Determination of Regulatory Review Period for Purposes of Patent Extension; RegranexRegister and Becaplermin Concentrate

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0841]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Regranex and Becaplermin Concentrate

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 Regranex and Becaplermin

Concentrate 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 those human biological products.

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 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 products

Regranex and Becaplermin Concentrate (becaplermin).

Regranex is indicated for the treatment of lower extremity

diabetic neuropathic ulcers that extend into the subcutaneous tissue or

beyond and have an adequate blood supply. Subsequent to this approval,

the Patent and Trademark Office received a patent term restoration

application for Regranex and Becaplermin Concentrate (U.S.

Patent No. 4,845,075) from ZymoGenetics, Inc., and the Patent and

Trademark Office requested FDA's assistance in determining this

patent's

[[Page 10475]]

eligibility for patent term restoration. In a letter dated January 29,

1999, FDA advised the Patent and Trademark Office that this human

biological product had undergone a regulatory review period and that

the approval of Regranex and Becaplermin Concentrate

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

Regranex and Becaplermin Concentrate is 2,790 days. Of this

time, 2,424 days occurred during the testing phase of the regulatory

review period, while 366 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:

April 29, 1990. The applicant claims March 30, 1990, as the date the

investigational new drug application (IND) became effective. However,

FDA records indicate that the IND effective date was April 29, 1990,

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 16,

1996. FDA has verified the applicant's claim that the product license

applications (PLA's) for Regranex (PLA 96-1408) and

Becaplermin Concentrate (PLA 96-1422) were initially submitted on

December 16, 1996.

3. The date the application was approved: December 16, 1997. FDA

has verified the applicant's claim that PLA 96-1408 and PLA 96-1422

were approved on December 16, 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 1,593 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 31, 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: February 16, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-5388 Filed 3-3-99; 8:45 am]

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