Biotech companies invest a lot in developing ways to rapidly diagnose diseases, identify people at risk for certain medical conditions, and determine which individuals will respond to particular drugs. This work often results in finding previously unknown variations in specific genes that predict if a person might develop a disease or respond to a treatment. In return for the investment to develop these medical tests, shouldn't companies have a certain right to profit from their discoveries? It is the main incentive for companies to make these sorts of investments.
However, genetic-based medical tests are really just looking at small differences in the genes between one person and another. The techniques used for genetic tests are standard procedures commonly practiced in biotechnology laboratories and all DNA is chemically very similar. It is not the way the tests are run that is unique. What makes a gene unique is the information encoded by the DNA, which is determined by the order in which the chemical components that make up DNA are linked together. Most genetic tests just determine what specific sequences of these components a person has on a certain gene. In other words, a genetic test mainly relies on the knowledge of what variations of DNA to look for, not on how to identify the variations.
The right to profit from new discoveries and technology is the logic behind patents, and the basis of a free-market approach to innovation. However, simple discoveries and naturally occurring material, including chemicals, cannot be patented. This, of course, includes human DNA. With most natural products, companies can patent specially developed methods to isolate the material or synthesize it in the lab. Genes are bit unique though. Since companies cannot own the natural sequence of our genes outright, they claim rights to the mimics, copies, and isolated fragments of the natural DNA that are used for research and genetic testing. As a result, there are patent claims to thousands of genes. However, no one is precisely clear what rights these gene patents provide, so now the question is in front of the Supreme Court.
The Court will has agreed to rule on gene patents in the case challenging Myriad Genetics' claims on the BRCA cancer genes. Myriad asserts it owns rights to gene tests that determine if women have certain mutations of the BRCA1 and BRCA2 genes, which indicate a high risk of developing breast and ovarian cancer. The case has important implications on healthcare research and practice. Should a company be able to stop other organizations from working on or testing people for genes they have patented? Can a company claim the exclusive right to tell a patient what particular variation of a gene they have? Generally, what rights do patents on specific gene sequences provide companies, and what's considered public unpatentable knowledge? Hopefully, that's what the Court will clarify.
Two recently posted articles explore some of the issues with this case. The Supreme Court Reviews Myriad's Gene Patents give an overview of the Myriad case, and Gene Patents: Can a Company Really Own Your DNA? discusses how companies go about patenting genes.