Food and Drug Administration [Docket No. 93E0353]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory
review period for Betaseron  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 biologic product.

ADDRESSES: Written comments and petitions should be directed to the Dockets
Management Branch (HFA305), Food and Drug Administration, rm. 123, 12420
Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health Affairs
(HFY20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 3014431382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98417) 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 biologic product Betaseron 
(Interferon beta-1b). Betaseron  is indicated for use in ambulatory patients
with relapsing-remitting multiple sclerosis to reduce the frequency of
clinical exacerbations. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for Betaseron  (U.S.
Patent No. 4,588,585) from the Cetus Oncology Corp., and the Patent and
Trademark Office requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated October 26, 1993,
FDA advised the Patent and Trademark Office that this human biologic product
had undergone a regulatory review period and that the approval of Betaseron 
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 Betaseron 
is 3,720 days. Of this time, 3,319 days occurred during the testing phase of
the regulatory review period, while 401 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 became effective: May 19, 1983. The applicant claims April 4,
1986, as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date was May
19, 1983, 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 351 of the Public Health Service Act: June 18,
1992. The applicant claims June 16, 1992, as the date the product license
application (PLA) for Betaseron  (PLA 920495) was initially submitted.
However, FDA records indicate that PLA 920495 was initially submitted on June
18, 1992.

3. The date the application was approved: July 23, 1993. FDA has verified the
applicant's claim that PLA 920495 was approved on July 23, 1993.

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 1,500 days of patent term extension.

Anyone with knowledge that any of the dates as published is incorrect may, on
or before March 7, 1994, 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 July 5, 1994, 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. 4142, 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: December 17, 1993.

Allen B. Duncan,

Acting Associate Commissioner for Health Affairs.

[FR Doc. 9436 Filed 1394; 8:45 am]

BILLING CODE 416001F


