83 FR 52481 - Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 201 (October 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 201 (October 17, 2018)
| Page Range | 52481-52483 | |
| FR Document | 2018-22566 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Notices] [Pages 52481-52483] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22566] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-E-6541] Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT 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 DUPIXENT 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 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 December 17, 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 April 15, 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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 17, 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 [[Page 52482]] 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-6541 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; DUPIXENT.'' 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 DUPIXENT (dupilumab). DUPIXENT is indicated for treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Subsequent to this approval, the USPTO received a patent term restoration application for DUPIXENT (U.S. Patent No. 7,608,693) from Regeneron Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 2, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of DUPIXENT 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 DUPIXENT is 2,728 days. Of this time, 2,485 days occurred during the testing phase of the regulatory review period, while 243 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 (21 U.S.C. 355(i)) became effective: October 10, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on October 10, 2009. 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): July 29, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for DUPIXENT (BLA 761055) was initially submitted on July 29, 2016. 3. The date the application was approved: March 28, 2017. FDA has verified the applicant's claim that BLA 761055 was approved on March 28, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several [[Page 52483]] statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,273 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: October 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22566 Filed 10-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices 52481
TABLE 1—STUDY DESIGN
High prominence Low prominence Absent
Physician labeling version.
Consumer-friendly version.
We will recruit a general population marketing, advertising, or have sufficient power to detect small-
sample of adult volunteers 18 years of pharmaceutical industries. We will use sized effects in the main study (table 2).
age or older. We will exclude health literacy quotas to ensure that our FDA estimates the burden of this
individuals who work for the U.S. sample includes participants with a collection of information as follows:
Department of Health and Human range of health literacy skills. With the
Services or work in the health care, sample sizes described below, we will
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Activity responses per burden per
respondents responses hours
respondent response
Pretest screener ........................................................... 916 1 1 0.08 (5 min.) ......... 73.28
Study screener ............................................................. 1,507 1 1 0.08 (5 min.) ......... 120.56
Pretest .......................................................................... 385 1 1 0.33 (20 min.) ....... 127.05
Main Study ................................................................... 633 1 1 0.33 (20 min.) ....... 208.89
Total ...................................................................... ........................ ........................ ........................ ............................... 529.78
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
References Dated: October 11, 2018. Furthermore, any interested person may
Leslie Kux, petition FDA for a determination
The following references are on Associate Commissioner for Policy. regarding whether the applicant for
display at the Dockets Management [FR Doc. 2018–22570 Filed 10–16–18; 8:45 am] extension acted with due diligence
Staff, Food and Drug Administration, during the regulatory review period by
BILLING CODE 4164–01–P
5630 Fishers Lane, Rm. 1061, Rockville, April 15, 2019. See ‘‘Petitions’’ in the
MD 20857, and is available for viewing SUPPLEMENTARY INFORMATION section for
by interested persons between 9 a.m. DEPARTMENT OF HEALTH AND more information.
and 4 p.m., Monday through Friday; the HUMAN SERVICES ADDRESSES: You may submit comments
reference marked with an asterisk is also as follows. Please note that late,
available electronically at https:// Food and Drug Administration untimely filed comments will not be
www.regulations.gov. The reference [Docket No. FDA–2017–E–6541] considered. Electronic comments must
without an asterisk is not on public be submitted on or before December 17,
display at https://www.regulations.gov Determination of Regulatory Review 2018. The https://www.regulations.gov
because it has copyright restriction, or it Period for Purposes of Patent electronic filing system will accept
is available as a published article. FDA Extension; DUPIXENT comments until 11:59 p.m. Eastern Time
has verified the website address, as of at the end of December 17, 2018.
AGENCY: Food and Drug Administration, Comments received by mail/hand
the date this document publishes in the HHS.
Federal Register, but websites are delivery/courier (for written/paper
ACTION: Notice. submissions) will be considered timely
subject to change over time.
if they are postmarked or the delivery
1. Beaver J.A., L.J. Howie, L. Pelosof, et SUMMARY: The Food and Drug
service acceptance receipt is on or
al. ‘‘A 25-Year Experience of U.S. Administration (FDA or the Agency) has before that date.
Food and Drug Administration determined the regulatory review period
for DUPIXENT and is publishing this Electronic Submissions
Accelerated Approval of Malignant
Hematology and Oncology Drugs notice of that determination as required Submit electronic comments in the
by law. FDA has made the following way:
and Biologics: A Review.’’ JAMA
Oncology. 2018; 4(6):849–856.
determination because of the • Federal eRulemaking Portal:
submission of an application to the https://www.regulations.gov. Follow the
doi:10.1001/jamaoncol.2017.5618.
Director of the U.S. Patent and instructions for submitting comments.
2. FDA Draft Guidance for Industry: Trademark Office (USPTO), Department Comments submitted electronically,
Labeling for Human Prescription of Commerce, for the extension of a including attachments, to https://
Drug and Biological Products patent which claims that human www.regulations.gov will be posted to
daltland on DSKBBV9HB2PROD with NOTICES
Approved Under the Accelerated biological product. the docket unchanged. Because your
Approval Pathway (March 2014) DATES: Anyone with knowledge that any comment will be made public, you are
(https://www.fda.gov/downloads/ of the dates as published (see the solely responsible for ensuring that your
Drugs/GuidanceCompliance SUPPLEMENTARY INFORMATION section) are comment does not include any
RegulatoryInformation/Guidances/ incorrect may submit either electronic confidential information that you or a
UCM390058.pdf). or written comments and ask for a third party may not wish to be posted,
redetermination by December 17, 2018. such as medical information, your or
VerDate Sep<11>2014 19:46 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/83_FR_52682/page/1.svg)
![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices 52483
statutory limitations in its calculations Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of the actual period for patent extension. of Commerce, for the extension of a written/paper submissions): Dockets
In its application for patent extension, patent which claims that human Management Staff (HFA–305), Food and
this applicant seeks 1,273 days of patent biological product. Drug Administration, 5630 Fishers
term extension. DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the • For written/paper comments
III. Petitions submitted to the Dockets Management
SUPPLEMENTARY INFORMATION section) are
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 December 17, 2018. 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 regarding whether the applicant for Instructions: All submissions received
CFR 60.30), any interested person may extension acted with due diligence must include the Docket No. FDA–
petition FDA for a determination during the regulatory review period by 2017–E–6527 for ’’Determination of
regarding whether the applicant for April 15, 2019. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes
extension acted with due diligence SUPPLEMENTARY INFORMATION section for of Patent Extension; BRINEURA.’’
during the regulatory review period. To more information. Received comments, those filed in a
meet its burden, the petition must ADDRESSES: You may submit comments
timely manner (see ADDRESSES), will be
comply with all the requirements of as follows. Please note that late, placed in the docket and, except for
§ 60.30, including but not limited to: untimely filed comments will not be those submitted as ‘‘Confidential
Must be timely (see DATES), must be considered. Electronic comments must Submissions,’’ publicly viewable at
filed in accordance with § 10.20, must be submitted on or before December 17, https://www.regulations.gov or at the
contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov Dockets Management Staff between 9
investigation, and must certify that a electronic filing system will accept a.m. and 4 p.m., Monday through
true and complete copy of the petition comments until 11:59 p.m. Eastern Time Friday.
has been served upon the patent • Confidential Submissions—To
at the end of December 17, 2018.
applicant. (See H. Rept. 857, part 1, 98th submit a comment with confidential
Comments received by mail/hand
Cong., 2d sess., pp. 41–42, 1984.) information that you do not wish to be
delivery/courier (for written/paper
Petitions should be in the format made publicly available, submit your
submissions) will be considered timely
specified in 21 CFR 10.30. comments only as a written/paper
if they are postmarked or the delivery
Submit petitions electronically to submission. You should submit two
service acceptance receipt is on or
https://www.regulations.gov at Docket copies total. One copy will include the
before that date.
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
Dated: October 11, 2018. instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
Leslie Kux,
including attachments, to https:// claimed confidential information
Associate Commissioner for Policy.
www.regulations.gov will be posted to redacted/blacked out, will be available
[FR Doc. 2018–22566 Filed 10–16–18; 8:45 am] for public viewing and posted on
the docket unchanged. Because your
BILLING CODE 4164–01–P
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND contact information to be made publicly
HUMAN SERVICES confidential information that you or a
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
[Docket No. FDA–2017–E–6527] confidential business information, such must identify this information as
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Determination of Regulatory Review as ‘‘confidential’’ will not be disclosed
Period for Purposes of Patent that if you include your name, contact
information, or other information that except in accordance with § 10.20 (21
Extension; BRINEURA CFR 10.20) and other applicable
identifies you in the body of your
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the information at: https://www.gpo.gov/
Administration (FDA or the Agency) has public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
determined the regulatory review period written/paper submission and in the 23389.pdf.
for BRINEURA and is publishing this manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
notice of that determination as required Submissions’’ and ‘‘Instructions’’). read background documents or the
by law. FDA has made the electronic and written/paper comments
determination because of the Written/Paper Submissions received, go to https://
submission of an application to the Submit written/paper submissions as www.regulations.gov and insert the
Director of the U.S. Patent and follows: docket number, found in brackets in the
VerDate Sep<11>2014 19:46 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/83_FR_52682/page/3.svg)
Document Created: 2018-10-17 01:47:45
Document Modified: 2018-10-17 01:47:45
| 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 December 17, 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 April 15, 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 52481 |
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