[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Notices]
[Page 58445-58446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se04-91]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003E-0260]
Determination of Regulatory Review Period for Purposes of Patent
Extension; AMEVIVE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for AMEVIVE and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an
[[Page 58446]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6699.
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 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 biological 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 biologic product
AMEVIVE (alefacept). AMEVIVE is indicated for the treatment of adult
patients with moderate to severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for AMEVIVE (U.S. Patent No. 5,547,853) from
Biogen, 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 November 18, 2003, FDA advised the
Patent and Trademark Office that this human biologic product had
undergone a regulatory review period and that the approval of AMEVIVE
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
AMEVIVE is 2,104 days. Of this time, 1,618 days occurred during the
testing phase of the regulatory review period, while 486 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 (21 U.S.C.
355(i)): April 29, 1997. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on April 29, 1997.
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): October 2, 2001. FDA has verified the
applicant's claim that the biological license application (BLA) for
Amevive (BLA 12536) was initially submitted on October 2, 2001.
3. The date the application was approved: January 30, 2003. FDA has
verified the applicant's claim that BLA 12536 was approved on January
30, 2003.
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 1,259 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 comments and ask for a redetermination by November
29, 2004. 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 March 29, 2005. 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: August 30, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-21874 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S