[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Notices]
[Pages 27271-27272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0615]


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

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 Neumega 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 biological 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. 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

[[Page 27272]]

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 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 biological 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 biological product 
Neumega (interleukin-11). Neumega is indicated for 
the prevention of severe thrombocytopenia and the reduction of the need 
for platelet transfusions following myelosuppressive chemotherapy in 
patients with nonmyeloid malignancies who are at high risk of severe 
thrombocytopenia. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for 
Neumega (U.S. Patent No. 5,215,895) from Genetics Institute, 
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 September 28, 1998, FDA advised the Patent and Trademark 
Office that this human biological product had undergone a regulatory 
review period and that the approval of Neumega 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 
Neumega is 1,854 days. Of this time, 1,513 days occurred 
during the testing phase of the regulatory review period, while 341 
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: 
October 30, 1992. The applicant claims October 25, 1992, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was October 
30, 1992, which was 30 days after FDA receipt of the IND.

    2. The date the application was initially submitted with respect to 
the human biological product under section 505 of the act: December 20, 
1996. FDA has verified the applicant's claim that the product license 
application (PLA) for Neumega (PLA 96-1433) was initially 
submitted on December 20, 1996.

    3. The date the application was approved: November 25, 1997. FDA 
has verified the applicant's claim that PLA 96-1433 was approved on 
November 25, 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 542 days of 
patent term extension.

    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before July 19, 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 November 15, 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 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: May 4, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-12527 Filed 5-18-99; 8:45 am]
BILLING CODE 4160-01-F