Human DNA cannot be patented by companies who want to protect genetic material and tests as their own intellectual property. The US Supreme Court has reversed three decades of patent awards, in a move that is predicted to cost biotech companies billions of pounds in lost revenue. VoR reports.
New ruling
The US Supreme Court has ruled that the natural building blocks of life cannot be patented.
It means that companies like Myriad Genetics, a company that developed a test for mutations in a gene which predisposes a woman to getting breast cancer, called BRCA, will no longer have a monopoly.
Before yesterday, Myriad offered the only BRCA test to women at $3,500 each.
It is the same test that revealed Angelina Jolie’s high risk of breast cancer earlier this year.
And just hours after the Supreme Court decision, several US laboratories announced they, too, would begin offering breast cancer gene testing, meaning that the test, and others, could become more affordable and more available to the public.
Yet, some biotech companies say that this ruling will damage the DNA research sector by deterring investment.
It comes as scientists and lawyers in Britain are challenging a European patent ban of embryonic stem cells.
Misjudged ban
Although different, both cases highlight problems for human gene patents on both sides of the Atlantic.
Scientists such Sir Ian Wilmut, who cloned Dolly the sheep, are calling on the European Court of Justice to rethink a 2011 ban, which they believe is blocking the development of new treatments for a range of diseases from Parkinson’s to heart disease.
Alex Denoon is a solicitor, at Lawford Davies Denoon, in London, who specialises in biotechnology.
He said that the EU ban is misjudged, and causes uncertainty.
However, in the EU, and with yesterday’s US ruling, genetic material that has been altered in a lab in some way is still eligible for a patent.
For example many pharmaceutical companies use manipulated DNA, called complimentary DNA, to produce proteins and antibodies such as insulin and human growth hormone, under patents.
Christoph Then is an EU patent law expert.
He said that the allowance for patents to be awarded to synthetic DNA means that the EU and US bans are not as damaging as some scientists fear.
However, US biotech companies have criticised the US judgement, saying that many companies risk billions of dollars in research, and that not being able to patent developments, means that their intellectual property will not be protected.
Sir Ian Wilmut and other British scientists say that the UK faces the same problem.
Exception rather than norm
Yet, some experts believe that some medical developments, particularly in creating a new treatment, rather than just diagnostic tests, are so complicated, that they are virtually impossible to replicate for another lab.
Alex Denoon says that this difficulty in replicating DNA therapies means that even without a patent, a company is “immune” from the threat of a rival company stealing their product.
The debate over whether companies can own isolated parts of human genes has been controversial for decades.
Christoph Then says that patents on embryonic stem cell developments commercialise the usage of human embryos, which is problematic in terms of bio-ethics.
Whatever the EU decision, with the US ruling in place, it seems that patents on natural DNA, will become the exception rather than the norm.