81 FR 83849 - Determination of Regulatory Review Period for Purposes of Patent Extension; CORE VALVE SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 225 (November 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 225 (November 22, 2016)
| Page Range | 83849-83850 | |
| FR Document | 2016-28047 |
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)] [Notices] [Pages 83849-83850] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28047] [[Page 83849]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos.: FDA-2015-E-0824; FDA-2015-E-0846; FDA-2015-E-0848; FDA- 2015-E-0850] Determination of Regulatory Review Period for Purposes of Patent Extension; CORE VALVE SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for CORE VALVE SYSTEM 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 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 January 23, 2017. 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 May 22, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-E-0824; FDA-2015-E-0846; FDA-2015-E-0848; and FDA-2015-E-0850 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; CORE VALVE SYSTEM''. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of 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 Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 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 20993-0002, 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 CORE VALVE SYSTEM. [[Page 83850]] CORE VALVE SYSTEM is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area <=0.8 cm\2\, a mean aortic valve gradient of >40 mmHg, or a peak aortic-jet velocity of 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and or serious irreversible morbidity >=50% at 30 days). Subsequent to this approval, the USPTO received patent term restoration applications for CORE VALVE SYSTEM (U.S. Patent Nos. 5,957,949; 7,018,406; 8,226,710; and 8,579,966 from Medtronic Corevalve LLC and U.S. Patent No. 5,957,949 from Medtronic Vascular Inc.), and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In two letters dated October 19, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of CORE VALVE SYSTEM 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 CORE VALVE SYSTEM is 1,194 days. Of this time, 1,017 days occurred during the testing phase of the regulatory review period, while 177 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 (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: October 13, 2010. FDA has verified the applicants' claims that the date the investigational device exemption required under section 520(g) of the FD&C act for human tests to begin became effective October 13, 2010. 2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): July 25, 2013. FDA has verified the applicants' claims that the premarket approval application (PMA) for CORE VALVE SYSTEM (PMA P130021) was initially submitted July 25, 2013. 3. The date the application was approved: January 17, 2014. FDA has verified the applicants' claims that PMA P130021 was approved on January 17, 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 applications for patent extension, these applicants seek 685 days, 360 days, or 66 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 ask for a redetermination (see DATES). 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. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28047 Filed 11-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83849
DEPARTMENT OF HEALTH AND comments, that information will be will not be disclosed except in
HUMAN SERVICES posted on https://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
Food and Drug Administration with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
[Docket Nos.: FDA–2015–E–0824; FDA– public, submit the comment as a 56469, September 18, 2015, or access
2015–E–0846; FDA–2015–E–0848; FDA– written/paper submission and in the
2015–E–0850]
the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Determination of Regulatory Review Submissions’’ and ‘‘Instructions’’). default.htm.
Period for Purposes of Patent Docket: For access to the docket to
Written/Paper Submissions
Extension; CORE VALVE SYSTEM read background documents or the
Submit written/paper submissions as electronic and written/paper comments
AGENCY: Food and Drug Administration, follows: received, go to https://
HHS. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
ACTION: Notice. written/paper submissions): Division of docket number, found in brackets in the
Dockets Management (HFA–305), Food heading of this document, into the
SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Administration (FDA) has determined Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
the regulatory review period for CORE • For written/paper comments Management, 5630 Fishers Lane, Rm.
VALVE SYSTEM and is publishing this submitted to the Division of Dockets 1061, Rockville, MD 20852.
notice of that determination as required Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
by law. FDA has made the comment, as well as any attachments, Beverly Friedman, Office of Regulatory
determination because of the except for information submitted, Policy, Food and Drug Administration,
submission of applications to the marked and identified, as confidential, 10903 New Hampshire Ave., Bldg. 51,
Director of the U.S. Patent and if submitted as detailed in Rm. 6250, Silver Spring, MD 20993–
Trademark Office (USPTO), Department ‘‘Instructions.’’ 0002, 301–796–3600.
of Commerce, for the extension of a Instructions: All submissions received
must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION:
patent which claims that medical
device. 2015–E–0824; FDA–2015–E–0846; I. Background
FDA–2015–E–0848; and FDA–2015–E–
DATES: Anyone with knowledge that any The Drug Price Competition and
0850 for ‘‘Determination of Regulatory Patent Term Restoration Act of 1984
of the dates as published (see the Review Period for Purposes of Patent
SUPPLEMENTARY INFORMATION section) are
(Pub. L. 98–417) and the Generic
Extension; CORE VALVE SYSTEM’’. Animal Drug and Patent Term
incorrect may submit either electronic Received comments will be placed in
or written comments and ask for a Restoration Act (Pub. L. 100–670)
the docket and, except for those generally provide that a patent may be
redetermination by January 23, 2017. submitted as ‘‘Confidential
Furthermore, any interested person may extended for a period of up to 5 years
Submissions,’’ publicly viewable at so long as the patented item (human
petition FDA for a determination https://www.regulations.gov or at the
regarding whether the applicant for drug product, animal drug product,
Division of Dockets Management medical device, food additive, or color
extension acted with due diligence between 9 a.m. and 4 p.m., Monday additive) was subject to regulatory
during the regulatory review period by through Friday. review by FDA before the item was
May 22, 2017. See ‘‘Petitions’’ in the • Confidential Submissions—To marketed. Under these acts, a product’s
SUPPLEMENTARY INFORMATION section for submit a comment with confidential regulatory review period forms the basis
more information. information that you do not wish to be for determining the amount of extension
ADDRESSES: You may submit comments made publicly available, submit your an applicant may receive.
as follows: comments only as a written/paper A regulatory review period consists of
submission. You should submit two two periods of time: A testing phase and
Electronic Submissions copies total. One copy will include the an approval phase. For medical devices,
Submit electronic comments in the information you claim to be confidential the testing phase begins with a clinical
following way: with a heading or cover note that states investigation of the device and runs
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS until the approval phase begins. The
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The approval phase starts with the initial
instructions for submitting comments. Agency will review this copy, including submission of an application to market
Comments submitted electronically, the claimed confidential information, in the device and continues until
including attachments, to https:// its consideration of comments. The permission to market the device is
www.regulations.gov will be posted to second copy, which will have the granted. Although only a portion of a
the docket unchanged. Because your claimed confidential information regulatory review period may count
comment will be made public, you are redacted/blacked out, will be available toward the actual amount of extension
solely responsible for ensuring that your for public viewing and posted on that the Director of USPTO may award
comment does not include any https://www.regulations.gov. Submit (half the testing phase must be
confidential information that you or a both copies to the Division of Dockets subtracted as well as any time that may
third party may not wish to be posted, Management. If you do not wish your
sradovich on DSK3GMQ082PROD with NOTICES
have occurred before the patent was
such as medical information, your or name and contact information to be issued), FDA’s determination of the
anyone else’s Social Security number, or made publicly available, you can length of a regulatory review period for
confidential business information, such provide this information on the cover a medical device will include all of the
as a manufacturing process. Please note sheet and not in the body of your testing phase and approval phase as
that if you include your name, contact comments and you must identify this specified in 35 U.S.C. 156(g)(3)(B).
information, or other information that information as ‘‘confidential.’’ Any FDA has approved for marketing the
identifies you in the body of your information marked as ‘‘confidential’’ medical device CORE VALVE SYSTEM.
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![83850 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
CORE VALVE SYSTEM is indicated for verified the applicants’ claims that PMA RUCONEST and is publishing this
relief of aortic stenosis in patients with P130021 was approved on January 17, notice of that determination as required
symptomatic heart disease due to severe 2014. by law. FDA has made the
native calcific aortic stenosis (aortic This determination of the regulatory determination because of the
valve area ≤0.8 cm2, a mean aortic valve review period establishes the maximum submission of applications to the
gradient of >40 mmHg, or a peak aortic- potential length of a patent extension. Director of the U.S. Patent and
jet velocity of 4.0 m/s) and with native However, the USPTO applies several Trademark Office (USPTO), Department
aortic annulus diameters between 18 statutory limitations in its calculations of Commerce, for the extension of a
and 29 mm who are judged by a heart of the actual period for patent extension. patent which claims that human
team, including a cardiac surgeon, to be In its applications for patent extension, biological product.
at extreme risk or inoperable for open these applicants seek 685 days, 360 DATES: Anyone with knowledge that any
surgical therapy (predicted risk of days, or 66 days of patent term of the dates as published (see the
operative mortality and or serious extension. SUPPLEMENTARY INFORMATION section) are
irreversible morbidity ≥50% at 30 days). incorrect may submit either electronic
III. Petitions
Subsequent to this approval, the USPTO or written comments and ask for a
received patent term restoration Anyone with knowledge that any of redetermination by January 23, 2017.
applications for CORE VALVE SYSTEM the dates as published are incorrect may Furthermore, any interested person may
(U.S. Patent Nos. 5,957,949; 7,018,406; submit either electronic or written petition FDA for a determination
8,226,710; and 8,579,966 from comments and ask for a redetermination regarding whether the applicant for
Medtronic Corevalve LLC and U.S. (see DATES). Furthermore, any interested extension acted with due diligence
Patent No. 5,957,949 from Medtronic person may petition FDA for a during the regulatory review period by
Vascular Inc.), and the USPTO determination regarding whether the May 22, 2017. See ‘‘Petitions’’ in the
requested FDA’s assistance in applicant for extension acted with due SUPPLEMENTARY INFORMATION section for
determining the patents’ eligibility for diligence during the regulatory review more information.
patent term restoration. In two letters period. To meet its burden, the petition ADDRESSES: You may submit comments
dated October 19, 2015, FDA advised must be timely (see DATES) and contain as follows:
the USPTO that this medical device had sufficient facts to merit an FDA
undergone a regulatory review period investigation. (See H. Rept. 857, part 1, Electronic Submissions
and that the approval of CORE VALVE 98th Cong., 2d sess., pp. 41–42, 1984.) Submit electronic comments in the
SYSTEM represented the first permitted Petitions should be in the format following way:
commercial marketing or use of the specified in 21 CFR 10.30. • Federal eRulemaking Portal:
product. Thereafter, the USPTO Submit petitions electronically to https://www.regulations.gov. Follow the
requested that FDA determine the https://www.regulations.gov at Docket instructions for submitting comments.
product’s regulatory review period. No. FDA–2013–S–0610. Submit written Comments submitted electronically,
petitions (two copies are required) to the including attachments, to https://
II. Determination of Regulatory Review
Division of Dockets Management (HFA– www.regulations.gov will be posted to
Period
305), Food and Drug Administration, the docket unchanged. Because your
FDA has determined that the 5630 Fishers Lane, Rm. 1061, Rockville, comment will be made public, you are
applicable regulatory review period for MD 20852. Petitions that have not been solely responsible for ensuring that your
CORE VALVE SYSTEM is 1,194 days. made publicly available on https:// comment does not include any
Of this time, 1,017 days occurred during www.regulations.gov may be viewed in confidential information that you or a
the testing phase of the regulatory the Division of Dockets Management third party may not wish to be posted,
review period, while 177 days occurred between 9 a.m. and 4 p.m., Monday such as medical information, your or
during the approval phase. These through Friday. anyone else’s Social Security number, or
periods of time were derived from the confidential business information, such
Dated: November 16, 2016.
following dates: as a manufacturing process. Please note
1. The date an exemption under Leslie Kux,
Associate Commissioner for Policy.
that if you include your name, contact
section 520(g) of the Federal Food, Drug, information, or other information that
and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2016–28047 Filed 11–21–16; 8:45 am]
identifies you in the body of your
U.S.C. 360j(g)) involving this device BILLING CODE 4164–01–P
comments, that information will be
became effective: October 13, 2010. FDA posted on https://www.regulations.gov.
has verified the applicants’ claims that • If you want to submit a comment
the date the investigational device DEPARTMENT OF HEALTH AND
with confidential information that you
exemption required under section HUMAN SERVICES
do not wish to be made available to the
520(g) of the FD&C act for human tests public, submit the comment as a
Food and Drug Administration
to begin became effective October 13, written/paper submission and in the
2010. [Docket Nos. FDA–2015–E–2663; FDA– manner detailed (see ‘‘Written/Paper
2. The date an application was 2015–E–2890]
Submissions’’ and ‘‘Instructions’’).
initially submitted with respect to the
device under section 515 of the Federal Determination of Regulatory Review Written/Paper Submissions
Food, Drug, and Cosmetic Act (21 U.S.C. Period for Purposes of Patent Submit written/paper submissions as
Extension; RUCONEST
sradovich on DSK3GMQ082PROD with NOTICES
360e): July 25, 2013. FDA has verified follows:
the applicants’ claims that the AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
premarket approval application (PMA) HHS. written/paper submissions): Division of
for CORE VALVE SYSTEM (PMA ACTION: Notice. Dockets Management (HFA–305), Food
P130021) was initially submitted July and Drug Administration, 5630 Fishers
25, 2013. SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
3. The date the application was Administration (FDA) has determined • For written/paper comments
approved: January 17, 2014. FDA has the regulatory review period for submitted to the Division of Dockets
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Document Created: 2018-02-14 08:29:27
Document Modified: 2018-02-14 08:29:27
| 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 January 23, 2017. 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 May 22, 2017. 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 20993-0002, 301-796-3600. | |
| FR Citation | 81 FR 83849 |
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