[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)] [Notices] [Pages 69632-69633] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-33453] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98E-0227] Determination of Regulatory Review Period for Purposes of Patent Extension; Silicone AMOARRAY Multifocal IOL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for Silicone AMO ARRAY multifocal IOL 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 medical device. 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 medical devices, the testing phase begins with a clinical [[Page 69633]] investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. 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 (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device Silicone AMO ARRAY multifocal IOL. Silicone AMO ARRAY multifocal IOL is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed and who may benefit from useful near vision without reading aid and increased spectacle independence across a range of distances where the potential visual effects associated with multifocality are acceptable. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for Silicone AMO ARRAY multifocal IOL (U.S. Patent No. 4,898,461) from Vision Pharmaceuticals, L.P., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated June 19, 1998, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of Silicone AMO ARRAY multifocal IOL 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 Silicone AMO ARRAY multifocal IOL is 2,846 days. Of this time, 2,478 days occurred during the testing phase of the regulatory review period, while 368 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date a clinical investigation involving this device was begun: November 22, 1989. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) for human tests to begin became effective on June 15, 1989. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on November 22, 1989, which represents the IDE effective date. 2. The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e): September 3, 1996. The applicant claims August 30, 1996, as the date the premarket approval application (PMA) for Silicone AMO ARRAY multifocal IOL (PMA P960028) was initially submitted. However, FDA records indicate that PMA P960028 was submitted on September 3, 1996. 3. The date the application was approved: September 5, 1997. FDA has verified the applicant's claim that PMA P960028 was approved on September 5, 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 1,533 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may, on or before February 16, 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 July 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: December 4, 1998. Thomas J. McGinnis, Deputy Associate Commissioner for Health Affairs. [FR Doc. 98-33453 Filed 12-16-98; 8:45 am] BILLING CODE 4160-01-F