[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34945-34946]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn06-117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E-0022]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SYMLIN
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 SYMLIN 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 http://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 SYMLIN
(pramlintide acetate). SYMLIN is given at mealtimes and is indicated
for Type 1 diabetes, as an adjunct treatment in patients who use
mealtime insulin therapy and who have failed to achieve desired glucose
control despite optimal insulin therapy, and for Type 2 diabetes, as an
adjunct treatment in patients who use mealtime insulin therapy and who
have failed to achieve desired glucose control despite optimal insulin
therapy, with or without a concurrent sulfonylurea agent and/or
metformin. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for SYMLIN (U.S. Patent
No. 5,686,411) from Amylin Pharmaceuticals, 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 SYMLIN 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
SYMLIN is 4,620 days. Of this time, 3,060 days occurred during the
testing phase of the regulatory review period, while 1,560 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:
July 24, 1992. The applicant claims July 29, 1992, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the
[[Page 34946]]
IND effective date was July 24, 1992, 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 act: December 8,
2000. The applicant claims December 7, 2000, as the date the new drug
application (NDA) for Symlin (NDA 21-332) was initially submitted.
However, FDA records indicate that NDA 21-332 was submitted on December
8, 2000.
3. The date the application was approved: March 16, 2005. FDA has
verified the applicant's claim that NDA 21-332 was approved on March
16, 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 1,586 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 15, 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 13,
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 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. E6-9414 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S