80 FR 23035 - Determination of Regulatory Review Period for Purposes of Patent Extension; KYNAMRO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

Page Range		23035-23036
FR Document		2015-09522

The Food and Drug Administration (FDA) has determined the regulatory review period for KYNAMRO 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.

Federal Register, Volume 80 Issue 79 (Friday, April 24, 2015)

[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 23035-23036]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09522]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0299]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; KYNAMRO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for KYNAMRO 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.

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

[[Page 23036]]

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 KYNAMRO 
(mipomersen sodium). KYNAMRO is indicated as an adjunct to lipid-
lowering medications and diet to reduce low density lipoprotein-
cholesterol, apolipoprotein B, total cholesterol, and non-high density 
lipoprotein-cholesterol in patients with homozygous familial 
hypercholesterolemia. Subsequent to this approval, the USPTO received a 
patent term restoration application for KYNAMRO (U.S. Patent No. 
7,511,131) from Genzyme Corporation, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 27, 2014, FDA advised the USPTO 
that this human drug product had undergone a regulatory review period 
and that the approval of KYNAMRO 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 
KYNAMRO is 2,601 days. Of this time, 2,294 days occurred during the 
testing phase of the regulatory review period, while 307 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 18, 2005. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on December 18, 2005.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: March 29, 
2012. FDA has verified the applicant's claim that the new drug 
application (NDA) for KYNAMRO (NDA 203568) was submitted on March 29, 
2012.
    3. The date the application was approved: January 29, 2013. FDA has 
verified the applicant's claim that NDA 203568 was approved on January 
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 853 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 June 23, 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 October 21, 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 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09522 Filed 4-23-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23035

regulatory review period forms the basis date was October 22, 2004, which was DEPARTMENT OF HEALTH AND
for determining the amount of extension 30 days after FDA receipt of the IND. HUMAN SERVICES
an applicant may receive. 2. The date the application was
A regulatory review period consists of Food and Drug Administration
initially submitted with respect to the
two periods of time: A testing phase and human drug product under section [Docket No. FDA–2014–E–0299]
an approval phase. For human drug 505(b) of the FD&C Act: April 18, 2008.
products, the testing phase begins when FDA has verified the applicant’s claim Determination of Regulatory Review
the exemption to permit the clinical that the biologics license application Period for Purposes of Patent
investigations of the drug becomes (BLA) for FLUBLOK (BLA 125285/0) Extension; KYNAMRO
effective and runs until the approval was submitted on April 18, 2008.
phase begins. The approval phase starts AGENCY: Food and Drug Administration,
with the initial submission of an 3. The date the application was HHS.
application to market the human drug approved: January 16, 2013. FDA has ACTION: Notice.
product and continues until FDA grants verified the applicant’s claim that BLA
125285/0 was approved on January 16, SUMMARY: The Food and Drug
permission to market the drug product. Administration (FDA) has determined
Although only a portion of a regulatory 2013.
the regulatory review period for
review period may count toward the This determination of the regulatory KYNAMRO and is publishing this
actual amount of extension that the review period establishes the maximum notice of that determination as required
Director of USPTO may award (for potential length of a patent extension. by law. FDA has made the
example, half the testing phase must be However, the USPTO applies several determination because of the
subtracted as well as any time that may statutory limitations in its calculations submission of an application to the
have occurred before the patent was of the actual period for patent extension. Director of the U.S. Patent and
issued), FDA’s determination of the In its application for patent extension, Trademark Office (USPTO), Department
length of a regulatory review period for this applicant seeks 5 years of patent of Commerce, for the extension of a
a human drug product will include all term extension. patent which claims that human drug
of the testing phase and approval phase product.
Anyone with knowledge that any of
as specified in 35 U.S.C. 156(g)(1)(B).
the dates as published are incorrect may ADDRESSES: Submit electronic
FDA has approved for marketing the submit to the Division of Dockets
human biological product FLUBLOK comments to http://
Management (see ADDRESSES) either www.regulations.gov. Submit written
(A/California/7/2009(h1N1), A/Victoria/
electronic or written comments and ask petitions (two copies are required) and
361/2011(H3N2), B/Wisconsin/1/2010).
for a redetermination by June 23, 2015. written comments to the Division of
FLUBLOK is a vaccine indicated for
Furthermore, any interested person may Dockets Management (HFA–305), Food
active immunization against disease
petition FDA for a determination and Drug Administration, 5630 Fishers
caused by influenza virus subtypes A
regarding whether the applicant for Lane, Rm. 1061, Rockville, MD 20852.
and type B contained in the vaccine.
extension acted with due diligence Submit petitions electronically to
Subsequent to this approval, the USPTO
during the regulatory review period by http://www.regulations.gov at Docket
received a patent term restoration
October 21, 2015. To meet its burden, No. FDA–2013–S–0610.
application for FLUBLOK (U.S. Patent
the petition must contain sufficient facts FOR FURTHER INFORMATION CONTACT:
No. 5,762,939) from Protein Sciences
to merit an FDA investigation. (See H. Beverly Friedman, Office of
Corporation, and the USPTO requested
FDA’s assistance in determining this Rept. 857, part 1, 98th Cong., 2d sess., Management, Food and Drug
patent’s eligibility for patent term pp. 41–42, 1984.) Petitions should be in Administration, 10001 New Hampshire
restoration. In a letter dated March 26, the format specified in 21 CFR 10.30. Ave., Hillandale Campus, Rm. 3180,
2014, FDA advised the USPTO that this Interested persons may submit to the Silver Spring, MD 20993, 301–796–
human drug product had undergone a Division of Dockets Management (see 7900.
regulatory review period and that the ADDRESSES) electronic or written SUPPLEMENTARY INFORMATION: The Drug
approval of FLUBLOK represented the comments and written or electronic Price Competition and Patent Term
first permitted commercial marketing or petitions. It is only necessary to send Restoration Act of 1984 (Pub. L. 98–417)
use of the product. Thereafter, the one set of comments. Identify comments and the Generic Animal Drug and Patent
USPTO requested that FDA determine with the docket number found in Term Restoration Act (Pub. L. 100–670)
the product’s regulatory review period. brackets in the heading of this generally provide that a patent may be
FDA has determined that the document. If you submit a written extended for a period of up to 5 years
applicable regulatory review period for petition, two copies are required. A so long as the patented item (human
FLUBLOK is 3,010 days. Of this time, petition submitted electronically must drug product, animal drug product,
1,275 days occurred during the testing be submitted to http:// medical device, food additive, or color
phase of the regulatory review period, www.regulations.gov, Docket No. FDA– additive) was subject to regulatory
while 1,735 days occurred during the 2013–S–0610. Comments and petitions review by FDA before the item was
approval phase. These periods of time that have not been made publicly marketed. Under these acts, a product’s
were derived from the following dates: available on http://www.regulations.gov regulatory review period forms the basis
1. The date an exemption under may be viewed in the Division of for determining the amount of extension
section 505(i) of the Federal Food, Drug, Dockets Management between 9 a.m. an applicant may receive.
tkelley on DSK3SPTVN1PROD with NOTICES

and Cosmetic Act (the FD&C Act) (21 and 4 p.m., Monday through Friday. A regulatory review period consists of
U.S.C. 355(i)) became effective: October Dated: April 20, 2015. two periods of time: A testing phase and
22, 2004. The applicant claims an approval phase. For human drug
Leslie Kux,
September 23, 2004, as the date the products, the testing phase begins when
investigational new drug application Associate Commissioner for Policy. the exemption to permit the clinical
(IND) became effective. However, FDA [FR Doc. 2015–09521 Filed 4–23–15; 8:45 am] investigations of the drug becomes
records indicate that the IND effective BILLING CODE 4164–01–P effective and runs until the approval

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23036 Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices

phase begins. The approval phase starts 3. The date the application was ACTION: Notice.
with the initial submission of an approved: January 29, 2013. FDA has
application to market the human drug verified the applicant’s claim that NDA SUMMARY: The Health Resources and
product and continues until FDA grants 203568 was approved on January 29, Services Administration (HRSA) is
permission to market the drug product. 2013. publishing this notice of petitions
Although only a portion of a regulatory This determination of the regulatory received under the National Vaccine
review period may count toward the review period establishes the maximum Injury Compensation Program (the
actual amount of extension that the potential length of a patent extension. Program), as required by Section
Director of USPTO may award (for However, the USPTO applies several 2112(b)(2) of the Public Health Service
example, half the testing phase must be statutory limitations in its calculations (PHS) Act, as amended. While the
subtracted as well as any time that may of the actual period for patent extension. Secretary of Health and Human Services
In its application for patent extension, is named as the respondent in all
have occurred before the patent was
this applicant seeks 853 days of patent proceedings brought by the filing of
issued), FDA’s determination of the
term extension. petitions for compensation under the
length of a regulatory review period for
Anyone with knowledge that any of Program, the United States Court of
a human drug product will include all
the dates as published are incorrect may Federal Claims is charged by statute
of the testing phase and approval phase
submit to the Division of Dockets with responsibility for considering and
as specified in 35 U.S.C. 156(g)(1)(B).
Management (see ADDRESSES) either acting upon the petitions.
FDA has approved for marketing the
electronic or written comments and ask FOR FURTHER INFORMATION CONTACT: For
human drug product KYNAMRO
for a redetermination by June 23, 2015. information about requirements for
(mipomersen sodium). KYNAMRO is
Furthermore, any interested person may filing petitions, and the Program in
indicated as an adjunct to lipid-
petition FDA for a determination general, contact the Clerk, United States
lowering medications and diet to reduce
regarding whether the applicant for Court of Federal Claims, 717 Madison
low density lipoprotein-cholesterol,
extension acted with due diligence Place NW., Washington, DC 20005,
apolipoprotein B, total cholesterol, and
during the regulatory review period by (202) 357–6400. For information on
non-high density lipoprotein-cholesterol
October 21, 2015. To meet its burden, HRSA’s role in the Program, contact the
in patients with homozygous familial
the petition must contain sufficient facts Director, National Vaccine Injury
hypercholesterolemia. Subsequent to
to merit an FDA investigation. (See H. Compensation Program, 5600 Fishers
this approval, the USPTO received a
Rept. 857, part 1, 98th Cong., 2d sess., Lane, Room 11C–26, Rockville, MD
patent term restoration application for 20857; (301) 443–6593.
KYNAMRO (U.S. Patent No. 7,511,131) pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30. SUPPLEMENTARY INFORMATION: The
from Genzyme Corporation, and the
USPTO requested FDA’s assistance in Interested persons may submit to the Program provides a system of no-fault
Division of Dockets Management (see compensation for certain individuals
determining this patent’s eligibility for
ADDRESSES) electronic or written who have been injured by specified
patent term restoration. In a letter dated
comments and written or electronic childhood vaccines. Subtitle 2 of Title
March 27, 2014, FDA advised the
petitions. It is only necessary to send XXI of the PHS Act, 42 U.S.C. 300aa–
USPTO that this human drug product
one set of comments. Identify comments 10 et seq., provides that those seeking
had undergone a regulatory review
with the docket number found in compensation are to file a petition with
period and that the approval of
brackets in the heading of this the U.S. Court of Federal Claims and to
KYNAMRO represented the first
document. If you submit a written serve a copy of the petition on the
permitted commercial marketing or use
petition, two copies are required. A Secretary of Health and Human
of the product. Thereafter, the USPTO
petition submitted electronically must Services, who is named as the
requested that FDA determine the respondent in each proceeding. The
product’s regulatory review period. be submitted to http://
www.regulations.gov, Docket No. FDA– Secretary has delegated this
FDA has determined that the responsibility under the Program to
applicable regulatory review period for 2013–S–0610.
Comments and petitions that have not HRSA. The Court is directed by statute
KYNAMRO is 2,601 days. Of this time, to appoint special masters who take
2,294 days occurred during the testing been made publicly available on
http://www.regulations.gov may be evidence, conduct hearings as
phase of the regulatory review period, appropriate, and make initial decisions
while 307 days occurred during the viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., as to eligibility for, and amount of,
approval phase. These periods of time compensation.
were derived from the following dates: Monday through Friday.
A petition may be filed with respect
1. The date an exemption under Dated: April 20, 2015. to injuries, disabilities, illnesses,
section 505(i) of the Federal Food, Drug, Leslie Kux, conditions, and deaths resulting from
and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. vaccines described in the Vaccine Injury
U.S.C. 355(i)) became effective: [FR Doc. 2015–09522 Filed 4–23–15; 8:45 am] Table (the Table) set forth at Section
December 18, 2005. FDA has verified BILLING CODE 4164–01–P 2114 of the PHS Act or as set forth at
the applicant’s claim that the date the 42 CFR 100.3, as applicable. This Table
investigational new drug application lists for each covered childhood vaccine
became effective was on December 18, DEPARTMENT OF HEALTH AND the conditions that may lead to
2005. HUMAN SERVICES compensation and, for each condition,
2. The date the application was the time period for occurrence of the
Health Resources and Services
tkelley on DSK3SPTVN1PROD with NOTICES

initially submitted with respect to the first symptom or manifestation of onset
human drug product under section Administration or of significant aggravation after
505(b) of the FD&C Act: March 29, 2012. vaccine administration. Compensation
National Vaccine Injury Compensation
FDA has verified the applicant’s claim may also be awarded for conditions not
Program; List of Petitions Received
that the new drug application (NDA) for listed in the Table and for conditions
KYNAMRO (NDA 203568) was AGENCY:Health Resources and Services that are manifested outside the time
submitted on March 29, 2012. Administration, HHS. periods specified in the Table, but only

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Document Created: 2015-12-16 08:43:15
Document Modified: 2015-12-16 08:43:15

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 23035

80 FR 23035 - Determination of Regulatory Review Period for Purposes of Patent Extension; KYNAMRO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 79 (April 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration