[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34388-34389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0133; FDA-2011-E-0136]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CYSVIEW (Previously HEXVIX)

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 CYSVIEW (previously HEXVIX) 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 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 the 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 CYSVIEW 
(hexaminolevulinate hydrochloride). CYSVIEW is an optical imaging agent 
indicated for use in the cystoscopic detection of non-muscle invasive 
papillary cancer of the bladder among patients suspected or known to 
have lesion(s) on the basis of a prior cystoscopy. Subsequent to this 
approval, the Patent and Trademark Office received patent term 
restoration applications for CYSVIEW (U.S. Patent Nos. 7,247,655 and 
7,348,361) from Photocure ASA, and the Patent and Trademark Office 
requested FDA's assistance in determining the patents' eligibilities 
for patent term restoration. In a letter dated June 9, 2011, FDA 
advised the Patent and Trademark Office that this human drug product 
had undergone a regulatory review period and that the approval of 
CYSVIEW 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 
CYSVIEW is 3,103 days. Of this time, 2,770 days occurred during the 
testing phase of the regulatory review period, while 333 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: November 30, 2001. The applicant claims October 29, 2001, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was November 30, 2001, 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: June 30, 
2009. FDA has verified the applicant's claim that the new drug 
application (NDA) for CYSVIEW (NDA 22-555) was submitted on June 30, 
2009.
    3. The date the application was approved: May 28, 2010. FDA has 
verified the applicant's claim that NDA 22-555 was approved on May 28, 
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 
applications for patent extension, this applicant seeks 686 days or 564 
days, respectively, 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 August 10, 2012. Furthermore, any interested person 
may petition FDA for a determination regarding whether the applicant 
for extension acted with due diligence during the regulatory review

[[Page 34389]]

period by December 10, 2012. 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: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14003 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P