Gene Patents

The Human Genome project has determined that there are approximately 20,500 genes in the human genome. These units of heredity control all aspects of metabolism, growth and development in human cells. Two major functions that genes control are the cell’s ability to divide or not divide. The genes that control normal cell division can be altered by mutation and this can result in abnormal or uncontrolled cell division.

These cell division controlling genes, called oncogenes and tumor-suppressor genes, play a key role in cancer. In their altered or mutated state, they can no longer function normally, and uncontrolled cell growth results, leading to tumor formation.

Other processes, including vascularization (nourishing the tumor with a blood supply) and metastasis (the spread of cancer cells to other locations in the body) are controlled by other genes. By monitoring the expression levels of all the genes involved in cancer initiation and progression we can provide a precise diagnosis of the type of cancer and give an accurate prognosis of outcome to the patient. The monitoring of gene expression levels will also provide the basis for choosing the most appropriate therapy for each individual patient.

There are now patents associated with around 10,000 genes in the human genome. Patents are extremely valuable to those developing products based on genetic discoveries. However, when patents limit the use of basic genetic information, they threaten to inhibit or limit biomedical research. We are concerned that the large number of patents associated with the human genome is limiting the integration of P4 medicine into health care either because of their restrictive nature or prohibitive costs. This maze of patents has the potential to inhibit the translation of genetic discoveries into affordable health care benefits.

The recent court ruling by United States District Court Judge Robert W. Sweet’s invalidation of seven patents related to the BRCA genes implicated in breast cancer is a step in the right direction towards rectifying what many feel is an improper use of patent law. This is good news for Iris and opens up another multi-billion-dollar market for products and services that the company previously didn’t plan on offering due to patent constraints.