The U.S. Supreme Court’s landmark ruling that DNA segments are a product of nature and hence not patent-eligible has worldwide significance because it settles the controversial issue of patenting human genes in the one jurisdiction where it has come to matter the most. Though the ruling said that the mere act of isolating genes “is not an act of invention,” it ruled, by the same yardstick, that complementary DNA (cDNA) does not occur in nature and is therefore patent-eligible. By walking a tightrope, the ruling has ensured that research on genetic testing is encouraged. The judgment strikes at the very foundation on which Myriad Genetics and the University of Utah Research Foundation have effectively monopolised BRCA1 and BRCA2 gene testing since 1994. By possessing the exclusive right to isolate the two genes for identifying the deleterious mutations that cause breast cancer, the company prevented the entry of cheaper and better techniques of identifying the mutations. That a patent was awarded even though the process of isolating genes was widely used at that time shows little application of mind. The ruling has spelled out in no uncertain terms that such an irrational grant of patents for laws and products of nature would end up “inhibiting future innovation” and is at odds with providing protection. The judgment effectively invalidates other patents granted for genes associated with diseases such as colon cancer, Alzheimer’s disease, and muscular dystrophy. But it is not clear if this ruling would invalidate patents granted to genes removed from plants and animals.
With the advent of whole genome sequencing, genetic testing has graduated to a different plane. Yet, patents granted to companies such as Myriad prevented new techniques from being used. Hence the unanimous decision by the nine judges to summarily reject patent protection to isolated genes has saved science and scientific research from the morass it had sunk into in recent times. While there can be no debate on whether scientific research should be rewarded, odious claims by Myriad and others should be roundly condemned. The prohibitive cost for a far inferior test had precluded many women from getting tested. With breast cancer being the leading cancer affecting women and about 10 per cent of breast cancer cases being hereditary in nature, the number of those who need to undergo genetic testing is high. Yet, the company’s greed had effectively prevented many women from getting tested. Thanks to the court’s decision, and greater awareness about genetic testing created recently by Angelina Jolie, who had a double mastectomy as she had a harmful mutation in BRCA1, more lives will be saved. And that’s what medical science is all about.