[Ip-health] Ontario: Defying patent threats by Myriad on gene-based cancer testing

Richard Elliott relliott@aidslaw.ca
Thu, 20 Sep 2001 09:33:00 -0400


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Hi all

Below is the latest item from Ontario's largest newspaper, published today,=
=20
re: the simmering public dispute over patents, as well as an item from the=
=20
Canadian Press wire regarding yesterday's meeting at which this government=
=20
position was articulated.  These are pleasantly surprising developments.=20
The current Ontario government is rabidly pro-business, so it's quite=20
astonishing for the Premier and Health minister of the province to be=20
saying things like "the benefits of the human genome project should not be=
=20
the property of a handful of people or companies," and that "monopoliy=20
pricing" threatens a publicly-funded, equitable system of health care=
 coverage.

A good example of how strong public support for public universal health=20
care can make even the most right-wing politicians, who must find the bucks=
=20
to pay for that system, feel the heat enough that they challenge their=20
corporate buddies.  Imagine if it even led to a renewed debate about=20
reinstating compulsory licensing into Canadian law (we lost it in the late=
=20
1980s and early 1990s thanks to a Conservative government in the pocket of=
=20
the pharmaceutical lobby).

This has the potential to get Canadians paying attention to the whole issue=
=20
of the imbalance in our patent regimes and the threat to equitable access=20
to health care.  We'll be trying to make the connection for them to the=20
global crisis, and it's pretty certain that it will be on the agenda in the=
=20
coming months for the country's health ministers.

Richard Elliott
Canadian HIV/AIDS Legal Network

************
Sep. 20, 02:00 EDT
Toronto Start

Gene tests for cancer won't stop
Harris pledges help with battle over U.S. patent
Caroline Mallan
QUEEN'S PARK BUREAU CHIEF
The Ontario government has given hospitals the green light to continue with=
=20
genetic testing for breast and ovarian cancers even though an American=20
company says it owns the patent on the genes in question.
Premier Mike Harris and Health Minister Tony Clement made the announcement=
=20
yesterday at a meeting of the provincial advisory committee on predictive=20
genetic technology and vowed to help hospitals fight any ensuing legal=20
battles with the American laboratory company.
British Columbia, worried about legal action, already stopped offering the=
=20
screening tests to its residents under medicare this past July.
The test helps identify women who possess an abnormal gene pattern likely=20
to lead to cancer at some point. Some women, armed with this knowledge, opt=
=20
to have preventative mastectomies or hysterectomies to ward off the disease.
The company that holds the patent, Myriad Genetics Laboratories in Salt=20
Lake City, Utah, wants all cancer-screening tests for two genes it owns to=
=20
be carried out at one of its own labs at a cost of $3,850 per test and has=
=20
sent cease and desist letters to provincial governments offering the=20
screening.
The provincial government pays hospitals $800 for each test. Ontario began=
=20
funding genetic testing and counselling at seven regional hospitals in=20
April, 2000.
About 1,000 Ontario women were tested for hereditary breast cancer last=20
year and close to 4,000 family members received counselling for the=20
possibility of carrying genetic disease.
The Premier called upon the federal government to revisit its patent laws=20
and come up with a clear stance on whether genes can be patented and if so,=
=20
for how long.
``If Ontario has to stand alone, we'll stand alone, but it is our hope that=
=20
other provinces will stand with us and, of course, it's the hope of all the=
=20
provinces that the federal government will stand for Canada,'' Harris told=
=20
reporters.
Harris said the U.S. and British governments have both sent strong messages=
=20
that commercial exploitation of the human genome research will not be=20
allowed if it means cures or disease detection are available only to those=
=20
who can afford them.
``I can't believe that anybody believes that the Myriad position is in any=
=20
way reflective of what the president of the United States articulated would=
=20
be the benefits of genome research to America and to the world,'' Harris=20
said of former U.S. president Bill Clinton's stance on the issue.
Myriad spokesperson Bill Hockett said the company's methodology is so=20
sophisticated that not using their labs could endanger women's health by=20
giving false results.
``I think we believe it's a major mistake on behalf of the women in Ontario=
=20
and a disservice to the health care system,'' he said. ``Women who have a=20
mutation will be found by our methods and not some of the other screening=20
methods being used.''
Myriad officials plan to present evidence of the superior quality of their=
=20
testing to health ministry officials in the near future, Hockett added.
But Dr. Ron Carter, president of the Canadian College of Medical=20
Geneticists, says often the research that led to mutated genes being=20
discovered was funded by taxpayers through universities and hospitals.
He said companies such as Myriad apply for patents at the very end of a=20
lengthy, taxpayer-funded process and then turn around and charge hospitals=
=20
to test for those genes.
``This is a very, very important issue,'' Carter said, adding new gene=20
discoveries could lead to new patents and more cost for the health care=20
system.
Clement said the issue needs greater international debate if advances in=20
medicine related to the human genome mapping project are not to be reserved=
=20
solely for the rich.

***************

http://news.excite.com/news/cp/010919/13/ontario-defies-us

Ontario defies U.S. gene company over cancer test, arguing health care at
risk
Updated: Wed, Sep 19 1:18 PM EDT
Ontario has no intention of following B.C. by excluding the predictive
test for ovarian and breast cancers from the province=92s health plan,
Premier Mike Harris said Wednesday. (CP Photo) (CP)

TORONTO (CP) - Ontario is defying an American company's demand that the
province stop funding a cancer-screening test, arguing private patents on
human genes that are used in such tests put Canada's health-care system at
serious risk.
Ontario has no intention of following British Columbia by excluding the
predictive test for ovarian and breast cancers from the province's health
plan, Premier Mike Harris said on Wednesday. Moreover, Harris told a
gathering of geneticists, Ottawa has to seize the initiative and look at
how Canada's patent laws are applied to the rapidly advancing field of
genetics.
"The frontier of gene patenting has been treated like the Wild West for
too long," said Harris.
"The benefits of a worldwide effort such as the human genome project
should not be the property of a handful of people or companies."
Myriad Genetics Laboratories, based in Salt Lake City, is demanding that
all cancer-screening tests based on two genes it holds the patents for be
done through its own laboratories.
It also threatened to sue any provinces that cover the cost of the tests
done in their hospitals.
Currently, Ontario pays $800 for each test based on the genes known as
BRCA 1 and 2. The same test done through Myriad or its licensees would
cost $3,850.
About 1,000 such tests were done in Ontario last year.
Dr. Ron Carter, president of the Canadian College on Medical Genetics,
warned that much more is at stake than access to this test.
"It's not just about one gene, it's about hundreds of genes to come," said
Carter.
"If this sets a precedent, we will not be able to afford our health-care
system."
Health Minister Tony Clement, who plans to raise the issue at next week's
health ministers meeting in St. John's, Nfld., agreed.
The "monopoly pricing of a whole new category of diagnostics" threatens
publicly funded health care and equitable coverage, Clement told the
Ontario Advisory Committee on Predictive Genetic Technology.
In a recent letter to Myriad, Clement said predictive screening should be
available to all women who require them and that paying hospitals to do
them does not infringe on its patents.
The threat of a lawsuit recently prompted British Columbia to pull the
plug on its funding, leaving hundreds of women hanging. Many had already
had their DNA extracted and banked.
But Harris said British Columbia is reconsidering its decision and called
for support in the fight against "monopoly gain" he said is not
"legitimate in this world."
He called on political leaders around the world to act in concert and act
quickly to avoid expensive court battles and bring order to the situation,
something he said would be fair to research companies as well.
"If Ontario has to stand alone, we'll stand alone, but it is our hope that
other provinces will stand with us and, of course, it's the hope of all
the provinces that the federal government will stand for Canada," Harris
said.
Carter noted that large amounts of public money go into scientific
discoveries in the form of grants for research and clinical trials.
"The patents typically taken out at the very end stage end of a long, long
process that the public has already paid for," he said.
Genes are patentable in Canada in largely because the century-old
definition of "invention" in the Patent Act.
As a result, federal patents granting sole commercial control in Canada
over at least a dozen human genes have been issued in recent years to
corporations, research institutes, hospitals and others.
Scores more patents are pending on genes associated with diseases ranging
from various cancers to Alzheimer's and obesity.
The American College of Medical Genetics has called for a ban on all
patenting of human genes, arguing the result is exorbitant user fees and
monopolistic licensing of genetic testing.





Richard Elliott
Director, Policy & Research / Directeur, politiques et recherche
Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien VIH/sida
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4
Tel : +1 (416) 595-1666                 Fax +1 (416) 595-0094
E-mail: relliott@aidslaw.ca     Web: www.aidslaw.ca

The Canadian HIV/AIDS Legal Network is a partner organisation of the
AIDS Law Project of South Africa.  -- Le R=E9seau juridique canadien=
 VIH/sida
est un organisme partenaire du AIDS Law Project de l'Afrique du Sud.

Please help fight world hunger.  One click a day sends FREE FOOD to
fight malnutrition, AIDS and other diseases. See:=
 http://www.thehungersite.com
____________________________________________________________________
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Content-Transfer-Encoding: quoted-printable

<html>
<font size=3D3>Hi all<br><br>
Below is the latest item from Ontario's largest newspaper, published
today, re: the simmering public dispute over patents, as well as an item
from the Canadian Press wire regarding yesterday's meeting at which this
government position was articulated.&nbsp; These are pleasantly
surprising developments. The current Ontario government is rabidly
pro-business, so it's quite astonishing for the Premier and Health
minister of the province to be saying things like &quot;the benefits of
the human genome project should not be the property of a handful of
people or companies,&quot; and that &quot;monopoliy pricing&quot;
threatens a publicly-funded, equitable system of health care
coverage.<br><br>
A good example of how strong public support for public universal health
care can make even the most right-wing politicians, who must find the
bucks to pay for that system, feel the heat enough that they challenge
their corporate buddies.&nbsp; Imagine if it even led to a renewed debate
about reinstating compulsory licensing into Canadian law (we lost it in
the late 1980s and early 1990s thanks to a Conservative government in the
pocket of the pharmaceutical lobby). <br><br>
This has the potential to get Canadians paying attention to the whole
issue of the imbalance in our patent regimes and the threat to equitable
access to health care.&nbsp; We'll be trying to make the connection for
them to the global crisis, and it's pretty certain that it will be on the
agenda in the coming months for the country's health ministers.<br><br>
Richard Elliott<br>
Canadian HIV/AIDS Legal Network<br><br>
************<br>
Sep. 20, 02:00 EDT<br>
Toronto Start<br><br>
</font><font face=3D"Times, Times" size=3D5>Gene tests for cancer won't
stop</font><font face=3D"Times, Times" size=3D3> <br>
Harris pledges help with battle over U.S. patent<br>
</font><font face=3D"Times, Times" size=3D2>Caroline Mallan<br>
QUEEN'S PARK BUREAU CHIEF<br>
</font><font size=3D3>The Ontario government has given hospitals the green
light to continue with genetic testing for breast and ovarian cancers
even though an American company says it owns the patent on the genes in
question. <br>
Premier Mike Harris and Health Minister Tony Clement made the
announcement yesterday at a meeting of the provincial advisory committee
on predictive genetic technology and vowed to help hospitals fight any
ensuing legal battles with the American laboratory company. <br>
British Columbia, worried about legal action, already stopped offering
the screening tests to its residents under medicare this past July.=20
<br>
The test helps identify women who possess an abnormal gene pattern likely
to lead to cancer at some point. Some women, armed with this knowledge,
opt to have preventative mastectomies or hysterectomies to ward off the
disease. <br>
The company that holds the patent, Myriad Genetics Laboratories in Salt
Lake City, Utah, wants all cancer-screening tests for two genes it owns
to be carried out at one of its own labs at a cost of $3,850 per test and
has sent cease and desist letters to provincial governments offering the
screening. <br>
The provincial government pays hospitals $800 for each test. Ontario
began funding genetic testing and counselling at seven regional hospitals
in April, 2000. <br>
About 1,000 Ontario women were tested for hereditary breast cancer last
year and close to 4,000 family members received counselling for the
possibility of carrying genetic disease. <br>
The Premier called upon the federal government to revisit its patent laws
and come up with a clear stance on whether genes can be patented and if
so, for how long. <br>
``If Ontario has to stand alone, we'll stand alone, but it is our hope
that other provinces will stand with us and, of course, it's the hope of
all the provinces that the federal government will stand for Canada,''
Harris told reporters. <br>
Harris said the U.S. and British governments have both sent strong
messages that commercial exploitation of the human genome research will
not be allowed if it means cures or disease detection are available only
to those who can afford them. <br>
``I can't believe that anybody believes that the Myriad position is in
any way reflective of what the president of the United States articulated
would be the benefits of genome research to America and to the world,''
Harris said of former U.S. president Bill Clinton's stance on the issue.
<br>
Myriad spokesperson Bill Hockett said the company's methodology is so
sophisticated that not using their labs could endanger women's health by
giving false results. <br>
``I think we believe it's a major mistake on behalf of the women in
Ontario and a disservice to the health care system,'' he said. ``Women
who have a mutation will be found by our methods and not some of the
other screening methods being used.'' <br>
Myriad officials plan to present evidence of the superior quality of
their testing to health ministry officials in the near future, Hockett
added. <br>
But Dr. Ron Carter, president of the Canadian College of Medical
Geneticists, says often the research that led to mutated genes being
discovered was funded by taxpayers through universities and hospitals.
<br>
He said companies such as Myriad apply for patents at the very end of a
lengthy, taxpayer-funded process and then turn around and charge
hospitals to test for those genes. <br>
``This is a very, very important issue,'' Carter said, adding new gene
discoveries could lead to new patents and more cost for the health care
system. <br>
Clement said the issue needs greater international debate if advances in
medicine related to the human genome mapping project are not to be
reserved solely for the rich. <br><br>
***************<br><br>
</font><font size=3D3 color=3D"#0000FF"><u><a=
 href=3D"http://news.excite.com/news/cp/010919/13/ontario-defies-us"=
 eudora=3D"autourl">http://news.excite.com/news/cp/010919/13/ontario-defies-=
us</a><br><br>
</u></font><font size=3D3>Ontario defies U.S. gene company over cancer
test, arguing health care at <br>
risk<br>
Updated: Wed, Sep 19 1:18 PM EDT<br>
Ontario has no intention of following B.C. by excluding the predictive
<br>
test for ovarian and breast cancers from the province=92s health plan,
<br>
Premier Mike Harris said Wednesday. (CP Photo) (CP)<br><br>
TORONTO (CP) - Ontario is defying an American company's demand that the
<br>
province stop funding a cancer-screening test, arguing private patents on
<br>
human genes that are used in such tests put Canada's health-care system
at <br>
serious risk. <br>
Ontario has no intention of following British Columbia by excluding the
<br>
predictive test for ovarian and breast cancers from the province's health
<br>
plan, Premier Mike Harris said on Wednesday. Moreover, Harris told a
<br>
gathering of geneticists, Ottawa has to seize the initiative and look at
<br>
how Canada's patent laws are applied to the rapidly advancing field of
<br>
genetics.<br>
&quot;The frontier of gene patenting has been treated like the Wild West
for <br>
too long,&quot; said Harris.<br>
&quot;The benefits of a worldwide effort such as the human genome project
<br>
should not be the property of a handful of people or
companies.&quot;<br>
Myriad Genetics Laboratories, based in Salt Lake City, is demanding that
<br>
all cancer-screening tests based on two genes it holds the patents for be
<br>
done through its own laboratories.<br>
It also threatened to sue any provinces that cover the cost of the tests
<br>
done in their hospitals.<br>
Currently, Ontario pays $800 for each test based on the genes known as
<br>
BRCA 1 and 2. The same test done through Myriad or its licensees would
<br>
cost $3,850.<br>
About 1,000 such tests were done in Ontario last year.<br>
Dr. Ron Carter, president of the Canadian College on Medical Genetics,
<br>
warned that much more is at stake than access to this test.<br>
&quot;It's not just about one gene, it's about hundreds of genes to
come,&quot; said <br>
Carter.<br>
&quot;If this sets a precedent, we will not be able to afford our
health-care <br>
system.&quot;<br>
Health Minister Tony Clement, who plans to raise the issue at next week's
<br>
health ministers meeting in St. John's, Nfld., agreed.<br>
The &quot;monopoly pricing of a whole new category of diagnostics&quot;
threatens <br>
publicly funded health care and equitable coverage, Clement told the
<br>
Ontario Advisory Committee on Predictive Genetic Technology.<br>
In a recent letter to Myriad, Clement said predictive screening should be
<br>
available to all women who require them and that paying hospitals to do
<br>
them does not infringe on its patents.<br>
The threat of a lawsuit recently prompted British Columbia to pull the
<br>
plug on its funding, leaving hundreds of women hanging. Many had already
<br>
had their DNA extracted and banked.<br>
But Harris said British Columbia is reconsidering its decision and called
<br>
for support in the fight against &quot;monopoly gain&quot; he said is not
<br>
&quot;legitimate in this world.&quot;<br>
He called on political leaders around the world to act in concert and act
<br>
quickly to avoid expensive court battles and bring order to the
situation, <br>
something he said would be fair to research companies as well.<br>
&quot;If Ontario has to stand alone, we'll stand alone, but it is our
hope that <br>
other provinces will stand with us and, of course, it's the hope of all
<br>
the provinces that the federal government will stand for Canada,&quot;
Harris <br>
said.<br>
Carter noted that large amounts of public money go into scientific <br>
discoveries in the form of grants for research and clinical trials.<br>
&quot;The patents typically taken out at the very end stage end of a
long, long <br>
process that the public has already paid for,&quot; he said.<br>
Genes are patentable in Canada in largely because the century-old <br>
definition of &quot;invention&quot; in the Patent Act.<br>
As a result, federal patents granting sole commercial control in Canada
<br>
over at least a dozen human genes have been issued in recent years to
<br>
corporations, research institutes, hospitals and others.<br>
Scores more patents are pending on genes associated with diseases ranging
<br>
from various cancers to Alzheimer's and obesity.<br>
The American College of Medical Genetics has called for a ban on all
<br>
patenting of human genes, arguing the result is exorbitant user fees and
<br>
monopolistic licensing of genetic testing.<br><br>
<br><br>
<br>
</font><x-sigsep><p></x-sigsep>
<font size=3D2>Richard Elliott<br>
Director, Policy &amp; Research / Directeur, politiques et=20
recherche<br>
Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien=20
VIH/sida<br>
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4<br>
Tel : +1 (416) 595-1666&nbsp;&nbsp;&nbsp;
<x-tab>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</x-tab><x-tab>&nbsp;&nbsp;&nbsp;&nbsp;=
&nbsp;&nbsp;&nbsp;&nbsp;</x-tab>Fax
+1 (416) 595-0094<br>
E-mail:
relliott@aidslaw.ca<x-tab>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</x-tab>Web:
<a href=3D"http://www.aidslaw.ca/"=
 eudora=3D"autourl">www.aidslaw.ca</a><br><br>
The Canadian HIV/AIDS Legal Network is a partner organisation of=20
the<br>
AIDS Law Project of South Africa.&nbsp; -- Le R=E9seau juridique canadien
VIH/sida<br>
est un organisme partenaire du AIDS Law Project de l'Afrique du
Sud.<br><br>
Please help fight world hunger.&nbsp; One click a day sends FREE FOOD
to<br>
fight malnutrition, AIDS and other diseases. See:
<a href=3D"http://www.thehungersite.com/"=
 eudora=3D"autourl">http://www.thehungersite.com</a><br>
____________________________________________________________________</font><=
/html>

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