US genetic test maker 23andMe is asking the FDA to approve its personalized DNA test, a saliva sample DNA test kit, a move which could make 23andMe a leader in the field and regulate applications which provide information on genetic risk factors for disease. Essentially the saliva test should shed light on what genetic variations an individual has at particular genes.
It is worth pondering then the potential minefield of IP problems that have arisen over gene patents and their possessive owners that could threaten implementation of personalised medicine.
Currently in the UK a patent cannot be granted for new varieties of plants or animals or a biological process that results in their production. Essentially genes, or their specific variations leading to disease, cannot have a patent. In contrast the US does allow genes to be patented, it is estimated 4000 gene patents have been granted. Indeed 23andMe recently announced they would be receiving their first patent on variations of a gene that is associated with Parkinson’s disease. In a recent blog post 23andMe stated that patents should not obstruct research or prevent people knowing their genetic make-up. 23andMe use the argument that drug development is expensive and patents ensure investors will see a return on investment. If patents protect innovation, is the discovery of a gene variant an innovation?
There has been particular controversy over the patent eligibility of isolated genes that are predictive of breast cancer risk. Myriad Genetics holds patents, and licenses patents from the University of Utah, on breast cancer associated genes. Myriad has also developed a test that indicates whether a woman has the genetic background to make her at risk from developing breast or ovarian cancers. In 2009 a lawsuit was filed against Myriad Genetics and the U.S. Patent and Trademark Office by professional medical organizations, patients and researchers. The plaintiffs claimed Myriad’s patents were invalid asthe genes in question were unpatentable products of nature. In a decision that shocked the biotechnology industry, a United States District judge in New York agreed, and invalidated the patents in 2010. However the Court of Appeals for the Federal Circuit reversed the ruling in July 2011, based on the chemical composition of DNA that has been isolated from the body differs in its chemical structure to DNA in vivo. The plaintiffs then appealed the case to the Supreme Court, which in March this year ordered the appeals court to reconsider its decision. Appellate judges in Washington, D.C., heard arguments in July and no decision as yet has been made.
Gene patents wield a double edge sword. On the one hand personalised medicine is moving towards multiplex testing of dozens or hundreds of genes, but the development of these tests could be severely hindered by gene patents and therefore a real obstacle to innovation in personalized medicine. Patents could also discourage other researchers from developing competing tests. However there is a clear argument that the tests won’t be developed at all if gene patents don’t exist, as they provide the financial incentive. The patent system should work to promote innovation and not stand in its way. Hopefully the Myriad ruling will bring some clearer guidance on how to get there from where we are today.