83 FR 5788 - Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5788-5790 | |
| FR Document | 2018-02591 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5788-5790] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02591] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-0632] Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZA 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 LYNPARZA 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 10, 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 8, 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 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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 [[Page 5789]] 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-0632 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; LYNPARZA.'' 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 LYNPARZA (olaparib). LYNPARZA is indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer whom have been treated with three or more prior lines of chemotherapy. Subsequent to this approval, the USPTO received a patent term restoration application for LYNPARZA (U.S. Patent No. 7,449,464) from Kudos Pharmaceuticals Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 2, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LYNPARZA 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 LYNPARZA is 3,012 days. Of this time, 2,692 days occurred during the testing phase of the regulatory review period, while 320 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: September 22, 2006. FDA has verified the applicant's claim that September 22, 2006, 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: February 3, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for LYNPARZA (NDA 206162) was initially submitted on February 3, 2014. 3. The date the application was approved: December 19, 2014. FDA has verified the applicant's claim that NDA 206162 was approved on December 19, 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 application for patent extension, this applicant seeks 1,275 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). [[Page 5790]] 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 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02591 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
![5788 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
toward the actual amount of extension 125582/0 was approved on March 4, for LYNPARZA and is publishing this
that the Director of USPTO may award 2016. notice of that determination as required
(for example, half the testing phase must This determination of the regulatory by law. FDA has made the
be subtracted as well as any time that review period establishes the maximum determination because of the
may have occurred before the patent potential length of a patent extension. submission of an application to the
was issued), FDA’s determination of the However, the USPTO applies several Director of the U.S. Patent and
length of a regulatory review period for statutory limitations in its calculations Trademark Office (USPTO), Department
a human biological product will include of the actual period for patent extension. of Commerce, for the extension of a
all of the testing phase and approval In its application for patent extension, patent which claims that human drug
phase as specified in 35 U.S.C. this applicant seeks 531 days of patent product.
156(g)(1)(B). term extension.
DATES: Anyone with knowledge that any
FDA has approved for marketing the III. Petitions of the dates as published (in the
human biologic product IDELVION SUPPLEMENTARY INFORMATION section) are
(Coagulation Factor IX (recombinant), Anyone with knowledge that any of
the dates as published are incorrect may incorrect may submit either electronic
albumin fusion protein). IDELVION is or written comments and ask for a
submit either electronic or written
indicated for the following: (1) On- redetermination by April 10, 2018.
comments and, under 21 CFR 60.24, ask
demand control and prevention of Furthermore, any interested person may
for a redetermination (see DATES).
bleeding episodes, (2) perioperative petition FDA for a determination
Furthermore, as specified in § 60.30 (21
management of bleeding, and (3) routine regarding whether the applicant for
CFR 60.30), any interested person may
prophylaxis to prevent or reduce the extension acted with due diligence
petition FDA for a determination
frequency of bleeding episodes. during the regulatory review period by
regarding whether the applicant for
Subsequent to this approval, the USPTO August 8, 2018. See ‘‘Petitions’’ in the
extension acted with due diligence
received a patent term restoration SUPPLEMENTARY INFORMATION section for
during the regulatory review period. To
application for IDELVION (U.S. Patent more information.
meet its burden, the petition must
No. 7,939,632) from CSL Behring GmbH, ADDRESSES: You may submit comments
comply with all the requirements of
and the USPTO requested FDA’s as follows. Please note that late,
§ 60.30, including but not limited to:
assistance in determining this patent’s untimely filed comments will not be
Must be timely (see DATES), must be
eligibility for patent term restoration. In considered. Electronic comments must
filed in accordance with § 10.20, must
a letter dated August 26, 2016, FDA be submitted on or before April 10,
contain sufficient facts to merit an FDA
advised the USPTO that this human 2018. The https://www.regulations.gov
investigation, and must certify that a
biological product had undergone a electronic filing system will accept
true and complete copy of the petition
regulatory review period and that the comments until midnight Eastern Time
has been served upon the patent
approval of IDELVION represented the at the end of April 10, 2018. Comments
applicant. (See H. Rept. 857, part 1, 98th
first permitted commercial marketing or received by mail/hand delivery/courier
Cong., 2d sess., pp. 41–42, 1984.)
use of the product. Thereafter, the (for written/paper submissions) will be
Petitions should be in the format
USPTO requested that FDA determine considered timely if they are
specified in 21 CFR 10.30.
the product’s regulatory review period. Submit petitions electronically to postmarked or the delivery service
II. Determination of Regulatory Review https://www.regulations.gov at Docket acceptance receipt is on or before that
Period No. FDA–2013–S–0610. Submit written date.
petitions (two copies are required) to the
FDA has determined that the Electronic Submissions
Dockets Management Staff (HFA–305),
applicable regulatory review period for Submit electronic comments in the
Food and Drug Administration, 5630
IDELVION is 1,479 days. Of this time, following way:
Fishers Lane, Rm. 1061, Rockville, MD
1,023 days occurred during the testing • Federal eRulemaking Portal:
20852.
phase of the regulatory review period, https://www.regulations.gov. Follow the
while 456 days occurred during the Dated: February 5, 2018.
instructions for submitting comments.
approval phase. These periods of time Leslie Kux, Comments submitted electronically,
were derived from the following dates: Associate Commissioner for Policy. including attachments, to https://
1. The date an exemption under [FR Doc. 2018–02666 Filed 2–8–18; 8:45 am] www.regulations.gov will be posted to
section 505(i) of the Federal Food, Drug, BILLING CODE 4164–01–P the docket unchanged. Because your
and Cosmetic Act (21 U.S.C. 355(i)) comment will be made public, you are
became effective: February 17, 2012. solely responsible for ensuring that your
FDA has verified the applicant’s claim DEPARTMENT OF HEALTH AND comment does not include any
that the date the investigational new HUMAN SERVICES confidential information that you or a
drug application became effective was third party may not wish to be posted,
on February 17, 2012. Food and Drug Administration
such as medical information, your or
2. The date the application was [Docket No. FDA–2016–E–0632] anyone else’s Social Security number, or
initially submitted with respect to the confidential business information, such
human biological product under section Determination of Regulatory Review as a manufacturing process. Please note
351 of the Public Health Service Act (42 Period for Purposes of Patent that if you include your name, contact
U.S.C. 262): December 5, 2014. FDA has Extension; LYNPARZA
sradovich on DSK3GMQ082PROD with NOTICES
information, or other information that
verified the applicant’s claim that the AGENCY: Food and Drug Administration, identifies you in the body of your
biologics license application (BLA) for HHS. comments, that information will be
IDELVION (BLA 125582/0) was initially ACTION: Notice. posted on https://www.regulations.gov.
submitted on December 5, 2014. • If you want to submit a comment
3. The date the application was SUMMARY: The Food and Drug with confidential information that you
approved: March 4, 2016. FDA has Administration (FDA or the Agency) has do not wish to be made available to the
verified the applicant’s claim that BLA determined the regulatory review period public, submit the comment as a
VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1](https://thefederalregister.org/doc/83_FR_5816/page/1.svg)
![5790 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Furthermore, as specified in § 60.30 (21 Furthermore, any interested person may identified, as confidential, if submitted
CFR 60.30), any interested person may petition FDA for a determination as detailed in ‘‘Instructions.’’
petition FDA for a determination regarding whether the applicant for Instructions: All submissions received
regarding whether the applicant for extension acted with due diligence must include the Docket Nos. FDA–
extension acted with due diligence during the regulatory review period by 2016–E–2267 and FDA–2016–E–2269
during the regulatory review period. To August 8, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
meet its burden, the petition must SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
comply with all the requirements of more information. Extension; ONIVYDE.’’ Received
§ 60.30, including but not limited to: ADDRESSES: You may submit comments comments, those filed in a timely
must be timely (see DATES), must be as follows. Please note that late, manner (see ADDRESSES), will be placed
filed in accordance with § 10.20, must untimely filed comments will not be in the dockets and, except for those
contain sufficient facts to merit an FDA considered. Electronic comments must submitted as ‘‘Confidential
investigation, and must certify that a be submitted on or before April 10, Submissions,’’ publicly viewable at
true and complete copy of the petition 2018. The https://www.regulations.gov https://www.regulations.gov or at the
has been served upon the patent electronic filing system will accept Dockets Management Staff between 9
applicant. (See H. Rept. 857, part 1, 98th comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Cong., 2d sess., pp. 41–42, 1984.) at the end of April 10, 2018. Comments Friday.
Petitions should be in the format received by mail/hand delivery/courier • Confidential Submissions—To
specified in 21 CFR 10.30. (for written/paper submissions) will be submit a comment with confidential
Submit petitions electronically to considered timely if they are information that you do not wish to be
https://www.regulations.gov at Docket postmarked or the delivery service made publicly available, submit your
No. FDA–2013–S–0610. Submit written acceptance receipt is on or before that comments only as a written/paper
petitions (two copies are required) to the date. submission. You should submit two
Dockets Management Staff (HFA–305), Electronic Submissions copies total. One copy will include the
Food and Drug Administration, 5630 information you claim to be confidential
Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the with a heading or cover note that states
20852. following way: ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Dated: February 5, 2018. https://www.regulations.gov. Follow the
Leslie Kux, Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Associate Commissioner for Policy. Comments submitted electronically, its consideration of comments. The
[FR Doc. 2018–02591 Filed 2–8–18; 8:45 am] including attachments, to https:// second copy, which will have the
BILLING CODE 4164–01–P www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your https://www.regulations.gov. Submit
HUMAN SERVICES comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Food and Drug Administration third party may not wish to be posted, contact information to be made publicly
[Docket Nos. FDA–2016–E–2267 and FDA– such as medical information, your or available, you can provide this
2016–E–2269] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note
Period for Purposes of Patent must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Extension; ONIVYDE 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
posted on https://www.regulations.gov. disclosure law. For more information
ACTION: Notice. • 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 ONIVYDE 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 Written/Paper Submissions read background documents or the
submission of applications to the electronic and written/paper comments
Submit written/paper submissions as
Director of the U.S. Patent and received, go to https://
follows:
Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
of Commerce, for the extension of a written/paper submissions): Dockets docket number, found in brackets in the
patent which claims that human drug heading of this document, into the
sradovich on DSK3GMQ082PROD with NOTICES
Management Staff (HFA–305), Food and
product. Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
of the dates as published (see 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 10, 2018. information submitted, marked and Policy, Food and Drug Administration,
VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1](https://thefederalregister.org/doc/83_FR_5816/page/3.svg)
Document Created: 2018-02-09 00:11:55
Document Modified: 2018-02-09 00:11:55
| 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 10, 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 8, 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 5788 |
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