83 FR 1366 - Determination of Regulatory Review Period for Purposes of Patent Extension; EPANOVA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 8 (January 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 8 (January 11, 2018)
| Page Range | 1366-1368 | |
| FR Document | 2018-00353 |
[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)] [Notices] [Pages 1366-1368] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00353] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-2657, FDA-2015-E-2658, FDA-2015-E-2659, and FDA-2015-E-2891] Determination of Regulatory Review Period for Purposes of Patent Extension; EPANOVA 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 EPANOVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the [[Page 1367]] 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 March 12, 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 10, 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 March 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 12, 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-2015-E-2891, FDA-2015-E-2657, FDA-2015-E-2658, FDA-2015-E-2659, and FDA-2015-E-2658 ``For Determination of Regulatory Review Period for Purposes of Patent Extension; EPANOVA.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the dockets 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 EPANOVA (omega-3-carboxylic acids). EPANOVA is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>=500 mg/ dL) hypertriglyceridemia. Subsequent to this approval, the USPTO received [[Page 1368]] patent term restoration applications for EPANOVA (U.S. Patent Nos. 5,948,818; 7,960,370; 7,792,795; and 8,383,678) from AstraZeneca Pharmaceuticals LP, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated December 1, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of EPANOVA 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 EPANOVA is 4,269 days. Of this time, 3,964 days occurred during the testing phase of the regulatory review period, while 305 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: August 29, 2002. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 29, 2002. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 5, 2013. The applicant claims July 3, 2013, as the date the NDA for EPANOVA was initially submitted. However, FDA records indicate that NDA 205060 was submitted on July 5, 2013, which is considered to be the NDA initially submitted date. 3. The date the application was approved: May 5, 2014. FDA has verified the applicant's claim that NDA 205060 was approved on May 5, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 682 days, 371 days, and 5 years 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 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00353 Filed 1-10-18; 8:45 am] BILLING CODE 4164-01-P
![1366 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
about FDA’s posting of comments to testing phase and approval phase as statutory limitations in its calculations
public dockets, see 80 FR 56469, specified in 35 U.S.C. 156(g)(4)(B). of the actual period for patent extension.
September 18, 2015, or access the FDA has approved for marketing the In its applications for patent extension,
information at: https://www.gpo.gov/ animal drug product ENTYCE this applicant seeks 1,826 and 1,827
fdsys/pkg/FR-2015-09-18/pdf/2015- (capromorelin). ENTYCE is indicated for days of patent term extension.
23389.pdf. appetite stimulation in dogs.
Subsequent to this approval, the USPTO III. Petitions
Docket: For access to the docket to
read background documents or the received patent term restoration Anyone with knowledge that any of
electronic and written/paper comments applications for ENTYCE (U.S. Patent the dates as published are incorrect may
received, go to https:// Nos. 6,107,306 and 6,673,929) from submit either electronic or written
www.regulations.gov and insert the RaQualia Pharma Inc., and the USPTO comments and, under 21 CFR 60.24, ask
docket number, found in brackets in the requested FDA’s assistance in for a redetermination (see DATES).
heading of this document, into the determining the patents’ eligibility for Furthermore, as specified in § 60.30 (21
‘‘Search’’ box and follow the prompts patent term restoration. In a letter dated CFR 60.30), any interested person may
and/or go to the Dockets Management December 1, 2016, FDA advised the petition FDA for a determination
Staff, 5630 Fishers Lane, Rm. 1061, USPTO that this animal drug product regarding whether the applicant for
Rockville, MD 20852. had undergone a regulatory review extension acted with due diligence
FOR FURTHER INFORMATION CONTACT:
period and that the approval of ENTYCE during the regulatory review period. To
Beverly Friedman, Office of Regulatory represented the first permitted meet its burden, the petition must
Policy, Food and Drug Administration, commercial marketing or use of the comply with all the requirements of
10903 New Hampshire Ave., Bldg. 51, product. Thereafter, the USPTO § 60.30, including but not limited to:
Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the Must be timely (see DATES), must be
301–796–3600. product’s regulatory review period. filed in accordance with § 10.20, must
II. Determination of Regulatory Review contain sufficient facts to merit an FDA
SUPPLEMENTARY INFORMATION:
Period investigation, and must certify that a
I. Background true and complete copy of the petition
FDA has determined that the has been served upon the patent
The Drug Price Competition and applicable regulatory review period for
Patent Term Restoration Act of 1984 applicant. (See H. Rept. 857, part 1, 98th
ENTYCE is 1,645 days. Of this time, Cong., 2d sess., pp. 41–42, 1984.)
(Pub. L. 98–417) and the Generic 1,589 days occurred during the testing
Animal Drug and Patent Term Petitions should be in the format
phase of the regulatory review period, specified in 21 CFR 10.30.
Restoration Act (Pub. L. 100–670) while 56 days occurred during the Submit petitions electronically to
generally provide that a patent may be approval phase. These periods of time https://www.regulations.gov at Docket
extended for a period of up to 5 years were derived from the following dates: No. FDA–2013–S–0610. Submit written
so long as the patented item (human 1. The date an exemption under petitions (two copies are required) to the
drug product, animal drug product, section 505(i) of the FD&C Act (21 Dockets Management Staff (HFA–305),
medical device, food additive, or color U.S.C. 355(i)) became effective: Food and Drug Administration, 5630
additive) was subject to regulatory November 16, 2011. The applicant Fishers Lane, Rm. 1061, Rockville, MD
review by FDA before the item was claims December 5, 2002, as the date the 20852.
marketed. Under these acts, a product’s investigational new animal drug
regulatory review period forms the basis Dated: January 4, 2018.
application (INAD) became effective.
for determining the amount of extension However, FDA records indicate that the Leslie Kux,
an applicant may receive. INAD effective date was November 16, Associate Commissioner for Policy.
A regulatory review period consists of 2011, which was the date a major health [FR Doc. 2018–00358 Filed 1–10–18; 8:45 am]
two periods of time: A testing phase and or environmental effects test is begun or BILLING CODE 4164–01–P
an approval phase. For animal drug the date on which the Agency
products, the testing phase begins on acknowledges the filing of a notice of
the earlier date when either a major claimed investigational exemption for a DEPARTMENT OF HEALTH AND
environmental effects test was initiated new animal drug, whichever is earlier. HUMAN SERVICES
for the drug or when an exemption 2. The date the application was
under section 512(j) of the Federal Food, initially submitted with respect to the Food and Drug Administration
Drug, and Cosmetic Act (FD&C Act) (21 animal drug product under section 512 [Docket Nos. FDA–2015–E–2657, FDA–
U.S.C. 360b(j)) became effective and of the FD&C Act (21 U.S.C. 360b): March 2015–E–2658, FDA–2015–E–2659, and FDA–
runs until the approval phase begins. 22, 2016. The applicant claims March 2015–E–2891]
The approval phase starts with the 21, 2016, as the date the new animal
initial submission of an application to drug application (NADA) for ENTYCE Determination of Regulatory Review
market the animal drug product and (NADA 141–457) was initially Period for Purposes of Patent
continues until FDA grants permission submitted. However, FDA records Extension; EPANOVA
to market the drug product. Although indicate that NADA 141–457 was AGENCY: Food and Drug Administration,
only a portion of a regulatory review submitted on March 22, 2016. HHS.
period may count toward the actual 3. The date the application was ACTION: Notice.
amount of extension that the Director of approved: May 16, 2016. FDA has
srobinson on DSK9F5VC42PROD with NOTICES
USPTO may award (for example, half verified the applicant’s claim that SUMMARY: The Food and Drug
the testing phase must be subtracted as NADA 141–457 was approved on May Administration (FDA or the Agency) has
well as any time that may have occurred 16, 2016. determined the regulatory review period
before the patent was issued), FDA’s This determination of the regulatory for EPANOVA and is publishing this
determination of the length of a review period establishes the maximum notice of that determination as required
regulatory review period for an animal potential length of a patent extension. by law. FDA has made the
drug product will include all of the However, the USPTO applies several determination because of the
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![1368 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
patent term restoration applications for regarding whether the applicant for visitor parking, and transportation may
EPANOVA (U.S. Patent Nos. 5,948,818; extension acted with due diligence be accessed at: https://www.fda.gov/
7,960,370; 7,792,795; and 8,383,678) during the regulatory review period. To AdvisoryCommittees/
from AstraZeneca Pharmaceuticals LP, meet its burden, the petition must AboutAdvisoryCommittees/
and the USPTO requested FDA’s comply with all the requirements of ucm408555.htm.
assistance in determining the patents’ § 60.30, including but not limited to: FDA is establishing a docket for
eligibility for patent term restoration. In Must be timely (see DATES), must be public comment on this meeting. The
a letter dated December 1, 2016, FDA filed in accordance with § 10.20, must docket number is FDA–2017–N–6925.
advised the USPTO that this human contain sufficient facts to merit an FDA The docket will close on April 6, 2018.
drug product had undergone a investigation, and must certify that a Submit either electronic or written
regulatory review period and that the true and complete copy of the petition comments on this public meeting by
approval of EPANOVA represented the has been served upon the patent April 6, 2018. Please note that late,
first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th untimely filed comments will not be
use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) considered. Electronic comments must
USPTO requested that FDA determine Petitions should be in the format be submitted on or before April 6, 2018.
the product’s regulatory review period. specified in 21 CFR 10.30. The https://www.regulations.gov
Submit petitions electronically to electronic filing system will accept
II. Determination of Regulatory Review
https://www.regulations.gov at Docket comments until midnight Eastern Time
Period
No. FDA–2013–S–0610. Submit written at the end of April 6, 2018. Comments
FDA has determined that the petitions (two copies are required) to the received by mail/hand delivery/courier
applicable regulatory review period for Dockets Management Staff (HFA–305), (for written/paper submissions) will be
EPANOVA is 4,269 days. Of this time, Food and Drug Administration, 5630 considered timely if they are
3,964 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD postmarked or the delivery service
phase of the regulatory review period, 20852. acceptance receipt is on or before that
while 305 days occurred during the date.
Dated: January 8, 2018.
approval phase. These periods of time Comments received on or before
Leslie Kux,
were derived from the following dates: February 26, 2018 will be provided to
1. The date an exemption under Associate Commissioner for Policy.
the committee. Comments received after
section 505(i) of the Federal Food, Drug, [FR Doc. 2018–00353 Filed 1–10–18; 8:45 am]
that date will be taken into
and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P
consideration by FDA.
355(i)) became effective: August 29,
You may submit comments as
2002. FDA has verified the applicant’s
DEPARTMENT OF HEALTH AND follows:
claim that the date the investigational
new drug application became effective HUMAN SERVICES Electronic Submissions
was on August 29, 2002.
2. The date the application was Food and Drug Administration Submit electronic comments in the
initially submitted with respect to the following way:
[Docket No. FDA–2017–N–6925]
human drug product under section • Federal eRulemaking Portal:
505(b) of the FD&C Act: July 5, 2013. Risk Communication Advisory https://www.regulations.gov. Follow the
The applicant claims July 3, 2013, as the Committee; Notice of Meeting; instructions for submitting comments.
date the NDA for EPANOVA was Establishment of a Public Docket; Comments submitted electronically,
initially submitted. However, FDA Request for Comments including attachments, to https://
records indicate that NDA 205060 was www.regulations.gov will be posted to
AGENCY: Food and Drug Administration, the docket unchanged. Because your
submitted on July 5, 2013, which is HHS.
considered to be the NDA initially comment will be made public, you are
submitted date. ACTION: Notice; establishment of a solely responsible for ensuring that your
3. The date the application was public docket; request for comments. comment does not include any
approved: May 5, 2014. FDA has confidential information that you or a
SUMMARY: The Food and Drug third party may not wish to be posted,
verified the applicant’s claim that NDA Administration (FDA) announces a
205060 was approved on May 5, 2014. such as medical information, your or
forthcoming public advisory committee anyone else’s Social Security number, or
This determination of the regulatory meeting of the Risk Communication
review period establishes the maximum confidential business information.
Advisory Committee. The general Please note that if you include your
potential length of a patent extension. function of the committee is to provide
However, the USPTO applies several name, contact information, or other
advice and recommendations to FDA on information that identifies you in the
statutory limitations in its calculations regulatory issues. The meeting will be
of the actual period for patent extension. body of your comments, that
open to the public. FDA is establishing information will be posted on https://
In its applications for patent extension, a docket for public comment on this
this applicant seeks 682 days, 371 days, www.regulations.gov.
document.
and 5 years of patent term extension. • If you want to submit a comment
DATES: The meeting will be held on with confidential information that you
III. Petitions March 5, 2018, from 8 a.m. to 5 p.m. and do not wish to be made available to the
Anyone with knowledge that any of March 6, 2018, from 9 a.m. to 12:30 p.m. public, submit the comment as a
srobinson on DSK9F5VC42PROD with NOTICES
the dates as published are incorrect may ADDRESSES: FDA White Oak Campus, written/paper submission and in the
submit either electronic or written 10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper
comments and, under 21 CFR 60.24, ask Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
for a redetermination (see DATES). 1503), Silver Spring, MD 20993–0002.
Written/Paper Submissions
Furthermore, as specified in § 60.30 (21 Answers to commonly asked questions
CFR 60.30), any interested person may including information regarding special Submit written/paper submissions as
petition FDA for a determination accommodations due to a disability, follows:
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Document Created: 2018-01-11 04:53:58
Document Modified: 2018-01-11 04:53:58
| 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 March 12, 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 10, 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 1366 |
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