NAME: WAYNE R. EBERHARDT, REG NBR 22,804 COMPANY: ADDR-1: 107 GREY BRIDGE ROW CITY, STATE ZIP: CARY, NC 27513 TELEPHONE: FAX: REPRESENT: SELF ------- 005-0001.TXT The following is submitted in response to the notice published in the Federal Register, Vol. 60, No. 10, January 17, 1995. ------- 005-0002.TXT Section I 1. Yes, the FDA should revise the patent term expiration dates listed in the Orange Book and Green Book. ------- 005-0003.TXT 2. The PTO should be required to certify new patent expiration dates only upon request by an interested party in the event of a dispute over the correct dates. ------- 005-0004.TXT 3. NDA and NADA holders should be required to submit revised patent expiration dates to the FDA by June 8, 1995. ------- 005-0005.TXT 4. The FDA should require certification by the NDA/NADA holder which includes, in addition to the patent number and new expiration date, the original expiration date, the first U. S. filing date on which the 20 year term is based, and, if the patent is subject to a terminal disclaimer, the patent number, first U.S. filing date and new expiration date ofthe patent on which the terminal disclaimer is based ------- 005-0006.TXT 5. Applicants with pending ANDAs or ANADAs should be required to revise their patent certifications within 30 days of the date of publication of the revised Orange/Green book. Any applicant claiming a substantial investment under Section 532(c)(2) should be required to make that claim within the above 30 day period and provide detailed substantiation thereof to the FDA and NDA/ANDA holder within a further period of 60 days. ------- 005-0007.TXT Section II Option 1. If the section 156 extension already issued by the PTO is simply added to the longer of the 17 or 20 year patent term, this could result in an extended patent term which exceeds 14 vears from date of market approval. Accordingly, this is not considered a viable option. ------- 005-0008.TXT Option 3, which limits the extension of Option 1 to the maximum 14 year term from date of market approval, presents a problem to the ANDA/ANADA applicant claiming a right under Section 532(c)(2) since this right would commence on the original 17 year expiration date, but would not continue during the Section 156 extension following expiration of the 20 year term. Thus the right under Section 532(c)(2) would be a temporary right of little practical value. ------- 005-0009.TXT To accommodate the different scope of rights granted under the URAA term extension and the Section 156 extension to both the patent holder and the ANDA applicant, the Section 156 extension should be calculated from the original 17 year expiration date for patents granted prior to June 8, 1995, and from the (original) 20 year expiration date for patents granted after June 8, 1995, and limited in each case to a maximum patent term of 14 years from date of market approval unless the current law is otherwise amended. ------- 005-0010.TXT The preceding comments and opinions are personal and not to be attributed to my employer or any organization of which I am a member.
Last Modified: March 1995