83 FR 62591 - Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 233 (December 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 233 (December 4, 2018)
| Page Range | 62591-62593 | |
| FR Document | 2018-26288 |
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)] [Notices] [Pages 62591-62593] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26288] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-E-3650] Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVA AGENCY: Food and Drug Administration, HHS. [[Page 62592]] ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OCALIVA 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 4, 2019. 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 3, 2019. 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 February 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 4, 2019. 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-2017-E-3650 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVA.'' 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/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, OCALIVA (obeticholic acid). OCALIVA is [[Page 62593]] indicated for treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Subsequent to this approval, the USPTO received a patent term restoration application for OCALIVA (U.S. Patent No. 7,138,390) from Intercept Pharmaceuticals, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated September 20, 2017, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of OCALIVA 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 OCALIVA is 3,742 days. Of this time, 3,408 days occurred during the testing phase of the regulatory review period, while 334 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: March 1, 2006. The applicant claims February 26, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was March 1, 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, 2015. The applicant claims June 26, 2015, as the date the new drug application (NDA) for OCALIVA (NDA 207999) was initially submitted. However, FDA records indicate that NDA 207999 was submitted on June 29, 2015. 3. The date the application was approved: May 27, 2016. FDA has verified the applicant's claim that NDA 207999 was approved on May 27, 2016. 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 1,826 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 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26288 Filed 12-3-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62591
information you claim to be confidential an approval phase. For human drug was initially submitted on January 29,
with a heading or cover note that states products, the testing phase begins when 2016.
‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical 3. The date the application was
CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes approved: January 19, 2017. FDA has
Agency will review this copy, including effective and runs until the approval verified the applicant’s claim that NDA
the claimed confidential information, in phase begins. The approval phase starts 208745 was approved on January 19,
its consideration of comments. The with the initial submission of an 2017.
second copy, which will have the application to market the human drug This determination of the regulatory
claimed confidential information product and continues until FDA grants review period establishes the maximum
redacted/blacked out, will be available permission to market the drug product. potential length of a patent extension.
for public viewing and posted on Although only a portion of a regulatory However, the USPTO applies several
https://www.regulations.gov. Submit review period may count toward the statutory limitations in its calculations
both copies to the Dockets Management actual amount of extension that the of the actual period for patent extension.
Staff. If you do not wish your name and Director of USPTO may award (for In its application for patent extension,
contact information to be made publicly example, half the testing phase must be this applicant seeks 1,771 days of patent
available, you can provide this subtracted as well as any time that may term extension.
information on the cover sheet and not have occurred before the patent was III. Petitions
in the body of your comments and you issued), FDA’s determination of the
length of a regulatory review period for Anyone with knowledge that any of
must identify this information as
a human drug product will include all the dates as published are incorrect may
‘‘confidential.’’ Any information marked
of the testing phase and approval phase submit either electronic or written
as ‘‘confidential’’ will not be disclosed
as specified in 35 U.S.C. 156(g)(1)(B). comments and, under 21 CFR 60.24, ask
except in accordance with § 10.20 (21
FDA has approved for marketing the for a redetermination (see DATES).
CFR 10.20) and other applicable
human drug product, TRULANCE Furthermore, as specified in § 60.30 (21
disclosure law. For more information
(plecanatide) indicated in adults for CFR 60.30), any interested person may
about FDA’s posting of comments to petition FDA for a determination
public dockets, see 80 FR 56469, treatment of chronic idiopathic
constipation. Subsequent to this regarding whether the applicant for
September 18, 2015, or access the extension acted with due diligence
information at: https://www.gpo.gov/ approval, the USPTO received a patent
term restoration application for during the regulatory review period. To
fdsys/pkg/FR-2015-09-18/pdf/2015- meet its burden, the petition must
23389.pdf. TRULANCE (U.S. Patent No. 7,041,786)
from Synergy Pharmaceuticals, Inc. and comply with all the requirements of
Docket: For access to the docket to § 60.30, including but not limited to:
read background documents or the the USPTO requested FDA’s assistance
in determining the patent’s eligibility Must be timely (see DATES), must be
electronic and written/paper comments filed in accordance with § 10.20, must
received, go to https:// for patent term restoration. In a letter
dated September 20, 2017, FDA advised contain sufficient facts to merit an FDA
www.regulations.gov and insert the investigation, and must certify that a
docket number, found in brackets in the the USPTO that this human drug
product had undergone a regulatory true and complete copy of the petition
heading of this document, into the has been served upon the patent
‘‘Search’’ box and follow the prompts review period and that the approval of
TRULANCE represented the first applicant. (See H. Rept. 857, part 1, 98th
and/or go to the Dockets Management Cong., 2d sess., pp. 41–42, 1984.)
Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use
of the product. Thereafter, the USPTO Petitions should be in the format
Rockville, MD 20852. specified in 21 CFR 10.30.
requested that FDA determine the
FOR FURTHER INFORMATION CONTACT: Submit petitions electronically to
product’s regulatory review period.
Beverly Friedman, Office of Regulatory https://www.regulations.gov at Docket
Policy, Food and Drug Administration, II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written
10903 New Hampshire Ave., Bldg. 51, Period petitions (two copies are required) to the
Rm. 6250, Silver Spring, MD 20993, FDA has determined that the Dockets Management Staff (HFA–305),
301–796–3600. applicable regulatory review period for Food and Drug Administration, 5630
SUPPLEMENTARY INFORMATION: TRULANCE is 3,186 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD
2,829 days occurred during the testing 20852.
I. Background
phase of the regulatory review period, Dated: November 28, 2018.
The Drug Price Competition and while 357 days occurred during the Leslie Kux,
Patent Term Restoration Act of 1984 approval phase. These periods of time Associate Commissioner for Policy.
(Pub. L. 98–417) and the Generic were derived from the following dates: [FR Doc. 2018–26289 Filed 12–3–18; 8:45 am]
Animal Drug and Patent Term 1. The date an exemption under
BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) section 505(i) of the Federal Food, Drug,
generally provide that a patent may be and Cosmetic Act (FD&C Act) (21 U.S.C.
extended for a period of up to 5 years 355(i)) became effective: May 2, 2008. DEPARTMENT OF HEALTH AND
so long as the patented item (human FDA has verified the applicant’s claim HUMAN SERVICES
drug product, animal drug product, that the date the investigational new
medical device, food additive, or color drug application became effective was Food and Drug Administration
additive) was subject to regulatory May 2, 2008.
review by FDA before the item was 2. The date the application was [Docket No. FDA–2017–E–3650]
marketed. Under these acts, a product’s initially submitted with respect to the
Determination of Regulatory Review
regulatory review period forms the basis human drug product under section
Period for Purposes of Patent
for determining the amount of extension 505(b) of the FD&C Act: January 29,
Extension; OCALIVA
an applicant may receive. 2016. FDA has verified the applicant’s
A regulatory review period consists of claim that the new drug application AGENCY: Food and Drug Administration,
two periods of time: A testing phase and (NDA) for TRULANCE (NDA 208745) HHS.
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![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices 62593
indicated for treatment of primary III. Petitions patent which claims that medical
biliary cholangitis in combination with Anyone with knowledge that any of device.
ursodeoxycholic acid (UDCA) in adults the dates as published are incorrect may DATES: Anyone with knowledge that any
with an inadequate response to UDCA, submit either electronic or written of the dates as published (see the
or as monotherapy in adults unable to comments and, under 21 CFR 60.24, ask SUPPLEMENTARY INFORMATION section) are
tolerate UDCA. Subsequent to this for a redetermination (see DATES). incorrect may submit either electronic
approval, the USPTO received a patent Furthermore, as specified in § 60.30 (21 or written comments and ask for a
term restoration application for CFR 60.30), any interested person may redetermination by February 4, 2019.
OCALIVA (U.S. Patent No. 7,138,390) petition FDA for a determination Furthermore, any interested person may
from Intercept Pharmaceuticals, Inc. and regarding whether the applicant for petition FDA for a determination
the USPTO requested FDA’s assistance extension acted with due diligence regarding whether the applicant for
in determining the patent’s eligibility during the regulatory review period. To extension acted with due diligence
for patent term restoration. In a letter meet its burden, the petition must during the regulatory review period by
dated September 20, 2017, FDA advised comply with all the requirements of June 3, 2019. See ‘‘Petitions’’ in the
the USPTO that this human drug § 60.30, including but not limited to: SUPPLEMENTARY INFORMATION section for
product had undergone a regulatory Must be timely (see DATES), must be more information.
review period and that the approval of filed in accordance with § 10.20, must
OCALIVA represented the first ADDRESSES: You may submit comments
contain sufficient facts to merit an FDA
permitted commercial marketing or use as follows. Please note that late,
investigation, and must certify that a
of the product. Thereafter, the USPTO untimely filed comments will not be
true and complete copy of the petition
requested that FDA determine the considered. Electronic comments must
has been served upon the patent
product’s regulatory review period. be submitted on or before February 4,
applicant. (See H. Rept. 857, part 1, 98th
2019. The https://www.regulations.gov
II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.)
electronic filing system will accept
Period Petitions should be in the format
comments until 11:59 p.m. Eastern Time
specified in 21 CFR 10.30.
FDA has determined that the at the end of February 4, 2019.
Submit petitions electronically to
applicable regulatory review period for Comments received by mail/hand
https://www.regulations.gov at Docket
OCALIVA is 3,742 days. Of this time, delivery/courier (for written/paper
No. FDA–2013–S–0610. Submit written
3,408 days occurred during the testing submissions) will be considered timely
petitions (two copies are required) to the
phase of the regulatory review period, if they are postmarked or the delivery
Dockets Management Staff (HFA–305),
while 334 days occurred during the service acceptance receipt is on or
Food and Drug Administration, 5630
approval phase. These periods of time before that date.
Fishers Lane, Rm. 1061, Rockville, MD
were derived from the following dates: 20852. Electronic Submissions
1. The date an exemption under Dated: November 28, 2018. Submit electronic comments in the
section 505(i) of the Federal Food, Drug, Leslie Kux, following way:
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: March 1, 2006.
Associate Commissioner for Policy. • Federal eRulemaking Portal:
The applicant claims February 26, 2006, [FR Doc. 2018–26288 Filed 12–3–18; 8:45 am] https://www.regulations.gov. Follow the
as the date the investigational new drug BILLING CODE 4164–01–P instructions for submitting comments.
application (IND) became effective. Comments submitted electronically,
However, FDA records indicate that the including attachments, to https://
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
IND effective date was March 1, 2006,
HUMAN SERVICES the docket unchanged. Because your
which was 30 days after FDA receipt of
the IND. comment will be made public, you are
Food and Drug Administration solely responsible for ensuring that your
2. The date the application was comment does not include any
initially submitted with respect to the [Docket No. FDA–2017–E–3547] confidential information that you or a
human drug product under section third party may not wish to be posted,
505(b) of the FD&C Act: June 29, 2015. Determination of Regulatory Review such as medical information, your or
The applicant claims June 26, 2015, as Period for Purposes of Patent anyone else’s Social Security number, or
the date the new drug application Extension; EXABLATE NEURO MODEL confidential business information, such
(NDA) for OCALIVA (NDA 207999) was 4000 TYPE 1.0 SYSTEM as a manufacturing process. Please note
initially submitted. However, FDA that if you include your name, contact
records indicate that NDA 207999 was AGENCY: Food and Drug Administration,
HHS. information, or other information that
submitted on June 29, 2015. identifies you in the body of your
ACTION: Notice.
3. The date the application was comments, that information will be
approved: May 27, 2016. FDA has SUMMARY: The Food and Drug posted on https://www.regulations.gov.
verified the applicant’s claim that NDA Administration (FDA or the Agency) has • If you want to submit a comment
207999 was approved on May 27, 2016. determined the regulatory review period with confidential information that you
This determination of the regulatory for EXABLATE NEURO MODEL 4000 do not wish to be made available to the
review period establishes the maximum TYPE 1.0 SYSTEM (EXABLATE) and is public, submit the comment as a
potential length of a patent extension. publishing this notice of that written/paper submission and in the
However, the USPTO applies several determination as required by law. FDA manner detailed (see ‘‘Written/Paper
statutory limitations in its calculations has made the determination because of Submissions’’ and ‘‘Instructions’’).
of the actual period for patent extension. the submission of an application to the
Written/Paper Submissions
In its application for patent extension, Director of the U.S. Patent and
this applicant seeks 1,826 days of patent Trademark Office (USPTO), Department Submit written/paper submissions as
term extension. of Commerce, for the extension of a follows:
VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\04DEN1.SGM 04DEN1](https://thefederalregister.org/doc/83_FR_62824/page/3.svg)
Document Created: 2018-12-04 00:42:49
Document Modified: 2018-12-04 00:42:49
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 4, 2019. 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 3, 2019. 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 | 83 FR 62591 |
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