81 FR 35028 - Determination of Regulatory Review Period for Purposes of Patent Extension; MEKINIST
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 | 35028-35029 | |
| FR Document | 2016-12859 |
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)] [Notices] [Pages 35028-35029] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12859] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2340] Determination of Regulatory Review Period for Purposes of Patent Extension; MEKINIST AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for MEKINIST 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 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-2014-E-2340 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; MEKINIST.'' 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 [[Page 35029]] 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 MEKINIST (trametinib dimethyl sulfoxide solvate). MEKINIST is indicated for treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutations as detected by an FDA-approved test. Subsequent to this approval, the USPTO received a patent term restoration application for MEKINIST (U.S. Patent No. 7,378,423) from Japan Tobacco, Inc., 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 MEKINIST 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 MEKINIST is 1,842 days. Of this time, 1,542 days occurred during the testing phase of the regulatory review period, while 300 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: May 15, 2008. FDA has verified the Japan Tobacco, Inc., claim that May 15, 2008, is the date the investigational new drug application became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 3, 2012. The applicant claims August 2, 2012, as the date the new drug application (NDA) for MEKINIST (NDA 204-114) was initially submitted. However, FDA records indicate that NDA 204-114 was submitted on August 3, 2012. 3. The date the application was approved: May 29, 2013. FDA has verified the applicant's claim that NDA 204-114 was approved on May 29, 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 623 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 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12859 Filed 5-31-16; 8:45 am] BILLING CODE 4164-01-P
![35028 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
the date the investigational new drug ACTION: Notice. and Drug Administration, 5630 Fishers
application (IND) became effective. Lane, Rm. 1061, Rockville, MD 20852.
2. The date the application was SUMMARY: The Food and Drug • For written/paper comments
initially submitted with respect to the Administration (FDA) has determined submitted to the Division of Dockets
human drug product under section the regulatory review period for Management, FDA will post your
505(b) of the FD&C Act: April 26, 2012. MEKINIST and is publishing this notice comment, as well as any attachments,
FDA has verified the applicant’s claim of that determination as required by except for information submitted,
that the new drug application (NDA) for law. FDA has made the determination marked and identified, as confidential,
OSPHENA (NDA 203505) was initially because of the submission of an if submitted as detailed in
submitted on April 26, 2012. application to the Director of the U.S. ‘‘Instructions.’’
3. The date the application was Patent and Trademark Office (USPTO), Instructions: All submissions received
approved: February 26, 2013. FDA has Department of Commerce, for the must include the Docket No. FDA–
verified the applicant’s claim that NDA extension of a patent which claims that 2014–E–2340 for ‘‘Determination of
203505 was approved on February 26, human drug product. Regulatory Review Period for Purposes
2013. DATES: Anyone with knowledge that any of Patent Extension; MEKINIST.’’
This determination of the regulatory of the dates as published (in the Received comments will be placed in
review period establishes the maximum SUPPLEMENTARY INFORMATION section) are the docket and, except for those
potential length of a patent extension. incorrect may submit either electronic submitted as ‘‘Confidential
However, the USPTO applies several or written comments and ask for a Submissions,’’ publicly viewable at
statutory limitations in its calculations redetermination by August 1, 2016. http://www.regulations.gov or at the
of the actual period for patent extension. Furthermore, any interested person may Division of Dockets Management
In its application for patent extension, petition FDA for a determination between 9 a.m. and 4 p.m., Monday
this applicant seeks 1,826 days of patent regarding whether the applicant for through Friday.
term extension. extension acted with due diligence • Confidential Submissions—To
during the regulatory review period by submit a comment with confidential
III. Petitions
November 28, 2016. See ‘‘Petitions’’ in information that you do not wish to be
Anyone with knowledge that any of the SUPPLEMENTARY INFORMATION section made publicly available, submit your
the dates as published are incorrect may for more information. comments only as a written/paper
submit either electronic or written submission. You should submit two
ADDRESSES: You may submit comments
comments and ask for a redetermination copies total. One copy will include the
as follows:
(see DATES). Furthermore, any interested information you claim to be confidential
person may petition FDA for a Electronic Submissions with a heading or cover note that states
determination regarding whether the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
applicant for extension acted with due following way: CONFIDENTIAL INFORMATION’’. The
diligence during the regulatory review • Federal eRulemaking Portal: http:// Agency will review this copy, including
period. To meet its burden, the petition www.regulations.gov. Follow the the claimed confidential information, in
must be timely (see DATES) and contain instructions for submitting comments. its consideration of comments. The
sufficient facts to merit an FDA Comments submitted electronically, second copy, which will have the
investigation. (See H. Rept. 857, part 1, including attachments, to http:// claimed confidential information
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to redacted/blacked out, will be available
Petitions should be in the format the docket unchanged. Because your for public viewing and posted on http://
specified in 21 CFR 10.30. comment will be made public, you are www.regulations.gov. Submit both
Submit petitions electronically to solely responsible for ensuring that your copies to the Division of Dockets
http://www.regulations.gov at Docket comment does not include any Management. If you do not wish your
No. FDA–2013–S–0610. Submit written confidential information that you or a name and contact information to be
petitions (two copies are required) to the third party may not wish to be posted, made publicly available, you can
Division of Dockets Management (HFA– such as medical information, your or provide this information on the cover
305), Food and Drug Administration, anyone else’s Social Security number, or sheet and not in the body of your
5630 Fishers Lane, Rm. 1061, Rockville, confidential business information, such comments and you must identify this
MD 20852. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Dated: May 25, 2016. that if you include your name, contact information marked as ‘‘confidential’’
Leslie Kux, information, or other information that will not be disclosed except in
Associate Commissioner for Policy. identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
[FR Doc. 2016–12823 Filed 5–31–16; 8:45 am]
posted on http://www.regulations.gov. information about FDA’s posting of
BILLING CODE 4164–01–P
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
read background documents or the
sradovich on DSK3TPTVN1PROD with NOTICES
[Docket No. FDA–2014–E–2340]
Submissions’’ and ‘‘Instructions’’).
electronic and written/paper comments
Written/Paper Submissions received, go to http://
Determination of Regulatory Review
Submit written/paper submissions as www.regulations.gov and insert the
Period for Purposes of Patent
follows: docket number, found in brackets in the
Extension; MEKINIST
• Mail/Hand delivery/Courier (for heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
HHS. Dockets Management (HFA–305), Food and/or go to the Division of Dockets
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![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_35133/page/2.svg)
Document Created: 2018-02-08 07:27:18
Document Modified: 2018-02-08 07:27:18
| 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 35028 |
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