83 FR 52837 - Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 202 (October 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 202 (October 18, 2018)
| Page Range | 52837-52839 | |
| FR Document | 2018-22699 |
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52837-52839] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22699] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-E-6698 and FDA-2017-E-6699] Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS 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 OCREVUS 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 17, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 16, 2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 17, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or 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-6698 and FDA-2017-E-6699 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS.'' Received comments, those filed in a timely [[Page 52838]] 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 OCREVUS (ocrelizumab). OCREVUS is indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis. Subsequent to this approval, the USPTO received a patent term restoration application for OCREVUS (U.S. Patent Nos. 7,799,900 and 8,562,992) from Genentech, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 6, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of OCREVUS 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 OCREVUS is 4,844 days. Of this time, 4,509 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 (21 U.S.C. 355(i)) became effective: December 25, 2003. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 25, 2003. 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): April 28, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for OCREVUS (BLA 761053) was initially submitted on April 28, 2016. 3. The date the application was approved: March 28, 2017. FDA has verified the applicant's claim that BLA 761053 was approved on March 28, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,358 days or 795 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. [[Page 52839]] Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22699 Filed 10-17-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices 52837
number 1825 to identify the guidance information. These collections of collections of information in the
you are requesting. information are subject to review by the following FDA regulations and guidance
IV. Paperwork Reduction Act of 1995 Office of Management and Budget have been approved by OMB as listed in
(OMB) under the Paperwork Reduction the following table:
This draft guidance refers to Act of 1995 (44 U.S.C. 3501–3520). The
previously approved collections of
OMB control
21 CFR part or guidance Topic No.
807, subpart E ................................. Premarket notification ........................................................................................................... 0910–0120
814, subparts A through E .............. Premarket approval ............................................................................................................... 0910–0231
814, subpart H ................................. Humanitarian Device Exemption ........................................................................................... 0910–0332
812 ................................................... Investigational Device Exemption ......................................................................................... 0910–0078
‘‘De Novo Classification Process De Novo classification process ............................................................................................. 0910–0844
(Evaluation of Automatic Class III
Designation)’’.
801 ................................................... Medical Device Labeling Regulations ................................................................................... 0910–0485
820 ................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation .............. 0910–0073
V. Other Issues for Consideration SUMMARY: The Food and Drug instructions for submitting comments.
The Agency invites comments on the Administration (FDA or the Agency) has Comments submitted electronically,
‘‘Content of Premarket Submissions for determined the regulatory review period including attachments, to https://
Management of Cybersecurity in for OCREVUS and is publishing this www.regulations.gov will be posted to
Medical Devices’’ draft guidance, in notice of that determination as required the docket unchanged. Because your
general, and on the following topics, in by law. FDA has made the comment will be made public, you are
particular: determination because of the solely responsible for ensuring that your
• Definition of CBOM: submission of applications to the comment does not include any
Director of the U.S. Patent and confidential information that you or a
Æ Whether a CBOM should include Trademark Office (USPTO), Department third party may not wish to be posted,
both software and hardware of Commerce, for the extension of a such as medical information, your or
components patent which claims that human anyone else’s Social Security number, or
• Type of information and level of biological product. confidential business information, such
detail that should be included in a DATES: Anyone with knowledge that any as a manufacturing process. Please note
CBOM of the dates as published (see the that if you include your name, contact
• Effective mechanisms for sharing SUPPLEMENTARY INFORMATION section) are information, or other information that
CBOM information incorrect may submit either electronic identifies you in the body of your
• Format the CBOM should take: or written comments and ask for a comments, that information will be
Æ Available formats that could be redetermination by December 17, 2018. posted on https://www.regulations.gov.
Furthermore, any interested person may • If you want to submit a comment
leveraged
petition FDA for a determination with confidential information that you
Æ Whether multiple formats would be
regarding whether the applicant for do not wish to be made available to the
able to co-exist
extension acted with due diligence public, submit the comment as a
• Appropriate frequency for updating written/paper submission and in the
the CBOM during the regulatory review period by
April 16, 2019. See ‘‘Petitions’’ in the manner detailed (see ‘‘Written/Paper
• Features of a CBOM that would Submissions’’ and ‘‘Instructions’’).
make it automatically consumable SUPPLEMENTARY INFORMATION section for
more information. Written/Paper Submissions
Dated: October 12, 2018.
ADDRESSES: You may submit comments Submit written/paper submissions as
Leslie Kux,
as follows. Please note that late, follows:
Associate Commissioner for Policy. untimely filed comments will not be • Mail/Hand delivery/Courier (for
[FR Doc. 2018–22697 Filed 10–17–18; 8:45 am] considered. Electronic comments must written/paper submissions): Dockets
BILLING CODE 4164–01–P be submitted on or before December 17, Management Staff (HFA–305), Food and
2018. The https://www.regulations.gov Drug Administration, 5630 Fishers
electronic filing system will accept Lane, Rm. 1061, Rockville, MD 20852.
DEPARTMENT OF HEALTH AND comments until 11:59 p.m. Eastern Time • For written/paper comments
HUMAN SERVICES at the end of December 17, 2018. submitted to the Dockets Management
Comments received by mail/hand Staff, FDA will post your comment, as
Food and Drug Administration
delivery/courier (for written/paper well as any attachments, except for
[Docket Nos. FDA–2017–E–6698 and FDA– submissions) will be considered timely information submitted, marked and
2017–E–6699] if they are postmarked or the delivery identified, as confidential, if submitted
service acceptance receipt is on or
khammond on DSK30JT082PROD with NOTICES
as detailed in ‘‘Instructions.’’
Determination of Regulatory Review before that date. Instructions: All submissions received
Period for Purposes of Patent must include the Docket Nos. FDA–
Extension; OCREVUS Electronic Submissions
2017–E–6698 and FDA–2017–E–6699
AGENCY: Food and Drug Administration, Submit electronic comments in the for ’’Determination of Regulatory
HHS. following way: Review Period for Purposes of Patent
• Federal eRulemaking Portal: Extension; OCREVUS.’’ Received
ACTION: Notice.
https://www.regulations.gov. Follow the comments, those filed in a timely
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![Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices 52839
Dated: October 12, 2018. instructions for submitting comments. its consideration of comments. The
Leslie Kux, Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2018–22699 Filed 10–17–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available
BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2016–E–3918] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Extension; AFSTYLA information, or other information that except in accordance with § 10.20 (21
identifies you in the body of your CFR 10.20) and other applicable
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the
Administration (FDA or the Agency) has information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
determined the regulatory review period
written/paper submission and in the 23389.pdf.
for AFSTYLA and is publishing this
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
notice of that determination as required
Submissions’’ and ‘‘Instructions’’). read background documents or the
by law. FDA has made the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of an application to the received, go to https://
Submit written/paper submissions as
Director of the U.S. Patent and www.regulations.gov and insert the
follows:
docket number, found in brackets in the
Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of Commerce, for the extension of a heading of this document, into the
written/paper submissions): Dockets
patent which claims that human ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
biological product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any
Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the • For written/paper comments Rockville, MD 20852.
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by December 17, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket No. FDA–
2016–E–3918 for ‘‘Determination of I. Background
during the regulatory review period by
April 16, 2019. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; AFSTYLA.’’ Patent Term Restoration Act of 1984
more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term
as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670)
untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be
considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years
be submitted on or before December 17, https://www.regulations.gov or at the so long as the patented item (human
2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product,
electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color
comments until 11:59 p.m. Eastern Time Friday. additive) was subject to regulatory
at the end of December 17, 2018. • Confidential Submissions—To review by FDA before the item was
Comments received by mail/hand submit a comment with confidential marketed. Under these acts, a product’s
delivery/courier (for written/paper information that you do not wish to be regulatory review period forms the basis
submissions) will be considered timely made publicly available, submit your for determining the amount of extension
if they are postmarked or the delivery comments only as a written/paper an applicant may receive.
submission. You should submit two A regulatory review period consists of
khammond on DSK30JT082PROD with NOTICES
service acceptance receipt is on or
before that date. copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human
Electronic Submissions with a heading or cover note that states biological products, the testing phase
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the
• Federal eRulemaking Portal: Agency will review this copy, including biological product becomes effective
https://www.regulations.gov. Follow the the claimed confidential information, in and runs until the approval phase
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Document Created: 2018-10-18 03:05:28
Document Modified: 2018-10-18 03:05:28
| 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 | |
| Contact | Beverly Friedman, Office of Regulatory | |
| FR Citation | 83 FR 52837 |
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