On April 15, 2013, the Supreme Court heard a challenge by a group of scientists to Myriad Genetics’ patent of the BRCA1 and 2 genes. On May 14, actress and humanitarian Angelina Jolie revealed that she’d had a preventive double mastectomy because testing had shown her to be positive for the BRCA1 mutation, bringing further attention to the Supreme Court’s upcoming decision.
Everyone has BRCA1 and 2 genes (BReast CAncer genes one and two). The function of the BRCA genes is to repair cell damage and keep breast cells growing normally. But when these genes contain abnormalities or mutations that are passed from generation to generation, the genes don’t function normally and breast cancer risk increases. Abnormal BRCA1 and BRCA2 genes may account for up to 10% of all breast cancers, or 1 out of every 10 cases.
Myriad has held a patent on these gene sequences for over a decade. The scientists challenging the company say that you can’t hold a patent on something that occurs naturally, even if you discovered it. They say giving exclusive rights to Myriad limits others’ ability to use the BRCA sequences to develop new therapies and tests. Women with these gene mutations, as well as breast cancer advocates, are concerned that the patent is stifling research and new discoveries that could help save their lives now. They contend that any obstacle in the way of progress in research must be removed. The removal of these limitations could help patients by reducing the costs of new tests and therapies and by stimulating potentially life-saving discoveries.
Myriad says that they need the patent in order to ensure profitability, so that they can attract investors and have enough funding to surmount the enormous costs of bringing the BRCA test to market. For example, one supporter of the company said that the average cost of bringing a new drug, therapy, or test to the market is 1.2 billion dollars. Myriad and its supporters are concerned that if the business isn’t profitable, discovery and innovation simply will not happen.
But the need to make money and the need for innovation is not what’s being argued in this case. The fundamental question is whether or not the sequence of a gene is patentable. In arguments before the court, several analogies were made. Imagine that the BRCA sequence is a baseball bat. The bat is cut out of the wood and is invented and therefore patentable. No one knew the bat was there until someone came along and thought it up and cut the wood in just the right places. Another analogy likened the sequence to the ingredients for cookies: eggs, flour, etc. You could patent a certain combination of the ingredients (a new type of cookie for instance) but you cannot patent the ingredients themselves.
Personally, I believe that more competition and variety in the marketplace of ideas will yield the best results for my patients. I also acknowledge the fact that the cost of bringing a new test or therapy to the market is extremely expensive and that profitability needs to be part of the equation.
What we really need are two things. The first is smarter regulation to reduce the burdens and costs of developing drugs, tests, and therapies. We are now seeing critical shortages of generic cancer drugs; this is partly related to the fact that cancer medications are so expensive to produce and the payback is too low for doing so. Secondly, the biomedical industry needs a revolutionary advance in technology: an innovation that fundamentally changes the way drugs and tests are developed and brought to market.
Breastcancer.org will be following this case closely and will provide updates as developments occur. We welcome your comments below!