In a season where a number of five/four U.S. Supreme Court Decisions have left the country divided or dubious over the ability of the court to issue decisions compatible with a modernized America, the unanimous decision in the Myriad Genetics Inc. patent case has been both wise and should contribute to our ongoing bio-medical research progress. The case was brought because The Myriad Genetics Company was in the process of treating the BRCA1 and BRCA2 genes as something they had patented. A woman who has a strong family history of breast cancer and has one of the BRCA genes has about a 50% to 80% likelihood of developing breast cancer, as opposed to the average 12% or 13% risk. Testing for this gene, or an increasing number of potentially diagnostic genes, is a major part of diagnostic and treatment improvement in the coming decades. Sophisticated observers of our health care system look on the use of genomics, if used properly, as one of the major roads to improving care, and potentially cutting costs.
A problem in this area, if pharmaceutical, or medical diagnostic companies could patent genes as they were discovered, would be higher costs and potentially limited access to their more general use. Of course, as in many legal cases, courts could go too far and if all research in medical genetics were outside the processes that could be patented, financial incentives for medical research in this area could be dramatically stifled. In this instance, the court was very wise, in differentiating between the genes themselves—part of our basic biochemistry—and techniques for analyzing our genome and ultimately ways to modify the genes. The court, while ruling that the genes, themselves, were in the public domain, the researchers could continue to patent their newly discovered or improved techniques for isolating or modifying these genes. That should have no inhibitory effect on this major area of research.
I see a future with a potential for certain of our rarer, single gene, inherited, disorders such as cystic fibrosis or sickle cell anemia, to ultimately be modified as the person develops. I also believe, with a greater overall effect on health statistics, the impact on major multiple gene diseases such as atherosclerosis, or certain auto-immune disorders, in diagnosis, prevention and treatment, will be left intact. The court’s thoughtfulness in this case has made the economics of accessibility as well as encouragement of research possible by its balanced Myriad decision.