<以下引用>
Nature 411, 622 (2001) c Macmillan Publishers Ltd. |
Patent ruling could cut PCR enzyme prices
REX DALTON
[SAN DIEGO] The European Patent Office (EPO) last week
revoked a patent for an important thermally
stable enzyme used in the polymerase
chain
reaction (PCR) process for DNA amplification.
The decision brings with it the prospect
that the price of the enzyme will fall.
Hoffmann-La Roche's patent for naturally
occurring Taq DNA polymerase ?obtained from the bacterium
Thermus aquaticus, which lives in hot springs ? is invalid
because it is not a novel invention
and is
based on previously published discoveries,
EPO officials say. Roche says it will
appeal
against the decision next year once
the formal
written opinion is issued by the EPO
in Munich.
Melinda Griffith, general counsel for Roche
Molecular Systems in Pleasanton, California,
downplayed what she called "an
intermediate-level"
decision. She said the panel of patent
examiners
responsible had made "many errors
of
law" during the three-day hearing,
which
ended on 30 May.
This is the second major Roche patent on
PCR to be revoked. In 1999, a federal
judge
in San Francisco ruled that Roche's
US patent
for native Taq was invalid (see Nature 402, 709; 1999) because it had been obtained with "intent
to mislead". Switzerland-based
Roche
is appealing against that decision,
and a
court ruling is expected next year.
In both the EPO and San Francisco cases,
the Roche patents were disputed by
Promega,
a Wisconsin-based company that markets
native
Taq and other reagents internationally. Three
other companies ? Bioline, New England
Biolabs
and Becton Dickinson ? supported Promega
in the EPO action. The companies argued
that
the EPO patent for native Taq, issued in 1997, should never have been
allowed and was granted only after
years
of pressure by Roche and its subsidiaries.
Roche still holds an EPO patent for a recombinant
version of Taq, which is created by inserting the gene
for Taq into another species of bacterium. Recombinant
Taq now accounts for a large proportion of the
market. But that patent is being challenged
by the London-based company Bioline.
Bioline declined to comment on the case.
But Griffith claims Roche's EPO patent
on
recombinant Taq is valid and enforceable.
In a separate action, Roche is suing Promega
in the German federal court for selling
Taq in Europe, alleging that the company is
infringing its patents. It remains
unclear
how the EPO will ruling will affect
this
action.
Promega lawyer Brenda Furlow claims that
more companies are now likely to start
selling
native Taq, creating a more competitive market that
will lower the price of the widely
used reagent.
Native Taq produced by the companies fighting Roche
costs 20?30% less than Roche charges,
she
notes.
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