83 FR 6859 - Determination of Regulatory Review Period for Purposes of Patent Extension; FETZIMA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 32 (February 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 32 (February 15, 2018)
| Page Range | 6859-6861 | |
| FR Document | 2018-03129 |
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)] [Notices] [Pages 6859-6861] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03129] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2326] Determination of Regulatory Review Period for Purposes of Patent Extension; FETZIMA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FETZIMA 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 16, 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 August 14, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time [[Page 6860]] at the end of April 16, 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-2014-E-2326 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; FETZIMA.'' 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. 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 FETZIMA (levomilnacipran hydrochloride). FETZIMA is indicated for treatment of Major Depressive Disorder. Subsequent to this approval, the USPTO received a patent term restoration application for FETZIMA (U.S. Patent No. RE43879) from Pierre Fabre Medicament, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 3, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of FETZIMA 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 FETZIMA is 1,602 days. Of this time, 1,298 days occurred during the testing phase of the regulatory review period, while 304 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: March 8, 2009. FDA has verified the Pierre Fabre Medicament claim that March 8, 2009, is the date the investigational new drug application (IND) became effective. [[Page 6861]] 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 25, 2012. The applicant claims September 24, 2012, as the date the NDA for FETZIMA was initially submitted. However, FDA records indicate that new drug application (NDA) 204168 was submitted on September 25, 2012. 3. The date the application was approved: July 25, 2013. FDA has verified the applicant's claim that NDA 204168 was approved on July 25, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 954 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, 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: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03129 Filed 2-14-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6859
SUPPLEMENTARY INFORMATION: commercial marketing or use of the applicant. (See H. Rept. 857, part 1, 98th
product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.)
I. Background
requested that FDA determine the Petitions should be in the format
The Drug Price Competition and product’s regulatory review period. specified in 21 CFR 10.30.
Patent Term Restoration Act of 1984 Submit petitions electronically to
(Pub. L. 98–417) and the Generic II. Determination of Regulatory Review
https://www.regulations.gov at Docket
Animal Drug and Patent Term Period
No. FDA–2013–S–0610. Submit written
Restoration Act (Pub. L. 100–670) FDA has determined that the petitions (two copies are required) to the
generally provide that a patent may be applicable regulatory review period for Dockets Management Staff (HFA–305),
extended for a period of up to 5 years AVEED is 2,923 days. Of this time, 541 Food and Drug Administration, 5630
so long as the patented item (human days occurred during the testing phase Fishers Lane, Rm. 1061, Rockville, MD
drug product, animal drug product, of the regulatory review period, while 20852.
medical device, food additive, or color 2,382 days occurred during the approval
Dated: February 9, 2018.
additive) was subject to regulatory phase. These periods of time were
Leslie Kux,
review by FDA before the item was derived from the following dates:
1. The date an exemption under Associate Commissioner for Policy.
marketed. Under these acts, a product’s
regulatory review period forms the basis section 505(i) of the Federal Food, Drug, [FR Doc. 2018–03136 Filed 2–14–18; 8:45 am]
for determining the amount of extension and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P
an applicant may receive. 355(i)) became effective: March 6, 2006.
A regulatory review period consists of The applicant claims March 3, 2006, as
two periods of time: A testing phase and the date the investigational new drug DEPARTMENT OF HEALTH AND
an approval phase. For human drug application (IND) became effective. HUMAN SERVICES
products, the testing phase begins when However, FDA records indicate that the
IND effective date was March 6, 2006, Food and Drug Administration
the exemption to permit the clinical
investigations of the drug becomes which was 30 days after FDA receipt of [Docket No. FDA–2014–E–2326]
effective and runs until the approval the IND.
phase begins. The approval phase starts 2. The date the application was Determination of Regulatory Review
with the initial submission of an initially submitted with respect to the Period for Purposes of Patent
application to market the human drug human drug product under section Extension; FETZIMA
product and continues until FDA grants 505(b) of the FD&C Act: August 28, AGENCY: Food and Drug Administration,
permission to market the drug product. 2007. FDA has verified the applicant’s HHS.
Although only a portion of a regulatory claim that the new drug application
(NDA) for AVEED (NDA 022219) was ACTION: Notice.
review period may count toward the
actual amount of extension that the initially submitted on August 28, 2007. SUMMARY: The Food and Drug
Director of USPTO may award (for 3. The date the application was Administration (FDA or the Agency) has
example, half the testing phase must be approved: March 5, 2014. FDA has determined the regulatory review period
subtracted as well as any time that may verified the applicant’s claim that NDA for FETZIMA and is publishing this
have occurred before the patent was 022219 was approved on March 5, 2014. notice of that determination as required
This determination of the regulatory by law. FDA has made the
issued), FDA’s determination of the
review period establishes the maximum determination because of the
length of a regulatory review period for
potential length of a patent extension. submission of an application to the
a human drug product will include all
However, the USPTO applies several Director of the U.S. Patent and
of the testing phase and approval phase
statutory limitations in its calculations Trademark Office (USPTO), Department
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the of the actual period for patent extension. of Commerce, for the extension of a
human drug product AVEED In its application for patent extension, patent which claims that human drug
(testosterone undecanoate). AVEED is this applicant seeks 435 days of patent product.
indicated for testosterone replacement term extension.
DATES: Anyone with knowledge that any
therapy in adult males for the following III. Petitions of the dates as published (in the
conditions that are associated with a Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are
deficiency or absence of endogenous the dates as published are incorrect may incorrect may submit either electronic
testosterone: submit either electronic or written or written comments and ask for a
• Primary hypogonadism (congenital or comments and, under 21 CFR 60.24, ask redetermination by April 16, 2018.
acquired) for a redetermination (see DATES). Furthermore, any interested person may
• Hypogonadotropic hypogonadism Furthermore, as specified in § 60.30 (21 petition FDA for a determination
(congenital or acquired) CFR 60.30), any interested person may regarding whether the applicant for
Subsequent to this approval, the petition FDA for a determination extension acted with due diligence
USPTO received a patent term regarding whether the applicant for during the regulatory review period by
restoration application for AVEED (U.S. extension acted with due diligence August 14, 2018. See ‘‘Petitions’’ in the
Patent No. 8,338,395) from Bayer during the regulatory review period. To SUPPLEMENTARY INFORMATION section for
Intellectual Property GmbH, and the meet its burden, the petition must more information.
USPTO requested FDA’s assistance in comply with all the requirements of ADDRESSES: You may submit comments
sradovich on DSK3GMQ082PROD with NOTICES
determining this patent’s eligibility for § 60.30, including but not limited to: as follows. Please note that late,
patent term restoration. In a letter dated Must be timely (see DATES), must be untimely filed comments will not be
November 2, 2015, FDA advised the filed in accordance with § 10.20, must considered. Electronic comments must
USPTO that this human drug product contain sufficient facts to merit an FDA be submitted on or before April 16,
had undergone a regulatory review investigation, and must certify that a 2018. The https://www.regulations.gov
period and that the approval of AVEED true and complete copy of the petition electronic filing system will accept
represented the first permitted has been served upon the patent comments until midnight Eastern Time
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![Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6861
2. The date the application was DEPARTMENT OF HEALTH AND the docket unchanged. Because your
initially submitted with respect to the HUMAN SERVICES comment will be made public, you are
human drug product under section solely responsible for ensuring that your
505(b) of the FD&C Act: September 25, Food and Drug Administration comment does not include any
2012. The applicant claims September [Docket Nos. FDA–2015–E–2604 and FDA– confidential information that you or a
24, 2012, as the date the NDA for 2015–E–2619] third party may not wish to be posted,
FETZIMA was initially submitted. such as medical information, your or
However, FDA records indicate that Determination of Regulatory Review anyone else’s Social Security number, or
new drug application (NDA) 204168 Period for Purposes of Patent confidential business information, such
Extension; ZYDELIG—New Drug as a manufacturing process. Please note
was submitted on September 25, 2012.
Application 205858 that if you include your name, contact
3. The date the application was information, or other information that
approved: July 25, 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
204168 was approved on July 25, 2013. ACTION: Notice. posted on https://www.regulations.gov.
This determination of the regulatory • If you want to submit a comment
SUMMARY: The Food and Drug
review period establishes the maximum with confidential information that you
Administration (FDA or the Agency) has
potential length of a patent extension. do not wish to be made available to the
determined the regulatory review period
public, submit the comment as a
However, the USPTO applies several for ZYDELIG based on new drug
written/paper submission and in the
statutory limitations in its calculations application (NDA) 205858 and is
manner detailed (see ‘‘Written/Paper
of the actual period for patent extension. publishing this notice of that
Submissions’’ and ‘‘Instructions’’).
In its application for patent extension, determination as required by law. FDA
this applicant seeks 954 days of patent has made the determination because of Written/Paper Submissions
term extension. the submission of applications to the Submit written/paper submissions as
Director of the U.S. Patent and follows:
III. Petitions Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of Commerce, for the extension of a written/paper submissions): Dockets
Anyone with knowledge that any of
patent which claims that human drug Management Staff (HFA–305), Food and
the dates as published are incorrect may
product and that NDA. Drug Administration, 5630 Fishers
submit either electronic or written
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
comments and ask for a redetermination
of the dates as published (see the • For written/paper comments
(see DATES). Furthermore, as specified in submitted to the Dockets Management
SUPPLEMENTARY INFORMATION section) are
§ 60.30 (21 CFR 60.30), any interested incorrect may submit either electronic Staff, FDA will post your comment, as
person may petition FDA for a or written comments and ask for a well as any attachments, except for
determination regarding whether the redetermination by April 16, 2018. information submitted, marked and
applicant for extension acted with due Furthermore, any interested person may identified, as confidential, if submitted
diligence during the regulatory review petition FDA for a determination as detailed in ‘‘Instructions.’’
period. To meet its burden, the petition regarding whether the applicant for Instructions: All submissions received
must comply with all the requirements extension acted with due diligence must include the Docket Nos. FDA–
of § 60.30, including but not limited to: during the regulatory review period by 2015–E–2604 and FDA–2015–E–2619
Must be timely (see DATES), must be August 14, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
filed in accordance with § 10.20, must SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
contain sufficient facts to merit an FDA more information. Extension; ZYDELIG—NDA 205858.’’
investigation, and must certify that a ADDRESSES: You may submit comments Received comments, those filed in a
true and complete copy of the petition as follows. Please note that late, timely manner (see ADDRESSES), will be
has been served upon the patent untimely filed comments will not be placed in the docket and, except for
applicant. (See H. Rept. 857, part 1, 98th considered. Electronic comments must those submitted as ‘‘Confidential
Cong., 2d sess., pp. 41–42, 1984.) be submitted on or before April 16, Submissions,’’ publicly viewable at
Petitions should be in the format 2018. The https://www.regulations.gov https://www.regulations.gov or at the
specified in 21 CFR 10.30. electronic filing system will accept Dockets Management Staff between 9
comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Submit petitions electronically to Friday.
at the end of April 16, 2018. Comments
https://www.regulations.gov at Docket
received by mail/hand delivery/courier • Confidential Submissions—To
No. FDA–2013–S–0610. Submit written submit a comment with confidential
(for written/paper submissions) will be
petitions (two copies are required) to the considered timely if they are information that you do not wish to be
Dockets Management Staff (HFA–305), postmarked or the delivery service made publicly available, submit your
Food and Drug Administration, 5630 acceptance receipt is on or before that comments only as a written/paper
Fishers Lane, Rm. 1061, Rockville, MD date. submission. You should submit two
20852. copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Dated: February 9, 2018.
with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
Submit electronic comments in the
Leslie Kux,
following way: ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2018–03129 Filed 2–14–18; 8:45 am] https://www.regulations.gov. Follow the Agency will review this copy, including
BILLING CODE 4164–01–P instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1](https://thefederalregister.org/doc/83_FR_6891/page/3.svg)
Document Created: 2018-02-15 00:21:03
Document Modified: 2018-02-15 00:21:03
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 August 14, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 83 FR 6859 |
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