83_FR_4243 83 FR 4223 - Determination of Regulatory Review Period for Purposes of Patent Extension; LONSURF

83 FR 4223 - Determination of Regulatory Review Period for Purposes of Patent Extension; LONSURF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range4223-4224
FR Document2018-01641

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

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018) 
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4223-4224]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01641]



[[Page 4223]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2476; FDA-2016-E-2472]


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

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 LONSURF and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of applications to the Director 
of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in 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 Nos. 
FDA-2016-E-2476 and FDA-2016-E-2472 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; LONSURF.'' 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 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.

[[Page 4224]]

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 LONSURF 
(trifluridine and tipiracil hydrochloride). LONSURF is indicated for 
the treatment of patients with metastatic colorectal cancer who have 
been previously treated with fluoropyrimidine-, oxalplatin- and 
irinotecan-based chemotherapy, an anti-vascular endothelial growth 
factor biological therapy, and if RAS wild-type, an anti-epidermal 
growth factor receptor therapy. Subsequent to this approval, the USPTO 
received patent term restoration applications for LONSURF (U.S. Patent 
Nos. 6,479,500 and 7,799,783) from Taiho Pharmaceutical Co., Ltd., and 
the USPTO requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated October 14, 
2016, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of LONSURF 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 
LONSURF is 6,083 days. Of this time, 5,805 days occurred during the 
testing phase of the regulatory review period, while 278 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 28, 1999. FDA has verified the Taiho Pharmaceutical 
Co., Ltd. claim that January 28, 1999, 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)/507 of the FD&C Act: 
December 19, 2014. FDA has verified the applicant's claim that the new 
drug application (NDA) for LONSURF (NDA 207981) was initially submitted 
on December 19, 2014.
    3. The date the application was approved: September 22, 2015. FDA 
has verified the applicant's claim that NDA 207981 was approved on 
September 22, 2015.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 1,827 days or 1,013 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. 2018-01641 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices 4223 DEPARTMENT OF HEALTH AND comment will be made public, you are for public viewing and posted on HUMAN SERVICES solely responsible for ensuring that your https://www.regulations.gov. Submit comment does not include any both copies to the Dockets Management Food and Drug Administration confidential information that you or a Staff. If you do not wish your name and third party may not wish to be posted, contact information to be made publicly [Docket Nos. FDA–2016–E–2476; FDA– 2016–E–2472] such as medical information, your or available, you can provide this anyone else’s Social Security number, or information on the cover sheet and not Determination of Regulatory Review confidential business information, such in the body of your comments and you Period for Purposes of Patent as a manufacturing process. Please note must identify this information as Extension; LONSURF that if you include your name, contact ‘‘confidential.’’ Any information marked information, or other information that as ‘‘confidential’’ will not be disclosed AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21 HHS. comments, that information will be CFR 10.20) and other applicable ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information • If you want to submit a comment about FDA’s posting of comments to SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469, Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/ for LONSURF and is publishing this written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- notice of that determination as required manner detailed (see ‘‘Written/Paper 23389.pdf. by law. FDA has made the Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to determination because of the read background documents or the Written/Paper Submissions submission of applications to the electronic and written/paper comments Director of the U.S. Patent and Submit written/paper submissions as received, go to https:// Trademark Office (USPTO), Department follows: www.regulations.gov and insert the of Commerce, for the extension of a • Mail/Hand delivery/Courier (for docket number, found in brackets in the patent which claims that human drug written/paper submissions): Dockets heading of this document, into the product. Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any and/or go to the Dockets Management Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (in the • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Rockville, MD 20852. incorrect may submit either electronic Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: or written comments and ask for a well as any attachments, except for Beverly Friedman, Office of Regulatory redetermination by April 2, 2018. information submitted, marked and Policy, Food and Drug Administration, Furthermore, any interested person may identified, as confidential, if submitted 10903 New Hampshire Ave., Bldg. 51, petition FDA for a determination as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993, regarding whether the applicant for Instructions: All submissions received 301–796–3600. extension acted with due diligence must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION: during the regulatory review period by 2016–E–2476 and FDA–2016–E–2472 July 30, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory I. Background SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent The Drug Price Competition and more information. Extension; LONSURF.’’ Received Patent Term Restoration Act of 1984 ADDRESSES: You may submit comments comments, those filed in a timely (Pub. L. 98–417) and the Generic as follows. Please note that late, manner (see ADDRESSES), will be placed Animal Drug and Patent Term untimely filed comments will not be in the docket and, except for those Restoration Act (Pub. L. 100–670) considered. Electronic comments must submitted as ‘‘Confidential generally provide that a patent may be be submitted on or before April 2, 2018. Submissions,’’ publicly viewable at extended for a period of up to 5 years The https://www.regulations.gov https://www.regulations.gov or at the so long as the patented item (human electronic filing system will accept Dockets Management Staff between 9 drug product, animal drug product, comments until midnight Eastern Time a.m. and 4 p.m., Monday through medical device, food additive, or color at the end of April 2, 2018. Comments Friday. additive) was subject to regulatory received by mail/hand delivery/courier • Confidential Submissions—To review by FDA before the item was (for written/paper submissions) will be submit a comment with confidential marketed. Under these acts, a product’s considered timely if they are information that you do not wish to be regulatory review period forms the basis postmarked or the delivery service made publicly available, submit your for determining the amount of extension acceptance receipt is on or before that comments only as a written/paper an applicant may receive. date. submission. You should submit two A regulatory review period consists of copies total. One copy will include the two periods of time: A testing phase and Electronic Submissions information you claim to be confidential an approval phase. For human drug Submit electronic comments in the with a heading or cover note that states products, the testing phase begins when following way: ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical daltland on DSKBBV9HB2PROD with NOTICES • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes https://www.regulations.gov. Follow the Agency will review this copy, including effective and runs until the approval instructions for submitting comments. the claimed confidential information, in phase begins. The approval phase starts Comments submitted electronically, its consideration of comments. The with the initial submission of an including attachments, to https:// second copy, which will have the application to market the human drug www.regulations.gov will be posted to claimed confidential information product and continues until FDA grants the docket unchanged. Because your redacted/blacked out, will be available permission to market the drug product. VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1

4224 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices Although only a portion of a regulatory 207981) was initially submitted on DEPARTMENT OF HEALTH AND review period may count toward the December 19, 2014. HUMAN SERVICES actual amount of extension that the 3. The date the application was Director of USPTO may award (for Food and Drug Administration approved: September 22, 2015. FDA has example, half the testing phase must be verified the applicant’s claim that NDA [Docket Nos. FDA–2016–E–1279 and FDA– subtracted as well as any time that may 2016–E–1282] 207981 was approved on September 22, have occurred before the patent was issued), FDA’s determination of the 2015. Determination of Regulatory Review length of a regulatory review period for This determination of the regulatory Period for Purposes of Patent a human drug product will include all review period establishes the maximum Extension; SAPIEN 3 of the testing phase and approval phase potential length of a patent extension. TRANSCATHETER HEART VALVE as specified in 35 U.S.C. 156(g)(1)(B). However, the USPTO applies several FDA has approved for marketing the statutory limitations in its calculations AGENCY: Food and Drug Administration, human drug product LONSURF of the actual period for patent extension. HHS. (trifluridine and tipiracil In its applications for patent extension, ACTION: Notice. hydrochloride). LONSURF is indicated this applicant seeks 1,827 days or 1,013 for the treatment of patients with SUMMARY: The Food and Drug days of patent term extension. metastatic colorectal cancer who have Administration (FDA or the Agency) has been previously treated with III. Petitions determined the regulatory review period fluoropyrimidine-, oxalplatin- and for SAPIEN 3 TRANSCATHETER irinotecan-based chemotherapy, an anti- Anyone with knowledge that any of HEART VALVE and is publishing this vascular endothelial growth factor the dates as published are incorrect may notice of that determination as required biological therapy, and if RAS wild- submit either electronic or written by law. FDA has made the type, an anti-epidermal growth factor comments and, under 21 CFR 60.24, ask determination because of the receptor therapy. Subsequent to this for a redetermination (see DATES). submission of applications to the approval, the USPTO received patent Furthermore, as specified in § 60.30 (21 Director of the U.S. Patent and term restoration applications for CFR 60.30), any interested person may Trademark Office (USPTO), Department LONSURF (U.S. Patent Nos. 6,479,500 petition FDA for a determination of Commerce, for the extension of a and 7,799,783) from Taiho regarding whether the applicant for patent which claims that medical Pharmaceutical Co., Ltd., and the extension acted with due diligence device. USPTO requested FDA’s assistance in during the regulatory review period. To DATES: Anyone with knowledge that any determining the patents’ eligibility for meet its burden, the petition must of the dates as published (in the patent term restoration. In a letter dated comply with all the requirements of SUPPLEMENTARY INFORMATION section) are October 14, 2016, FDA advised the § 60.30, including but not limited to: incorrect may submit either electronic USPTO that this human drug product must be timely (see DATES), must be or written comments and ask for a had undergone a regulatory review filed in accordance with § 10.20, must redetermination by April 2, 2018. period and that the approval of contain sufficient facts to merit an FDA Furthermore, any interested person may LONSURF represented the first investigation, and must certify that a petition FDA for a determination permitted commercial marketing or use true and complete copy of the petition regarding whether the applicant for of the product. Thereafter, the USPTO has been served upon the patent extension acted with due diligence requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th during the regulatory review period by product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) July 30, 2018. See ‘‘Petitions’’ in the II. Determination of Regulatory Review Petitions should be in the format SUPPLEMENTARY INFORMATION section for Period specified in 21 CFR 10.30. more information. FDA has determined that the ADDRESSES: You may submit comments Submit petitions electronically to applicable regulatory review period for https://www.regulations.gov at Docket as follows. Please note that late, LONSURF is 6,083 days. Of this time, untimely filed comments will not be No. FDA–2013–S–0610. Submit written 5,805 days occurred during the testing considered. Electronic comments must petitions (two copies are required) to the phase of the regulatory review period, be submitted on or before April 2, 2018. Dockets Management Staff (HFA–305), The https://www.regulations.gov while 278 days occurred during the Food and Drug Administration, 5630 electronic filing system will accept approval phase. These periods of time were derived from the following dates: Fishers Lane, Rm. 1061, Rockville, MD comments until midnight Eastern Time 1. The date an exemption under 20852. at the end of April 2, 2018. Comments section 505(i) of the Federal Food, Drug, Dated: January 24, 2018. received by mail/hand delivery/courier and Cosmetic Act (the FD&C Act) (21 Leslie Kux, (for written/paper submissions) will be U.S.C. 355(i)) became effective: January Associate Commissioner for Policy. considered timely if they are 28, 1999. FDA has verified the Taiho postmarked or the delivery service [FR Doc. 2018–01641 Filed 1–29–18; 8:45 am] Pharmaceutical Co., Ltd. claim that acceptance receipt is on or before that January 28, 1999, is the date the BILLING CODE 4164–01–P date. investigational new drug application Electronic Submissions (IND) became effective. daltland on DSKBBV9HB2PROD with NOTICES 2. The date the application was Submit electronic comments in the initially submitted with respect to the following way: human drug product under section • Federal eRulemaking Portal: 505(b)/507 of the FD&C Act: December https://www.regulations.gov. Follow the 19, 2014. FDA has verified the instructions for submitting comments. applicant’s claim that the new drug Comments submitted electronically, application (NDA) for LONSURF (NDA including attachments, to https:// VerDate Sep<11>2014 18:18 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1


Document Created: 2018-10-26 10:13:31
Document Modified: 2018-10-26 10:13:31
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 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.
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 Citation83 FR 4223 
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