BIO Letter to Ontario Premier on Gene Patenting

If you ignore or remove intellectual property protection on biotechnology products, then the next generation of predictive tests and medicines will never materialize.</p>

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.


Carl B. Feldbaum
Biotechnology Industry Organization