[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Notices]
[Pages 21299-21300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0175 and FDA-2009-E-0173]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; VIMPAT--NDA 22-254

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 VIMPAT based on new drug application (NDA) 
22-254 for VIMPAT injection 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 patents 
which claim the human drug product, VIMPAT. The regulatory review 
period determination for VIMPAT Tablets is publishing in this issue of 
the Federal Register.

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 http://www.regulations.gov.

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 0993-0002, 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 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 VIMPAT 
(lacosamide). VIMPAT injection is indicated as adjunctive therapy in 
the treatment of partial-onset seizures in patients with epilepsy aged 
17 years and older when oral administration is temporarily not 
feasible. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for VIMPAT (U.S. Patent 
Nos. 5,654,301 and RE38,551) from Research Corporation Technologies, 
Inc., and the Patent and Trademark Office requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated September 29, 2009, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of VIMPAT 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 
VIMPAT is 3,452 days. Of this time, 3,055 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 act) (21 U.S.C. 355(i)) became effective: 
May 19, 1999. The applicant claims November 14, 2003, as the date an 
investigational new drug application (IND) became effective. However, 
according to FDA records, this IND was not the first IND received for 
this active ingredient. In general, FDA has used the first IND of the 
active ingredient of the drug product as the beginning of the testing 
phase, if information derived from this first IND was or could have 
been relied on or was relevant for approval to market the drug product. 
FDA records indicate that the effective date of the first IND for 
lacosamide was May 19, 1999, which was 30 days after FDA receipt of 
this first IND. This is the same IND and the same date FDA determined 
was the beginning of the regulatory review period for Vimpat Tablets 
approved under new drug application (NDA) 22-253. The regulatory review 
period determination for VIMPAT Tablets is publishing in this issue of 
the Federal Register.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 28, 
2007. FDA has verified the applicant's claim that the new drug 
application (NDA) 22-254 for VIMPAT injection was submitted on 
September 28, 2007.
    3. The date the application was approved: October 28, 2008. FDA has 
verified the applicant's claim that NDA 22-254 was approved on October 
28, 2008.
    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 1,104 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 June 22, 2010. 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 October 20, 
2010. To meet its burden,

[[Page 21300]]

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 numbers 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: March 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-9509 Filed 4-22-10; 8:45 am]
BILLING CODE 4160-01-S