Determination of Regulatory Review Period for Purposes of Patent Extension; SILIQ, 53476-53478 [2018-23058]

Download as PDF khammond on DSK30JT082PROD with NOTICES 53476 Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices federal IT platform (i.e., HealthCare.gov). HHS anticipates that consumers may use this information to inform plan selection. As stated in the final rule Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310; March 27, 2012), broader implementation will continue to be addressed in separate rulemaking issued by HHS, and the Departments of Labor and the Treasury (the Departments). Consistent with Public Health Service Act (PHS Act) 1 section 2715A, which largely extends the transparency reporting provisions set forth in section 1311(e)(3) to non-grandfathered group health plans (including large group and self-insured health plans) and health insurance issuers offering group and individual health insurance coverage (non-QHP issuers), the Departments intend to propose other transparency reporting requirements at a later time, through a separate rulemaking conducted by the Departments, for nonQHP issuers and non-grandfathered group health plans. Those proposed reporting requirements may differ from those prescribed in the HHS proposal under section 1311(e)(3), and will take into account differences in markets, reporting requirements already in existence for non-QHPs (including group health plans), and other relevant factors. The Departments also intend to streamline reporting under multiple reporting provisions and reduce unnecessary duplication. The Departments intend to implement any transparency reporting requirements applicable to non-QHP issuers and nongrandfathered group health plans only after notice and comment, and after giving those issuers and plans sufficient time, following the publication of final rules, to come into compliance with those requirements. Form Number: CMS–10572 (OMB control number: 0938–1310); Frequency: Annually; Affected Public: Private Sector (Business or other for-profits); Number of Respondents: 160; Number of Responses: 160; Total Annual Hours: 10,880. (For questions regarding this collection contact Valisha Jackson at (301) 492–5145.) 5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Collection to Support QHP Certification and other 1 PHS Act section 2715A also is incorporated into section 715(a)(1) of the Employee Retirement Income Security Act and section 9815(a)(1) of the Internal Revenue Code. VerDate Sep<11>2014 20:20 Oct 22, 2018 Jkt 247001 Financial Management and Exchange Operations; Use: As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange is responsible for the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and nondiscrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR 155 and 156, based on the Patient Protection and Affordable Care Act (PPACA), as well as other standards determined by the Exchange. Issuers can offer individual and small group market plans outside of the Exchanges that are not QHPs. The instruments in this information collection will be used for the 2020 certification process and beyond. Providing these instruments now will give issuers and other stakeholders more opportunity to familiarize themselves with the instruments before releasing the 2020 application. Form Number: CMS–10433 (OMB control number: 0938–1187); Frequency: Annually; Affected Public: State, Local, or Tribal Governments, Private Sector (Business or other for-profits); Number of Respondents: 2,892 Number of Responses: 2,892; Total Annual Hours: 68,666. (For questions regarding this collection contact Joshua Annas at (301) 492–4407). 6. Type of Information Collection Request: Request for a new OMB control number; Title of Information Collection: The State Flexibility to Stabilize the Market Grant Program Reporting; Use: Section 1003 of the Affordable Care Act (ACA) adds a new section 2794 to the PHS Act entitled, ‘‘Ensuring That Consumers Get Value for Their Dollars.’’ Specifically, section 2794(a) requires the Secretary of the Department of Health and Human Services (the Secretary) (HHS), in conjunction with the States, to establish a process for the annual review of health insurance premiums to protect consumers from unreasonable rate increases. Section 2794(c) directs the Secretary to carry out a program to award grants to States. Section 2794(c)(2)(B) specifies that any appropriated Rate Review Grant funds that are not fully obligated by the end of FY 2014 shall remain available to the Secretary for grants to States for PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 planning and implementing the insurance market reforms and consumer protections under Part A of title XXVII of the Public Health Service Act (PHS Act). States that are awarded funds under this funding opportunity are required to provide CMS with four quarterly reports and one annual report (except for the last year of the grant) until the end of the grant period detailing the state’s progression towards planning and/or implementing the preselected market reforms under Part A of Title XXVII of the PHS Act. A final report is due at the end of the grant period. Form Number: CMS–10657 (OMB control number: 0938–NEW); Frequency: Annually and Quarterly; Affected Public: State, Local or Tribal Governments; Number of Respondents: 31; Total Annual Responses: 5; Total Annual Hours: 2,108. (For policy questions regarding this collection contact Jim Taing at (301) 492–4182.) Dated: October 17, 2018. William N. Parham, III, Director, Paperwork Reduction Staff. Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–23027 Filed 10–22–18; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2017–E–5940, FDA– 2017–E–5941, FDA–2017–E–5943, and FDA– 2017–E–5944] Determination of Regulatory Review Period for Purposes of Patent Extension; SILIQ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SILIQ 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 December 24, 2018. Furthermore, any interested person may petition FDA for a determination SUMMARY: E:\FR\FM\23OCN1.SGM 23OCN1 Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 22, 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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 24, 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. khammond on DSK30JT082PROD with NOTICES 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.’’ VerDate Sep<11>2014 20:20 Oct 22, 2018 Jkt 247001 Instructions: All submissions received must include the Docket Nos. FDA– 2017–E–5940, FDA–2017–E–5941, FDA–2017–E–5943, and FDA–2017–E– 5944 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; SILIQ.’’ 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 § 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 53477 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 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 SILIQ (brodalumab). SILIQ is indicated for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Subsequent to this approval, the USPTO received patent term restoration applications for SILIQ (U.S. Patent Nos. 7,767,206; 7,939,070; 8,435,518; and 8,545,842) from KirinAmgen, Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated January 9, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SILIQ represented the first permitted commercial marketing or use of the E:\FR\FM\23OCN1.SGM 23OCN1 53478 Federal Register / Vol. 83, No. 205 / Tuesday, October 23, 2018 / Notices product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. khammond on DSK30JT082PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SILIQ is 3,101 days. Of this time, 2,643 days occurred during the testing phase of the regulatory review period, while 458 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: August 22, 2008. The applicant claims September 26, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 22, 2008, which was 30 days after FDA receipt of an earlier IND. 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): November 16, 2015. FDA has verified the applicant’s claim that the biologics license application (BLA) for SILIQ (BLA 761032) was initially submitted on November 16, 2015. 3. The date the application was approved: February 15, 2017. FDA has verified the applicant’s claim that BLA 761032 was approved on February 15, 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 1,156 days, 906 days, or 847 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 VerDate Sep<11>2014 20:20 Oct 22, 2018 Jkt 247001 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 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23058 Filed 10–22–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0386] Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products.’’ DATES: Submit either electronic or written comments on the collection of information by December 24, 2018. 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 24, 2018. The https://www.regulations.gov electronic filing system will accept SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 comments until 11:59 p.m. Eastern Time at the end of December 24, 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– 2012–N–0386 for ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products.’’ 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 E:\FR\FM\23OCN1.SGM 23OCN1

Agencies

[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53476-53478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23058]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and 
FDA-2017-E-5944]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SILIQ

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 SILIQ 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 
December 24, 2018. Furthermore, any interested person may petition FDA 
for a determination

[[Page 53477]]

regarding whether the applicant for extension acted with due diligence 
during the regulatory review period by April 22, 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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 24, 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 Nos. 
FDA-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and FDA-2017-E-5944 
for ``Determination of Regulatory Review Period for Purposes of Patent 
Extension; SILIQ.'' 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.gpo.gov/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 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 SILIQ 
(brodalumab). SILIQ is indicated for treatment of moderate to severe 
plaque psoriasis in adult patients who are candidates for systemic 
therapy or phototherapy and have failed to respond or have lost 
response to other systemic therapies. Subsequent to this approval, the 
USPTO received patent term restoration applications for SILIQ (U.S. 
Patent Nos. 7,767,206; 7,939,070; 8,435,518; and 8,545,842) from Kirin-
Amgen, Inc., and the USPTO requested FDA's assistance in determining 
the patents' eligibility for patent term restoration. In a letter dated 
January 9, 2018, FDA advised the USPTO that this human biological 
product had undergone a regulatory review period and that the approval 
of SILIQ represented the first permitted commercial marketing or use of 
the

[[Page 53478]]

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 
SILIQ is 3,101 days. Of this time, 2,643 days occurred during the 
testing phase of the regulatory review period, while 458 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: August 22, 
2008. The applicant claims September 26, 2009, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 22, 2008, 
which was 30 days after FDA receipt of an earlier IND.
    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): November 16, 2015. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
SILIQ (BLA 761032) was initially submitted on November 16, 2015.
    3. The date the application was approved: February 15, 2017. FDA 
has verified the applicant's claim that BLA 761032 was approved on 
February 15, 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 1,156 days, 906 days, or 847 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 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23058 Filed 10-22-18; 8:45 am]
 BILLING CODE 4164-01-P