83_FR_4510 83 FR 4489 - Determination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA

83 FR 4489 - Determination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 21 (January 31, 2018)

Page Range4489-4490
FR Document2018-01920

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LENVIMA 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 83 Issue 21 (Wednesday, January 31, 2018) 
[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4489-4490]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1245]


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

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 LENVIMA 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 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-2016-E-1245 for ''Determination of Regulatory Review Period for 
Purposes of Patent Extension; LENVIMA.'' 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

[[Page 4490]]

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. 
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 LENVIMA 
(lenvatinib mesylate). LENVIMA is indicated for treatment of patients 
with locally recurrent or metastatic, progressive, radioactive iodine-
refractory differentiated thyroid cancer. Subsequent to this approval, 
the USPTO received a patent term restoration application for LENVIMA 
(U.S. Patent No. 7,253,286) from EISAI R&D Management Co., Ltd., and 
the USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated July 12, 
2016, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of LENVIMA 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 
LENVIMA is 3,580 days. Of this time, 3,396 days occurred during the 
testing phase of the regulatory review period, while 184 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: April 28, 2005. FDA has verified the applicant's claim that 
April 28, 2005, 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: August 14, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for LENVIMA (NDA 206947) was initially submitted on 
August 14, 2014.
    3. The date the application was approved: February 13, 2015. FDA 
has verified the applicant's claim that NDA 206947 was approved on 
February 13, 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 1,465 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. 2018-01920 Filed 1-30-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 21 / Wednesday, January 31, 2018 / Notices 4489 2. The date the application was DEPARTMENT OF HEALTH AND solely responsible for ensuring that your initially submitted with respect to the HUMAN SERVICES comment does not include any human drug product under section confidential information that you or a 505(b) of the FD&C Act: October 3, 2012. Food and Drug Administration third party may not wish to be posted, FDA has verified the applicant’s claim [Docket No. FDA–2016–E–1245] such as medical information, your or that the new drug application (NDA) for anyone else’s Social Security number, or DUAVEE (NDA 022247) was initially Determination of Regulatory Review confidential business information, such submitted on October 3, 2012. Period for Purposes of Patent as a manufacturing process. Please note Extension; LENVIMA that if you include your name, contact 3. The date the application was information, or other information that approved: October 3, 2013. FDA has AGENCY: Food and Drug Administration, identifies you in the body of your verified the applicant’s claim that NDA HHS. comments, that information will be 022247 was approved on October 3, ACTION: Notice. posted on https://www.regulations.gov. 2013. • If you want to submit a comment This determination of the regulatory SUMMARY: The Food and Drug with confidential information that you review period establishes the maximum Administration (FDA or the Agency) has do not wish to be made available to the determined the regulatory review period public, submit the comment as a potential length of a patent extension. for LENVIMA and is publishing this written/paper submission and in the However, the USPTO applies several notice of that determination as required manner detailed (see ‘‘Written/Paper statutory limitations in its calculations by law. FDA has made the Submissions’’ and ‘‘Instructions’’). of the actual period for patent extension. determination because of the In its application for patent extension, Written/Paper Submissions submission of an application to the this applicant seeks 5 years of patent Director of the U.S. Patent and Submit written/paper submissions as term extension. Trademark Office (USPTO), Department follows: of Commerce, for the extension of a • Mail/Hand delivery/Courier (for III. Petitions written/paper submissions): Dockets patent which claims that human drug Anyone with knowledge that any of product. Management Staff (HFA–305), Food and the dates as published are incorrect may Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. submit either electronic or written of the dates as published (in the • For written/paper comments comments and, under 21 CFR 60.24, ask SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management for a redetermination (see DATES). incorrect may submit either electronic Staff, FDA will post your comment, as Furthermore, as specified in § 60.30 (21 or written comments and ask for a well as any attachments, except for CFR 60.30), any interested person may redetermination by April 2, 2018. information submitted, marked and petition FDA for a determination Furthermore, any interested person may identified, as confidential, if submitted regarding whether the applicant for petition FDA for a determination as detailed in ‘‘Instructions.’’ extension acted with due diligence regarding whether the applicant for Instructions: All submissions received during the regulatory review period. To extension acted with due diligence must include the Docket No. FDA– meet its burden, comply with all the during the regulatory review period by 2016–E–1245 for ’’Determination of requirements of § 60.30, including but July 30, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes not limited to: Must be timely (see SUPPLEMENTARY INFORMATION section for of Patent Extension; LENVIMA.’’ DATES), must be filed in accordance with more information. Received comments, those filed in a § 10.20, must contain sufficient facts to ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be merit an FDA investigation, and must as follows. Please note that late, placed in the docket and, except for certify that a true and complete copy of untimely filed comments will not be those submitted as ‘‘Confidential the petition has been served upon the considered. Electronic comments must Submissions,’’ publicly viewable at patent applicant. (See H. Rept. 857, part be submitted on or before April 2, 2018. https://www.regulations.gov or at the 1, 98th Cong., 2d sess., pp. 41–42, 1984.) The https://www.regulations.gov Dockets Management Staff between 9 Petitions should be in the format electronic filing system will accept a.m. and 4 p.m., Monday through specified in 21 CFR 10.30. comments until midnight Eastern Time Friday. at the end of April 2, 2018. Comments • Confidential Submissions—To Submit petitions electronically to received by mail/hand delivery/courier submit a comment with confidential https://www.regulations.gov at Docket (for written/paper submissions) will be information that you do not wish to be No. FDA–2013–S–0610. Submit written considered timely if they are made publicly available, submit your petitions (two copies are required) to the postmarked or the delivery service comments only as a written/paper Dockets Management Staff (HFA–305), acceptance receipt is on or before that submission. You should submit two Food and Drug Administration, 5630 date. copies total. One copy will include the Fishers Lane, Rm. 1061, Rockville, MD information you claim to be confidential 20852. Electronic Submissions with a heading or cover note that states Dated: January 24, 2018. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ The Leslie Kux, • Federal eRulemaking Portal: Agency will review this copy, including sradovich on DSK3GMQ082PROD with NOTICES Associate Commissioner for Policy. https://www.regulations.gov. Follow the the claimed confidential information, in [FR Doc. 2018–01894 Filed 1–30–18; 8:45 am] instructions for submitting comments. its consideration of comments. The BILLING CODE 4164–01–P Comments submitted electronically, second copy, which will have the including attachments, to https:// claimed confidential information 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 VerDate Sep<11>2014 17:36 Jan 30, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1

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


Document Created: 2018-01-31 00:58:00
Document Modified: 2018-01-31 00:58:00
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 4489 
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