81 FR 10630 - Determination of Regulatory Review Period for Purposes of Patent Extension; ANORO ELLIPTA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 40 (March 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 40 (March 1, 2016)
| Page Range | 10630-10632 | |
| FR Document | 2016-04370 |
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)] [Notices] [Pages 10630-10632] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04370] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2371] Determination of Regulatory Review Period for Purposes of Patent Extension; ANORO ELLIPTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ANORO ELLIPTA 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 May 2, 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 August 29, 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 [[Page 10631]] 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-2371 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ANORO ELLIPTA.'' 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 ANORO ELLIPTA (umeclidinium/vilanterol). ANORO ELLIPTA is indicated for the long- term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Subsequent to this approval, the USPTO received a patent term restoration application for ANORO ELLIPTA (U.S. Patent No. 7,488,827) from Glaxo Group Limited, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ANORO ELLIPTA 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 ANORO ELLIPTA is 1,589 days. Of this time, 1,223 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 14, 2009. The applicant claims August 13, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 14, 2009, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 18, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for ANORO ELLIPTA (NDA 203975) was initially submitted on December 18, 2012. 3. The date the application was approved: December 18, 2013. FDA has verified the applicant's claim that NDA 203975 was approved on December 18, 2013. [[Page 10632]] 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 966 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. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 24, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04370 Filed 2-29-16; 8:45 am] BILLING CODE 4164-01-P
![10630 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
I. Background II. Determination of Regulatory Review www.regulations.gov may be viewed in
Period the Division of Dockets Management
The Drug Price Competition and between 9 a.m. and 4 p.m., Monday
Patent Term Restoration Act of 1984 FDA has determined that the
applicable regulatory review period for through Friday.
(Pub. L. 98–417) and the Generic
INVOKANA is 2,137 days. Of this time, Dated: February 24, 2016.
Animal Drug and Patent Term
1,834 days occurred during the testing Leslie Kux,
Restoration Act (Pub. L. 100–670)
phase of the regulatory review period, Associate Commissioner for Policy.
generally provide that a patent may be
while 303 days occurred during the [FR Doc. 2016–04369 Filed 2–29–16; 8:45 am]
extended for a period of up to 5 years approval phase. These periods of time BILLING CODE 4164–01–P
so long as the patented item (human were derived from the following dates:
drug product, animal drug product, 1. The date an exemption under
medical device, food additive, or color section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21 HUMAN SERVICES
review by FDA before the item was U.S.C. 355(i)) became effective: May 25,
marketed. Under these acts, a product’s 2007. FDA has verified the Mitsubishi Food and Drug Administration
regulatory review period forms the basis Tanabe Pharma Corporation of Osaka, [Docket No. FDA–2014–E–2371]
for determining the amount of extension Japan claim that May 25, 2007, is the
an applicant may receive. date the investigational new drug Determination of Regulatory Review
A regulatory review period consists of application became effective Period for Purposes of Patent
two periods of time: A testing phase and 2. The date the application was Extension; ANORO ELLIPTA
an approval phase. For human drug initially submitted with respect to the
human drug product under section AGENCY: Food and Drug Administration,
products, the testing phase begins when HHS.
the exemption to permit the clinical 505(b) of the FD&C Act: May 31, 2012.
FDA has verified the applicant’s claim ACTION: Notice.
investigations of the drug becomes
that the new drug application (NDA) for
effective and runs until the approval SUMMARY: The Food and Drug
INVOKANA (NDA 204042) was initially
phase begins. The approval phase starts submitted on May 31, 2012. Administration (FDA) has determined
with the initial submission of an 3. The date the application was the regulatory review period for ANORO
application to market the human drug approved: March 29, 2013. FDA has ELLIPTA and is publishing this notice
product and continues until FDA grants verified the applicant’s claim that NDA of that determination as required by
permission to market the drug product. 204042 was approved on March 29, law. FDA has made the determination
Although only a portion of a regulatory 2013. because of the submission of an
review period may count toward the This determination of the regulatory application to the Director of the U.S.
actual amount of extension that the review period establishes the maximum Patent and Trademark Office (USPTO),
Director of USPTO may award (for potential length of a patent extension. Department of Commerce, for the
example, half the testing phase must be However, the USPTO applies several extension of a patent which claims that
subtracted as well as any time that may statutory limitations in its calculations human drug product.
have occurred before the patent was of the actual period for patent extension. DATES: Anyone with knowledge that any
issued), FDA’s determination of the In its application for patent extension, of the dates as published (in the
length of a regulatory review period for this applicant seeks 256 days of patent SUPPLEMENTARY INFORMATION section) are
a human drug product will include all term extension. incorrect may submit either electronic
of the testing phase and approval phase or written comments and ask for a
III. Petitions redetermination by May 2, 2016.
as specified in 35 U.S.C. 156(g)(1)(B).
Anyone with knowledge that any of Furthermore, any interested person may
FDA has approved for marketing the the dates as published are incorrect may petition FDA for a determination
human drug product INVOKANA submit either electronic or written regarding whether the applicant for
(canagliflozin). INVOKANA is indicated comments and ask for a redetermination extension acted with due diligence
as an adjunct to diet and exercise to (see DATES). Furthermore, any interested during the regulatory review period by
improve glycemic control in adults with person may petition FDA for a August 29, 2016. See ‘‘Petitions’’ in the
type 2 diabetes mellitus. Subsequent to determination regarding whether the SUPPLEMENTARY INFORMATION section for
this approval, the USPTO received a applicant for extension acted with due more information.
patent term restoration application for diligence during the regulatory review ADDRESSES: You may submit comments
INVOKANA (U.S. Patent No. 8,222,219) period. To meet its burden, the petition as follows:
from Mitsubishi Tanabe Pharma must be timely (see DATES) and contain
Corporation of Osaka, Japan, and the sufficient facts to merit an FDA Electronic Submissions
USPTO requested FDA’s assistance in investigation. (See H. Rept. 857, part 1, Submit electronic comments in the
determining this patent’s eligibility for 98th Cong., 2d sess., pp. 41–42, 1984.) following way:
patent term restoration. In a letter dated Petitions should be in the format • Federal eRulemaking Portal: http://
May 11, 2015, FDA advised the USPTO specified in 21 CFR 10.30. www.regulations.gov. Follow the
Submit petitions electronically to instructions for submitting comments.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
that this human drug product had
undergone a regulatory review period http://www.regulations.gov at Docket Comments submitted electronically,
and that the approval of INVOKANA No. FDA–2013–S–0610. Submit written including attachments, to http://
represented the first permitted petitions (two copies are required) to the www.regulations.gov will be posted to
Division of Dockets Management (HFA– the docket unchanged. Because your
commercial marketing or use of the
305), Food and Drug Administration, comment will be made public, you are
product. Thereafter, the USPTO
5630 Fishers Lane, Rm. 1061, Rockville, solely responsible for ensuring that your
requested that FDA determine the
MD 20852. Petitions that have not been comment does not include any
product’s regulatory review period. made publicly available on http:// confidential information that you or a
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![10632 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
This determination of the regulatory document entitled ‘‘Enforcement Policy • Mail/Hand delivery/Courier (for
review period establishes the maximum Regarding Investigational New Drug written/paper submissions): Division of
potential length of a patent extension. Requirements for Use of Fecal Dockets Management (HFA–305), Food
However, the USPTO applies several Microbiota for Transplantation to Treat and Drug Administration, 5630 Fishers
statutory limitations in its calculations Clostridium difficile Infection Not Lane, Rm. 1061, Rockville, MD 20852.
of the actual period for patent extension. Responsive to Standard Therapies; Draft • For written/paper comments
In its application for patent extension, Guidance for Industry.’’ The draft submitted to the Division of Dockets
this applicant seeks 966 days of patent guidance document provides members Management, FDA will post your
term extension. of the medical and scientific community comment, as well as any attachments,
and other interested persons with notice except for information submitted,
III. Petitions marked and identified, as confidential,
that, when finalized, we intend to
Anyone with knowledge that any of exercise enforcement discretion under if submitted as detailed in
the dates as published are incorrect may limited conditions, regarding the ‘‘Instructions.’’
submit either electronic or written investigational new drug (IND) Instructions: All submissions received
comments and ask for a redetermination requirements for the use of fecal must include the Docket No. FDA–
(see DATES). Furthermore, any interested microbiota for transplantation (FMT) to 2013–D–0811 for ‘‘Enforcement Policy
person may petition FDA for a treat C. difficile infection not Regarding Investigational New Drug
determination regarding whether the responding to standard therapies. The Requirements for Use of Fecal
applicant for extension acted with due draft guidance replaces the draft Microbiota for Transplantation to Treat
diligence during the regulatory review guidance of the same title dated March Clostridium difficile Infection Not
period. To meet its burden, the petition 2014 and, when finalized, is intended to Responsive to Standard Therapies.’’
must be timely (see DATES) and contain supersede the document of the same Received comments will be placed in
sufficient facts to merit an FDA title, dated July 2013. the docket and, except for those
investigation. (See H. Rept. 857, part 1, DATES: Although you can comment on submitted as ‘‘Confidential
98th Cong., 2d sess., pp. 41–42, 1984.) any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
Petitions should be in the format 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
specified in 21 CFR 10.30. considers your comment on this draft Division of Dockets Management
Submit petitions electronically to guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
http://www.regulations.gov at Docket final version of the guidance, submit through Friday.
No. FDA–2013–S–0610. Submit written either electronic or written comments • Confidential Submissions—To
petitions (two copies are required) to the on the draft guidance by May 31, 2016. submit a comment with confidential
Division of Dockets Management (HFA– information that you do not wish to be
ADDRESSES: You may submit comments
305), Food and Drug Administration, made publicly available, submit your
as follows:
5630 Fishers Lane, Rm. 1061, Rockville, comments only as a written/paper
MD 20852. Petitions that have not been Electronic Submissions submission. You should submit two
made publicly available on http:// Submit electronic comments in the copies, total. One copy will include the
www.regulations.gov may be viewed in following way: information you claim to be confidential
the Division of Dockets Management • Federal eRulemaking Portal: http:// with a heading or cover note that states
between 9 a.m. and 4 p.m., Monday www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
through Friday. instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Dated: February 24, 2016. Comments submitted electronically, Agency will review this copy, including
including attachments, to http:// the claimed confidential information, in
Leslie Kux,
www.regulations.gov will be posted to its consideration of comments. The
Associate Commissioner for Policy.
the docket unchanged. Since your second copy, which will have the
[FR Doc. 2016–04370 Filed 2–29–16; 8:45 am] claimed confidential information
comment will be made public, you are
BILLING CODE 4164–01–P
solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
confidential information that you or a http://www.regulations.gov. Submit
DEPARTMENT OF HEALTH AND both copies to the Division of Dockets
HUMAN SERVICES third party may not wish to be posted,
such as medical information, your or Management. If you do not wish your
Food and Drug Administration anyone else’s Social Security number, or name and contact information to be
confidential business information, such made publicly available, you can
[Docket No. FDA–2013–D–0811] as a manufacturing process. Please note provide this information on the cover
that if you include your name, contact sheet and not in the body of your
Enforcement Policy Regarding comments, and you must identify this
information, or other information that
Investigational New Drug information as ‘‘confidential.’’ Any
identifies you in the body of your
Requirements for Use of Fecal information marked as ‘‘confidential’’
comments, that information will be
Microbiota for Transplantation To Treat will not be disclosed except in
posted on http://www.regulations.gov.
Clostridium difficile Infection Not
• If you want to submit a comment accordance with 21 CFR 10.20 and other
Responsive to Standard Therapies; applicable disclosure law. For more
with confidential information that you
Draft Guidance for Industry; information about FDA’s posting of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
do not wish to be made available to the
Availability comments to public dockets, see 80 FR
public, submit the comment as a
AGENCY: Food and Drug Administration, written/paper submission and in the 56469, September 18, 2015, or access
HHS. manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
default.htm.
SUMMARY: The Food and Drug Written/Paper Submissions Docket: For access to the docket to
Administration (FDA or Agency) is Submit written/paper submissions as read background documents or the
announcing the availability of a draft follows: electronic and written/paper comments
VerDate Sep<11>2014 20:18 Feb 29, 2016 Jkt 238001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\01MRN1.SGM 01MRN1](https://thefederalregister.org/doc/81_FR_10670/page/3.svg)
Document Created: 2018-02-02 15:00:11
Document Modified: 2018-02-02 15:00:11
| 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 May 2, 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 August 29, 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 10630 |
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