An ongoing legal battle over whether companies can file patents on human genes — yes, really — is heating up, and I can promise you haven’t heard the end of it.
In late March a federal court threw out two patents linked to breast and ovarian cancer held by genetic testing company Myriad Genetics. The company plans to appeal the ruling, and my guess would be that it will make it to the Supreme Court. The outcome could have a huge impact on the entire gene-based pharmaceuticals industry.
The fact that these genes are indeed patented is nothing new — about 20% of the human genome has already been patented by companies that “discovered” them (through isolation and purification methods) and have developed genetic tests and drugs based on the genes. The companies are able to reap sole profits from these products due to their exclusive patents.
But patients object to the ownership of genes (a forehead-slapping concept for any person to grasp, truly) because they cannot get a second opinion on results of genetic tests like Myriad’s, and also because the tests are sold with an extremely high price tag. The idea of companies being allowed to own genes seems absurd to begin with when examined on the basic premise (used by the federal judge in the Myriad Genetics case) that naturally occurring substances cannot be patented.
The biotechnology companies that own these patents in turn argue that they should hold rights to genes that they’ve put time and money into discovering. They also contend that if they can’t patent their discoveries, they won’t be able to fund the development of new products based on those genes.
Now, the companies can get additional patents on the products later on, but without the initial gene patent they are not guaranteed market exclusivity for those products, and they can’t profit on partering or licensing the gene to other developers. Universities also profit from licensing out genetic patents to development firms.
However, some argue that research companies should be competing based on the quality of their discoveries and technologies, instead of playing “who patents the gene first,” and that the invalidation of single-gene patents will open the door to better, broader genetic-testing methods.
It seems pretty obvious that the federal judge ruled wisely in this case, but for some the issue is not so cut and dried, and the decision could end up being repealed. While pharmaceutical development firms’ methods are easy to criticize as they are generally focused on achieving the highest profit, they also provide the means to improve modern medicine through new discoveries. However it turns out, resolution of this case needs to allow for what’s best for the general public, which to me means access to the most innovative medical care possible, including second opinions on diagnostics and a variety of treatment options.