# Determination of Regulatory Review Period for Purposes of Patent Extension; AlbunexRegister > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A95-5183 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** March 2, 1995 - **Citation:** 60 FR 11671 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 94E-0360] Determination of Regulatory Review Period for Purposes of Patent Extension; Albunex AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for Albunex 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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The [[Page 11672]] 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 Albunex. Albunex is indicated as an aid for ultrasound contrast enhancement of ventricular chambers and improvement of endocardial border definition in patients with suboptimal echoes undergoing ventricular function and regional wall motion studies. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for Albunex (U.S. Patent No. 4,844,882) from Molecular Biosystems, 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 December 19, 1994, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of Albunex represented the first commercial marketing 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 Albunex is 2,397 days. Of this time, 975 days occurred during the testing phase of the regulatory review period, while 1,422 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: January 14, 1988. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) for human tests to begin became effective on August 18, 1987. However, FDA records indicate that IDE was conditionally approved on January 14, 1988, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): September 14, 1990. The applicant claims September 11, 1990, as the date the premarket approval application (PMA) for Albunex (PMA P900059) was initially submitted. However, FDA records indicate that PMA P900059 was submitted on September 14, 1990. 3. The date the application was approved: August 5, 1994. FDA has verified the applicant's claim that PMA P900059 was approved on August 5, 1994. 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 763 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may, on or before May 1, 1995, 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 29, 1995, 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 24, 1995. Allen B. Duncan, Acting Associate Commissioner for Health Affairs. [FR Doc. 95-5183 Filed 3-1-95; 8:45 am] BILLING CODE 4160-01-F --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-5183. Public record. Not legal advice.