80 FR 25303 - Determination of Regulatory Review Period for Purposes of Patent Extension; TUDORZA PRESSAIR

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

Page Range		25303-25304
FR Document		2015-10336

The Food and Drug Administration (FDA) has determined the regulatory review period for TUDORZA PRESSAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 80 Issue 85 (Monday, May 4, 2015)

[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25303-25304]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0476 and FDA-2013-E-0654]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; TUDORZA PRESSAIR

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TUDORZA PRESSAIR and is publishing this 
notice of that determination as required by law. FDA has made the 
determination because of the submission of applications to the Director 
of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.

SUPPLEMENTARY INFORMATION: 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 TUDORZA 
PRESSAIR (aclidinium bromide). TUDORZA PRESSAIR is indicated for the 
long-term maintenance treatment of bronchospasm associated with chronic 
obstructive pulmonary disease, including chronic bronchitis and 
emphysema. Subsequent to this approval, the USPTO received patent term 
restoration applications for TUDORZA PRESSAIR (U.S. Patent Nos. 
6,750,226 and 7,078,412) from Almiral, S.A., and the USPTO requested 
FDA's assistance in determining the patents eligibilities for patent 
term restoration. In a letter dated July 16, 2013, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of TUDORZA PRESSAIR represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO

[[Page 25304]]

requested that FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
TUDORZA PRESSAIR is 3,136 days. Of this time, 2,739 days occurred 
during the testing phase of the regulatory review period, while 397 
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: December 24, 2003. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on December 24, 2003.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: June 23, 
2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for TUDORZA PRESSAIR (NDA 202-450) was submitted on 
June 23, 2011.
    3. The date the application was approved: July 23, 2012. FDA has 
verified the applicant's claim that NDA 202-450 was approved on July 
23, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 1,679 or 1,298 days of patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) either electronic or written comments and ask for a 
redetermination by July 6, 2015. 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 2, 2015. To meet its burden, the petition must 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610.
    Comments and 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: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10336 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25303

patent’s eligibility for patent term Interested persons may submit to the Administration, 10001 New Hampshire
restoration. In a letter dated May 2, Division of Dockets Management (see Ave., Hillandale Campus, Rm. 3180,
2014, FDA advised the USPTO that this ADDRESSES) electronic or written Silver Spring, MD 20993, 301–796–
human drug product had undergone a comments and written or electronic 7900.
regulatory review period and that the petitions. It is only necessary to send SUPPLEMENTARY INFORMATION: The Drug
approval of KAZANO represented the one set of comments. Identify comments Price Competition and Patent Term
first permitted commercial marketing or with the docket number found in Restoration Act of 1984 (Pub. L. 98–417)
use of the product. Thereafter, the brackets in the heading of this and the Generic Animal Drug and Patent
USPTO requested that FDA determine document. If you submit a written Term Restoration Act (Pub. L. 100–670)
the product’s regulatory review period. petition, two copies are required. A generally provide that a patent may be
FDA has determined that the petition submitted electronically must extended for a period of up to 5 years
applicable regulatory review period for be submitted to http:// so long as the patented item (human
KAZANO is 1,365 days. Of this time, www.regulations.gov, Docket No. FDA– drug product, animal drug product,
934 days occurred during the testing 2013–S–0610. Comments and petitions medical device, food additive, or color
phase of the regulatory review period, that have not been made publicly additive) was subject to regulatory
while 431 days occurred during the available on http://www.regulations.gov review by FDA before the item was
approval phase. These periods of time may be viewed in the Division of marketed. Under these acts, a product’s
were derived from the following dates: Dockets Management between 9 a.m. regulatory review period forms the basis
1. The date an exemption under and 4 p.m., Monday through Friday. for determining the amount of extension
section 505(i) of the Federal Food, Drug, Dated: April 28, 2015. an applicant may receive.
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, A regulatory review period consists of
U.S.C. 355(i)) became effective: May 3, Associate Commissioner for Policy. two periods of time: A testing phase and
2009. The applicant claims May 4, 2009, an approval phase. For human drug
[FR Doc. 2015–10335 Filed 5–1–15; 8:45 am]
as the date the investigational new drug products, the testing phase begins when
BILLING CODE 4164–01–P
application (IND) became effective. the exemption to permit the clinical
However, FDA records indicate that the investigations of the drug becomes
IND effective date was May 3, 2009, effective and runs until the approval
DEPARTMENT OF HEALTH AND
which was 30 days after FDA receipt of phase begins. The approval phase starts
HUMAN SERVICES
the IND. with the initial submission of an
2. The date the application was Food and Drug Administration application to market the human drug
initially submitted with respect to the product and continues until FDA grants
human drug product under section [Docket Nos. FDA–2013–E–0476 and FDA–
2013–E–0654]
permission to market the drug product.
505(b) of the FD&C Act: November 22, Although only a portion of a regulatory
2011. FDA has verified the applicant’s Determination of Regulatory Review review period may count toward the
claim that the new drug application Period for Purposes of Patent actual amount of extension that the
(NDA) for KAZANO (NDA 203–414) Extension; TUDORZA PRESSAIR Director of USPTO may award (for
was submitted on November 22, 2011. example, half the testing phase must be
3. The date the application was AGENCY: Food and Drug Administration, subtracted as well as any time that may
approved: January 25, 2013. FDA has HHS. have occurred before the patent was
verified the applicant’s claim that NDA ACTION: Notice. issued), FDA’s determination of the
203–414 was approved on January 25, length of a regulatory review period for
2013. SUMMARY: The Food and Drug
a human drug product will include all
This determination of the regulatory Administration (FDA) has determined
of the testing phase and approval phase
review period establishes the maximum the regulatory review period for
as specified in 35 U.S.C. 156(g)(1)(B).
potential length of a patent extension. TUDORZA PRESSAIR and is publishing FDA has approved for marketing the
However, the USPTO applies several this notice of that determination as human drug product TUDORZA
statutory limitations in its calculations required by law. FDA has made the PRESSAIR (aclidinium bromide).
of the actual period for patent extension. determination because of the TUDORZA PRESSAIR is indicated for
In its application for patent extension, submission of applications to the the long-term maintenance treatment of
this applicant seeks 102 days of patent Director of the U.S. Patent and bronchospasm associated with chronic
term extension. Trademark Office (USPTO), Department obstructive pulmonary disease,
Anyone with knowledge that any of of Commerce, for the extension of a including chronic bronchitis and
the dates as published are incorrect may patent which claims that human drug emphysema. Subsequent to this
submit to the Division of Dockets product. approval, the USPTO received patent
Management (see ADDRESSES) either ADDRESSES: Submit electronic term restoration applications for
electronic or written comments and ask comments to http:// TUDORZA PRESSAIR (U.S. Patent Nos.
for a redetermination by July 6, 2015. www.regulations.gov. Submit written 6,750,226 and 7,078,412) from Almiral,
Furthermore, any interested person may petitions (two copies are required) and S.A., and the USPTO requested FDA’s
petition FDA for a determination written comments to the Division of assistance in determining the patents
regarding whether the applicant for Dockets Management (HFA–305), Food eligibilities for patent term restoration.
and Drug Administration, 5630 Fishers
mstockstill on DSK4VPTVN1PROD with NOTICES

extension acted with due diligence In a letter dated July 16, 2013, FDA
during the regulatory review period by Lane, rm. 1061, Rockville, MD 20852. advised the USPTO that this human
November 2, 2015. To meet its burden, Submit petitions electronically to http:// drug product had undergone a
the petition must contain sufficient facts www.regulations.gov at Docket No. regulatory review period and that the
to merit an FDA investigation. (See H. FDA–2013–S–0610. approval of TUDORZA PRESSAIR
Rept. 857, part 1, 98th Cong., 2d sess., FOR FURTHER INFORMATION CONTACT: represented the first permitted
pp. 41–42, 1984.) Petitions should be in Beverly Friedman, Office of commercial marketing or use of the
the format specified in 21 CFR 10.30. Management, Food and Drug product. Thereafter, the USPTO

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25304 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices

requested that FDA determine the be submitted to http:// address and phone number below.
product’s regulatory review period. www.regulations.gov, Docket No. FDA– Interested parties should refer to the
FDA has determined that the 2013–S–0610. meeting subject as the HRSA Council on
applicable regulatory review period for Comments and petitions that have not Graduate Medical Education.
TUDORZA PRESSAIR is 3,136 days. Of been made publicly available on http:// The conference call-in number is:
this time, 2,739 days occurred during www.regulations.gov may be viewed in 888–566–5974. The passcode is:
the testing phase of the regulatory the Division of Dockets Management 4439136.
review period, while 397 days occurred between 9 a.m. and 4 p.m., Monday The webinar link is https://
during the approval phase. These through Friday. hrsa.connectsolutions.com/bhw_
periods of time were derived from the Dated: April 28, 2015.
cogmemay2015/.
following dates: Contact: Anyone requesting
Leslie Kux, information regarding the COGME
1. The date an exemption under
section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. should contact Dr. Joan Weiss,
and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2015–10336 Filed 5–1–15; 8:45 am] Designated Federal Official within the
U.S.C. 355(i)) became effective: BILLING CODE 4164–01–P Bureau of Health Workforce, Health
December 24, 2003. FDA has verified Resources and Services Administration,
the applicant’s claim that the date the in one of three ways: (1) Send a request
investigational new drug application DEPARTMENT OF HEALTH AND to the following address: Dr. Joan Weiss,
became effective was on December 24, HUMAN SERVICES Designated Federal Official, Bureau of
2003. Health Workforce, Health Resources and
Health Resources and Service
2. The date the application was Services Administration, Parklawn
initially submitted with respect to the Administration Building, Room 12C–05, 5600 Fishers
human drug product under section Council on Graduate Medical Lane, Rockville, Maryland 20857; (2)
505(b) of the FD&C Act: June 23, 2011. Education; Notice of Meeting call (301) 443–0430; or (3) send an email
FDA has verified the applicant’s claim to jweiss@hrsa.gov.
that the new drug application (NDA) for In accordance with section 10(a)(2) of
Jackie Painter,
TUDORZA PRESSAIR (NDA 202–450) the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given Director, Division of the Executive Secretariat.
was submitted on June 23, 2011.
3. The date the application was of the following meeting: [FR Doc. 2015–10354 Filed 5–1–15; 8:45 am]
approved: July 23, 2012. FDA has Name: Council on Graduate Medical
BILLING CODE 4165–15–P
verified the applicant’s claim that NDA Education (COGME).
202–450 was approved on July 23, 2012. Dates and Times: May 21, 2015 (10:00
This determination of the regulatory a.m.–4:00 p.m. EST). DEPARTMENT OF HEALTH AND
review period establishes the maximum Place: Webinar, and Conference Call HUMAN SERVICES
potential length of a patent extension. Format.
Status: The meeting will be open to the Health Resources and Services
However, the USPTO applies several
public. Administration
statutory limitations in its calculations Purpose: The COGME provides advice and
of the actual period for patent extension. recommendations to the Secretary of the Agency Information Collection
In its applications for patent extension, Department of Health and Human Services Activities: Submission to OMB for
this applicant seeks 1,679 or 1,298 days and to Congress on a range of issues Review and Approval; Public Comment
of patent term extension. including the supply and distribution of Request
Anyone with knowledge that any of physicians in the United States, current and
the dates as published are incorrect may future physician shortages or excesses, issues AGENCY: Health Resources and Services
submit to the Division of Dockets relating to foreign medical school graduates, Administration, HHS.
the nature and financing of medical
Management (see ADDRESSES) either ACTION: Notice.
education training, and the development of
electronic or written comments and ask performance measures and longitudinal
for a redetermination by July 6, 2015. SUMMARY: In compliance with section
evaluation of medical education programs.
Furthermore, any interested person may The COGME members will continue their
3507(a)(1)(D) of the Paperwork
petition FDA for a determination discussion on Graduate Medical Education Reduction Act of 1995, the Health
regarding whether the applicant for (GME) innovations. Resources and Services Administration
extension acted with due diligence Agenda: The COGME agenda includes an (HRSA) has submitted an Information
during the regulatory review period by opportunity for members to continue their Collection Request (ICR) to the Office of
discussion on Graduate Medical Education Management and Budget (OMB) for
November 2, 2015. To meet its burden, (GME) innovations including GME
the petition must contain sufficient facts review and approval. Comments
architecture, reform, and financing. submitted during the first public review
to merit an FDA investigation. (See H. The official agenda will be available 2 days
Rept. 857, part 1, 98th Cong., 2d sess., of this ICR will be provided to OMB.
prior to the meeting on the HRSA Web site
pp. 41–42, 1984.) Petitions should be in at http://www.hrsa.gov/advisorycommittees/ OMB will accept further comments from
the format specified in 21 CFR 10.30. bhpradvisory/cogme/index.html the public during the review and
Interested persons may submit to the SUPPLEMENTARY INFORMATION: Members approval period.
Division of Dockets Management (see of the public will have the opportunity DATES: Comments on this ICR should be
ADDRESSES) electronic or written to provide comments. Requests to make received no later than June 3, 2015.
ADDRESSES: Submit your comments,
mstockstill on DSK4VPTVN1PROD with NOTICES

comments and written or electronic oral comments or provide written
petitions. It is only necessary to send comments to the COGME should be sent including the Information Collection
one set of comments. Identify comments to Dr. Joan Weiss, Designated Federal Request Title, to the desk officer for
with the docket number found in Official, using the address and phone HRSA, either by email to OIRA_
brackets in the heading of this number below. Individuals who plan to submission@omb.eop.gov or by fax to
document. If you submit a written participate on the conference call or 202–395–5806.
petition, two copies are required. A webinar should notify Dr. Weiss at least FOR FURTHER INFORMATION CONTACT: To
petition submitted electronically must 3 days prior to the meeting, using the request a copy of the clearance requests

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Document Created: 2018-02-21 10:22:57
Document Modified: 2018-02-21 10:22:57

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.
Contact		Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation		80 FR 25303

80 FR 25303 - Determination of Regulatory Review Period for Purposes of Patent Extension; TUDORZA PRESSAIR

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 85 (May 4, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration