Since 1982, genes used in certain biomedical innovations have been patented. However, a recent court case is calling for a review of patenting guidelines when it comes to human genes. Some advocates for loosening patent regulations indicate that by buying and holding patents on a particular gene known to be beneficial for therapeutic purposes, a company could stall research in a deliberate attempt to corner the market on a competing therapy. Proponents for continued patenting of genes say that the way the system currently works has led to a wide variety of useful treatments.
While most of the early patents on certain genes are nearing their 20 year lifespan, other companies are looking at the current debate as they look to create new genes, modify existing genes or create gene therapies which may be affected by the outcome of the current litigation. The majority of the findings from the comprehensive human genome project are in the public domain. The majority of polls taken on public opinion regarding the subject indicate that genes should not be patented or at least treated the same way as a piece of property or inanimate object is treated by patent law. The Supreme Court is now hearing arguments on both sides of the issue.
The current patent debate looks at very specific instances where a company holds a patent on a gene and prevents other companies from conducting parallel research, while science, by nature, has an open-community aspect to the sharing of ideas and testing and re-testing colleagues’ findings. The courts are now in a position to draw the line as to where open access to gene-related data will be. In the case of cancers, where people are waiting for new therapies to save lives, proponents for open access have strong allies. At the same time, in order to bring a gene therapy to fruition, many years of research and much funding is needed. Companies who do all the preliminary work expect compensation so that they can continue to fund their future research.
The current case asks the court to decide whether genes existing in their natural state can be patented, or would patenting be an option once extracted and mutated, or should patents just cover therapies derived from those genes? It also asks the court to weigh in on where the line is between patenting a specific gene that has been extracted and then altered for laboratory tests. Specifically, the courts are expected to weigh in on where a company can draw the line between what is actually present in the current genome and what is theoretically possible based on potentially subsequent mutations of that gene which are not yet derived. In other words can a company hold a patent on a gene and all its possible mutations for the life of the patent?
The genes at the heart of the current debate are the BRCA1 and BRCA2 genes which are implicated in drastically increasing a person’s chance of developing cancer. Potentially billions of dollars are at stake for companies developing treatments and doing research related to these genes. Proponents for an open science want the freedom to allow research labs all over the world to have access to the data and genes needed to get new therapies and research breakthroughs out into the public domain as quickly as possible. Individuals with monetary interests in the gene are seeking fair compensation and control of their discoveries up to this point and in the future.
The BRCA genes entered into more public awareness most recently with Angelina Jolie’s recent announcement of her double mastectomy as a way of heading off cancer, which had killed her mother. Individuals with the BRCA gene mutation have a 3 to 7 times more likely chance of developing breast cancer. In the United States, breast cancer occurs in 1 in 8 women and approximately 1 in 1000 men annually. Student and career changers interested in a career in healthcare are entering the field at an important time in medicine where current court debates will have long-term effects on the future of gene-related therapies, including the on-going development of personalized medicine in the coming decades.
