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Federal Register / Vol. 55, No. 68 / Monday, April 9, 1990 / Notices

[Docket No. 85E-0310] Determination of Regulatory Review Period for Purposes of Patent Extension; Lac-HydrinTM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for LacHydrinT 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 (HFA305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:

and Cosmetic Act become effective: none. FDA has verified the applicant's claim that Product License Application (PLA) Ref. No. 84-0502 did not have a related investigational new drug application. 2. The date the application was initiallysubmitted with respect to the human drug product under section 351 of the PublicHealth Service Act: October 12, 1984. FDA has verified the applicant's claim that PLA Ref. No. 840502 was initially submitted on October 12, 1984. 3. The date the application was approved: December 13, 1989. FDA has verified the applicant's claim that PLA Ref. No. 84-0502 was approved on December 13, 1989. 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 730 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may, on or before June 8. 1990, 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 October 8, 1990, 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: April 2, 1990. Stuart L. Nightingale, Associate Commissionerfor Health Affairs. [FR Doc. 90-8086 Filed 4-8-90; 8:45 am]
BILLING CODE 4160-01-

Nancy E. Pirt, Office of Health Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1382. 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 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 approved for marketing the human drug product Lac-Hydrin T . LacHydrinT is indicated for treatment of ichthyosis and xerosis. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration M application for Lac-Hydrin T (U.S. Patent No. 4,105,783) from Westwood Pharmaceuticals, Inc., and requested FDA's assistance in determining the patent's eligibility for patent term restoration. FDA, in a letter dated September 13, 1985, advised the Patent and Trademark Office that the human drug product had undergone a regulatory review period. Initially, the Patent and Trademark Office decided that the product was not eligible for patent extension because lactic acid, the active ingredient claimed for the product in the application, did not represent the first commercial marketing or use. The Patent and Trademark Office's decision was upheld by the court in Westwood Inc. v. Quigg, Civil Pharmaceuticals, Action No. 88-2198 (D.D.C. Nov. 30, 1989). Thereafter, the decision in Glaxo OperationUK Ltd. v. Quigg, Appeal No. 89-1407 (Fed. Cir. Jan. 24, 1990), was handed down, wherein the court held that a product whose active ingredient is a salt or ester of a previously approved active ingredient is entitled to patent extension, unless the product's active ingredient or a salt or ester of that active ingredient has been previously approved. On the basis of the Glaxo case, the applicant filed a petition for reconsideration of denial of patent extension with the Patent and Trademark Office, in which the applicant now averred that the active M ingredient in Lac-Hydrin T was ammonium lactate, a salt of lactic acid. By a letter, dated February 12, 1990, FDA advised the Patent and Trademark T Office that the approval of Lac-Hydrin represented the first permitted commercial marketing or use the active ingredient ammonium lactate. In addition, no salt or ester of ammonium lactate has been previously approved. 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

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Federal Register / Vol. 55, No. 68 / Monday, Aph-l 9, 1990 / Notices 13195 I Monday, April 9, 1990 I Notices 13195 TM Absent the project direct costs may be Dockets Management Branch between 9 0 Lac-Hydrin is 541 days. Of this time, claimed only once and will not be paid a.m. and 4 p.m., Monday through Friday. days occurred during the testing phase under both sections 1886(h) and 1861(v). review period, while of the regulatory Dated: April 2, 1990. In this demonstration an emphasis is 541 days occurred during the approval Stuart L.Nightingale, being placed on cost effectiveness of the phrase. These periods of time were Associate Commissionerfor Health Affairs. projects. Sponsors of proposed projects derived from the following dates: [FR Doc. 90-8085 Filed 4-6-90; 8:45 am] must describe areas of additional costs 1. The date an exemption under associated with the project which they of the FederalFood,'Drug, BILLING CODE 4160-01-M section 505(i) feel would be paid under section and Cosmetic Act become effective: 1861(v). These costs are to be estimated None. The applicant claims February 28, and Services Health Resources for each of the three years of the 1983, as the date the exemption under Administration demonstration project. The costs and subsection 505(i) became effective. Announcement of Cycle for Rural the cost effectiveness of a proposed However, review of FDA's official Health Medical Education project will be considered during the records indicates that no application for Demonstration Projects review of proposals. such an exemption was submitted prior Additional costs may result from, for AGENCY: Health Resources and Services new drug to the approval of the example, arrangements for supervision Administration, HHS. application (NDA) (NDA 19-155) for of the residents at the rural site, housing ACTION: Notice. Lac-HydrinTM. of the residents, and travel by residents 2. The dote the applicationwas and supervisors from the sponsoring SUMMARY: The Health Resources and initiallysubmitted with respect to the hospital. Any request for payment of Services Administration (HRSA) in human drug product under section additional costs under the project will coordination with the Health Care 505(b) of the FederalFood,Drug, and be reviewed by the Medicare Financing Administration (HCFA) Cosmetic Act: November 1, 1983. FDA intermediaries to determine the announces its intent to accept proposals has verified the applicant's claim that accuracy and reasonableness of the for Rural Health Medical Education NDA 19-155 was initially submitted on claim. It is emphasized that Medicare Demonstration Projects authorized by November 1, 1983. will only pay the sponsoring hospitals section 4038 of the Omnibus Budget 3. The date application was approved: Reconciliation Act of 1987 (Pub. L. 100for Medicare's share of the cost. The April 24, 1985. FDA has verified the sponsoring hospital will have to seek 203) (the Act), as amended by section applicant's claim that NDA 19-155 was payment from other payers for costs of 6216 of the Omnibus Budget the demonstration related to nonapproved on April 24, 1985. Reconciliation Act of 1989 (Pub. L. 100Medicare patients. Also, residents This determination of the regulatory 239). participating in the project may be review period establishes the maximum This is a demonstration to assist counted as "on-site" or "off-site" potential length of a patent extension. physicians to develop clinical personnel for purposes of determining However, the U.S. Patent and experience in rural areas using payment direct medical education costs; however, applies several Trademark Office for graduate medical education under statutory limitations in its calculations purposes each resident may be counted only once. the Social Security Act. For the There will be no payment under these of the actual period for patent extension. of payments for the indirect costs of projects directly to rural hospitals. All In its application for patent extension, graduate medical education, pursuant to payments under the demonstration this applicant seeks 664 days of patent section 1886(d)(5)(B) of the Social projects will be made to the sponsoring term extension. Security Act, a resident participating in hospitals. this project, who works for any part of a Anyone with knowledge that any of The Notice requests that hospitals year at a small rural hospital, shall be the dates as published is incorrect may, interested in entering into an agreement treated as if the resident were working on or before June 8, 1990, submit to the with the Department notify the Health at the sponsoring hospital on September Dockets Management Branch (address Resources and Services Administration. 1 of that year and shall not be treated as above) written comments and ask for a

Federal Resister I Vol. 55, No. 68

redetermination. Furthermore, any interested person may petition FDA, on or before May 8, 1990, 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

if the resident was working in the small rural hospital. Medicare's share of the direct graduate medical education costs of the sponsoring hospital will be increased for the duration of the project to meet any reasonable additional direct costs incurred for the education and training of resident physicians at the rural site. The sponsoring hospital will be required to accumulate separately the costs of the demonstration project. Medicare will pay the sponsoring hospital for Medicare's share of the additional costs the hospital incurs in connection with the project computed pursuant to the reasonable cost authority in section 1861(v) of the Act. Payment for these costs will be in addition to the payments otherwise due the hospital under section 1886(h).

DATES: To receive consideration to enter

into an agreement with the Department to conduct a demonstration project, a project proposal should be received by
July 8, 1990. Materials regarding entry

into an agreement will be sent only to

those programs and hospitals making a

request.
ADDRESSES: Request for information on entering into an agreement and other

questions should be directed to: Chief, Special Projects and Data Analysis Branch, Division of Medicine, Bureau of
Health Professions, Health Resources and Services Administration, Parklawn

Building, room 4C-04, 5600 Fishers Lane,

Rockville, Maryland 29857.

I For more information call the Chief,

Special Projects and Data Analysis Branch on (301) 443-6785.

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