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Supreme CourtAn update on my earlier post about Angelina Jolie and her decision to undergo a preventive double mastectomy after genetic tests showed she carried a gene (BRACA1) that greatly increased her risk of breast and cervical cancer.

As some of the commentators on that post pointed out, the genetic test that Jolie had is expensive and in some countries – the US being one of them – not covered under public health (national insurance) schemes. For many women, this would have put the test out of financial reach. The reason why the genetic test for the BRACA 1 (and also BRACA 2) genes is so expensive is because the genes had been patented by a biotechnology company, Myriad Genetics, which had identified the genes. Myriad therefore was the only company able to offer tests for the BRACA1 and 2 genes. That exclusivity came with a price tag: the tests cost over $4000.

But today the US Supreme Court ruled that companies cannot patent human genes. So bye-bye to Myriad’s protective patent of BRACA 1 and 2, and hello competition. More companies will now be able to develop their own tests for BRACA 1 and 2 and offer them to the public. This is good news for two reasons. Economics kicks in. The increased competition will mean cheaper genetic tests. Jolie’s revelation may also mean more women will ask for them, and the increased demand may also help reduce the cost. And also, by freeing the genes from patent protection, more researchers will be able to work on them. The Supreme Court’s ruling applies to all human genes, as well. So patents of other human genes are also void and work on those genes is now also up for grabs. (You can, however, still patent engineered genes. It’s just the naturally occurring ones you can’t patent. Identifying a gene is not enough to secure patent protection.)

The history of patenting drugs and other medical discoveries is a fraught one. I’ll say a bit about drug patenting, because that’s the paradigm example here and illustrates the issues at stake. Before 1938, pharmaceutical companies were able to protect their products from being copied simply by keeping the ingredients secret. But in 1938, the Food, Drug and Cosmetic Act required companies to reveal all of a drug’s ingredients. This was to try and protect the public – drugs might contain dangerous compounds. Doctors needed to know exactly what they were prescribing. Patients needed to know exactly what they were taking. So…make ’em say what goes in the pill. But there was a trade-off: forcing drug companies to reveal their recipes meant that companies looked instead to patents to protect their inventions, rather than relying on secrecy.

Developing a new drug costs pharmaceutical companies or research institutes huge amounts of money. Doing the research costs money; testing and trialling the drugs costs money; and many lines of research just don’t produce a viable drug at the end of it. But drug regulations require companies to be completely clear about what has gone into a drug and how it is made – no secrets allowed. The idea is that patents should create an economic environment that makes it worth while for pharma companies to bring drugs to market, while still protecting the public from unknown ingredients in drugs. And patents work very well at doing that in some instances.

But there are also problems, as the BRACA 1 genetic test case makes clear. By denying competition for a fixed period, patenting buoys the price of drugs while they are still under patent. That is the whole point of patenting, and generally we’re fine with that as a mechanism for encouraging and rewarding innovation. But when the product in question is not so much a new type of TV but a new type of live-saving drug…or a genetic test for cancer…is it still OK to be actively keeping it expensive and restricting competition? There’s an argument that patenting is fine as a way of stimulating the market for, say, luxury goods, but inappropriate in the health industry. The history of drug legislation pushed pharma companies towards patenting, but we still haven’t yet worked out a good way of balancing public interest with encouraging innovation when it comes to the health market. One big area of interest in drug development is looking to the natural world for drugs – anti-biotics secreted by bacteria or exotic compounds found in the skin of Amazonian frogs, say. It is not clear yet whether the Supreme Court’s ruling will affect those lines of inquiry.

But right now, following the Supreme Court’s ruling, five clinical laboratory companies have announced they will start offering tests for BRACA 1 and 2 – and at less than Myriad’s price.

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