Hollywood actor Angelina Jolie's well-publicised decision to have a prophylactic double mastectomy may have renewed the debate on genetic testing for breast cancer -- Ms. Jolie carries a cancer-linked gene, BRCA1 – but it has also revived the discussion on whether private corporations can own the patent to genes.
Although Ms. Jolie said women should undergo genetic testing if they believed they were in the “at risk” category for getting cancer, she acknowledged that at $3,000 or more per procedure, the cost of testing for BRCA1 and BRCA2 “remains an obstacle for many women.”
What her op-ed did not mention is that the sole right to administer the tests is held by a Utah-based genetics firm called Myriad Genetics. It is this company that is responsible for setting fees for testing significantly above the $200 or so that other labs charged before Myriad moved to enforce its patent.
Myriad’s patent application for monopoly ownership of the BRCA genes is facing challenges from civil rights groups such as the American Civil Liberties Union, which initially filed a lawsuit in 2009 charging that the patents were “unconstitutional and invalid.” In November 2012 the Supreme Court agreed to hear arguments on the patentability of human genes. The matter is due to come up in a month’s time.
The ACLU and other plaintiffs have essentially argued that human genes cannot be patented because they are classic products of nature, notwithstanding the fact that the U.S. Patent and Trademark Office has already granted thousands of patents on human genes and about 20 per cent of all human genes are already under patent.
Although in theory there may be a humanitarian case against allowing a virtual gene monopoly via patent, the signs are ominous. On the same day that Ms. Jolie’s story was published, the Supreme Court ruled 9-0 in favour of the patent rights of agri-business giant Monsanto and against the claims of an Indiana soybean farmer, Vaughn Bowman.
Regarding the patenting of an entity occurring in nature, a key precedent is the 1980 Supreme Court ruling that handed – in a 5-4 split decision – a patent to an Indian-American scientist, Ananda Mohan Chakrabarty, for producing bacterium known as pseudomonas putida, which is capable of breaking down crude oil and could be deployed to soak up oil spills.
In that case the court disregarded the fact that Mr. Chakrabarty sought a patent for a living micro-organism, instead emphasising that it constituted a “manufacture” or “composition of matter.”
If Myriad wins next month it will thus be armed with patent-induced market exclusivity to continue charging a relatively high fee for the BRCA despite tests in other labs being cheaper and providing fewer false positive results. As numerous experts have pointed out, getting a second opinion would also be a theoretical impossibility in this scenario.
In an article written in Slate magazine two days before Ms. Jolie’s op-ed ran, Nobel Prize-winning economist Joseph Stiglitz said that Myriad Genetics’ classic economic argument in favour of patents, namely that weaker intellectual property rights would undermine incentives to innovate, falls down because its “innovation” would have been made in any case by a major, publicly-funded, international effort to decode the entire human genome.
“The social benefits of Myriad’s slightly earlier discovery have been dwarfed by the costs that its callous pursuit of profit has imposed,” Professor Stiglitz argued, invoking an echo of the recent case of pharmaceutical giant Novartis seeking an “ever-greening” patent for cancer-drug Glivec in India.
Myriad appears to be poised for success in the battle to own every human being’s BRCA genes the moment they are taken out of the body. Not only do precedents point toward the likelihood of the Supreme Court ruling in its favour, the share price of the company already jumped by nearly four per cent to a three-year high on the day the NYT article was published.
One concern sparked by the celebrity endorsement of pre-emptive testing and invasive procedures was that it could fuel a rush for these options despite some specialists questioning the cancer statistics on which the claims were based.
For example Dr. Gilbert Welch, a professor of medicine and co-author of “Over-diagnosed: Making People Sick in the Pursuit of Health,” said to CNN news that less than one per cent of women have either BRCA1 or BRCA2 and that of the 458,000 women who die from breast cancer worldwide each year 90 per cent have nothing to do with BRCA1 “because most breast cancer is sporadic.”
Even for those who are in that section of the population, less than one half of one percent, which is truly at risk from the gene mutation, the U.S.’ premier public medical research group, the National Institutes of Health, points out that numerous alternatives to surgery exist, including increasing cancer surveillance with imaging tests or taking medications to reduce cancer risk.
