Monday, September 14, 2009

Gene Patents: What lies ahead?

Suman Sahai
During my summer at Princeton this year, two issues took up a lot of newsprint. One was the outbreak of flu, the other, an extraordinary law suit that challenges human gene patents. The gene patent story has lessons for India since our patent laws appear to be under a lot of pressure to allow the patenting of genes.

The gene patent challenge in the US deals with a breast cancer patient who took a genetic test to see if her genes also put her at higher risk for ovarian cancer, in which case she would have had to get her ovaries removed. The test was positive but the patient wanted a second test as a reconfirmation. She could not do so since the test had been patented by a company called Myriad Genetics, and would cost thousands of dollars. Myriad Genetics owns the patents for two breast cancer genes, BRCA 1 and BRCA2 and controls all aspects related to these genes including testing for their presence. Women, who carry mutations of these two genes, come into the high risk category for breast and ovarian cancer. Early detection is crucial to save lives.

Doctors can scan women with a family history and those found to have defective copies of the genes can be regularly screened for early detection of any cancers. Angered by the power of corporations to deny lifesaving diagnosis and treatment to people, the American Civil Liberties Union filed the unique lawsuit against Myriad Genetics. Plaintiffs in this unusual case include breast cancer patients and professional scientific and medical
organizations. The case was filed in the federal court in New York in May 2009 and the outcome is eagerly awaited by public interest groups who have been long fighting for a
fairer, more egalitarian healthcare system.

Scientists at the human genetics program at the New York University School of Medicine, which is a plaintiff in the lawsuit, say that many laboratories have the capacity to conduct BRCA tests faster than Myriad Genetics and at a cost that is a fraction of the $3000 that Myriad charges. The scientific community in general is of the view that
market forces should be allowed to operate in such cases, which would ensure better and cheaper BRCA gene tests. The court’s verdict in the case will decide whether testing for
fairly prevalent diseases like breast cancer will become more accessible to patients or whether they will continue to be shackled by patents and monopolies.

The United States Patents Office has maintained a pro active and aggressive stand on granting gene patents. The decoding of the human genome resulted in a flurry of patent activities chiefly in the US. After a few ups and downs regarding how much genetic material could be patented without knowledge of its functions, a less frenetic but nevertheless substantial patent activity has become the established norm. Almost three million gene related patents have been issued in the United States alone. Patents can be
taken out on genes, on gene mutations and any investigative or therapeutic procedures linked to these genes or their mutants.

Over 20 percent of the human genome has already been patented. This includes genes for Alzheimer's, colon cancer, breast cancer, asthma and some other diseases. The implications of these patents are that pharmaceutical companies and researchers in universities can control the kind of research can be done on those genes, the diagnostic
tests that can be developed from that research and how much those diagnostic tests and treatments will cost. The fall out of such patents has been to stifle clinical research on the genetic predisposition and early detection of breast and ovarian cancer leading to avoidable suffering for women and hugely expensive testing, out of the reach of the average person.

The situation gets worse when patent holding companies like Myriad Genetics licence out rights to other companies to extend the areas where their patents will operate. The Australian biotechnology company, Genetic Technologies, obtained the Australian and New Zealand rights to the BRCA1 and BRCA2 genes from Myriad Genetics in 2003.

The company initially said it would not enforce its legal claim over the gene, and described it as their “gift to the Australian people”. But this has changed. Unable to resist the lure of profits, Genetic Technologies is now charging $2100 per scan of the breast cancer genes.

India's healthcare system is fragile to begin with and the poor already find it very difficult to get medical care. We must ensure that further injustice is not done to patients in the name of promoting innovation. Gene patents should not be permitted in our IPR system. In fact such patents should be deemed illegal, unconstitutional, obstructive of scientific
progress and violative of human rights.

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