Taq Patent 'obtained by fraud'

Tim at hgmp.mrc.ac.uk Tim at hgmp.mrc.ac.uk
Thu Jan 13 09:21:48 EST 2000

I'm not a lawyer.  But, according to the printed ruling handed down, the
parties of the legal action must appear again in court on January 27,
2000.  I
think things may be "finalized" at that time for this proceeding.  You
can be
sure, however, that Roche will vigorously pursue its options for
appealing the
ruling.  I would also expect that Roche will continue to defend and
royalties from the production and use of Taq, unless the judge declares
the patent and related royalties cannot be enforced during any appeals
process.  Therefore, it may be a long time (maybe several years) before
process reaches its conclusion.  Assuming Roche ultimately loses I would
forward to generally lower prices for Taq and products that utilize Taq.
would at least await the results of the proceeding of January 27 before
speculating upon the ruling's effect pertaining to the patents covering

daemon at hgmp.mrc.ac.uk, [mailto:daemon at hgmp.mrc.ac.uk], On, Behalf, Of

> 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
> say a bit more about the probable consequences and how much weight
> ruling by a District Court actually carries..
> Dr Kevin O'Donnell
> Scottish Agricultural Science Agency
> Edinburgh
> EH12 8NJ
> UK
> Tel.: +44 131 244 8924 Fax: +44 131 244 8926
> http://www.sasa.gov.uk
> 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
> annually.
> In carefully worded and lengthy written findings, Judge Vaughn Walker
> the Northern District of California in San Francisco concluded that
> 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
> key to genetic identification and analysis, and researchers use both
> processes extensively worldwide in pursuit of prevention of or cures
> disease.
> The Court's decision renders this primary Taq patent unenforceable and
> sets the stage for a finding of unenforcability for all related Taq
> 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
> 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
> 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
> pleased that the Court validated what the worldwide scientific
> has believed for years: that Taq was first purified by others, and
> Cetus must have misrepresented facts to the US Patent Office in order
> obtain the patent. Soon after Roche sued Promega in 1992, we uncovered
> evidence of Cetus' fraudulent actions in obtaining the Taq patent in
> 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
> the expense of the scientific community worldwide."
> James Troupis of Michael Best & Friedrich LLP, lead counsel for
> notes that cases involving fraud of this scope and magnitude are rare.
> "The U.S. patent system grants monopolies to patent holders in
> 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
> tolerated."
> 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
> may be arranged through the number below.
> Contact
> Diana Frank, Executive Assistant
> (608) 277-2513
> dfrank at promega.com
> ---

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