83 FR 4490 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS
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 | 4490-4492 | |
| FR Document | 2018-01889 |
[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)] [Notices] [Pages 4490-4492] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01889] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-0640] Determination of Regulatory Review Period for Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS 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 MOBI-C CERVICAL DISC PROSTHESIS and is publishing this notice of that determination as required by law. FDA has made the [[Page 4491]] 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 medical device. 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 2, 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 July 30, 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. 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-2015-E-0640 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; MOBI-C CERVICAL DISC PROSTHESIS.'' 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device MOBI-C CERVICAL DISC PROSTHESIS. MOBI-C CERVICAL DISC PROSTHESIS is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or [[Page 4492]] myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. Subsequent to this approval, the USPTO received a patent term restoration application for MOBI-C CERVICAL DISC PROSTHESIS (U.S. Patent No. 8,627,999) from Beaurain et al., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 5, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of MOBI-C CERVICAL DISC PROSTHESIS 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 MOBI-C CERVICAL DISC PROSTHESIS is 2,758 days. Of this time, 1,821 days occurred during the testing phase of the regulatory review period, while 937 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: January 20, 2006. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on October 14, 2005. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to begin on January 20, 2006, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): January 14, 2011. FDA has verified the applicant's claim that the premarket approval application (PMA) for MOBI-C CERVICAL DISC PROSTHESIS (PMA P110002) was initially submitted January 14, 2011. 3. The date the application was approved: August 7, 2013. FDA has verified the applicant's claim that PMA P110002 was approved on August 7, 2013. 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 323 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. 2018-01889 Filed 1-30-18; 8:45 am] BILLING CODE 4164-01-P
![4490 Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices
both copies to the Dockets Management actual amount of extension that the However, the USPTO applies several
Staff. If you do not wish your name and Director of USPTO may award (for statutory limitations in its calculations
contact information to be made publicly example, half the testing phase must be of the actual period for patent extension.
available, you can provide this subtracted as well as any time that may In its application for patent extension,
information on the cover sheet and not have occurred before the patent was this applicant seeks 1,465 days of patent
in the body of your comments and you issued), FDA’s determination of the term extension.
must identify this information as length of a regulatory review period for
III. Petitions
‘‘confidential.’’ Any information marked a human drug product will include all
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase Anyone with knowledge that any of
except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may
CFR 10.20) and other applicable FDA has approved for marketing the submit either electronic or written
disclosure law. For more information human drug product LENVIMA comments and, under 21 CFR 60.24, ask
about FDA’s posting of comments to (lenvatinib mesylate). LENVIMA is for a redetermination (see DATES).
public dockets, see 80 FR 56469, indicated for treatment of patients with Furthermore, as specified in § 60.30 (21
September 18, 2015, or access the locally recurrent or metastatic, CFR 60.30), any interested person may
information at: https://www.gpo.gov/ progressive, radioactive iodine- petition FDA for a determination
fdsys/pkg/FR-2015-09-18/pdf/2015- refractory differentiated thyroid cancer. regarding whether the applicant for
23389.pdf. Subsequent to this approval, the USPTO extension acted with due diligence
Docket: For access to the docket to received a patent term restoration during the regulatory review period. To
read background documents or the application for LENVIMA (U.S. Patent meet its burden, the petition must
electronic and written/paper comments No. 7,253,286) from EISAI R&D comply with all the requirements of
received, go to https:// Management Co., Ltd., and the USPTO § 60.30, including but not limited to:
www.regulations.gov and insert the requested FDA’s assistance in must be timely (see DATES), must be
docket number, found in brackets in the determining this patent’s eligibility for filed in accordance with § 10.20, must
heading of this document, into the patent term restoration. In a letter dated contain sufficient facts to merit an FDA
‘‘Search’’ box and follow the prompts July 12, 2016, FDA advised the USPTO investigation, and must certify that a
and/or go to the Dockets Management that this human drug product had true and complete copy of the petition
Staff, 5630 Fishers Lane, Rm. 1061, undergone a regulatory review period has been served upon the patent
Rockville, MD 20852. and that the approval of LENVIMA applicant. (See H. Rept. 857, part 1, 98th
represented the first permitted Cong., 2d sess., pp. 41–42, 1984.)
FOR FURTHER INFORMATION CONTACT:
commercial marketing or use of the Petitions should be in the format
Beverly Friedman, Office of Regulatory specified in 21 CFR 10.30.
Policy, Food and Drug Administration, product. Thereafter, the USPTO
requested that FDA determine the Submit petitions electronically to
10903 New Hampshire Ave., Bldg. 51, https://www.regulations.gov at Docket
Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period.
No. FDA–2013–S–0610. Submit written
301–796–3600. II. Determination of Regulatory Review petitions (two copies are required) to the
SUPPLEMENTARY INFORMATION: Period Dockets Management Staff (HFA–305),
I. Background FDA has determined that the Food and Drug Administration, 5630
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD
The Drug Price Competition and LENVIMA is 3,580 days. Of this time, 20852.
Patent Term Restoration Act of 1984 3,396 days occurred during the testing Dated: January 24, 2018.
(Pub. L. 98–417) and the Generic phase of the regulatory review period,
Animal Drug and Patent Term Leslie Kux,
while 184 days occurred during the Associate Commissioner for Policy.
Restoration Act (Pub. L. 100–670) approval phase. These periods of time
generally provide that a patent may be [FR Doc. 2018–01920 Filed 1–30–18; 8:45 am]
were derived from the following dates:
extended for a period of up to 5 years 1. The date an exemption under BILLING CODE 4164–01–P
so long as the patented item (human section 505(i) of the Federal Food, Drug,
drug product, animal drug product, and Cosmetic Act (the FD&C Act) (21
medical device, food additive, or color DEPARTMENT OF HEALTH AND
U.S.C. 355(i)) became effective: April
additive) was subject to regulatory HUMAN SERVICES
28, 2005. FDA has verified the
review by FDA before the item was applicant’s claim that April 28, 2005, is Food and Drug Administration
marketed. Under these acts, a product’s the date the investigational new drug
regulatory review period forms the basis application (IND) became effective. [Docket No. FDA–2015–E–0640]
for determining the amount of extension 2. The date the application was
an applicant may receive. initially submitted with respect to the Determination of Regulatory Review
A regulatory review period consists of human drug product under section Period for Purposes of Patent
two periods of time: A testing phase and 505(b) of the FD&C Act: August 14, Extension; MOBI–C CERVICAL DISC
an approval phase. For human drug 2014. FDA has verified the applicant’s PROSTHESIS
products, the testing phase begins when claim that the new drug application AGENCY: Food and Drug Administration,
the exemption to permit the clinical (NDA) for LENVIMA (NDA 206947) was HHS.
investigations of the drug becomes initially submitted on August 14, 2014. ACTION: Notice.
effective and runs until the approval
sradovich on DSK3GMQ082PROD with NOTICES
3. The date the application was
phase begins. The approval phase starts approved: February 13, 2015. FDA has SUMMARY: The Food and Drug
with the initial submission of an verified the applicant’s claim that NDA Administration (FDA or the Agency) has
application to market the human drug 206947 was approved on February 13, determined the regulatory review period
product and continues until FDA grants 2015. for MOBI–C CERVICAL DISC
permission to market the drug product. This determination of the regulatory PROSTHESIS and is publishing this
Although only a portion of a regulatory review period establishes the maximum notice of that determination as required
review period may count toward the potential length of a patent extension. by law. FDA has made the
VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1](https://thefederalregister.org/doc/83_FR_4511/page/1.svg)
![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
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Document Created: 2018-01-31 00:58:46
Document Modified: 2018-01-31 00:58:46
| 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 2, 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 July 30, 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 4490 |
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