The Monopoly on Genetic Human Genes
The US Supreme Court recently decided this very issue in the case of Association for Molecular Pathology, et al v Myriad Genetics, Inc.
Myriad Genetics (“Myriad”) carries out tests for BRCA genes, the genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Patients can undergo genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Woman with the faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer. This form of testing recently made news headlines when Angelina Jolie revealed that she underwent a double mastectomy after one of the BRCA genes was identified in her body.
Myriad obtained patent protection for the two human genes known as BRCA1 and BRCA2 which correlate with this increased risk, along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes.
These patents granted Myriad the right to control access to the BRCA genes and prohibited others from researching or doing diagnostic testing of the genes.
In their patents, Myriad claimed protection for every naturally-occurring version of those genes, including mutations, on the basis that they had invented something by isolating the genes from the body. The Association of Molecular Pathology (“AMP”) representing a variety of genetic researchers, medical organizations and patients, all of whom had been accused of infringing on Myriad’s patents on the BRCA genes, contended that human genes were not patentable on the basis that they are a product of nature. Patent protection cannot be obtained for products of nature by virtue of Section 101 of the United States Code and AMP alleged that the mere fact that the genes were isolated from the body did not mean that it was patentable.
The Supreme Court agreed with AMP and held that the BRCA1 and BRCA2 genes were naturally occurring and were therefore not patentable. However, it was held that the synthetically created genetic material, or cDNA, was patentable.
The decision has had mixed reviews. While the decision comes as a relief to geneticists who can now make use of the BRCA genes, companies involved in biotechnology research might find it to be a financial blow by limiting commercial incentives to continue researching into DNA.
In the wake of this decision, companies and universities announced that they will provide the tests for the BRCA genes. Myriad last week sued two such companies, Ambry Genetics and Gene by Gene, claiming that the tests infringed other patents owed by Myriad which had not been invalidated by the court.
The outcome of this on-going litigation will help to shape the biotechnology research industry and the way in which companies approach the protection of the fruits of their research and development.
Hillary Brennan – Candidate Practitioner