You may Not Patent my Genes!

In a decisive blow to the fraud-mongers in the biotech industry and US Patent office, U.S. District Court Judge Robert Sweet in New York State invalidated part of seven patents granted to Myriad on the BRCA1 and BRCA2 genes. BRCA1 and BRCA2 are two alleles or variants of a tumour suppressor gene that is found in all humans and responsible, under normal situations, in removing malignancies that may arise. The BRCA1/2 mutational variants substantially increase the risk of a carrier developing breast, ovarian, prostate, pancreatic, colon, and other cancers. Based on current data, females carrying either of these two mutations, will encounter lifetime risks above normal for developing ovarian cancer at 10-20% for BRCA-2 mutations and 40-60% for BRCA-1 mutations.

USA Today outlines the discovery process of BRCA1/2:

The genes for both BRCA1 and BRCA2 were first patented by geneticist and Myriad founder Mark Skolnick, who in the 1990s began looking at detailed family histories to zero in on the genetic basis for breast cancer. Family histories helped him figure out which genes probably carried the mutations. Using gene sequencing, he found exactly where on the genes the mutations occur.

For the past twenty years, due to legal gimmickry, the biotech industry has been able to wage a concerted racket against patients and scientific advancement.

A case was filed against Myriad Genetics by the ACLU and the New York-based Public Patent Foundation on behalf of doctors, patients and several medical groups, including the Association for Molecular Pathology and the American College of Medical Genetics. To the surprise of both legal analysts and the biotech industry, Judge Sweet effectively told Myriad as described by Stanford Law Professor Hank Greely, “You didn't invent this, you didn't make it, and you shouldn't get a patent on it!"

The Judge overturned all the patent claims held by the defendant, based on the fact that they cover products of nature and abstract ideas. In his decision, Judge Sweet wrote:

The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA’s existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101.

Beyond the legal arguments, there exists the practical dimension that these patents impinge on necessary scientific research, inhibit patients from effectively ascertaining their genetic profiles and evaluating treatment options, and gouge consumers with excessive charges. In the latter case, Myriad Genetics charged patients $3,000 to assess whether they were carriers of the BRCA1 or 2 alleles. Patients like Lisbeth Ceriani, who was diagnosed with an aggressive form of cancer in both of her breasts, had to wait a year and a half to find out if she needed to have her ovaries also removed, because Myriad Genetics refused to deal with her insurance company (Massachusetts MediAid), due to the low reimbursement rate provided.

The Economist magazine discussess a report published by Duke University researchers, which concludes that gene patenting and its monopoly granting status prevents access to these critical tests for many poor Americans, prevents diagnostic accountability from the monopoly providers, and hampers business innovation in the field of medical diagnostics.

Again and again, the typical business model in America is to put the profits of individual corporations over the collective needs and in this case the lives of ordinary people. My genes, your genes, or that of any organism on this planet are not for sale, nor is it the ownership of crooked scientists who have sold their souls to profit on the exploitation of the genetic commons.