[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12974-12975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-E-0483 and FDA-2010-E-0484]
Determination of Regulatory Review Period for Purposes of Patent
Extension; AMPYRA
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 AMPYRA 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 that human drug product.
ADDRESSES: Submit electronic comments to
http:[sol][sol]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. 6222, 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 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 AMPYRA
(dalfampridine). AMPYRA is indicated to improve walking in patients
with multiple sclerosis. Subsequent to this approval, the Patent and
Trademark Office received patent term restoration applications for
AMPYRA (U.S. Patent Nos. 5,370,879 and 5,540,938) from Elan Pharma
International Ltd., and the Patent and Trademark Office requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated September 30, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of AMPYRA 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
AMPYRA is 9,845 days. Of this time, 9,569 days occurred during the
testing phase of the regulatory review period, while 276 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: February 10, 1983. The applicant claims January 1, 1980, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND was initially
placed on clinical hold. The applicant was informed that the
investigational studies were allowed to proceed on February 10, 1983,
the effective date 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: April 22,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for AMPYRA (NDA 22-250) was submitted on April 22,
2009.
3. The date the application was approved: January 22, 2010. FDA has
verified the applicant's claim that NDA 22-250 was approved on January
22, 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 1,827 and 1,826
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) either electronic or written comments and ask for a
redetermination by May 9, 2011. 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 September 5, 2011. To meet its burden, the petition must contain
sufficient facts
[[Page 12975]]
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. It is no longer
necessary to send three copies of mailed 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:[sol][sol]www.regulations.gov may be viewed in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-5312 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P