[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13684-13685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-E-0156]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ZYTIGA
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 ZYTIGA 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 Patents
and Trademarks, 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 along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6284, Silver Spring, MD 20993-0002, 301-796-3602.
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
[[Page 13685]]
actual amount of extension that the Director of Patents and Trademarks
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 recently approved for marketing the human drug product ZYTIGA
(abiraterone acetate). ZYTIGA is indicated for use in combination with
prednisone for the treatment of patients with metastatic castration-
resistant prostate cancer who have received prior chemotherapy
containing docetaxel. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
ZYTIGA (U.S. Patent No. 5,604,213) from BTG International LTD, and the
Patent and Trademark Office requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated July 9, 2012, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of ZYTIGA represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
ZYTIGA is 1,927 days. Of this time, 1,797 days occurred during the
testing phase of the regulatory review period, while 130 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: January 19, 2006. The applicant claims January 28, 2006, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 19, 2006, 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
20, 2010. FDA has verified the applicant's claim that the new drug
application (NDA) for ZYTIGA (NDA 202-379) was submitted on December
20, 2010.
3. The date the application was approved: April 28, 2011. FDA has
verified the applicant's claim that NDA 202-379 was approved on April
28, 2011.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,024 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 April 29, 2013. 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 27, 2013. 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 petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. Comments and petitions that have not been
made publicly available on regulations.gov may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04645 Filed 2-27-13; 8:45 am]
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