Taq Patent 'obtained by fraud'

daemon at hgmp.mrc.ac.uk daemon at hgmp.mrc.ac.uk
Wed Jan 12 10:01:44 EST 2000

In case anyone else, like me, managed to miss this in the run up to
Christmas, here is a press release from Promega regarding a US court
ruling on the Taq patent. I'd be interested to hear from anyone who can
say a bit more about the probable consequences and how much weight this
ruling by a District Court actually carries..

Dr Kevin O'Donnell
Scottish Agricultural Science Agency
EH12 8NJ    
Tel.: +44 131 244 8924 Fax: +44 131 244 8926

Promega press release follows:

For Immediate Release

MADISON, WISCONSIN, USA (December 7, 1999)

Remaining Taq and PCR Patents Worldwide May Fall

A Federal District Court today ruled that "[a]ll claims of the '818
patent are . . . unenforceable", and in so doing found that a key
biotechnology patent owned by Hoffmann-LaRoche on Taq polymerase was
obtained by fraud on the U.S. Patent and Trademark Office. The current
global market for Taq sales alone is estimated to approach $200 million

In carefully worded and lengthy written findings, Judge Vaughn Walker of
the Northern District of California in San Francisco concluded that the
patent was obtained by fraud. In eight separate instances, the Court
found that the patent holder had intentionally withheld material
information and distorted important facts in obtaining the patent. 

The patent at issue-the '818 Taq patent--involves an enzyme, Taq DNA
polymerase, which is a critical component in such important biotech
processes as polymerase chain reaction (PCR) and gene sequencing. PCR is
key to genetic identification and analysis, and researchers use both
processes extensively worldwide in pursuit of prevention of or cures for

The Court's decision renders this primary Taq patent unenforceable and
sets the stage for a finding of unenforcability for all related Taq and
PCR patents. This is a major blow to Hoffmann-LaRoche, putting in
jeopardy its entire Taq and related PCR patent portfolio. It also
undermines the current PCR licensing strategy of both Roche and its
licensing partner, Perkin-Elmer, both of whom rely heavily on sales of
licensed Taq to obtain PCR royalties.

The Court based its decision on extensive testimony and documentary
evidence presented by Madison, Wisconsin-based Promega Corporation
during a four-week trial in February 1999. Hailing the decision as a
victory for the scientific research community, Promega Chairman and CEO,
William Linton, stated, "The decision is a significant victory,
particularly for the research community. The Court has reaffirmed the
importance of honesty and integrity on the part of scientists and
companies in the pursuit of patents. The decision also recognized the
seminal discoveries of Professor John Trela and his lab in 1974 and Dr.
Kaledin in 1980, who first published the isolation and purification of
this key enzyme in the scientific literature."

The Court found the evidence of fraud in this case to be overwhelming.
Dr. Randall Dimond, Chief Technical Officer for Promega, noted, "We are
pleased that the Court validated what the worldwide scientific community
has believed for years: that Taq was first purified by others, and that
Cetus must have misrepresented facts to the US Patent Office in order to
obtain the patent. Soon after Roche sued Promega in 1992, we uncovered
evidence of Cetus' fraudulent actions in obtaining the Taq patent in the
US and immediately brought it to the attention of senior Roche
officials. Unfortunately, Roche chose to ignore the fraud, instead
continuing a pattern of deception by obtaining equivalent patents in
other countries. The Court's decision finally puts an end to their
deception and to the huge profits they've reaped from that deception at
the expense of the scientific community worldwide."

James Troupis of Michael Best & Friedrich LLP, lead counsel for Promega,
notes that cases involving fraud of this scope and magnitude are rare.
"The U.S. patent system grants monopolies to patent holders in exchange
for complete candor and disclosure. Judge Walker's comprehensive
findings and conclusions reaffirm that where there are gross abuses of
this duty of candor, such as occurred in this case, they will not be

In addition to the financial impact of lost sales and royalties, Roche
faces the prospect of monetary damages and other sanctions. 

The complete text of Judge Walker's order, along with extensive
information on the case, may be obtained from Promega's web site:
www.promega.com, "Patent News". Phone interviews with quoted individuals
may be arranged through the number below.


Diana Frank, Executive Assistant
(608) 277-2513
dfrank at promega.com 


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