83 FR 7054 - Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7054-7056 | |
| FR Document | 2018-03218 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7054-7056] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03218] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-2512 and FDA-2016-E-2511] Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has [[Page 7055]] determined the regulatory review period for COTELLIC 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 drug 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 April 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 August 15, 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 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 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 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-2016-E-2512 and FDA-2016-E-2511 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; COTELLIC.'' 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 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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product COTELLIC (cobimetinib). COTELLIC is indicated for treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, [[Page 7056]] in combination with vemurafenib. Subsequent to this approval, the USPTO received patent term restoration applications for COTELLIC (U.S. Patent Nos. 7,803,839 and 8,362,002) from Exelixis, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 26, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of COTELLIC 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 COTELLIC is 3,219 days. Of this time, 2,884 days occurred during the testing phase of the regulatory review period, while 335 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: January 19, 2007. FDA has verified the Exelixis, Inc. claim that January 19, 2007, is the date the investigational new drug application became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: December 11, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for COTELLIC (NDA 206192) was initially submitted on December 11, 2014. 3. The date the application was approved: November 10, 2015. FDA has verified the applicant's claim that NDA 206192 was approved on November 10, 2015. 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 1,013 days or 676 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: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03218 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7054 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
II. Topics for Discussion at the Public number of participants from each go/connectpro_overview. FDA has
Meeting organization. Registrants will receive verified the website addresses in this
As mandated by section 502(d) of the confirmation when they have been document as of the date this document
FDA Reauthorization Act of 2017 accepted. If time and space permit, publishes in the Federal Register, but
(FDARA), this FDA meeting on the onsite registration on the day of the websites are subject to change over time.
public workshop will be provided Transcripts: Please be advised that as
development and labeling of pediatric
beginning at 7:30 a.m. We will let soon as a transcript of the public
medical devices is being convened with
registrants know if registration closes meeting is available, it will be accessible
representatives from the medical device
before the day of the public meeting. at https://www.regulations.gov. It may
industry, academia, recipients of
If you need special accommodations be viewed at the Dockets Management
funding under section 305 of the due to a disability, please contact Peggy Staff (see ADDRESSES). A link to the
Pediatric Medical Device Safety and Roney at the Center for Devices and transcript will also be available on the
Improvement Act of 2007, medical Radiological Health, Food and Drug internet at https://www.fda.gov/
provider organizations, and Administration, 10903 New Hampshire MedicalDevices/NewsEvents/
organizations representing patients and Ave., Bldg. 32, Rm. 5231, Silver Spring, WorkshopsConferences/default.htm.
consumers (see Pub. L. 110–85; 42 MD 20993–0002, 301–796–5671, (Select this public workshop from the
U.S.C. 282 note). Peggy.Roney@fda.hhs.gov, no later than
As directly outlined in FDARA, the posted events list.)
June 1, 2018.
meeting shall include consideration of Requests for Oral Presentations: IV. References
ways to: (1) Improve research During online registration, you may The following references are on
infrastructure and research networks to indicate if you wish to present during a display at the Dockets Management Staff
facilitate the conduct of clinical studies public comment session and which (see ADDRESSES) and are available for
of devices for pediatric populations that topic(s) you wish to address. FDA will viewing by interested persons between
would result in the approval or do its best to accommodate requests to 9 a.m. and 4 p.m., Monday through
clearance, and labeling of medical make public comments. Individuals and Friday; they are also available
devices for such populations; (2) organizations with common interests are electronically at https://
appropriately use extrapolation under urged to consolidate or coordinate their www.regulations.gov.
section 515A(b) of the FD&C Act (21 presentations, and request time for a
U.S.C. 360e–1(b)); (3) enhance the 1. FDA’s guidance for Industry and FDA
joint presentation, or submit requests for Staff: ‘‘Premarket Assessment of Pediatric
appropriate use of postmarket registries designated representatives to participate Medical Devices,’’ available at https://
and data to increase pediatric medical in the focused sessions. We encourage www.fda.gov/downloads/MedicalDevices/
device labeling; (4) increase FDA persons who are interested in making an DeviceRegulationandGuidance/
assistance to medical device oral presentation during a public GuidanceDocuments/ucm089742.pdf.
manufacturers in developing devices for comment session to indicate their intent 2. FDA’s guidance for Industry and FDA
pediatric populations that are approved on the registration form by 3 p.m. Staff: ‘‘Providing Information about Pediatric
or cleared, and labeled, for their use; Eastern Time on June 29, 2018. Based Uses of Medical Devices,’’ available at
and (5) identify current barriers to https://www.fda.gov/downloads/
on the number of applicants for oral MedicalDevices/DeviceRegulation
pediatric device development and presentations, FDA will distribute the andGuidance/GuidanceDocuments/
incentives to address such barriers. available time equally among all UCM339465.pdf.
A detailed agenda will be posted on presenters and inform selected 3. FDA’s guidance for Industry and FDA
the following website in advance of the presenters of the public presentation Staff: ‘‘Leveraging Existing Clinical Data for
workshop at https://www.fda.gov/ agenda by July 6, 2018. If selected for Extrapolation to Pediatric Uses of Medical
MedicalDevices/NewsEvents/ presentation, any presentation materials Devices,’’ available at https://www.fda.gov/
WorkshopsConferences/default.htm. must be emailed to Victoria Wagman at ucm/groups/fdagov-public/@fdagov-meddev-
Select this event from the list of items Victoria.wagman@fda.hhs.gov no later gen/documents/document/ucm444591.pdf.
provided. than July 13, 2018. No commercial or Dated: February 12, 2018.
III. Participating in the Public Meeting promotional material will be permitted Leslie Kux,
to be presented or distributed at the
Registration: To register for the public Associate Commissioner for Policy.
public meeting.
meeting, please visit FDA’s Medical Streaming Webcast of the public [FR Doc. 2018–03215 Filed 2–15–18; 8:45 am]
Devices News & Events—Workshops & meeting: This public meeting will also BILLING CODE 4164–01–P
Conferences calendar at https:// be webcast. The webcast link will be
www.fda.gov/MedicalDevices/ available on the registration web page
NewsEvents/WorkshopsConferences/ after August 6, 2018. Please visit FDA’s DEPARTMENT OF HEALTH AND
default.htm. (Select this public Medical Devices News & Events— HUMAN SERVICES
workshop from the posted events list.) Workshops & Conferences calendar
Please provide complete contact Food and Drug Administration
(https://www.fda.gov/MedicalDevices/
information for each attendee, including NewsEvents/WorkshopsConferences/ [Docket Nos. FDA–2016–E–2512 and FDA–
name, title, affiliation, address, email, default.htm) and select this event from 2016–E–2511]
and telephone number. the list of items provided. Organizations
Registration is free, and in-person are requested to register all participants Determination of Regulatory Review
attendance is based on space but view using one connection per Period for Purposes of Patent
daltland on DSKBBV9HB2PROD with NOTICES
availability, with priority given to early location. Extension; COTELLIC
registrants. Persons interested in If you have never attended a Connect AGENCY: Food and Drug Administration,
attending this public meeting must Pro event before, test your connection at HHS.
register by August 6, 2018, 3 p.m. https://collaboration.fda.gov/common/ ACTION: Notice.
Eastern Time. Early registration is help/en/support/meeting_test.htm. To
recommended because seating is get a quick overview of the Connect Pro SUMMARY: The Food and Drug
limited; therefore, FDA may limit the program, visit https://www.adobe.com/ Administration (FDA or the Agency) has
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![7056 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
in combination with vemurafenib. extension acted with due diligence Electronic Submissions
Subsequent to this approval, the USPTO during the regulatory review period. To Submit electronic comments in the
received patent term restoration meet its burden, the petition must following way:
applications for COTELLIC (U.S. Patent comply with all the requirements of • Federal eRulemaking Portal:
Nos. 7,803,839 and 8,362,002) from § 60.30, including but not limited to: https://www.regulations.gov. Follow the
Exelixis, Inc., and the USPTO requested Must be timely (see DATES), must be instructions for submitting comments.
FDA’s assistance in determining the filed in accordance with § 10.20, must Comments submitted electronically,
patents’ eligibility for patent term contain sufficient facts to merit an FDA including attachments, to https://
restoration. In a letter dated September investigation, and must certify that a www.regulations.gov will be posted to
26, 2016, FDA advised the USPTO that true and complete copy of the petition the docket unchanged. Because your
this human drug product had undergone has been served upon the patent comment will be made public, you are
a regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th solely responsible for ensuring that your
approval of COTELLIC represented the Cong., 2d sess., pp. 41–42, 1984.) comment does not include any
first permitted commercial marketing or Petitions should be in the format confidential information that you or a
use of the product. Thereafter, the specified in 21 CFR 10.30. third party may not wish to be posted,
USPTO requested that FDA determine Submit petitions electronically to such as medical information, your or
the product’s regulatory review period. https://www.regulations.gov at Docket anyone else’s Social Security number, or
II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written confidential business information, such
Period petitions (two copies are required) to the as a manufacturing process. Please note
Dockets Management Staff (HFA–305), that if you include your name, contact
FDA has determined that the Food and Drug Administration, 5630
applicable regulatory review period for information, or other information that
Fishers Lane, Rm. 1061, Rockville, MD identifies you in the body of your
COTELLIC is 3,219 days. Of this time, 20852.
2,884 days occurred during the testing comments, that information will be
phase of the regulatory review period, Dated: February 12, 2018. posted on https://www.regulations.gov.
while 335 days occurred during the Leslie Kux, • If you want to submit a comment
approval phase. These periods of time Associate Commissioner for Policy. with confidential information that you
were derived from the following dates: [FR Doc. 2018–03218 Filed 2–15–18; 8:45 am] do not wish to be made available to the
1. The date an exemption under BILLING CODE 4164–01–P
public, submit the comment as a
section 505(i) of the Federal Food, Drug, written/paper submission and in the
and Cosmetic Act (FD&C Act) (21 U.S.C. manner detailed (see ‘‘Written/Paper
355(i)) became effective: January 19, DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
2007. FDA has verified the Exelixis, Inc. HUMAN SERVICES Written/Paper Submissions
claim that January 19, 2007, is the date
the investigational new drug application Food and Drug Administration Submit written/paper submissions as
became effective. follows:
2. The date the application was [Docket No. FDA–2014–D–1540] • Mail/Hand delivery/Courier (for
initially submitted with respect to the written/paper submissions): Dockets
human drug product under section 505 Migraine: Developing Drugs for Acute Management Staff (HFA–305), Food and
of the FD&C Act: December 11, 2014. Treatment; Guidance for Industry; Drug Administration, 5630 Fishers
FDA has verified the applicant’s claim Availability Lane, Rm. 1061, Rockville, MD 20852.
that the new drug application (NDA) for • For written/paper comments
AGENCY: Food and Drug Administration, submitted to the Dockets Management
COTELLIC (NDA 206192) was initially HHS.
submitted on December 11, 2014. Staff, FDA will post your comment, as
3. The date the application was ACTION: Notice of availability. well as any attachments, except for
approved: November 10, 2015. FDA has information submitted, marked and
SUMMARY: The Food and Drug identified, as confidential, if submitted
verified the applicant’s claim that NDA Administration (FDA or Agency) is
206192 was approved on November 10, as detailed in ‘‘Instructions.’’
announcing the availability of a Instructions: All submissions received
2015. guidance for industry entitled
This determination of the regulatory must include the Docket No. FDA–
‘‘Migraine: Developing Drugs for Acute 2014–D–1540 for ‘‘Migraine: Developing
review period establishes the maximum Treatment.’’ The purpose of this
potential length of a patent extension. Drugs for Acute Treatment; Guidance
guidance is to assist sponsors in the for Industry; Availability.’’ Received
However, the USPTO applies several clinical development of prescription
statutory limitations in its calculations comments will be placed in the docket
drugs for the acute treatment of and, except for those submitted as
of the actual period for patent extension. migraine. This guidance focuses on
In its applications for patent extension, ‘‘Confidential Submissions,’’ publicly
specific drug development and trial viewable at https://www.regulations.gov
this applicant seeks 1,013 days or 676 design issues that are unique to the
days of patent term extension. or at the Dockets Management Staff
study of prescription drugs for the acute between 9 a.m. and 4 p.m., Monday
III. Petitions treatment of migraine. This guidance through Friday.
Anyone with knowledge that any of finalizes the draft guidance of the same • Confidential Submissions—To
the dates as published are incorrect may name issued October 22, 2014. submit a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
submit either electronic or written DATES: The announcement of the information that you do not wish to be
comments and, under 21 CFR 60.24, ask guidance is published in the Federal made publicly available, submit your
for a redetermination (see DATES). Register on February 16, 2018. comments only as a written/paper
Furthermore, as specified in § 60.30 (21 ADDRESSES: You may submit either submission. You should submit two
CFR 60.30), any interested person may electronic or written comments on copies total. One copy will include the
petition FDA for a determination Agency guidances at any time as information you claim to be confidential
regarding whether the applicant for follows: with a heading or cover note that states
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Document Created: 2018-02-16 00:55:41
Document Modified: 2018-02-16 00:55:41
| 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 April 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 August 15, 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 7054 |
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