[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34749-34750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2008-E-0268 and FDA-2008-E-0267]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040

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 BYSTOLIC and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications 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 comments and petitions 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. 6222, Silver Spring, MD 20993-0002 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 human drug product 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 BYSTOLIC 
(nebivolol hydrochloride). BYSTOLIC is indicated for the treatment of 
hypertension. Subsequent to this approval, the Patent and Trademark 
Office received two patent term restoration applications for BYSTOLIC 
(U.S. Patent Nos. 5,759,580 and 6,545,040) from Forest Laboratories, 
Inc., and the Patent and Trademark Office requested FDA's assistance in 
determining the patents' eligibilities for patent term restoration. In 
a letter dated June 10, 2008, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of BYSTOLIC 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 
BYSTOLIC is 6,790 days. Of this time, 5,463 days occurred during the 
testing phase and 1,327 days occurred during the approval phase. These 
periods of time were derived from the following dates:
    1. The date an exemption under subsection 505(i) of the Federal 
Food, Drug, and Cosmetic Act (the act) (U.S.C. 355 (i)) involving this 
drug product became effective: May 17, 1989. The applicant claims July 
6, 2000, as the date the investigational new drug application (IND) 
became effective. However, FDA records indicate that the IND originally 
became effective on May 17, 1989, which was 30 days after FDA receipt 
of the original IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the Federal Food, Drug, 
and Cosmetic Act: April 30, 2004. The applicant claims April 29, 2004, 
as the date the new drug application (NDA) for BYSTOLIC (NDA 21-742) 
was initially submitted. However, FDA records indicate that NDA 21-742 
was submitted on April 30, 2004.
    3. The date the application was approved: December 17, 2007. FDA 
has verified the applicant's claim that NDA 21-742 was approved on 
December 17, 2007. 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 applications for patent extension, this applicant 
seeks 1,828 days of patent term extension for U.S. Patent No. 5,759,580 
and 619 days of patent term extension for U.S. Patent No. 6,545,040.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by August 17, 2010. Furthermore, any interested person may petition FDA 
for a determination

[[Page 34750]]

regarding whether the applicant for extension acted with due diligence 
during the regulatory review period by December 15, 2010. 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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 10, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-14814 Filed 6-17-10; 8:45 am]
BILLING CODE 4160-01-S