80 FR 26275 - Determination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26275-26276
FR Document		2015-11001

The Food and Drug Administration (FDA) has determined the regulatory review period for HVAD ROTARY BLOOD PUMP 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 medical device.

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26275-26276]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-11001]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1652]

Determination of Regulatory Review Period for Purposes of Patent
Extension; HVAD ROTARY BLOOD PUMP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for HVAD ROTARY BLOOD PUMP 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 medical
device.

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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device HVAD ROTARY BLOOD
PUMP. HVAD ROTARY BLOOD PUMP is indicated for use as a bridge to
cardiac transplantation in patients who are at risk of death from
refractory end-stage left ventricular heart failure. Subsequent to this
approval, the USPTO received a patent term restoration application for
HVAD ROTARY BLOOD PUMP (U.S. Patent No. 6,234,772) from HeartWare,
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 18, 2014, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of HVAD
ROTARY BLOOD PUMP represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
HVAD ROTARY BLOOD PUMP is 1,667 days. Of this time, 973 days occurred
during the testing phase of the regulatory review period, while 694
days occurred during the approval phase. These periods of time were
derived from the following dates:

[[Page 26276]]

1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: April 30, 2008. FDA has verified the
applicant's claim that the date the investigational device exemption
required under section 520(g) of the FD&C act for human tests to begin
became effective April 30, 2008.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD& C Act (21 U.S.C. 360e):
December 28, 2010. The applicant claims December 23, 2010, as the date
the premarket approval application (PMA) for HVAD ROTARY BLOOD PUMP
(PMA P100047) was initially submitted. However, FDA records indicate
that PMA P100047 was submitted on December 28, 2010.
3. The date the application was approved: November 20, 2012. FDA
has verified the applicant's claim that PMA P100047 was approved on
November 20, 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 application for patent extension,
this applicant seeks 818 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 3, 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: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11001 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26275

approval phase. These periods of time petition, two copies are required. A and the Generic Animal Drug and Patent
were derived from the following dates: petition submitted electronically must Term Restoration Act (Pub. L. 100–670)
1. The date an exemption under be submitted to http:// generally provide that a patent may be
section 505(i) of the Federal Food, Drug, www.regulations.gov, Docket No. FDA– extended for a period of up to 5 years
and Cosmetic Act (the FD&C Act) (21 2013–S–0610. so long as the patented item (human
U.S.C. 355(i)) became effective: August Comments and petitions that have not drug product, animal drug product,
12, 2002. The applicant claims February been made publicly available on medical device, food additive, or color
13, 2002, as the date the investigational http://www.regulations.gov may be additive) was subject to regulatory
new animal drug application (INAD) viewed in the Division of Dockets review by FDA before the item was
became effective. However, FDA records Management between 9 a.m. and 4 p.m., marketed. Under these acts, a product’s
indicate that the INAD effective date Monday through Friday. regulatory review period forms the basis
was August 12, 2002, which was the for determining the amount of extension
Dated: May 1, 2015.
date a major health or environmental an applicant may receive.
effects test is begun or the date on Leslie Kux, A regulatory review period consists of
which the Agency acknowledges the Associate Commissioner for Policy. two periods of time: A testing phase and
filing of a notice of claimed [FR Doc. 2015–11003 Filed 5–6–15; 8:45 am] an approval phase. For medical devices,
investigational exemption for a new BILLING CODE 4164–01–P the testing phase begins with a clinical
animal drug, whichever is earlier. investigation of the device and runs
2. The date the application was until the approval phase begins. The
initially submitted with respect to the DEPARTMENT OF HEALTH AND approval phase starts with the initial
animal drug product under section 512 HUMAN SERVICES submission of an application to market
of the FD&C Act (21 U.S.C. 360b): the device and continues until
August 2, 2012. The applicant claims Food and Drug Administration permission to market the device is
July 20, 2012, as the date the new [Docket No. FDA–2013–E–1652] granted. Although only a portion of a
animal drug Application (NADA) for regulatory review period may count
OVUGEL RE42072 (NADA 141–339) Determination of Regulatory Review toward the actual amount of extension
was initially submitted. However, FDA Period for Purposes of Patent that the Director of USPTO may award
records indicate that NADA 141–339 Extension; HVAD ROTARY BLOOD (half the testing phase must be
was submitted on August 2, 2012. PUMP subtracted as well as any time that may
3. The date the application was have occurred before the patent was
approved: September 18, 2012. FDA has AGENCY: Food and Drug Administration, issued), FDA’s determination of the
verified the applicant’s claim that HHS. length of a regulatory review period for
NADA 141–339 was approved on ACTION: Notice. a medical device will include all of the
September 18, 2012. testing phase and approval phase as
This determination of the regulatory SUMMARY: The Food and Drug specified in 35 U.S.C. 156(g)(3)(B).
review period establishes the maximum Administration (FDA) has determined FDA has approved for marketing the
potential length of a patent extension. the regulatory review period for HVAD medical device HVAD ROTARY BLOOD
However, the USPTO applies several ROTARY BLOOD PUMP and is PUMP. HVAD ROTARY BLOOD PUMP
statutory limitations in its calculations publishing this notice of that is indicated for use as a bridge to
of the actual period for patent extension. determination as required by law. FDA cardiac transplantation in patients who
In its applications for patent extension, has made the determination because of are at risk of death from refractory end-
this applicant seeks 331 or 1,826 days the submission of an application to the stage left ventricular heart failure.
of patent term extension. Director of the U.S. Patent and Subsequent to this approval, the USPTO
Anyone with knowledge that any of Trademark Office (USPTO), Department received a patent term restoration
the dates as published are incorrect may of Commerce, for the extension of a application for HVAD ROTARY BLOOD
submit to the Division of Dockets patent which claims that medical PUMP (U.S. Patent No. 6,234,772) from
Management (see ADDRESSES) either device. HeartWare, Inc., and the USPTO
electronic or written comments and ask ADDRESSES: Submit electronic requested FDA’s assistance in
for a redetermination by July 6, 2015. comments to http:// determining this patent’s eligibility for
Furthermore, any interested person may www.regulations.gov. Submit written patent term restoration. In a letter dated
petition FDA for a determination petitions (two copies are required) and March 18, 2014, FDA advised the
regarding whether the applicant for written comments to the Division of USPTO that this medical device had
extension acted with due diligence Dockets Management (HFA–305), Food undergone a regulatory review period
during the regulatory review period by and Drug Administration, 5630 Fishers and that the approval of HVAD
November 3, 2015. To meet its burden, Lane, Rm. 1061, Rockville, MD 20852. ROTARY BLOOD PUMP represented
the petition must contain sufficient facts Submit petitions electronically to the first permitted commercial
to merit an FDA investigation. (See H. http://www.regulations.gov at Docket marketing or use of the product.
Rept. 857, part 1, 98th Cong., 2d sess., No. FDA–2013–S–0610. Thereafter, the USPTO requested that
pp. 41–42, 1984.) Petitions should be in FDA determine the product’s regulatory
FOR FURTHER INFORMATION CONTACT:
the format specified in 21 CFR 10.30. review period.
Interested persons may submit to the Beverly Friedman, Office of FDA has determined that the
Management, Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES

Division of Dockets Management (see applicable regulatory review period for
ADDRESSES) electronic or written
Administration, 10001 New Hampshire HVAD ROTARY BLOOD PUMP is 1,667
comments and written or electronic Ave., Hillandale Campus, Rm. 3180, days. Of this time, 973 days occurred
petitions. It is only necessary to send Silver Spring, MD 20993, 301–796– during the testing phase of the
one set of comments. Identify comments 7900. regulatory review period, while 694
with the docket number found in SUPPLEMENTARY INFORMATION: The Drug days occurred during the approval
brackets in the heading of this Price Competition and Patent Term phase. These periods of time were
document. If you submit a written Restoration Act of 1984 (Pub. L. 98–417) derived from the following dates:

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26276 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

1. The date an exemption under available on http://www.regulations.gov DEPARTMENT OF HEALTH AND
section 520(g) of the Federal Food, Drug, may be viewed in the Division of HUMAN SERVICES
and Cosmetic Act (the FD&C Act) (21 Dockets Management between 9 a.m.
U.S.C. 360j(g)) involving this device and 4 p.m., Monday through Friday. Food and Drug Administration
became effective: April 30, 2008. FDA Dated: May 1, 2015. [Docket No. FDA–2014–E–0100]
has verified the applicant’s claim that Leslie Kux,
the date the investigational device Determination of Regulatory Review
Associate Commissioner for Policy.
exemption required under section Period for Purposes of Patent
520(g) of the FD&C act for human tests [FR Doc. 2015–11001 Filed 5–6–15; 8:45 am]
Extension; SIGNIFOR
to begin became effective April 30, BILLING CODE 4164–01–P

2008. AGENCY: Food and Drug Administration,
2. The date an application was HHS.
initially submitted with respect to the DEPARTMENT OF HEALTH AND ACTION: Notice.
device under section 515 of the FD& C HUMAN SERVICES
Act (21 U.S.C. 360e): December 28, SUMMARY: The Food and Drug
2010. The applicant claims December Food and Drug Administration Administration (FDA) has determined
23, 2010, as the date the premarket the regulatory review period for
approval application (PMA) for HVAD [Docket No. FDA–2013–N–0878] SIGNIFOR and is publishing this notice
ROTARY BLOOD PUMP (PMA of that determination as required by
P100047) was initially submitted. Agency Information Collection law. FDA has made the determination
However, FDA records indicate that Activities; Announcement of Office of because of the submission of an
PMA P100047 was submitted on Management and Budget Approval; application to the Director of the U.S.
December 28, 2010. Premarket Notification for a New Patent and Trademark Office (USPTO),
3. The date the application was Dietary Ingredient Department of Commerce, for the
approved: November 20, 2012. FDA has extension of a patent which claims that
verified the applicant’s claim that PMA AGENCY: Food and Drug Administration, human drug product.
P100047 was approved on November HHS.
ADDRESSES: Submit electronic
20, 2012. ACTION: Notice. comments to http://
This determination of the regulatory www.regulations.gov. Submit written
review period establishes the maximum SUMMARY: The Food and Drug petitions (two copies are required) and
potential length of a patent extension. Administration (FDA) is announcing written comments to the Division of
However, the USPTO applies several that a collection of information entitled, Dockets Management (HFA–305), Food
statutory limitations in its calculations ‘‘Premarket Notification for a New and Drug Administration, 5630 Fishers
of the actual period for patent extension. Dietary Ingredient’’ has been approved Lane, Rm. 1061, Rockville, MD 20852.
In its application for patent extension, by the Office of Management and Submit petitions electronically to
this applicant seeks 818 days of patent Budget (OMB) under the Paperwork http://www.regulations.gov at Docket
term extension. Reduction Act of 1995. No. FDA–2013–S–0610.
Anyone with knowledge that any of
FOR FURTHER INFORMATION CONTACT: FDA FOR FURTHER INFORMATION CONTACT:
the dates as published are incorrect may
PRA Staff, Office of Operations, Food Beverly Friedman, Office of
submit to the Division of Dockets
Management (see ADDRESSES) either and Drug Administration, 8455 Management, Food and Drug
electronic or written comments and ask Colesville Rd., COLE–14526, Silver Administration, 10001 New Hampshire
for a redetermination by July 6, 2015. Spring, MD 20993–0002, PRAStaff@ Ave., Hillandale Campus, Rm. 3180,
Furthermore, any interested person may fda.hhs.gov. Silver Spring, MD 20993, 301–796–
petition FDA for a determination 7900.
SUPPLEMENTARY INFORMATION: On
regarding whether the applicant for February 27, 2015, the Agency SUPPLEMENTARY INFORMATION: The Drug
extension acted with due diligence submitted a proposed collection of Price Competition and Patent Term
during the regulatory review period by information entitled, ‘‘Premarket Restoration Act of 1984 (Pub. L. 98–417)
November 3, 2015. To meet its burden, Notification for a New Dietary and the Generic Animal Drug and Patent
the petition must contain sufficient facts Ingredient’’ to OMB for review and Term Restoration Act (Pub. L. 100–670)
to merit an FDA investigation. (See H. clearance under 44 U.S.C. 3507. An generally provide that a patent may be
Rept. 857, part 1, 98th Cong., 2d sess., Agency may not conduct or sponsor, extended for a period of up to 5 years
pp. 41–42, 1984.) Petitions should be in and a person is not required to respond so long as the patented item (human
the format specified in 21 CFR 10.30. to, a collection of information unless it drug product, animal drug product,
Interested persons may submit to the displays a currently valid OMB control medical device, food additive, or color
Division of Dockets Management (see number. OMB has now approved the additive) was subject to regulatory
ADDRESSES) electronic or written information collection and has assigned review by FDA before the item was
comments and written or electronic OMB control number 0910–0330. The marketed. Under these acts, a product’s
petitions. It is only necessary to send approval expires on March 31, 2018. A regulatory review period forms the basis
one set of comments. Identify comments copy of the supporting statement for this for determining the amount of extension
with the docket number found in information collection is available on an applicant may receive.
mstockstill on DSK4VPTVN1PROD with NOTICES

brackets in the heading of this the Internet at http://www.reginfo.gov/ A regulatory review period consists of
document. If you submit a written public/do/PRAMain. two periods of time: A testing phase and
petition, two copies are required. A an approval phase. For human drug
petition submitted electronically must Dated: May 4, 2015. products, the testing phase begins when
be submitted to http:// Leslie Kux, the exemption to permit the clinical
www.regulations.gov, Docket No. FDA– Associate Commissioner for Policy. investigations of the drug becomes
2013–S–0610. Comments and petitions [FR Doc. 2015–10997 Filed 5–6–15; 8:45 am] effective and runs until the approval
that have not been made publicly BILLING CODE 4164–01–P phase begins. The approval phase starts

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Document Created: 2015-12-16 07:50:31
Document Modified: 2015-12-16 07:50:31

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 26275

80 FR 26275 - Determination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration