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Another interesting read out of Biotech daily before court finding handed down

FERMISCAN
Fermiscan is suing the inventor of its x-ray diffraction hair test Prof Veronica James
claiming a new test using finger nails and skin is an improvement on their patent.
Prof James sold the 1998 hair x-ray diffraction patent to Fermiscan in 2004 and has been
the subject of legal action brought against her by Fermiscan - including an Anton Piller
order allowing the company to search and seize her private property.
Following the initial court action, the company and Prof James reached a settlement which
included an agreement that Prof James would not disparage the company, which has
been interpreted as a silencing order against the scientist.
Middleton’s intellectual property partner Jane Owen is not bound by the settlement and
told Biotech Daily there would be a hearing at the New South Wales Supreme Court on
May 25, 2009.
Ms Owen said Fermiscan alleges that Prof James has breached the settlement clause
preventing her from disparaging the company and that Fermiscan alleged that work Prof
James had undertaken on x-ray diffraction of finger nails and skin was “an improvement”
to the original patent they acquired from Prof James in 2004.
On January 3, 2008 Prof James filed international patent application PCT/AU2008/000005
entitled ‘Biometrics Diagnosis’ with the Australian Patent Office.
On July 17, 2008 the World Intellectual Property Organisation published the application on
its website with the description: “The invention provides a method of detecting neoplastic
or neurological disorders comprising exposing skin or nails to X-ray diffraction and
detecting changes in the ultrastructure of the skin or nails, and also provides an
instrument when used in the method of detection.”
An adjunct professor at the Australian National University’s Research School of
Chemistry, Prof James article entitled ‘Fiber diffraction of skin and nails provides an
accurate diagnosis of malignancies’ was published online in the International Journal of
Cancer on February 3, 2009 byWiley Interscience (www.interscience.wiley.com).
The article says that an early diagnosis of malignancies correlates directly with a better
prognosis, but for many malignancies there are no readily available, noninvasive, costeffective
diagnostic tests with patients often presenting too late for effective treatment.
“This article describes for the first time the use of fiber diffraction patterns of skin or
fingernails, using X-ray sources, as a biometric diagnostic method for detecting neoplastic
disorders including but not limited to melanoma, breast, colon and prostate cancers.
“With suitable further development, an early low-cost, totally non-invasive yet reliable
diagnostic test could be conducted on a regular basis in local radiology facilities, as a
confirmatory test for other diagnostic procedures or as a mass screening test using
suitable small angle X-ray beam-lines at synchrotrons.”
The abstract is at http://www3.interscience.wiley.com/journal/121664971/abstract.
Fermiscan alleges that x-ray diffraction of skin and nails is merely “an improvement” on
Prof James’s original patent for x-ray diffraction of hair to detect breast cancer.
Fermiscan managing director David Young told Biotech Daily that he was “prohibited from
talking about it”.
“We are not talking about it until it’s resolved,” Mr Young said.
“We hope one day she will win a Nobel Prize for the technology and [it will] make her very
rich,” Mr Young said. “She has a royalty stream for the product,” he said.
Asked whether the matter could not be resolved without legal action, Mr Young said he
wished it could be.
Prof James’ solicitor Jane Owen said the skin and nail test was “absolutely a new
invention”.
“The diffraction process has been used since the 1930s to examine biological materials,”
Ms Owen said. “The difference is the use of different biological materials to test for
cancers and different cancers to those in the 1998 Fermiscan patent.”
“It’s a complete over-simplification to think you can substitute a nail for a hair and then
expect to automatically predict the results will be the same. The new patent application is
for different biological materials for the detection of different and further types of cancer.”
“If Fermiscan’s claim was valid, it would be tantamount to saying that they own all x-ray
diffraction processes for all biological material.
“Their patent simply doesn’t go that far,” Ms Owen said.
Prof James has an Order of Australia Medal for her services to the deaf and there is an
annual two day camp called the Veronica James Science Challenge for Hearing Impaired
Children supported by the University of Sydney’s Faculty of Medicine through its
department of pathology. Prof James has worked on breast cancer since the 1980s.
Fermiscan was down 1.5 cents or 7.89 percent to 17.5 cents.
BIOTECH DAILY EDITORIAL
Whatever the merits of the case Fermiscan is mounting against Prof Veronica James, it is
simply bad for the biotechnology sector when a scientist is hounded by a company.
Fermiscan is spending its investors’ money to take the most drastic action possible
against the inventor of its technology and soon it will be requiring Polartechnics
shareholders to follow suit.
It is not credible that the company cannot find a creative role for Prof James assisting in
this most interesting method of non-invasively detecting very early cancer.
Together they could be saving women’s lives.
It is most poignant when the circumstances of the plaintiff Fermiscan are compared with
those of the defendant Prof Veronica James
Prof James is receiving legal assistance on a no-win, no-pay basis and is supported by
women concerned with the high incidence of breast cancer. She should be allowed to
retire in dignity and comfort, instead of facing endless court cases because she continues
to research her life’s passion.When she could not find suitable equipment, she designed
and engineered it herself. She should be celebrated as a great pioneering scientist.
Fermiscan is spending investors’ money, for what purpose?
If Prof James disparages their test, originally based on her work, so what?
This is science. Evidence rules.
The company has not explained why legal action is necessary.
And to the best of Biotech Daily’s knowledge neither Prof James nor Fermiscan have
been able to clearly demonstrate superior results with the x-ray diffraction of hair process
above the standard of care of mammography and biopsy.
If Prof James’s skin and nail test does prove superior, Fermiscan could apologize, waive
all previous agreements, pay a suitable fee and hire Prof James as a consultant.
Regardless of any facts and argument to be played out in court, one thing is clear, this
case should never have begun and Biotech Daily strongly opposes the silencing of
scientists with anything other than scientific evidence.
Biotech Daily believes that regardless of subsequent events, originating scientists should
be celebrated by those who seek to capitalize on their creativity.
The Fermiscan Polartechnics merger will give the new company, Novus Diagnostics, an
opportunity to reappraise the relationship with Prof James.
David Langsam
Editor