81 FR 35029 - Determination of Regulatory Review Period for Purposes of Patent Extension; OTEZLA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 105 (June 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 105 (June 1, 2016)
| Page Range | 35029-35031 | |
| FR Document | 2016-12829 |
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)] [Notices] [Pages 35029-35031] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12829] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-0861] Determination of Regulatory Review Period for Purposes of Patent Extension; OTEZLA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for OTEZLA 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 August 1, 2016. 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 November 28, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 35030]] 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2015-E-0861 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; OTEZLA.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 OTEZLA (apremilast). OTEZLA is indicated for treatment of adult patients with active psoriatic arthritis. Subsequent to this approval, the USPTO received a patent term restoration application for OTEZLA (U.S. Patent No. 7,427,638) from Celgene Corporation, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of OTEZLA 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 OTEZLA is 3,494 days. Of this time, 3,128 days occurred during the testing phase of the regulatory review period, while 366 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: August 28, 2004. FDA has verified the Celgene Corporation claim that August 28, 2004, 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: March 21, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for OTEZLA (NDA 205437) was initially submitted on March 21, 2013. 3. The date the application was approved: March 21, 2014. FDA has verified the applicant's claim that NDA 205437 was approved on March 21, 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, [[Page 35031]] this applicant seeks 1,186 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, 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 be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (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 http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: May 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12829 Filed 5-31-16; 8:45 am] BILLING CODE 4161-01-P
![Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices 35029
Management, 5630 Fishers Lane, Rm. regulatory review period and that the No. FDA–2013–S–0610. Submit written
1061, Rockville, MD 20852. approval of MEKINIST represented the petitions (two copies are required) to the
FOR FURTHER INFORMATION CONTACT: first permitted commercial marketing or Division of Dockets Management (HFA–
Beverly Friedman, Office of Regulatory use of the product. Thereafter, the 305), Food and Drug Administration,
Policy, Food and Drug Administration, USPTO requested that FDA determine 5630 Fishers Lane, Rm. 1061, Rockville,
10903 New Hampshire Ave., Bldg. 51, the product’s regulatory review period. MD 20852.
Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review Dated: May 26, 2016.
301–796–3600. Period Leslie Kux,
SUPPLEMENTARY INFORMATION: Associate Commissioner for Policy.
FDA has determined that the
I. Background applicable regulatory review period for [FR Doc. 2016–12859 Filed 5–31–16; 8:45 am]
The Drug Price Competition and MEKINIST is 1,842 days. Of this time, BILLING CODE 4164–01–P
Patent Term Restoration Act of 1984 1,542 days occurred during the testing
(Pub. L. 98–417) and the Generic phase of the regulatory review period,
while 300 days occurred during the DEPARTMENT OF HEALTH AND
Animal Drug and Patent Term HUMAN SERVICES
Restoration Act (Pub. L. 100–670) approval phase. These periods of time
generally provide that a patent may be were derived from the following dates:
1. The date an exemption under Food and Drug Administration
extended for a period of up to 5 years
section 505(i) of the Federal Food, Drug, [Docket No. FDA–2015–E–0861]
so long as the patented item (human
and Cosmetic Act (the FD&C Act) (21
drug product, animal drug product, Determination of Regulatory Review
U.S.C. 355(i)) became effective: May 15,
medical device, food additive, or color Period for Purposes of Patent
2008. FDA has verified the Japan
additive) was subject to regulatory Extension; OTEZLA
Tobacco, Inc., claim that May 15, 2008,
review by FDA before the item was
is the date the investigational new drug AGENCY: Food and Drug Administration,
marketed. Under these acts, a product’s
application became effective. HHS.
regulatory review period forms the basis 2. The date the application was
for determining the amount of extension initially submitted with respect to the ACTION: Notice.
an applicant may receive. human drug product under section
A regulatory review period consists of SUMMARY: The Food and Drug
505(b) of the FD&C Act: August 3, 2012. Administration (FDA) has determined
two periods of time: A testing phase and The applicant claims August 2, 2012, as
an approval phase. For human drug the regulatory review period for
the date the new drug application OTEZLA and is publishing this notice of
products, the testing phase begins when (NDA) for MEKINIST (NDA 204–114)
the exemption to permit the clinical that determination as required by law.
was initially submitted. However, FDA FDA has made the determination
investigations of the drug becomes records indicate that NDA 204–114 was
effective and runs until the approval because of the submission of an
submitted on August 3, 2012. application to the Director of the U.S.
phase begins. The approval phase starts 3. The date the application was
with the initial submission of an Patent and Trademark Office (USPTO),
approved: May 29, 2013. FDA has
application to market the human drug Department of Commerce, for the
verified the applicant’s claim that NDA
product and continues until FDA grants extension of a patent which claims that
204–114 was approved on May 29,
permission to market the drug product. human drug product.
2013.
Although only a portion of a regulatory This determination of the regulatory DATES: Anyone with knowledge that any
review period may count toward the review period establishes the maximum of the dates as published (in the
actual amount of extension that the potential length of a patent extension. SUPPLEMENTARY INFORMATION section) are
Director of USPTO may award (for However, the USPTO applies several incorrect may submit either electronic
example, half the testing phase must be statutory limitations in its calculations or written comments and ask for a
subtracted as well as any time that may of the actual period for patent extension. redetermination by August 1, 2016.
have occurred before the patent was In its application for patent extension, Furthermore, any interested person may
issued), FDA’s determination of the this applicant seeks 623 days of patent petition FDA for a determination
length of a regulatory review period for term extension. regarding whether the applicant for
a human drug product will include all extension acted with due diligence
of the testing phase and approval phase III. Petitions during the regulatory review period by
as specified in 35 U.S.C. 156(g)(1)(B). Anyone with knowledge that any of November 28, 2016. See ‘‘Petitions’’ in
FDA has approved for marketing the the dates as published are incorrect may the SUPPLEMENTARY INFORMATION section
human drug product MEKINIST submit either electronic or written for more information.
(trametinib dimethyl sulfoxide solvate). comments and ask for a redetermination ADDRESSES: You may submit comments
MEKINIST is indicated for treatment of (see DATES). Furthermore, any interested as follows:
patients with unresectable or metastatic person may petition FDA for a
melanoma with BRAF V600E mutations determination regarding whether the Electronic Submissions
as detected by an FDA-approved test. applicant for extension acted with due Submit electronic comments in the
Subsequent to this approval, the USPTO diligence during the regulatory review following way:
received a patent term restoration period. To meet its burden, the petition • Federal eRulemaking Portal: http://
application for MEKINIST (U.S. Patent must be timely (see DATES) and contain www.regulations.gov. Follow the
sradovich on DSK3TPTVN1PROD with NOTICES
No. 7,378,423) from Japan Tobacco, Inc., sufficient facts to merit an FDA instructions for submitting comments.
and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1, Comments submitted electronically,
assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.) including attachments, to http://
eligibility for patent term restoration. In Petitions should be in the format www.regulations.gov will be posted to
a letter dated May 11, 2015, FDA specified in 21 CFR 10.30. the docket unchanged. Because your
advised the USPTO that this human Submit petitions electronically to comment will be made public, you are
drug product had undergone a http://www.regulations.gov at Docket solely responsible for ensuring that your
VerDate Sep<11>2014 21:59 May 31, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/81_FR_35134/page/1.svg)
![Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices 35031
this applicant seeks 1,186 days of patent INFORMATION section for registration date browsers Internet Explorer version 11
term extension. and information. and Firefox versions 6 or higher. All
III. Petitions ADDRESSES: The public workshop will requests to make app demonstrations
be held at FDA’s White Oak campus, must be received by 5 p.m., June 6,
Anyone with knowledge that any of 10903 New Hampshire Ave., Building 2016. FDA will determine the amount of
the dates as published are incorrect may 31 (The Great Room 1503A), Silver time allotted to each presenter and the
submit either electronic or written Spring, MD 20993. For information approximate time each app
comments and ask for a redetermination regarding ground transportation, demonstration is to begin, and will
(see DATES). Furthermore, any interested airports, lodging, driving, and parking, select and notify participants by 5 p.m.,
person may petition FDA for a please refer to: http://www.fda.gov/ June 10, 2016. If selected for an app
determination regarding whether the AboutFDA/WorkingatFDA/ demonstration, any demonstration
applicant for extension acted with due BuildingsandFacilities/ materials must be emailed to Lonnie
diligence during the regulatory review WhiteOakCampusInformation/
period. To meet its burden, the petition Smith (see FOR FURTHER INFORMATION
ucm241740.htm. Entrance for the public
CONTACT) no later than 5 p.m., June 16,
must be timely (see DATES) and contain workshop participants (non-FDA
sufficient facts to merit an FDA employees) is through Building 1 where 2016. No commercial or promotional
investigation. (See H. Rept. 857, part 1, routine security check procedures will material will be permitted to be
98th Cong., 2d sess., pp. 41–42, 1984.) be performed. For parking and security presented or distributed at the public
Petitions should be in the format information, please refer to http:// workshop.
specified in 21 CFR 10.30. www.fda.gov/AboutFDA/ Registration: There is no registration
Submit petitions electronically to WorkingatFDA/BuildingsandFacilities/ fee to attend the public workshop. Early
http://www.regulations.gov at Docket WhiteOakCampusInformation/ registration is recommended because
No. FDA–2013–S–0610. Submit written ucm241740.htm. seating is limited, and registration will
petitions (two copies are required) to the FOR FURTHER INFORMATION CONTACT: be on a first-come, first-served basis.
Division of Dockets Management (HFA– Lonnie Smith, Office of Health There will be no onsite registration.
305), Food and Drug Administration, Informatics, Office of Chief Scientist, Persons interested in attending this
5630 Fishers Lane, Rm. 1061, Rockville, Office of Commissioner, Food and Drug workshop must register by sending the
MD 20852. Administration, 10903 New Hampshire attendee’s full name and email address
Dated: May 25, 2016. Ave., Silver Spring, MD 20993–0002, via email message to openFDA@
Leslie Kux, 301–796–8503, email: lonnie.smith@ fda.hhs.gov before June 10, 2016. For
Associate Commissioner for Policy. fda.hhs.gov. those without Internet access, please
[FR Doc. 2016–12829 Filed 5–31–16; 8:45 am] SUPPLEMENTARY INFORMATION: OpenFDA, contact Lonnie Smith (see FOR FURTHER
BILLING CODE 4161–01–P an FDA Office of Health Informatics INFORMATION CONTACT) to register.
initiative launched in June 2014, is Streaming Webcast of the Public
making it easier for researchers, Workshop: This public workshop will
DEPARTMENT OF HEALTH AND scientists, web developers, and other
also be Webcast. Persons interested in
HUMAN SERVICES FDA regulatory stakeholders to access
viewing the Webcast must register by 4
and use datasets in an open standard
Food and Drug Administration format. p.m., June 10, 2016. Early registration is
The project aims to create easy access recommended because Webcast
[Docket No. FDA–2016–N–0001] to public data and a new level of connections are limited. Organizations
openness and accountability, ensure the are requested to register all participants,
OpenFDA Public Workshop privacy and security of public FDA data, but to view using one connection per
educate the public, and save lives. location. Webcast participants will be
AGENCY: Food and Drug Administration, Members of the scientific community sent technical system requirements after
HHS. can use openFDA to have their registration and will be sent connection
ACTION: Notice of public workshop. applications automatically query the access information after June 10, 2016.
data through APIs. OpenFDA increases If you need special accommodations
SUMMARY: The Food and Drug
the efficiency and speed of accessing due to a disability, please contact
Administration (FDA) is announcing a
datasets by using cutting-edge, open- Lonnie Smith (see FOR FURTHER
public workshop entitled: OpenFDA
source code modules in a cloud-based
Public Workshop. The purpose of the INFORMATION CONTACT) at least 7 days in
environment.
public workshop is to provide a forum Requests for openFDA app advance.
for the openFDA system user demonstrations: This public workshop Dated: May 26, 2016.
community to engage in a robust includes demonstrations of mobile apps Leslie Kux,
interactive discussion and provide specifically developed for utilization of
feedback to FDA regarding openFDA’s Associate Commissioner for Policy.
openFDA data. During registration you [FR Doc. 2016–12826 Filed 5–31–16; 8:45 am]
platform, application programming may indicate if you wish to provide a
interfaces (APIs), downloadable demonstration of an app which you BILLING CODE 4164–01–P
harmonized datasets, and possible have created that utilizes openFDA data.
enhancements to the openFDA platform, FDA will do its best to accommodate
sradovich on DSK3TPTVN1PROD with NOTICES
as well as to view the demonstration of requests to demonstrate openFDA-based
various applications (apps) specifically apps. The openFDA app demonstrations
developed for utilization of openFDA should not include any presentation
data. slides and, due to FDA internet firewall
DATES: The public workshop will be restrictions, will be limited to only
held on June 20, 2016, from 9 a.m. to 12 information and displays accessible via
p.m. See the SUPPLEMENTARY apps which can be accessed via internet
VerDate Sep<11>2014 21:59 May 31, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/81_FR_35134/page/3.svg)
Document Created: 2018-02-08 07:27:10
Document Modified: 2018-02-08 07:27:10
| 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 August 1, 2016. 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 November 28, 2016. 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 | 81 FR 35029 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR