Patents and your health.

• Author: Ries, Nola M.
• Position: Special Report on Intellectual Property

Intellectual property issues are of growing importance in the health care field. Legislators, judges, researchers and the public are currently grappling with complex questions regarding the appropriate boundaries of patent law, particularly in regard to patents on genes and higher life forms. Patents are a form of intellectual property protection that grant an inventor a monopoly over an invention for a specific period of time. In other words, the inventor acquires the exclusive privilege to make and use the invention and sell it to others. Inventions that are new, useful, and non-obvious are patentable under Canada's Patent Act. Because years of work and millions of dollars often go into research, it is only fair to grant patents so inventors have time to gain some return on their investment. By providing this protection, patents encourage scientific research and innovation.

However, recent advances in genetic research and technology have created challenging issues in the field of intellectual property law. Will patents on genetic tests limit access to health care services and drive up health care costs? Should genetically-altered animals be considered patentable inventions? How will the Canadian legal environment affect our growing biotechnology industry and our international competitiveness? These complex questions have recently made headlines in Canada in regard to patent claims over genes associated with breast cancer and genetically modified mice used for cancer research.

Genetic Testing for Hereditary Breast Cancer

Over the past two years, controversy has brewed in Canada regarding the impact of patents on access to genetic testing for breast cancer. Approximately 5 to 10% of breast cancer cases are hereditary, meaning that women with specific genetic mutations are at high risk of developing the disease. Two genes, known as BRCA 1 and BRCA 2, are associated

with breast (and ovarian) cancer. An American company, Myriad Genetics Inc., developed a testing procedure to detect the mutations and currently holds patents in Canada that cover the genetic sequencing process that identifies mutations in the genes that are associated with cancer.

In 2001, Myriad sought to enforce its patents in Canada and demanded that provinces, including Alberta, Ontario and British Columbia, cease doing their own testing and obtain tests only through a Myriad-approved lab. Myriad charges close to $4000 for each test, compared to the cost of around $1000 in...