NAME: JOHN JAMES MCGLEW, REG NBR 31,903 COMPANY: MCGLEW AND TUTTLE, P.C. COUNSELORS AT LAW ADDR-1: SCARBOROUGH STATION CITY, STATE ZIP: SCARBOROUGH, NY 10510-0827 TELEPHONE: (914)941-5600 FAX: (914)941-5855 REPRESENT: COMPANY ------- 016-0001.TXT VYe address the questions regarding he Effect of URAA on Existing P8ent Term Extensioris !1_der 35 U.S*C ~i5fi. ------- 016-0002.TXT 1. Should PTO take any action wlth respoct to eSsting patenl term ezeenslons under Section 156? ------- 016-0003.TXT If ths PTO takes no action, a logicS interpretation will be the third interpretabon provided in the notice. That is, the new w clearly provides a ionger term than the original 1 7-year term for those pat2nts wharein the 2Gyear term from filing is longer. The law also spemfically preoludes a peent trom belng extended beyond the 1 syeat itation. Wlthout the Patent Offico uking any action, patentees can det~mine that Meir extension shcwld be added on to te ionger of 17-years or 20-years from filing, provided that the terrn doss not go beyond the 14 years from _ FDA approval. ------- 016-0004.TXT 2. What appro3ch should PTO take with resp›ct to the calculation of new patent term extensiorls under secUon 1567 where tho patent Is entilled to the longer of the 17 or 20-year patent term under tile URAA? ------- 016-0005.TXT The first interpretation appears loglcal but it clearly does run the risk of violation of 35 U,S.C. Sedon 1 56(c)(3). Some law change appears necessary for the first interpretation to be aeceDted. ------- 016-0006.TXT The second interpretation proposed is not in aecordance with the new law and provides potentily Inequitable results. It z ceminly possible under the second interpretation for a patant to be extended a short term and actuily expirs before K would have explred If it wefe gIven the duraSon based on 20 yeas from filing ciate. This second interpretation should not be adopteci. ------- 016-0007.TXT The third interpretation is cleariy the best as to what the term of the patent should be. if the 20-year from ffling term is lon~er, exterlsions should be added on to determine the new patent term. Howevy, it i5 not clearly necessary for the PT0 to advise the originN patent term extensions in arder to avoid problems with 35 U.S.C. Sectlon 156(c)(3). That is, this law should take effect whether or not the Patent Offioe feYises the extensions granted. If the Pkent OfElce does feel it is necessary to revise these extensionsj tl~is would still be the best approach as this i8 the only approach that fully takes into aceount the changes ln the laut and takes Into account exisEng law.
Last Modified: March 1995