4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-3084]
Determination of Regulatory Review Period for Purposes of Patent Extension; SPEVIGO
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 SPEVIGO 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 SUPPLEMENTARY
INFORMATION) are incorrect must submit either electronic or written comments and ask for a
redetermination by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER]. 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 [INSERT DATE 180 DAYS AFTER DATE OF PUBLICATION IN
THE FEDERAL REGISTER]. 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. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of [INSERT DATE 60 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are
received 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-2023-E-3084

for “Determination of Regulatory Review Period for Purposes of Patent Extension; SPEVIGO.”
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, 240-402-7500.
•

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 § 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.govinfo.gov/content/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, 240-402-7500.

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 or biological 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 SPEVIGO (spesolimabsbzo). SPEVIGO is indicated for the treatment of generalized pustular psoriasis flares in adults.
Subsequent to this approval, the USPTO received a patent term restoration application for

SPEVIGO (U.S. Patent No. 9,023,995) from Boehringer Ingelheim International GmbH, and the
USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term
restoration. In a letter dated January 18, 2024, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that the approval of SPEVIGO
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 SPEVIGO is 1,729
days. Of this time, 1,393 days occurred during the testing phase of the regulatory review period,
while 336 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: December 9, 2017. FDA has verified the applicant’s
claim that the date the investigational new drug application became effective was on December
9, 2017.
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 1, 2021.
FDA has verified the applicant’s claim that the biologics license application (BLA) for
SPEVIGO (BLA 761244) was initially submitted on October 1, 2021.
3. The date the application was approved: September 1, 2022. FDA has verified the
applicant’s claim that BLA 761244 was approved on September 1, 2022.
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 1,033 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 § 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 § 60.30, including but not limited to: must be timely (see DATES), must
be filed in accordance with § 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-2013S-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: July 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15239 Filed: 7/10/2024 8:45 am; Publication Date: 7/11/2024]