80 FR 22528 - Determination of Regulatory Review Period for Purposes of Patent Extension; COMETRIQ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

Page Range		22528-22528
FR Document		2015-09302

The Food and Drug Administration (FDA) has determined the regulatory review period for COMETRIQ 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 77 (Wednesday, April 22, 2015)

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22528]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-09302]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0131]

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

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 COMETRIQ 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 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 COMETRIQ
(cabozanitinib (S)-maleate). COMETRIQ is indicated for the treatment of
patients with progressive, metastatic medullary thyroid cancer.
Subsequent to this approval, the USPTO received a patent term
restoration application for COMETRIQ (U.S. Patent No. 7,579,473) from
Exelixis, Incorporated, 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 COMETRIQ 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
COMETRIQ is 2,698 days. Of this time, 2,513 days occurred during the
testing phase of the regulatory review period, while 185 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: July 13, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 13, 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: May 29,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for COMETRIQ (NDA 203756) was submitted on May 29,
2012.
3. The date the application was approved: November 29, 2012. FDA
has verified the applicant's claim that NDA 203756 was approved on
November 29, 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 688 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 22, 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 19, 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 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09302 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P

22528 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices

II. Electronic Access drug product, animal drug product, new drug application became effective
Persons with access to the Internet medical device, food additive, or color was on July 13, 2005.
may obtain the documents at http:// additive) was subject to regulatory 2. The date the application was
www.fda.gov/MedicalDevices/ review by FDA before the item was initially submitted with respect to the
ProductsandMedicalProcedures/ marketed. Under these acts, a product’s human drug product under section
DeviceApprovalsandClearances/ regulatory review period forms the basis 505(b) of the FD&C Act: May 29, 2012.
PMAApprovals/default.htm. for determining the amount of extension FDA has verified the applicant’s claim
an applicant may receive. that the new drug application (NDA) for
Dated: April 16, 2015. A regulatory review period consists of
Leslie Kux, COMETRIQ (NDA 203756) was
two periods of time: A testing phase and submitted on May 29, 2012.
Associate Commissioner for Policy. an approval phase. For human drug
[FR Doc. 2015–09298 Filed 4–21–15; 8:45 am] products, the testing phase begins when 3. The date the application was
BILLING CODE 4164–01–P the exemption to permit the clinical approved: November 29, 2012. FDA has
investigations of the drug becomes verified the applicant’s claim that NDA
effective and runs until the approval 203756 was approved on November 29,
DEPARTMENT OF HEALTH AND phase begins. The approval phase starts 2012.
HUMAN SERVICES with the initial submission of an This determination of the regulatory
application to market the human drug review period establishes the maximum
Food and Drug Administration product and continues until FDA grants potential length of a patent extension.
[Docket No. FDA–2014–E–0131] permission to market the drug product. However, the USPTO applies several
Although only a portion of a regulatory statutory limitations in its calculations
Determination of Regulatory Review review period may count toward the of the actual period for patent extension.
Period for Purposes of Patent actual amount of extension that the In its application for patent extension,
Extension; COMETRIQ Director of USPTO may award (for this applicant seeks 688 days of patent
AGENCY: Food and Drug Administration, example, half the testing phase must be term extension.
HHS. subtracted as well as any time that may
Anyone with knowledge that any of
have occurred before the patent was
ACTION: Notice. the dates as published are incorrect may
issued), FDA’s determination of the
submit to the Division of Dockets
SUMMARY: The Food and Drug length of a regulatory review period for
Management (see ADDRESSES) either
Administration (FDA) has determined a human drug product will include all
electronic or written comments and ask
the regulatory review period for of the testing phase and approval phase
for a redetermination by June 22, 2015.
COMETRIQ and is publishing this as specified in 35 U.S.C. 156(g)(1)(B).
Furthermore, any interested person may
notice of that determination as required FDA has approved for marketing the
petition FDA for a determination
by law. FDA has made the human drug product COMETRIQ
regarding whether the applicant for
determination because of the (cabozanitinib (S)-maleate). COMETRIQ
extension acted with due diligence
submission of an application to the is indicated for the treatment of patients
during the regulatory review period by
Director of the U.S. Patent and with progressive, metastatic medullary
October 19, 2015. To meet its burden,
Trademark Office (USPTO), Department thyroid cancer. Subsequent to this
the petition must contain sufficient facts
of Commerce, for the extension of a approval, the USPTO received a patent
term restoration application for to merit an FDA investigation. (See H.
patent which claims that human drug Rept. 857, part 1, 98th Cong., 2d sess.,
product. COMETRIQ (U.S. Patent No. 7,579,473)
from Exelixis, Incorporated, and the pp. 41–42, 1984.) Petitions should be in
ADDRESSES: Submit electronic USPTO requested FDA’s assistance in the format specified in 21 CFR 10.30.
comments to http:// determining this patent’s eligibility for Interested persons may submit to the
www.regulations.gov. Submit written patent term restoration. In a letter dated Division of Dockets Management (see
petitions (two copies are required) and March 27, 2014, FDA advised the ADDRESSES) electronic or written
written comments to the Division of USPTO that this human drug product comments and written or electronic
Dockets Management (HFA–305), Food had undergone a regulatory review petitions. It is only necessary to send
and Drug Administration, 5630 Fishers period and that the approval of one set of comments. Identify comments
Lane, Rm. 1061, Rockville, MD 20852. COMETRIQ represented the first with the docket number found in
Submit petitions electronically to permitted commercial marketing or use brackets in the heading of this
http://www.regulations.gov at Docket of the product. Thereafter, the USPTO document. If you submit a written
No. FDA–2013–S–0610. requested that FDA determine the petition, two copies are required. A
FOR FURTHER INFORMATION CONTACT: product’s regulatory review period. petition submitted electronically must
Beverly Friedman, Office of FDA has determined that the be submitted to http://
Management, Food and Drug applicable regulatory review period for www.regulations.gov, Docket No. FDA–
Administration, 10001 New Hampshire COMETRIQ is 2,698 days. Of this time, 2013–S–0610. Comments and petitions
Ave., Hillandale Campus, Rm. 3180, 2,513 days occurred during the testing that have not been made publicly
Silver Spring, MD 20993, 301–796– phase of the regulatory review period, available on http://www.regulations.gov
7900. while 185 days occurred during the may be viewed in the Division of
asabaliauskas on DSK5VPTVN1PROD with NOTICES

SUPPLEMENTARY INFORMATION: The Drug approval phase. These periods of time Dockets Management between 9 a.m.
Price Competition and Patent Term were derived from the following dates: and 4 p.m., Monday through Friday.
Restoration Act of 1984 (Pub. L. 98–417) 1. The date an exemption under Dated: April 16, 2015.
and the Generic Animal Drug and Patent section 505(i) of the Federal Food, Drug,
Leslie Kux,
Term Restoration Act (Pub. L. 100–670) and Cosmetic Act (the FD&C Act) (21
generally provide that a patent may be U.S.C. 355(i)) became effective: July 13, Associate Commissioner for Policy.
extended for a period of up to 5 years 2005. FDA has verified the applicant’s [FR Doc. 2015–09302 Filed 4–21–15; 8:45 am]
so long as the patented item (human claim that the date the investigational BILLING CODE 4164–01–P

VerDate Sep<11>2014 18:00 Apr 21, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 E:\FR\FM\22APN1.SGM 22APN1

Document Created: 2015-12-16 08:27:45
Document Modified: 2015-12-16 08:27:45

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 22528

80 FR 22528 - Determination of Regulatory Review Period for Purposes of Patent Extension; COMETRIQ

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration