83 FR 4492 - Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 21 (January 31, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 21 (January 31, 2018)
| Page Range | 4492-4494 | |
| FR Document | 2018-01890 |
[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)] [Notices] [Pages 4492-4494] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01890] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2661] Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA 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 KEYTRUDA 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. 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 April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 2, 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. 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 July 30, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. 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 [[Page 4493]] 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-2015-E-2661 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA.'' 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 KEYTRUDA (pembrolizumab). KEYTRUDA is a programmed death receptor-1 (PD-1)- blocking antibody indicated for the treatment of: Patients with unresectable or metastatic melanoma. Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-ligand 1 (PD-L1) expression (Tumor Proportion Score (TPS) >= 50%) as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC. Patients with metastatic NSCLC whose tumors express PD-L1 (TPS >= 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum- containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Subsequent to this approval, the USPTO received a patent term restoration application for KEYTRUDA (U.S. Patent No. 8,354,509) from Merck Sharp & Dohme B.V., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of KEYTRUDA 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 [[Page 4494]] KEYTRUDA is 1,338 days. Of this time, 1,148 days occurred during the testing phase of the regulatory review period, while 190 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: January 7, 2011. The applicant claims January 8, 2011, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 7, 2011, which was the first date after FDA receipt of the IND that the investigational studies were allowed to proceed. 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): February 27, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for KEYTRUDA (BLA 125514/0) was initially submitted on February 27, 2014. 3. The date the application was approved: September 4, 2014. FDA has verified the applicant's claim that BLA 125514/0 was approved on September 4, 2014. 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 83 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: January 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01890 Filed 1-30-18; 8:45 am] BILLING CODE 4164-01-P
![4492 Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices
myelopathy due to a single-level This determination of the regulatory by law. FDA has made the
abnormality localized to the level of the review period establishes the maximum determination because of the
disc space and at least one of the potential length of a patent extension. submission of an application to the
following conditions confirmed by However, the USPTO applies several Director of the U.S. Patent and
radiographic imaging (CT, MRI, X-rays): statutory limitations in its calculations Trademark Office (USPTO), Department
herniated nucleus pulposus, of the actual period for patent extension. of Commerce, for the extension of a
spondylosis (defined by the presence of In its application for patent extension, patent which claims that human
osteophytes), and/or visible loss of disc this applicant seeks 323 days of patent biological product.
height compared to adjacent levels. term extension. DATES: Anyone with knowledge that any
Subsequent to this approval, the USPTO III. Petitions of the dates as published (in the
received a patent term restoration SUPPLEMENTARY INFORMATION section) are
application for MOBI–C CERVICAL Anyone with knowledge that any of incorrect may submit either electronic
DISC PROSTHESIS (U.S. Patent No. the dates as published are incorrect may or written comments and ask for a
8,627,999) from Beaurain et al., and the submit either electronic or written redetermination by April 2, 2018. See
USPTO requested FDA’s assistance in comments and, under 21 CFR 60.24, ask
‘‘Petitions’’ in the SUPPLEMENTARY
determining this patent’s eligibility for for a redetermination (see DATES).
INFORMATION section for more
patent term restoration. In a letter dated Furthermore, as specified in § 60.30 (21
information.
November 5, 2015, FDA advised the CFR 60.30), any interested person may
petition FDA for a determination ADDRESSES: You may submit comments
USPTO that this medical device had
regarding whether the applicant for as follows. Please note that late,
undergone a regulatory review period
extension acted with due diligence untimely filed comments will not be
and that the approval of MOBI–C
during the regulatory review period. To considered. Electronic comments must
CERVICAL DISC PROSTHESIS
meet its burden, the petition must be submitted on or before April 2, 2018.
represented the first permitted
comply with all the requirements of The https://www.regulations.gov
commercial marketing or use of the
§ 60.30, including but not limited to: electronic filing system will accept
product. Thereafter, the USPTO
Must be timely (see DATES), must be comments until midnight Eastern Time
requested that FDA determine the
filed in accordance with § 10.20, must at the end of April 2, 2018. Comments
product’s regulatory review period.
contain sufficient facts to merit an FDA received by mail/hand delivery/courier
II. Determination of Regulatory Review investigation, and must certify that a (for written/paper submissions) will be
Period true and complete copy of the petition considered timely if they are
has been served upon the patent postmarked or the delivery service
FDA has determined that the
applicant. (See H. Rept. 857, part 1, 98th acceptance receipt is on or before that
applicable regulatory review period for
Cong., 2d sess., pp. 41–42, 1984.) date. Furthermore, any interested
MOBI–C CERVICAL DISC PROSTHESIS
Petitions should be in the format person may petition FDA for a
is 2,758 days. Of this time, 1,821 days
specified in 21 CFR 10.30. determination regarding whether the
occurred during the testing phase of the
Submit petitions electronically to applicant for extension acted with due
regulatory review period, while 937
https://www.regulations.gov at Docket diligence during the regulatory review
days occurred during the approval
No. FDA–2013–S–0610. Submit written period by July 30, 2018. See ‘‘Petitions’’
phase. These periods of time were
petitions (two copies are required) to the in the SUPPLEMENTARY INFORMATION
derived from the following dates:
Dockets Management Staff (HFA–305), section for more information.
1. The date an exemption under Food and Drug Administration, 5630
section 520(g) of the Federal Food, Drug, Electronic Submissions
Fishers Lane, Rm. 1061, Rockville, MD
and Cosmetic Act (FD&C Act) (21 U.S.C. 20852. Submit electronic comments in the
360j(g)) involving this device became following way:
Dated: January 24, 2018.
effective: January 20, 2006. The • Federal eRulemaking Portal:
applicant claims that the investigational Leslie Kux, https://www.regulations.gov. Follow the
device exemption (IDE) required under Associate Commissioner for Policy. instructions for submitting comments.
section 520(g) of the FD&C Act for [FR Doc. 2018–01889 Filed 1–30–18; 8:45 am] Comments submitted electronically,
human tests to begin became effective BILLING CODE 4164–01–P including attachments, to https://
on October 14, 2005. However, FDA www.regulations.gov will be posted to
records indicate that the IDE was the docket unchanged. Because your
determined substantially complete for DEPARTMENT OF HEALTH AND comment will be made public, you are
clinical studies to begin on January 20, HUMAN SERVICES solely responsible for ensuring that your
2006, which represents the IDE effective comment does not include any
date. Food and Drug Administration
confidential information that you or a
2. The date an application was [Docket No. FDA–2015–E–2661] third party may not wish to be posted,
initially submitted with respect to the such as medical information, your or
device under section 515 of the FD&C Determination of Regulatory Review anyone else’s Social Security number, or
Act (21 U.S.C. 360e): January 14, 2011. Period for Purposes of Patent confidential business information, such
FDA has verified the applicant’s claim Extension; KEYTRUDA as a manufacturing process. Please note
that the premarket approval application AGENCY: Food and Drug Administration, that if you include your name, contact
(PMA) for MOBI–C CERVICAL DISC
sradovich on DSK3GMQ082PROD with NOTICES
HHS. information, or other information that
PROSTHESIS (PMA P110002) was ACTION: Notice. identifies you in the body of your
initially submitted January 14, 2011. comments, that information will be
3. The date the application was SUMMARY: The Food and Drug posted on https://www.regulations.gov.
approved: August 7, 2013. FDA has Administration (FDA or the Agency) has • If you want to submit a comment
verified the applicant’s claim that PMA determined the regulatory review period with confidential information that you
P110002 was approved on August 7, for KEYTRUDA and is publishing this do not wish to be made available to the
2013. notice of that determination as required public, submit the comment as a
VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1](https://thefederalregister.org/doc/83_FR_4513/page/1.svg)
![4494 Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices
KEYTRUDA is 1,338 days. Of this time, Submit petitions electronically to at the end of April 2, 2018. Comments
1,148 days occurred during the testing https://www.regulations.gov at Docket received by mail/hand delivery/courier
phase of the regulatory review period, No. FDA–2013–S–0610. Submit written (for written/paper submissions) will be
while 190 days occurred during the petitions (two copies are required) to the considered timely if they are
approval phase. These periods of time Dockets Management Staff (HFA–305), postmarked or the delivery service
were derived from the following dates: Food and Drug Administration, 5630 acceptance receipt is on or before that
1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD date.
section 505(i) of the Federal Food, Drug, 20852.
and Cosmetic Act (21 U.S.C. 355(i)) Electronic Submissions
Dated: January 24, 2018.
became effective: January 7, 2011. The Submit electronic comments in the
Leslie Kux,
applicant claims January 8, 2011, as the following way:
Associate Commissioner for Policy.
date the investigational new drug • Federal eRulemaking Portal:
application (IND) became effective. [FR Doc. 2018–01890 Filed 1–30–18; 8:45 am]
https://www.regulations.gov. Follow the
However, FDA records indicate that the BILLING CODE 4164–01–P
instructions for submitting comments.
IND effective date was January 7, 2011, Comments submitted electronically,
which was the first date after FDA including attachments, to https://
receipt of the IND that the DEPARTMENT OF HEALTH AND
www.regulations.gov will be posted to
investigational studies were allowed to HUMAN SERVICES
the docket unchanged. Because your
proceed. comment will be made public, you are
2. The date the application was Food and Drug Administration
solely responsible for ensuring that your
initially submitted with respect to the [Docket Nos. FDA–2016–E–1586 and FDA– comment does not include any
human biological product under section 2017–E–4452] confidential information that you or a
351 of the Public Health Service Act (42 third party may not wish to be posted,
U.S.C. 262): February 27, 2014. FDA has Determination of Regulatory Review
such as medical information, your or
verified the applicant’s claim that the Period for Purposes of Patent
anyone else’s Social Security number, or
biologics license application (BLA) for Extension; CRESEMBA—New Drug
confidential business information, such
KEYTRUDA (BLA 125514/0) was Application 207501
as a manufacturing process. Please note
initially submitted on February 27, AGENCY: Food and Drug Administration, that if you include your name, contact
2014. HHS. information, or other information that
3. The date the application was
ACTION: Notice. identifies you in the body of your
approved: September 4, 2014. FDA has
comments, that information will be
verified the applicant’s claim that BLA SUMMARY: The Food and Drug posted on https://www.regulations.gov.
125514/0 was approved on September 4, Administration (FDA or the Agency) has
2014. • If you want to submit a comment
determined the regulatory review period with confidential information that you
This determination of the regulatory for CRESEMBA as approved under new
review period establishes the maximum do not wish to be made available to the
drug application (NDA) 207501 and is public, submit the comment as a
potential length of a patent extension. publishing this notice of that
However, the USPTO applies several written/paper submission and in the
determination as required by law. FDA manner detailed (see ‘‘Written/Paper
statutory limitations in its calculations has made the determination because of
of the actual period for patent extension. Submissions’’ and ‘‘Instructions’’).
the submission of applications to the
In its application for patent extension, Director of the U.S. Patent and Written/Paper Submissions
this applicant seeks 83 days of patent Trademark Office (USPTO), Department
term extension. Submit written/paper submissions as
of Commerce, for the extension of a follows:
III. Petitions patent which claims that human drug • Mail/Hand delivery/Courier (for
Anyone with knowledge that any of product as approved under NDA written/paper submissions): Dockets
the dates as published are incorrect may 207501. Management Staff (HFA–305), Food and
submit either electronic or written DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
comments and, under 21 CFR 60.24 ask of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
for a redetermination (see DATES). SUPPLEMENTARY INFORMATION section) are • For written/paper comments
Furthermore, as specified in § 60.30 (21 incorrect may submit either electronic submitted to the Dockets Management
CFR 60.30), any interested person may or written comments and ask for a Staff, FDA will post your comment, as
petition FDA for a determination redetermination by April 2, 2018. well as any attachments, except for
regarding whether the applicant for Furthermore, any interested person may information submitted, marked and
extension acted with due diligence petition FDA for a determination identified, as confidential, if submitted
during the regulatory review period. To regarding whether the applicant for as detailed in ‘‘Instructions.’’
meet its burden, the petition must extension acted with due diligence Instructions: All submissions received
comply with all the requirements of during the regulatory review period by must include the Docket Nos. FDA–
§ 60.30, including but not limited to: July 30, 2018. See ‘‘Petitions’’ in the 2016–E–1586 and FDA–2017–E–4452
Must be timely (see DATES), must be SUPPLEMENTARY INFORMATION section for for ‘‘Determination of Regulatory
filed in accordance with § 10.20, must more information. Review Period for Purposes of Patent
contain sufficient facts to merit an FDA ADDRESSES: You may submit comments Extension; CRESEMBA—NDA 207501.’’
sradovich on DSK3GMQ082PROD with NOTICES
investigation, and must certify that a as follows. Please note that late, Received comments, those filed in a
true and complete copy of the petition untimely filed comments will not be timely manner (see ADDRESSES), will be
has been served upon the patent considered. Electronic comments must placed in the dockets and, except for
applicant. (See H. Rept. 857, part 1, 98th be submitted on or before April 2, 2018. those submitted as ‘‘Confidential
Cong., 2d sess., pp. 41–42, 1984.) The https://www.regulations.gov Submissions,’’ publicly viewable at
Petitions should be in the format electronic filing system will accept https://www.regulations.gov or at the
specified in 21 CFR 10.30. comments until midnight Eastern Time Dockets Management Staff between 9
VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1](https://thefederalregister.org/doc/83_FR_4513/page/3.svg)
Document Created: 2018-01-31 00:58:18
Document Modified: 2018-01-31 00:58:18
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. 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 4492 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR