[Federal Register Volume 64, Number 41 (Wednesday, March 3, 1999)]
[Notices]
[Pages 10303-10304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0796]


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

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

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6620.

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. 100670) 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 Commissioner 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 
LumenHance (manganese chloride USP). LumenHance is 
indicated for use as a magnetic resonance imaging (MRI) contrast media, 
to enhance the delineation of the upper gastrointestinal tract to 
distinguish it from organs and tissues that are adjacent to the upper 
regions of the gastrointestinal tract. Subsequent to this approval, the 
Patent and Trademark Office received a patent term restoration 
application for LumenHance (U.S. Patent No. 5,368,840) from 
Bracco Diagnostics 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 December 14, 1998, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of 
LumenHance 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 
LumenHance is 1,796 days. Of this time, 1,067 days occurred 
during the testing phase of the regulatory review period, while 729 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date an exemption under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: The 
applicant claims January 18, 1993, as the date the investigational new 
drug application (IND) became effective. However, FDA records indicate 
that the IND effective date was January 20, 1993, 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 of the act: December 22, 1995. 
The applicant claims December 20, 1995, as the date the new drug 
application (NDA) for LumenHance (NDA 20-686) was initially 
submitted. However, FDA records indicate that NDA 20-686 was submitted 
on December 22, 1995.
    3. The date the application was approved: December 19, 1997. FDA 
has verified the applicant's claim that NDA 20-686 was approved on 
December 19, 1997.
    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 20 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before May 3, 1999, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before August 30, 1999, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. 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 Dockets 
Management Branch (address above) in three copies (except that 
individuals may submit

[[Page 10304]]

single copies) and identified with the docket number found in brackets 
in the heading of this document. Comments and petitions may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: February 16, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-5130 Filed 3-2-99; 8:45 am]
BILLING CODE 4160-01-F