Who owns your genes? Among others, medical diagnostics companies, which — in certain cases, along with universities — exercise tight control over them. Nearly 20 per cent of the human genome is already patented. But in a recent landmark judgment, Robert Sweet, a senior U.S. federal judge who serves on the United States District for the Southern District of New York, invalidated seven of the 23 patents on two genes — BRCA1 and BRCA2. In 2008, the Myriad Genetics won a protracted battle to retain some European patents on BRCA1; the scope of the patents was reduced to cover only certain mutations. The two genes are commonly tested for mutations to determine the risk of developing breast and ovarian cancer. The Utah-based Myriad Genetics and the University of Utah Research Foundation hold the patents. Though patents cannot be granted to ‘products of nature,’ thousands of genes have been patented on the ground that isolated and purified genes are distinctly different in character and composition from those present in our body. Significantly, the invalidation of Myriad’s patents has come on the basis of the very arguments the company’s counterparts had put forth earlier in defence of gene patents. What is laudable is Judge Sweet’s brilliant assessment of scientific facts to invalidate every claim of the company. For instance, he refused to accept that isolated and purified genes are structurally and compositionally different from those occurring in the body. The verdict also summarily rejects as “erroneous” the premise that isolated DNA molecules are like any other chemical compound.
Judge Sweet’s ruling will have great implications if it is upheld by the Court of Appeals for the Federal Circuit. The district court’s decision will not be binding on other federal courts, and the decision will not automatically extend to all U.S. gene patents. Yet there is a real possibility of more pleas coming up before courts for invalidating many gene patents . Exclusive licences, with some exceptions, are a great barrier to fostering research. There is no incentive to make diagnostic tests cheaper either; Myriad charges about $3,000 to sequence the two genes to look for cancer-causing mutations. The fact that 10-15 per cent of all inheritable breast and ovarian cancers have a mutation in these two genes, and about 5,000 new cases of both cancers are detected every year in the European Union makes a strong case against exclusive licences. The National Institutes of Health encourages non-exclusive licences for gene diagnostics. This currently provides a standard for NIH employees, and may soon become applicable to those receiving NIH grants.