Determination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL, 34139-34140 [E6-9214]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 113 (Tuesday, June 13, 2006)]
[Notices]
[Pages 34139-34140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0043]


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

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 TYGACIL 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 written 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 https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug 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 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 TYGACIL 
(tigecycline). TYGACIL is indicated for the treatment of infections 
caused by susceptible strains of the designated microorganisms in the 
conditions listed in this paragraph for patients 18 years of age and 
older: (1) Complicated skin and skin structure infections caused by 
Escherichia coli (E. coli), Enterococcus (Entero.) faecalis 
(vancomycin-susceptible isolates only), Staphlococcus (Staph.) aureus 
(methicillin-susceptible and -resistant isolates), Streptococcus 
(Strept.) agalactiae, Strept. anginosus group (includes S. anginosus, 
S. intermedius, and S. constellatus), Strept. Pyogenes, and Bacteroides 
(B.) fragilis, and (2) Complicated intra-abdominal infections caused by 
Citrobacter freundii, Enterobacter cloacae, E. coli, Klebsiella (K.) 
oxytoca, K. pneumoniae, Entero. faecalis (vancomycin-suspectible 
isolates only), Staph. aureus (methicillin-susceptible isolates only), 
Strept. anginosus group (includes S. anginosus, S. intermedius, and S. 
constellatus), B. fragilis, B. thetaiotaomicron, B. uniformis, B. 
vulgatus, Clostridium perfringens, and Peptostreptococcus micros. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for TYGACIL (U.S. Patent No. 
5,529,990) from Wyeth Holdings Corp., 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 24, 
2006, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of TYGACIL 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 
TYGACIL is 2,487 days. Of this time, 2,304 days occurred during the 
testing phase of the regulatory review period, while 183 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 act) (21 U.S.C. 355(i)) became effective: 
August 26, 1998. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on August 
26, 1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: December 15, 
2004. FDA has verified the applicant's claim that the new drug 
application (NDA) for Tygacil (NDA 21-821) was initially submitted on 
December 15, 2004.
    3. The date the application was approved: June 15, 2005. FDA has 
verified the applicant's claim that NDA 21-821 was approved on June 15, 
2005.
    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 1,335 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 August 14, 2006. 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 December 11, 
2006. 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

[[Page 34140]]

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 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9214 Filed 6-12-06; 8:45 am]
BILLING CODE 4160-01-S