2001年6月11日 ダビデとゴリアテ: タック特許戦
印象に残る面白い漫画です。これも長いですが引用させてもらいます。
Nature 402, 709 (1999) c Macmillan Publishers Ltd. |
Roche's Taq patent 'obtained by deceit', rules US court
REX DALTON
[SAN DIEGO] A federal judge in San Francisco ruled last
week that the patent for the naturally
occurring
form of the widely used reagent Taq DNA polymerase was fraudulently obtained
and is thus invalid.
The decision could mean increased competition
leading to cheaper reagent prices,
as well
as legal action to recover unnecessary
costs.
And, depending on future court rulings,
the
patent dispute may also undermine a
related
patent for the DNA-amplification process
of PCR (polymerase chain reaction).
The judge ruled that the US Patent and Trademark
Office was misled a decade ago by scientists
from the Cetus Corporation, which was
bought
by the Swiss company Hoffmann-La Roche
in
1991 (see Nature 397, 460; 1999). Roche purchased the Taq patent as part of the deal.
The ruling was issued in a long-running federal
lawsuit in which Roche originally accused
the Promega Corporation of infringing
its
patent by selling its own native Taq to researchers. This lawsuit began after
a disagreement between Roche and Promega
over Taq licensing terms. Promega, a privately held
Wisconsin company, is also involved
in challenging
Roche's patent in Europe.
After hearing evidence earlier this year
during a trial in San Francisco, US
district
judge Vaughn Walker ruled that there
were
eight instances in which Roche scientists
had engaged in "inequitable conduct"
with "intent to mislead"
to secure
the Taq patent.
These involved misstatements or the withholding
of scientific information during the
patent
office's review process. They included
withholding
details about how Taq binds in a phosphocellulose column, misleading
statements about Taq's fidelity compared with previously described
enzymes, and presenting a key experiment
as having been performed when it had
not
been done.
In his ruling, Walker likened the conduct
of Roche scientists to "scientific
misconduct".
Roche officials deny that their scientists
engaged in impropriety, and say they
plan
to appeal. And they insist their other
patents
are not affected or threatened.
The judge will hold a hearing next month
to begin the process by which Promega
will
seek financial remedies in the case.
If his
ruling stands, Roche's patent for native
Taq will be void and unenforceable.
He ruled that all claims of Roche's patent
are unenforceable. The patent includes
three
claims, one of which is for the native
Taq and another for recombinant Taq. Therefore, Promega argues, Roche's patent
covering both native and recombinant
Taq is unenforceable.
Furthermore, because the judge has ruled
that Roche's patent is unenforceable
for
Taq, Promega attorneys plan to argue that Roche's
patent on PCR, which relies on the
use of
Taq, is also unenforceable. But Roche disputes
this, saying the ruling only affects
native
Taq, which is used by a much smaller proportion
of the research community for PCR reactions.
Among the issues expected to come out of
the case are Taq pricing, the amount Roche is now alleged
to have received improperly under its
patent,
and reimbursement plans.
For instance, Taq was sold by some biotech firms for around
16 cents per unit before Cetus was
granted
its patent in 1989. Taq is now sold for at least 30 cents per unit
by companies licensed by Roche. These
companies
pay Roche 15 to 17 cents per unit,
claims
Promega attorney James Troupis.
The biotech community is speculating on who
will try to recover what funds. US
government
agencies such as the National Institutes
of Health (NIH), the National Science
Foundation
and the Department of Energy are huge
purchasers
of Taq, either directly or through grants to scientists
and universities.
Taq is reportedly the most-purchased reagent
under NIH grants. Agency officials
decline
to say what actions might be taken
to recover
any funds, pointing out that a decision
on
such legal action would come from the
US
Department of Justice. Justice officials
were unavailable for comment.
Meanwhile, at least one other company, New
England Biolabs of Massachusetts, is
considering
re-entering the market to offer Taq (see Nature 390, 327; 1997). Its decision, combined with the elimination
of Roche's royalty fee, may lead to
cheaper
pricing for Taq. But Roche insists the judge's decision
will have little financial impact because
the company believes the recombinant
Taq patent is unaffected.