bedaquiline). SIRTURO is indicated for combination therapy in adults (>=18 years) with pulmonary multi-drug resistant tuberculosis. Subsequent to this approval, the USPTO received a patent term restoration application for SIRTURO (U.S. Patent No. 7,498,343) from Janssen Pharmaceutica, N.V., 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 SIRTURO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO [[Page 76696]] 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 SIRTURO is 2,213 days. Of this time, 2,030 days occurred during the testing phase of the regulatory review period, while 183 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: December 9, 2006. The applicant claims November 9, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 9, 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: June 29, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for SIRTURO (NDA 204384) was initially submitted on June 29, 2012. 3. The date the application was approved: December 28, 2012. FDA has verified the applicant's claim that NDA 204384 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 741 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. 2015-31098 Filed 12-9-15; 8:45 am] BILLING CODE 4164-01-P
![76694 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
its consideration of comments. The with the initial submission of an application (NDA) for FULYZAQ (NDA
second copy, which will have the application to market the human drug 202292) was initially submitted.
claimed confidential information product and continues until FDA grants However, FDA records indicate that
redacted/blacked out, will be available permission to market the drug product. NDA 202292 was submitted on
for public viewing and posted on http:// Although only a portion of a regulatory December 5, 2011.
www.regulations.gov. Submit both review period may count toward the 3. The date the application was
copies to the Division of Dockets actual amount of extension that the approved: December 31, 2012. FDA has
Management. If you do not wish your Director of USPTO may award (for verified the applicant’s claim that NDA
name and contact information to be example, half the testing phase must be 202292 was approved on December 31,
made publicly available, you can subtracted as well as any time that may 2012.
provide this information on the cover have occurred before the patent was This determination of the regulatory
sheet and not in the body of your issued), FDA’s determination of the review period establishes the maximum
comments and you must identify this length of a regulatory review period for potential length of a patent extension.
information as ‘‘confidential.’’ Any a human drug product will include all However, the USPTO applies several
information marked as ‘‘confidential’’ of the testing phase and approval phase statutory limitations in its calculations
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). of the actual period for patent extension.
accordance with 21 CFR 10.20 and other FDA has approved for marketing the
human drug product FULYZAQ III. Petitions
applicable disclosure law. For more
information about FDA’s posting of (crofelemer). FULYZAQ is indicated for Anyone with knowledge that any of
comments to public dockets, see 80 FR the symptomatic relief of non-infectious the dates as published are incorrect may
56469, September 18, 2015, or access diarrhea in adult patients with HIV/ submit either electronic or written
the information at: http://www.fda.gov/ AIDS on anti-retroviral therapy. comments and ask for a redetermination
regulatoryinformation/dockets/ Subsequent to this approval, the USPTO (see DATES). Furthermore, any interested
default.htm. received a patent term restoration person may petition FDA for a
Docket: For access to the docket to application for FULYZAQ (U.S. Patent determination regarding whether the
read background documents or the No. 7,323,195) from Napo applicant for extension acted with due
electronic and written/paper comments Pharmaceuticals, Inc., and the USPTO diligence during the regulatory review
received, go to http:// requested FDA’s assistance in period. To meet its burden, the petition
www.regulations.gov and insert the determining this patent’s eligibility for must be timely (see DATES) and contain
docket number, found in brackets in the patent term restoration. In a letter dated sufficient facts to merit an FDA
heading of this document, into the May 23, 2014, FDA advised the USPTO investigation. (See H. Rept. 857, part 1,
‘‘Search’’ box and follow the prompts that this human drug product had 98th Cong., 2d sess., pp. 41–42, 1984.)
and/or go to the Division of Dockets undergone a regulatory review period Petitions should be in the format
Management, 5630 Fishers Lane, Rm. and that the approval of FULYZAQ specified in 21 CFR 10.30.
1061, Rockville, MD 20852. represented the first permitted Submit petitions electronically to
commercial marketing or use of the http://www.regulations.gov at Docket
FOR FURTHER INFORMATION CONTACT:
product. Thereafter, the USPTO No. FDA–2013–S–0610. Submit written
Beverly Friedman, Office of Regulatory requested that FDA determine the
Policy, Food and Drug Administration, petitions (two copies are required) to the
product’s regulatory review period. Division of Dockets Management (HFA–
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review 305), Food and Drug Administration,
301–796–3600. Period 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
SUPPLEMENTARY INFORMATION: FDA has determined that the
made publicly available on http://
applicable regulatory review period for
I. Background www.regulations.gov may be viewed in
FULYZAQ is 7,784 days. Of this time,
The Drug Price Competition and the Division of Dockets Management
7,391 days occurred during the testing
Patent Term Restoration Act of 1984 between 9 a.m. and 4 p.m., Monday
phase of the regulatory review period,
(Pub. L. 98–417) and the Generic through Friday.
while 393 days occurred during the
Animal Drug and Patent Term approval phase. These periods of time Dated: December 4, 2015.
Restoration Act (Pub. L. 100–670) were derived from the following dates: Leslie Kux,
generally provide that a patent may be 1. The date an exemption under Associate Commissioner for Policy.
extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, [FR Doc. 2015–31097 Filed 12–9–15; 8:45 am]
so long as the patented item (human and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
drug product, animal drug product, U.S.C. 355(i)) became effective:
medical device, food additive, or color September 11, 1991. The applicant
additive) was subject to regulatory claims August 14, 1991, as the date the DEPARTMENT OF HEALTH AND
review by FDA before the item was investigational new drug application HUMAN SERVICES
marketed. Under these acts, a product’s (IND) became effective. However, FDA
regulatory review period forms the basis records indicate that the IND effective Food and Drug Administration
for determining the amount of extension date was September 11, 1991, which
an applicant may receive. was 30 days after FDA receipt of the [Docket No. FDA–2014–E–0265]
mstockstill on DSK4VPTVN1PROD with NOTICES
A regulatory review period consists of first IND from the sponsor for this new
two periods of time: A testing phase and drug. Determination of Regulatory Review
an approval phase. For human drug 2. The date the application was Period for Purposes of Patent
products, the testing phase begins when initially submitted with respect to the Extension; SIRTURO
the exemption to permit the clinical human drug product under section AGENCY: Food and Drug Administration,
investigations of the drug becomes 505(b) of the FD&C Act: December 5, HHS.
effective and runs until the approval 2011. The applicant claims December
ACTION: Notice.
phase begins. The approval phase starts 16, 2011, as the date the new drug
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![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_76931/page/3.svg)
Document Created: 2015-12-14 13:28:56
Document Modified: 2015-12-14 13:28:56
| 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 76694 |
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