82_FR_56837 82 FR 56609 - Determination of Regulatory Review Period for Purposes of Patent Extension; VELTASSA

82 FR 56609 - Determination of Regulatory Review Period for Purposes of Patent Extension; VELTASSA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

Page Range56609-56610
FR Document2017-25761

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELTASSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 82 Issue 228 (Wednesday, November 29, 2017) 
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56609-56610]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2216]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; VELTASSA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for VELTASSA and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by January 
29, 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 29, 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-2016-E-2216 for ''Determination of Regulatory Review Period for 
Purposes of Patent Extension; VELTASSA.'' 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,

[[Page 56610]]

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 VELTASSA 
(patiromer sorbitex calcium). VELTASSA is indicated for the treatment 
of hyperkalemia. Subsequent to this approval, the USPTO received a 
patent term restoration application for VELTASSA (U.S. Patent No. 
8,147,873) from Relypsa, Inc., and the USPTO requested FDA's assistance 
in determining this patent's eligibility for patent term restoration. 
In a letter dated September 1, 2016, FDA advised the USPTO that this 
human drug product had undergone a regulatory review period and that 
the approval of VELTASSA 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 
VELTASSA is 2,844 days. Of this time, 2,478 days occurred during the 
testing phase of the regulatory review period, while 366 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: January 9, 2008. FDA has verified the applicant's claim that 
January 9, 2008, is the date the investigational new drug application 
(IND) became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: October 
21, 2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for VELTASSA (NDA 205739) was initially submitted on 
October 21, 2014.
    3. The date the application was approved: October 21, 2015. FDA has 
verified the applicant's claim that NDA 205739 was approved on October 
21, 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 application for patent extension, 
this applicant seeks 832 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: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25761 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56609 IV. Paperwork Reduction Act of 1995 electronic filing system will accept a.m. and 4 p.m., Monday through This draft guidance refers to comments until midnight Eastern Time Friday. previously approved collections of at the end of January 29, 2018. • Confidential Submissions—To information found in FDA regulations. Comments received by mail/hand submit a comment with confidential The collections of information in this delivery/courier (for written/paper information that you do not wish to be guidance were approved under OMB submissions) will be considered timely made publicly available, submit your control number 0910–0598. The if they are postmarked or the delivery comments only as a written/paper collections of information in 21 CFR service acceptance receipt is on or submission. You should submit two part 54 have been approved under before that date. copies total. One copy will include the 0910–0396, and the collections of information you claim to be confidential Electronic Submissions information in 21 CFR parts 50 and 56 with a heading or cover note that states Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS have been approved under OMB control following way: number 0910–0755. CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including Dated: November 22, 2017. https://www.regulations.gov. Follow the the claimed confidential information, in Leslie Kux, instructions for submitting comments. its consideration of comments. The Associate Commissioner for Policy. Comments submitted electronically, second copy, which will have the [FR Doc. 2017–25775 Filed 11–28–17; 8:45 am] including attachments, to https:// claimed confidential information BILLING CODE 4164–01–P www.regulations.gov will be posted to redacted/blacked out, will be available the docket unchanged. Because your for public viewing and posted on comment will be made public, you are https://www.regulations.gov. Submit DEPARTMENT OF HEALTH AND solely responsible for ensuring that your both copies to the Dockets Management HUMAN SERVICES comment does not include any Staff. If you do not wish your name and confidential information that you or a contact information to be made publicly Food and Drug Administration third party may not wish to be posted, available, you can provide this such as medical information, your or information on the cover sheet and not [Docket No. FDA–2016–E–2216] anyone else’s Social Security number, or in the body of your comments and you Determination of Regulatory Review confidential business information, such must identify this information as Period for Purposes of Patent as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Extension; VELTASSA that if you include your name, contact as ‘‘confidential’’ will not be disclosed information, or other information that except in accordance with § 10.20 (21 AGENCY: Food and Drug Administration, identifies you in the body of your CFR 10.20) and other applicable HHS. comments, that information will be disclosure law. For more information ACTION: Notice. posted on https://www.regulations.gov. about FDA’s posting of comments to • If you want to submit a comment public dockets, see 80 FR 56469, SUMMARY: The Food and Drug with confidential information that you September 18, 2015, or access the Administration (FDA or the Agency) has do not wish to be made available to the information at: https://www.gpo.gov/ determined the regulatory review period public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- for VELTASSA and is publishing this written/paper submission and in the 23389.pdf. notice of that determination as required manner detailed (see ‘‘Written/Paper Docket: For access to the docket to by law. FDA has made the Submissions’’ and ‘‘Instructions’’). read background documents or the determination because of the electronic and written/paper comments Written/Paper Submissions submission of an application to the received, go to https:// Director of the U.S. Patent and Submit written/paper submissions as www.regulations.gov and insert the Trademark Office (USPTO), Department follows: • Mail/Hand delivery/Courier (for docket number, found in brackets in the of Commerce, for the extension of a heading of this document, into the patent which claims that human drug written/paper submissions): Dockets Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts product. and/or go to the Dockets Management Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, of the dates as published (in 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 January 29, 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– during the regulatory review period by 2016–E–2216 for ’’Determination of I. Background May 29, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and pmangrum on DSK3GDR082PROD with NOTICES1 SUPPLEMENTARY INFORMATION section for of Patent Extension; VELTASSA.’’ 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 January 29, 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, VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

56610 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices medical device, food additive, or color is the date the investigational new drug DEPARTMENT OF HEALTH AND additive) was subject to regulatory application (IND) became effective. HUMAN SERVICES review by FDA before the item was 2. The date the application was marketed. Under these acts, a product’s Food and Drug Administration initially submitted with respect to the regulatory review period forms the basis [Docket No. FDA–2017–D–5625] human drug product under section for determining the amount of extension 505(b) of the FD&C Act: October 21, an applicant may receive. Recommendations for Dual 510(k) and A regulatory review period consists of 2014. FDA has verified the applicant’s Clinical Laboratory Improvement two periods of time: a testing phase and claim that the new drug application Amendments Waiver by Application an approval phase. For human drug (NDA) for VELTASSA (NDA 205739) Studies; Draft Guidance for Industry products, the testing phase begins when was initially submitted on October 21, and Food and Drug Administration the exemption to permit the clinical 2014. Staff; Availability investigations of the drug becomes 3. The date the application was effective and runs until the approval approved: October 21, 2015. FDA has AGENCY: Food and Drug Administration, phase begins. The approval phase starts HHS. verified the applicant’s claim that NDA with the initial submission of an 205739 was approved on October 21, ACTION: Notice of availability. application to market the human drug 2015. SUMMARY: The Food and Drug product and continues until FDA grants This determination of the regulatory Administration (FDA or Agency) is permission to market the drug product. review period establishes the maximum announcing the availability of the draft Although only a portion of a regulatory potential length of a patent extension. guidance entitled ‘‘Recommendations review period may count toward the However, the USPTO applies several for Dual 510(k) and Clinical Laboratory actual amount of extension that the statutory limitations in its calculations Improvement Amendments (CLIA) Director of USPTO may award (for of the actual period for patent extension. Waiver by Application Studies.’’ It example, half the testing phase must be subtracted as well as any time that may In its application for patent extension, describes study designs for generating have occurred before the patent was this applicant seeks 832 days of patent data that supports both 510(k) clearance issued), FDA’s determination of the term extension. and CLIA waived categorization. Use of length of a regulatory review period for the Dual 510(k) and CLIA Waiver by a human drug product will include all III. Petitions Application pathway is optional; of the testing phase and approval phase however, FDA believes this pathway is Anyone with knowledge that any of in many instances the least burdensome as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may FDA has approved for marketing the and fastest approach for manufacturers submit either electronic or written to obtain a CLIA waived categorization human drug product VELTASSA comments and, under 21 CFR 60.24, ask in addition to 510(k) clearance for new (patiromer sorbitex calcium). VELTASSA is indicated for the for a redetermination (see DATES). In Vitro Diagnostic (IVD) devices. FDA treatment of hyperkalemia. Subsequent Furthermore, as specified in § 60.30 (21 believes increased use of this pathway to this approval, the USPTO received a CFR 60.30), any interested person may will speed up the process of bringing patent term restoration application for petition FDA for a determination simple and accurate IVD devices to VELTASSA (U.S. Patent No. 8,147,873) regarding whether the applicant for CLIA waived settings, which will better from Relypsa, Inc., and the USPTO extension acted with due diligence serve patients and providers. This draft requested FDA’s assistance in during the regulatory review period. To guidance is not final nor is it in effect determining this patent’s eligibility for meet its burden, the petition must at this time. patent term restoration. In a letter dated comply with all the requirements of DATES: Submit either electronic or September 1, 2016, FDA advised the § 60.30, including but not limited to: written comments on the draft guidance USPTO that this human drug product Must be timely (see DATES), must be by January 29, 2018 to ensure that the had undergone a regulatory review filed in accordance with § 10.20, must Agency considers your comment on this period and that the approval of contain sufficient facts to merit an FDA draft guidance before it begins work on VELTASSA represented the first investigation, and must certify that a the final version of the guidance. permitted commercial marketing or use true and complete copy of the petition ADDRESSES: You may submit comments of the product. Thereafter, the USPTO has been served upon the patent on any guidance at any time as follows: requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th Electronic Submissions product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format Submit electronic comments in the II. Determination of Regulatory Review following way: Period specified in 21 CFR 10.30. • Federal eRulemaking Portal: FDA has determined that the Submit petitions electronically to https://www.regulations.gov. Follow the applicable regulatory review period for https://www.regulations.gov at Docket instructions for submitting comments. VELTASSA is 2,844 days. Of this time, No. FDA–2013–S–0610. Submit written Comments submitted electronically, 2,478 days occurred during the testing petitions (two copies are required) to the including attachments, to https:// phase of the regulatory review period, Dockets Management Staff (HFA–305), www.regulations.gov will be posted to while 366 days occurred during the Food and Drug Administration, 5630 the docket unchanged. Because your pmangrum on DSK3GDR082PROD with NOTICES1 approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD comment will be made public, you are were derived from the following dates: 20852. solely responsible for ensuring that your 1. The date an exemption under Dated: November 24, 2017. comment does not include any section 505(i) of the Federal Food, Drug, confidential information that you or a Leslie Kux, and Cosmetic Act (the FD&C Act) (21 third party may not wish to be posted, U.S.C. 355(i)) became effective: January Associate Commissioner for Policy. such as medical information, your or 9, 2008. FDA has verified the [FR Doc. 2017–25761 Filed 11–28–17; 8:45 am] anyone else’s Social Security number, or applicant’s claim that January 9, 2008, BILLING CODE 4164–01–P confidential business information, such VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2017-11-29 01:26:25
Document Modified: 2017-11-29 01:26:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 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 May 29, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly 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 Citation82 FR 56609 
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