Document ID: FDA-2011-E-0277-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extensions: BEYAZ
Posted Date: 2013-01-31T05:00Z

[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6826-6827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02086]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0277]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined

[[Page 6827]]

the regulatory review period for BEYAZ 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 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 BEYAZ 
(drospirenone, ethinyl estradiol, and levomefolate calcium). BEYAZ is 
indicated for use in women to: Prevent pregnancy; treat symptoms of 
premenstrual dysphoric disorder for women who choose to use an oral 
contraceptive for contraception; treat moderate acne for women at least 
14 years old only if the patient desires an oral contraceptive for 
birth control; and raise folate levels in women who choose to use an 
oral contraceptive for contraception. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for BEYAZ (U.S. Patent No. 6,441,168) from Eprova AG, and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated March 28, 2012, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of BEYAZ 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 
BEYAZ is 1,271 days. Of this time, 874 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: April 4, 2007. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on April 4, 2007.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: August 24, 
2009. The applicant claims August 21, 2009, as the date the new drug 
application (NDA) for BEYAZ (NDA 22-532) was initially submitted. 
However, FDA records indicate that NDA 22-532 was submitted on August 
24, 2009.
    3. The date the application was approved: September 24, 2010. FDA 
has verified the applicant's claim that NDA 22-532 was approved on 
September 24, 2010.
    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 834 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 1, 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 July 30, 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 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: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02086 Filed 1-30-13; 8:45 am]
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