Medicine is evolving from a global, one-size-fits-all approach to a more individualized approach that tailors treatment specifically for each patient.
This “personalized” approach is based on a variety of factors, most of which are dependent on a patient’s genetic profile as well as genetic components of a disease itself. Accordingly, technology in the area of personalized medicine is largely dependent on exploitation of portions of the human genome.
For the past several decades, the U.S. Patent and Trademark Office has been granting patents on isolated DNA molecules – often referred to as gene patents. The owner of a gene patent could prevent others from making, using or selling anything that required the use of the particular gene patented. Until recently, Myriad Genetics Inc. owned gene patents for the BRCA1 and 2 genes, a specific mutation in either gene being associated with an increased incidence of breast and ovarian cancer.
In June, the U.S. Supreme Court unanimously held that Myriad’s gene patents were not eligible for patent protection. In Association for Molecular Pathology v. Myriad Genetics, the court found that isolated genomic DNA is a product of nature by characterizing the chemical structure of DNA by its nucleotide sequence.
This factual finding led to the conclusion that the claimed isolated DNA is exactly the same as it exists in nature. However, the court ruled that Myriad’s patent claims directed to complementary DNA (cDNA) are patentable since these molecules are synthetically produced and, therefore, not products of nature. Additionally, Myriad retained some of its patent protection for methods of using the BRCA1 and 2 gene sequence for genetic testing.
However, the breadth and strength of these patent claims were affected by an earlier Supreme Court decision in 2012, Mayo v. Prometheus. Moreover, cDNA is not required in most genetic testing and, therefore, has little value in personalized medicine.
Supporters of the Myriad decision claim that eliminating gene patents will promote research by providing free access to the human genome for all without the fear of lawsuit. Interestingly, Myriad presented evidence that about 10,000 research reports relating to the BRCA genes have been published in peer-reviewed scientific journals since the Myriad patents issued. Simply stated, that’s a lot of research. However, without strong patent rights, the ability to commercialize technology in personalized medicine will be limited to those that can do so without investors or partners, which does not generally include universities, nonprofits and startups.
This article appeared in the August 8, 2013, issue of The Journal Record. It is reproduced with permission from the publisher. © The Journal Record Publishing Co.