82 FR 56612 - Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 228 (November 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 228 (November 29, 2017)
| Page Range | 56612-56613 | |
| FR Document | 2017-25772 |
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)] [Notices] [Pages 56612-56613] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25772] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1292] Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REXULTI 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 January 29, 2018. 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 May 29, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2016-E-1292 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/ [[Page 56613]] fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 REXULTI (brexpiprazole). REXULTI is indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. Treatment of schizophrenia. Subsequent to this approval, the USPTO received a patent term restoration application for REXULTI (U.S. Patent No. 7,888,362) from Otsuka Pharmaceutical Co., Ltd., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of REXULTI 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 REXULTI is 2,636 days. Of this time, 2,271 days occurred during the testing phase of the regulatory review period, while 365 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: April 23, 2008. The applicant claims April 20, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was April 23, 2008, 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: July 11, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for REXULTI (NDA 205422) was initially submitted on July 11, 2014. 3. The date the application was approved: July 10, 2015. FDA has verified the applicant's claim that NDA 205422 was approved on July 10, 2015. 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 868 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25772 Filed 11-28-17; 8:45 am] BILLING CODE 4164-01-P
![56612 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
at https://www.fda.gov/MedicalDevices/ for REXULTI and is publishing this written/paper submission and in the
DeviceRegulationandGuidance/ notice of that determination as required manner detailed (see ‘‘Written/Paper
GuidanceDocuments/default.htm. by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
Guidance documents are also available determination because of the
Written/Paper Submissions
at https://www.regulations.gov. Persons submission of an application to the
unable to download an electronic copy Director of the U.S. Patent and Submit written/paper submissions as
of ‘‘Recommendations for Dual 510(k) Trademark Office (USPTO), Department follows:
and CLIA Waiver by Application of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
Studies’’ may send an email request to patent which claims that human drug written/paper submissions): Dockets
CDRH-Guidance@fda.hhs.gov to receive product. Management Staff (HFA–305), Food and
an electronic copy of the document. DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
Please use the document number 16038 of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
to identify the guidance you are
SUPPLEMENTARY INFORMATION section) are • For written/paper comments
requesting. submitted to the Dockets Management
incorrect may submit either electronic
IV. Paperwork Reduction Act of 1995 or written comments and ask for a Staff, FDA will post your comment, as
redetermination by January 29, 2018. well as any attachments, except for
This draft guidance also refers to information submitted, marked and
previously approved collections of Furthermore, any interested person may
petition FDA for a determination identified, as confidential, if submitted
information found in FDA regulations. as detailed in ‘‘Instructions.’’
The collections of information in 21 regarding whether the applicant for
extension acted with due diligence Instructions: All submissions received
CFR 54 have been approved under
during the regulatory review period by must include the Docket No. FDA–
0910–0396; the collections of
May 29, 2018. See ‘‘Petitions’’ in the 2016–E–1292 for ’’Determination of
information in 21 CFR parts 50 and 56
SUPPLEMENTARY INFORMATION section for Regulatory Review Period for Purposes
have been approved under OMB control
more information. of Patent Extension; REXULTI.’’
number 0910–0755, the collections of
information in 21 CFR 807 have been ADDRESSES: You may submit comments Received comments, those filed in a
approved under 0910–0120; the as follows. Please note that late, timely manner (see ADDRESSES), will be
collections of information in the untimely filed comments will not be placed in the docket and, except for
guidance document entitled considered. Electronic comments must those submitted as ‘‘Confidential
‘‘Recommendations for Clinical be submitted on or before January 29, Submissions,’’ publicly viewable at
Laboratory Improvement Amendments 2018. The https://www.regulations.gov https://www.regulations.gov or at the
of 1988 (CLIA) Waiver Applications for electronic filing system will accept Dockets Management Staff between 9
Manufacturers of In Vitro Diagnostic comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Devices’’ have been approved under at the end of January 29, 2018. Friday.
0910–0598, the collections of Comments received by mail/hand • Confidential Submissions—To
information in the guidance document delivery/courier (for written/paper submit a comment with confidential
entitled ‘‘Requests for Feedback on submissions) will be considered timely information that you do not wish to be
Medical Device Submissions’’ have been if they are postmarked or the delivery made publicly available, submit your
approved under 0910–0756; and the service acceptance receipt is on or comments only as a written/paper
collections of information in the before that date. submission. You should submit two
guidance document entitled copies total. One copy will include the
Electronic Submissions information you claim to be confidential
‘‘Administrative Procedures for Clinical
Laboratory Improvement Amendments Submit electronic comments in the with a heading or cover note that states
of 1988 Categorization’’ have been following way: ‘‘THIS DOCUMENT CONTAINS
approved under 0910–0607. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
Dated: November 22, 2017.
instructions for submitting comments. the claimed confidential information, in
Leslie Kux, Comments submitted electronically, its consideration of comments. The
Associate Commissioner for Policy. including attachments, to https:// second copy, which will have the
[FR Doc. 2017–25774 Filed 11–28–17; 8:45 am] www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4164–01–P the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
DEPARTMENT OF HEALTH AND comment does not include any both copies to the Dockets Management
HUMAN SERVICES confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
Food and Drug Administration
such as medical information, your or available, you can provide this
[Docket No. FDA–2016–E–1292] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note must identify this information as
Period for Purposes of Patent that if you include your name, contact ‘‘confidential.’’ Any information marked
pmangrum on DSK3GDR082PROD with NOTICES1
Extension; REXULTI information, or other information that as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21
HHS. comments, that information will be CFR 10.20) and other applicable
ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information
• If you want to submit a comment about FDA’s posting of comments to
SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469,
Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the
determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/
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![Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56613
fdsys/pkg/FR-2015-09-18/pdf/2015- • Treatment of schizophrenia. CFR 60.30), any interested person may
23389.pdf. Subsequent to this approval, the petition FDA for a determination
Docket: For access to the docket to USPTO received a patent term regarding whether the applicant for
read background documents or the restoration application for REXULTI extension acted with due diligence
electronic and written/paper comments (U.S. Patent No. 7,888,362) from Otsuka during the regulatory review period. To
received, go to https:// Pharmaceutical Co., Ltd., and the meet its burden, the petition must
www.regulations.gov and insert the USPTO requested FDA’s assistance in comply with all the requirements of
docket number, found in brackets in the determining this patent’s eligibility for § 60.30, including but not limited to:
heading of this document, into the patent term restoration. In a letter dated Must be timely (see DATES), must be
‘‘Search’’ box and follow the prompts July 12, 2016, FDA advised the USPTO filed in accordance with § 10.20, must
and/or go to the Dockets Management that this human drug product had contain sufficient facts to merit an FDA
Staff, 5630 Fishers Lane, Rm. 1061, undergone a regulatory review period investigation, and must certify that a
Rockville, MD 20852. and that the approval of REXULTI true and complete copy of the petition
FOR FURTHER INFORMATION CONTACT: represented the first permitted has been served upon the patent
Beverly Friedman, Office of Regulatory commercial marketing or use of the applicant. (See H. Rept. 857, part 1, 98th
Policy, Food and Drug Administration, product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.)
10903 New Hampshire Ave., Bldg. 51, requested that FDA determine the Petitions should be in the format
Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period. specified in 21 CFR 10.30.
301–796–3600. Submit petitions electronically to
II. Determination of Regulatory Review
SUPPLEMENTARY INFORMATION: https://www.regulations.gov at Docket
Period
No. FDA–2013–S–0610. Submit written
I. Background FDA has determined that the petitions (two copies are required) to the
The Drug Price Competition and applicable regulatory review period for Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 REXULTI is 2,636 days. Of this time, Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic 2,271 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term phase of the regulatory review period, 20852.
Restoration Act (Pub. L. 100–670) while 365 days occurred during the
Dated: November 24, 2017.
generally provide that a patent may be approval phase. These periods of time
extended for a period of up to 5 years were derived from the following dates: Leslie Kux,
so long as the patented item (human 1. The date an exemption under Associate Commissioner for Policy.
drug product, animal drug product, section 505(i) of the Federal Food, Drug, [FR Doc. 2017–25772 Filed 11–28–17; 8:45 am]
medical device, food additive, or color and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
additive) was subject to regulatory U.S.C. 355(i)) became effective: April
review by FDA before the item was 23, 2008. The applicant claims April 20,
marketed. Under these acts, a product’s 2008, as the date the investigational new DEPARTMENT OF HEALTH AND
regulatory review period forms the basis drug application (IND) became effective. HUMAN SERVICES
for determining the amount of extension However, FDA records indicate that the
an applicant may receive. IND effective date was April 23, 2008, Food and Drug Administration
A regulatory review period consists of which was 30 days after FDA receipt of [Docket No. FDA–2014–E–1653]
two periods of time: A testing phase and the IND.
an approval phase. For human drug 2. The date the application was Determination of Regulatory Review
products, the testing phase begins when initially submitted with respect to the Period for Purposes of Patent
the exemption to permit the clinical human drug product under section Extension; SOLX SYSTEM
investigations of the drug becomes 505(b) of the FD&C Act: July 11, 2014.
AGENCY: Food and Drug Administration,
effective and runs until the approval FDA has verified the applicant’s claim
phase begins. The approval phase starts HHS.
that the new drug application (NDA) for
with the initial submission of an REXULTI (NDA 205422) was initially ACTION: Notice.
application to market the human drug submitted on July 11, 2014. SUMMARY: The Food and Drug
product and continues until FDA grants 3. The date the application was Administration (FDA or the Agency) has
permission to market the drug product. approved: July 10, 2015. FDA has determined the regulatory review period
Although only a portion of a regulatory verified the applicant’s claim that NDA for SOLX SYSTEM and is publishing
review period may count toward the 205422 was approved on July 10, 2015. this notice of that determination as
actual amount of extension that the This determination of the regulatory
required by law. FDA has made the
Director of USPTO may award (for review period establishes the maximum
determination because of the
example, half the testing phase must be potential length of a patent extension.
submission of an application to the
subtracted as well as any time that may However, the USPTO applies several
Director of the U.S. Patent and
have occurred before the patent was statutory limitations in its calculations
Trademark Office (USPTO), Department
issued), FDA’s determination of the of the actual period for patent extension.
of Commerce, for the extension of a
length of a regulatory review period for In its application for patent extension,
patent which claims that human drug
a human drug product will include all this applicant seeks 868 days of patent
product.
of the testing phase and approval phase term extension.
pmangrum on DSK3GDR082PROD with NOTICES1
as specified in 35 U.S.C. 156(g)(1)(B). DATES: Anyone with knowledge that any
FDA has approved for marketing the III. Petitions of the dates as published (in the
human drug product REXULTI Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are
(brexpiprazole). REXULTI is indicated the dates as published are incorrect may incorrect may submit either electronic
for: submit either electronic or written or written comments and ask for a
• Use as an adjunctive therapy to comments and, under 21 CFR 60.24, ask redetermination by January 29, 2018.
antidepressants for the treatment of for a redetermination (see DATES). Furthermore, any interested person may
major depressive disorder. Furthermore, as specified in § 60.30 (21 petition FDA for a determination
VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1](https://thefederalregister.org/doc/82_FR_56840/page/2.svg)
Document Created: 2017-11-29 01:26:32
Document Modified: 2017-11-29 01:26:32
| 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 January 29, 2018. 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 May 29, 2018. 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 | 82 FR 56612 |
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