THE US COURT of Appeals for the Federal Circuit handed down a momentous decision on July 29th. It decided that you could patent life. This meant that yes, as companies making discoveries about parts of the human genome had argued for a decade, you could monopolise reward for gene-based discoveries by lodging a patent to control them.
The sun rose the next day and the world continued to turn despite shrill warnings from some scientific quarters, but there is no doubt the decision will have a long-term impact on the conduct of those involved in medical research internationally. It will provide greater financial incentive – if any was needed – to make medical discoveries related to our shared genetic heritage and then patent them for later financial gain. It also serves to validate existing patent claims already lodged.
Those in favour of being able to patent these microscopic but powerful parcels of human life argue that incentivising researchers with financial gain will encourage more research, leading to more discoveries that will cure disease and benefit mankind.
Those who believe in a regime that prevents this and allows free access to all genomic discoveries counter argue that patents close the door on further research into, say, a gene discovery because any subsequent findings will infringe a standing patent. This cuts further explorative research off at the knees and encourages scientists to look elsewhere for the next big discovery.
It is important which way this argument flows. The Court of Appeals decision was on a case involving the Association for Molecular Pathology v the US Patent and Trademark Office. It related to existing patents held by Myriad Genetics Inc on two genes, BRCA1 and BRCA2.
These are gene discoveries linked to the great American geneticist Prof Mary-Claire King and are associated with breast cancer. BRCA1 was the first gene discovered that was directly connected to the appearance of breast cancer, making King’s findings so significant. It also makes the tussle related to patent control over BRCA1 and 2 so very important.
A federal court ruling last year determined that Myriad’s patent on the genes was not valid, but the case was quickly appealed. The Court of Appeals decision overturned that earlier decision and allows Myriad to retain its patent control.
One could debate the rights and wrongs of this interminably and never reach a meeting of minds. And this case is likely to find its way into the US Supreme Court, so the debate will continue. Like all good arguments, it has so many dimensions, not least the morality of claiming exclusive ownership over a bit of human life that already exists within all of our genomes.
The debate also drags the whole question of patents into the spotlight, forcing us to think about whether this is the right way to go about protecting intellectual property and ensuring commercial revenue streams for those who make discoveries. Today scientists are keenly aware of the potential value of their discoveries, and successfully applying for patents has become an indicator of quality research. Academics are positively encouraged by the Government through agencies such as Enterprise Ireland to protect their discoveries in the hopes of later job creation and wealth for the State.
Yet most scientists here suggest that, while some discoveries might warrant patents, most of them should be shared by all and access should be open for the good of scientific endeavour and the benefit of humankind. Here then is yet another conflict: should research paid for by the taxpayer be expected to yield up benefits for the State, as currently stressed by government? Or does it represent an investment in a greater good?
Jonas Salk, the scientist who developed the first polio vaccine, made a definitive decision in this regard. He made his discoveries and developed the vaccine, and was later asked by the media who controlled the patent. “There is no patent. Could you patent the sun?” was his simple response.
Economist Tim Harford suggests other reasons why we may want to think again about our reliance on patenting to incentivise research and encourage discovery and innovation. In his new book, Adapt: Why Success Always Starts With Failure, he maintains that patenting actually thwarts scientific activity in a number of ways (see pages 24-27).
Discoveries are often patented but then left on a shelf and not commercialised, he maintains, stillborn ideas that are not developed. The ability to patent is not in itself sufficient to encourage innovation and research. Nor does it help that when governments fund research there are tremendous efforts to ensure the taxpayer’s investment succeeds. Research failure is not an option as it makes the research seem like a waste of money.
Harford argues that failure is a natural consequence of trying and that it must be tolerated in order to encourage free thinking and adventurousness when conducting research. This freedom to fail or succeed is what will incentivise discovery and drive the next great wave of innovation.