[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Notices]
[Pages 28979-28980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0501]


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

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 GARDASIL 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 biological product.

ADDRESSES: Submit written or electronic comments and petitions to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug

[[Page 28980]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological 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 biological 
product and continues until FDA grants permission to market the 
biological 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 biological 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 biological product 
GARDASIL (Quadrivalent Human Papillomavirus Recombinant Vaccine). 
GARDASIL is indicated for vaccination in females 9 to 26 years of age 
for prevention of the following diseases caused by Human Papillomavirus 
(HPV) Types 6, 11, 16, and 18: Cervical cancer, genital warts 
(condyloma acuminata), and the following precancerous or dysplastic 
lesions: Cervical adenocarcinoma in situ (AIS); cervical 
intraepithelial neoplasia (CIN) grade 1, grade 2, and grade 3; vulvar 
intraepithelial neoplasia (VIN) grade 2 and grade 3; and vaginal 
intraepithelial neoplasia (VaIN) grade 2 and grade 3. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for GARDASIL (U.S. Patent No. 5,820,870) from 
Merck & Co., Inc., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated February 6, 2007, FDA advised the Patent 
and Trademark Office that this human biological product had undergone a 
regulatory review period and that the approval of GARDASIL represented 
the first permitted commercial marketing or use of the product. Shortly 
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 
GARDASIL is 2,215 days. Of this time, 2,031 days occurred during the 
testing phase of the regulatory review period, while 184 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 (21 U.S.C. 355(i)) became effective: May 17, 
2000. The applicant claims May 14, 2000, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 17, 2000, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): December 7, 2005. FDA has verified the 
applicant's claim that the product license application (BLA) for 
GARDASIL (BLA 125126/0) was initially submitted on December 7, 2005.
    3. The date the application was approved: June 8, 2006. FDA has 
verified the applicant's claim that BLA 125126/0 was approved on June 
8, 2006.
    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 1,200 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) written or electronic comments and ask for a redetermination 
by July 23, 2007. 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 November 19, 
2007. 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 7, 2007.
Jane A. Axelrad
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-9950 Filed 5-22-07; 8:45 am]
BILLING CODE 4160-01-S