Comments from John James McGlew

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


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 016-0001.TXT

    VYe address the questions regarding he Effect of URAA on Existing
P8ent Term Extensioris !1_der 35 U.S*C ~i5fi.

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 016-0002.TXT

    1.  Should PTO take any action wlth respoct to eSsting patenl
term ezeenslons under Section 156?

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 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.

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 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?

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 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.

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 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.

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 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