Document ID: FDA-2001-E-0027-0020
Agency: fda
Document Type: Notice
Title: Determinations of Regulatory Review Periods for Purposes of Patent Extensions: ANGIOMAX
Posted Date: 2010-12-16T05:00Z

[Federal Register Volume 75, Number 241 (Thursday, December 16, 2010)]
[Notices]
[Pages 78714-78715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31583]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2001-E-0027]

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

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 ANGIOMAX 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

[[Page 78715]]

Director of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://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 approved for marketing the human drug product ANGIOMAX 
(bivalirudin). ANGIOMAX is indicated for use as an anticoagulant in 
patients with unstable angina undergoing percutaneous transluminal 
coronary angioplasty. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
ANGIOMAX (U.S. Patent No. 5,196,404) from The Medicines Company, and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated September 6, 2001, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period, that the approval of ANGIOMAX represented the first permitted 
commercial marketing or use of the product, and that the patent term 
restoration application was untimely within the meaning of 35 U.S.C. 
section 156(d)(1).
    On August 3, 2010, in The Medicines Company v. David Kappos et al., 
Civil Action No. 01:10-cv-286, the United States District Court for the 
Eastern District of Virginia, Alexandria Division, ordered the United 
States Patent and Trademark Office to consider The Medicines Company's 
patent term restoration application for ANGIOMAX to have been timely 
filed. 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 
ANGIOMAX is 3,665 days. Of this time, 2,576 days occurred during the 
testing phase of the regulatory review period, while 1,089 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: December 5, 1990. The applicant claims November 2, 1990, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was December 5, 1990, 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 FD&C Act: December 
23, 1997. FDA has verified the applicant's claim that the new drug 
application (NDA) for ANGIOMAX (NDA 20-873) was submitted on December 
23, 1997.
    3. The date the application was approved: December 15, 2000. FDA 
has verified the applicant's claim that NDA 20-873 was approved on 
December 15, 2000.
    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 1,773 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 February 14, 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 June 14, 2011. 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.
    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 regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31583 Filed 12-15-10; 8:45 am]
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