83 FR 61643 - Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61643-61645 | |
| FR Document | 2018-26033 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61643-61645] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26033] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-6603 and FDA-2017-E-6604] Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA 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 KEVZARA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological 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 January 29, 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 May 29, 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 January 29, 2019. The https://www.regulations.gov [[Page 61644]] electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 29, 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 Nos. FDA-2017-E-6603 and FDA-2017-E-6604 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; KEVZARA.'' 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product KEVZARA (sarilumab). KEVZARA is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs. Subsequent to this approval, the USPTO received patent term restoration applications for KEVZARA (U.S. Patent Nos. 7,582,298 and 8,568,721) from Regeneron Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 6, 2018 (revised), FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of KEVZARA 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 KEVZARA is 3,478 days. Of this time, 2,907 days occurred during the testing phase of the regulatory review period, while 571 days occurred during the [[Page 61645]] 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 (21 U.S.C. 355(i)) became effective: November 15, 2007. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 15, 2007. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 30, 2015. FDA has verified the applicant's claim that the biologics license application (BLA) for KEVZARA (BLA 761037) was initially submitted on October 30, 2015. 3. The date the application was approved: May 22, 2017. FDA has verified the applicant's claim that BLA 761037 was approved on May 22, 2017. 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 applications for patent extension, this applicant seeks 1,234 or 937 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 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26033 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
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comments only as a written/paper Agenda: The Committee will discuss at least 7 days in advance of the
submission. You should submit two new drug application 210934 for meeting.
copies total. One copy will include the sotagliflozin oral tablet, sponsored by FDA is committed to the orderly
information you claim to be confidential Sanofi-Aventis U.S. LLC, for the conduct of its advisory committee
with a heading or cover note that states proposed indication: Adjunct to insulin meetings. Please visit our website at
‘‘THIS DOCUMENT CONTAINS therapy to improve glycemic control in https://www.fda.gov/
CONFIDENTIAL INFORMATION.’’ FDA adults with type 1 diabetes mellitus. AdvisoryCommittees/AboutAdvi
will review this copy, including the FDA intends to make background soryCommittees/ucm111462.htm for
claimed confidential information, in its material available to the public no later procedures on public conduct during
consideration of comments. The second than 2 business days before the meeting. advisory committee meetings.
copy, which will have the claimed If FDA is unable to post the background Notice of this meeting is given under
confidential information redacted/ material on its website prior to the the Federal Advisory Committee Act (5
blacked out, will be available for public meeting, the background material will U.S.C. app. 2).
viewing and posted on https:// be made publicly available at the Dated: November 26, 2018.
www.regulations.gov. Submit both location of the advisory committee Leslie Kux,
copies to the Dockets Management Staff. meeting, and the background material Associate Commissioner for Policy.
If you do not wish your name and will be posted on FDA’s website after
[FR Doc. 2018–25990 Filed 11–29–18; 8:45 am]
contact information be made publicly the meeting. Background material is
BILLING CODE 4164–01–P
available, you can provide this available at https://www.fda.gov/
information on the cover sheet and not AdvisoryCommittees/Calendar/
in the body of your comments and you default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
must identify the information as appropriate advisory committee meeting HUMAN SERVICES
‘‘confidential.’’ Any information marked link.
as ‘‘confidential’’ will not be disclosed Procedure: Interested persons may Food and Drug Administration
except in accordance with 21 CFR 10.20 present data, information, or views,
and other applicable disclosure law. For orally or in writing, on issues pending [Docket Nos. FDA–2017–E–6603 and FDA–
more information about FDA’s posting 2017–E–6604]
before the Committee. All electronic and
of comments to public dockets, see 80 written submissions submitted to the Determination of Regulatory Review
FR 56469, September 18, 2015, or access Docket (see ADDRESSES) on or before Period for Purposes of Patent
the information at: https://www.gpo.gov/ January 3, 2019, will be provided to the Extension; KEVZARA
fdsys/pkg/FR-2015-09-18/pdf/2015- Committee. Oral presentations from the
23389.pdf. public will be scheduled between AGENCY: Food and Drug Administration,
Docket: For access to the docket to approximately 1 p.m. to 2 p.m. Those HHS.
read background documents or the individuals interested in making formal ACTION: Notice.
electronic and written/paper comments oral presentations should notify the
received, go to https:// contact person and submit a brief SUMMARY: The Food and Drug
www.regulations.gov and insert the statement of the general nature of the Administration (FDA or the Agency) has
docket number, found in brackets in the evidence or arguments they wish to determined the regulatory review period
heading of this document, into the present, the names and addresses of for KEVZARA and is publishing this
‘‘Search’’ box and follow the prompts proposed participants, and an notice of that determination as required
and/or go to the Dockets Management indication of the approximate time by law. FDA has made the
Staff, 5630 Fishers Lane, Rm. 1061, requested to make their presentation on determination because of the
Rockville, MD 20852. or before December 27, 2018. Time submission of applications to the
FOR FURTHER INFORMATION CONTACT: allotted for each presentation may be Director of the U.S. Patent and
LaToya Bonner, Center for Drug limited. If the number of registrants Trademark Office (USPTO), Department
Evaluation and Research, Food and requesting to speak is greater than can of Commerce, for the extension of a
Drug Administration, 10903 New be reasonably accommodated during the patent which claims that human
Hampshire Ave., Bldg. 31, Rm. 2417, scheduled open public hearing session, biological product.
Silver Spring, MD 20993–0002, 301– FDA may conduct a lottery to determine DATES: Anyone with knowledge that any
796–9001, Fax: 301–847–8533, email: the speakers for the scheduled open of the dates as published (see the
EMDAC@fda.hhs.gov, or FDA Advisory public hearing session. The contact SUPPLEMENTARY INFORMATION section) are
Committee Information Line, 1–800– person will notify interested persons incorrect may submit either electronic
741–8138 (301–443–0572 in the regarding their request to speak by or written comments and ask for a
Washington, DC area). A notice in the December 28, 2018. redetermination by January 29, 2019.
Federal Register about last minute Persons attending FDA’s advisory Furthermore, any interested person may
modifications that impact a previously committee meetings are advised that petition FDA for a determination
announced advisory committee meeting FDA is not responsible for providing regarding whether the applicant for
cannot always be published quickly access to electrical outlets. extension acted with due diligence
enough to provide timely notice. For press inquiries, please contact the during the regulatory review period by
Therefore, you should always check the Office of Media Affairs at fdaoma@ May 29, 2019. See ‘‘Petitions’’ in the
FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540. SUPPLEMENTARY INFORMATION section for
amozie on DSK3GDR082PROD with NOTICES1
AdvisoryCommittees/default.htm and FDA welcomes the attendance of the more information.
scroll down to the appropriate advisory public at its advisory committee ADDRESSES: You may submit comments
committee meeting link, or call the meetings and will make every effort to as follows. Please note that late,
advisory committee information line to accommodate persons with disabilities. untimely filed comments will not be
learn about possible modifications If you require accommodations due to a considered. Electronic comments must
before coming to the meeting. disability, please contact LaToya Bonner be submitted on or before January 29,
SUPPLEMENTARY INFORMATION: (see FOR FURTHER INFORMATION CONTACT) 2019. The https://www.regulations.gov
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![Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61645
approval phase. These periods of time Dated: November 26, 2018. instructions for submitting comments.
were derived from the following dates: Leslie Kux, Comments submitted electronically,
1. The date an exemption under Associate Commissioner for Policy. including attachments, to https://
section 505(i) of the Federal Food, Drug, [FR Doc. 2018–26033 Filed 11–29–18; 8:45 am] www.regulations.gov will be posted to
and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P the docket unchanged. Because your
became effective: November 15, 2007. comment will be made public, you are
FDA has verified the applicant’s claim solely responsible for ensuring that your
DEPARTMENT OF HEALTH AND comment does not include any
that the date the investigational new
HUMAN SERVICES confidential information that you or a
drug application became effective was
third party may not wish to be posted,
on November 15, 2007. Food and Drug Administration such as medical information, your or
2. The date the application was anyone else’s Social Security number, or
[Docket No. FDA–2016–E–3305]
initially submitted with respect to the confidential business information, such
human biological product under section Determination of Regulatory Review as a manufacturing process. Please note
351 of the Public Health Service Act (42 Period for Purposes of Patent that if you include your name, contact
U.S.C. 262): October 30, 2015. FDA has Extension; PROVAYBLUE information, or other information that
verified the applicant’s claim that the identifies you in the body of your
biologics license application (BLA) for AGENCY: Food and Drug Administration, comments, that information will be
KEVZARA (BLA 761037) was initially HHS. posted on https://www.regulations.gov.
submitted on October 30, 2015. ACTION: Notice. • If you want to submit a comment
3. The date the application was with confidential information that you
SUMMARY: The Food and Drug do not wish to be made available to the
approved: May 22, 2017. FDA has Administration (FDA or the Agency) has
verified the applicant’s claim that BLA public, submit the comment as a
determined the regulatory review period
761037 was approved on May 22, 2017. written/paper submission and in the
for PROVAYBLUE and is publishing
manner detailed (see ‘‘Written/Paper
This determination of the regulatory this notice of that determination as
Submissions’’ and ‘‘Instructions’’).
review period establishes the maximum required by law. FDA has made the
potential length of a patent extension. determination because of the Written/Paper Submissions
However, the USPTO applies several submission of an application to the Submit written/paper submissions as
statutory limitations in its calculations Director of the U.S. Patent and follows:
of the actual period for patent extension. Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
In its applications for patent extension, of Commerce, for the extension of a written/paper submissions): Dockets
this applicant seeks 1,234 or 937 days patent which claims that human drug Management Staff (HFA–305), Food and
of patent term extension. product. Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
III. Petitions of the dates as published (see the • For written/paper comments
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
Anyone with knowledge that any of
incorrect may submit either electronic Staff, FDA will post your comment, as
the dates as published are incorrect may
or written comments and ask for a well as any attachments, except for
submit either electronic or written
redetermination by January 29, 2019. information submitted, marked and
comments and, under 21 CFR 60.24, ask
Furthermore, any interested person may identified, as confidential, if submitted
for a redetermination (see DATES).
petition FDA for a determination as detailed in ‘‘Instructions.’’
Furthermore, as specified in § 60.30 (21 Instructions: All submissions received
regarding whether the applicant for
CFR 60.30), any interested person may must include the Docket No. FDA–
extension acted with due diligence
petition FDA for a determination 2016–E–3305 for ‘‘Determination of
during the regulatory review period by
regarding whether the applicant for Regulatory Review Period for Purposes
May 29, 2019. See ‘‘Petitions’’ in the
extension acted with due diligence of Patent Extension; PROVAYBLUE.’’
SUPPLEMENTARY INFORMATION section for
during the regulatory review period. To Received comments, those filed in a
more information.
meet its burden, the petition must timely manner (see ADDRESSES), will be
ADDRESSES: You may submit comments
comply with all the requirements of placed in the docket and, except for
§ 60.30, including but not limited to: as follows. Please note that late,
untimely filed comments will not be those submitted as ‘‘Confidential
Must be timely (see DATES), must be Submissions,’’ publicly viewable at
filed in accordance with § 10.20, must considered. Electronic comments must
be submitted on or before January 29, https://www.regulations.gov or at the
contain sufficient facts to merit an FDA Dockets Management Staff between 9
investigation, and must certify that a 2019. The https://www.regulations.gov
electronic filing system will accept a.m. and 4 p.m., Monday through
true and complete copy of the petition Friday.
has been served upon the patent comments until 11:59 p.m. Eastern Time
at the end of January 29, 2019. • Confidential Submissions—To
applicant. (See H. Rept. 857, part 1, 98th submit a comment with confidential
Cong., 2d sess., pp. 41–42, 1984.) Comments received by mail/hand
delivery/courier (for written/paper information that you do not wish to be
Petitions should be in the format made publicly available, submit your
specified in 21 CFR 10.30. submissions) will be considered timely
if they are postmarked or the delivery comments only as a written/paper
Submit petitions electronically to service acceptance receipt is on or submission. You should submit two
amozie on DSK3GDR082PROD with NOTICES1
https://www.regulations.gov at Docket before that date. copies total. One copy will include the
No. FDA–2013–S–0610. Submit written information you claim to be confidential
petitions (two copies are required) to the Electronic Submissions with a heading or cover note that states
Dockets Management Staff (HFA–305), Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration, 5630 following way: CONFIDENTIAL INFORMATION.’’ The
Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: Agency will review this copy, including
20852. https://www.regulations.gov. Follow the the claimed confidential information, in
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Document Created: 2018-11-30 04:36:32
Document Modified: 2018-11-30 04:36:32
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 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 May 29, 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 61643 |
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