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The Honorable Michael Harris, M.P.P.
Premier of Ontario
Legislative Assembly of Ontario
Room 281
Legislative Building
Toronto, Ontario
M7A 1A1
Dear Premier Harris:
I read with concern your remarks about modifying Canadian patent laws
to prevent private firms from patenting human genes ("Ontario to
defy U.S. patents on cancer genes", September 20, 2001, National
Post). Canada is home to the second-largest biotechnology industry in
the world, an innovative industry that generates $5 billion per year
and 65,000 jobs, most of them well paid and highly skilled. Ontario
is the hub of much of this activity, and for that reason the Biotechnology
Industry Organization has selected Toronto for its 2002 international
meeting, the world's largest biotechnology event attracting more than
14,000 participants from 45 nations.
BIO has a strong presence in Canada. Of our 1,045 members, 115 are
in Canada. Additionally, nearly 10% of BIO members recruited in the
last year are Canadian. The biotechnology industry is clearly robust
in Canada but its foundation is fragile. That foundation consists of
the worldwide patent system that ensures those who invest years of their
lives and hundreds of millions of dollars to develop life-saving products
for which no or few therapies exist now, will be rewarded for their
efforts.
In your statement before the Ontario Advisory Committee on Predictive
Genetic Tests, you indicated that Canadian laws should be amended to
prevent private firms from patenting human genes so that Canadians would
have long-term access to genetic tests, including a test for breast
cancer predisposition. While your arguments are well-intentioned, they
are based on the erroneous premise that ignoring or modifying patent
laws will make gene screening tests more affordable and accessible.
In fact the opposite is true.
If you ignore or remove intellectual property protection on biotechnology
products, then the next generation of predictive tests and medicines
will never materialize. For many biotechnology companies, patents are
the only assets from which they attract the investment necessary to
develop life-saving products. In the long run, the development of these
life saving products will not only save many lives but also save billions
of dollars in the Canadian health care system. The inability to obtain
or enforce patent rights will eliminate the impetus that is necessary
for innovation. I would also add that in the specific case of genetic
tests, lifting patent restrictions and allowing unfettered competition
would create a patchwork of quality assurance and quality control since
each lab would carry out its own version of the test.
In its short two decades of existence, the biotech industry has produced
over 100 biotech drugs and vaccines that have helped more than 270 million
people worldwide. Another 350 biotech medicines are in late-stage clinical
trials. Why? Because the patent laws have created a nurturing environment
amenable to risk-taking.
Many observers share your concern about "patenting genes."
Rest assured, patents are not granted on the raw DNA sequences of genes,
nor are they granted on genes as they exist in nature. A patent is awarded
only if one can describe a gene's role in human health or other commercial
application. It sometimes takes years of painstaking work to replicate
a gene, discover exactly what it does, and then turn that discovery
into a commercial application that can then enter animal and clinical
testing; that testing can then take five to ten years to complete. Those
commercial applications therefore constitute real "inventions."
There are lots of compounds in nature that the biopharmaceutical industry
has developed as drugs and biologics. Interferons, interleukins, insulin,
and prostate specific antigen (PSA) are found in nature, but they are
not found in forms that are usable as drugs or biologics. It took "inventions"
- patentable breakthroughs - to transform the initial discoveries of
the genes into life-saving products. Any threat to the patenting system
can wreak havoc on the investment climate that supports development
of such products.
The Biotechnology Industry Organization, which represents over 1000
companies, academic institutions and state biotechnology centers worldwide,
urges you to reconsider your position.
Sincerely,
Carl B. Feldbaum
President
Biotechnology Industry Organization
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