Could scientists patent human genes? U.S. Supreme Court to rule on legal battle that could change the future of medical research
A US Supreme Court hearing began today to rule on whether scientists and corporations can patent human genes.
Opponents of the patents, including James Watson, the Nobel Prize-winning co-discoverer of the structure of DNA, argue that letting companies claim parts of genes will slow down or cripple lifesaving medical research.
But supporters say that banning companies from profiting from their discoveries would stop them investing in genetic research.
The US Patent and Trademark Office has granted patents for almost 30 years on at least 4,000 human genes to companies, universities and others that have discovered and decoded them.
Patents now cover some 40 per cent of the human genome, according to a study led by Christopher Mason of Weill Cornell Medical College.
If the Supreme Court rules that human DNA can be claimed as intellectual property, it would remain off limits to everyone else without the permission of the patent holder.
The lawsuit, filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, challenges seven patents held by Myriad Genetics Inc on two human genes linked to breast and ovarian cancer.
Myriad's BRCA analysis test looks for mutations on the breast cancer predisposition gene, or BRCA.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer.
Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer.
The mutations are most common in people of eastern European Jewish descent. Myriad sells the only BRCA gene test.
The legal issues centre around whether the genes that Myriad patented, called BRCA1 and BRCA2, are natural phenomena.
The American Civil Liberties Union says human DNA is a product of nature, and as such not patentable under the Patent Act, and in March 2010 a New York district court agreed.
But the US Court of Appeals for the Federal Circuit has twice ruled that genes can be patented and the case landed in the Supreme Court.
Myriad argues that its patents are for genes that have been 'isolated', which makes them products of human ingenuity and, therefore, patentable.
The American Medical Association, the American Society of Human Genetics, the March of Dimes and James Watson, among others, have filed briefs asking the court to invalidate Myriad's patents on BRCA1 and BRCA2.
On the other side are Myriad and industry groups such as the Biotechnology Industry Organization (BIO) and the Animal Health Institute.
They say that if gene patenting is ruled invalid, companies - with no guarantee they could profit from their discoveries - would stop investing in genetics research, to the detriment not only of patients but the economy.
'The intellectual framework that
comes out of the decision could have a significant impact on other
patents - for antibiotics, vaccines, hormones, stem cells and
diagnostics on infectious microbes that are found in nature,' Robert
Cook-Deegan, director for genome ethics, law and policy at Duke
University, said in a statement.
'This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications,' he said.
'What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes,' said Karuna Jagger, executive director of Breast Cancer Action.
The ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
'Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself,' said Christopher A. Hansen, the ACLU's lawyer in court papers.
'A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter.'
The Obama administration seems to agree. Artificially created DNA can be patented, but 'isolated but otherwise unmodified genomic DNA is not patent-eligible,' Solicitor General Donald Verrilli said in court papers.
Previously the high court unanimously threw out patents on a Prometheus Laboratories, Inc, test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.
Opponents of the patents, including James Watson, the Nobel Prize-winning co-discoverer of the structure of DNA, argue that letting companies claim parts of genes will slow down or cripple lifesaving medical research.
But supporters say that banning companies from profiting from their discoveries would stop them investing in genetic research.
The US Patent and Trademark Office has granted patents for almost 30 years on at least 4,000 human genes to companies, universities and others that have discovered and decoded them.
Patents now cover some 40 per cent of the human genome, according to a study led by Christopher Mason of Weill Cornell Medical College.
If the Supreme Court rules that human DNA can be claimed as intellectual property, it would remain off limits to everyone else without the permission of the patent holder.
The lawsuit, filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, challenges seven patents held by Myriad Genetics Inc on two human genes linked to breast and ovarian cancer.
Myriad's BRCA analysis test looks for mutations on the breast cancer predisposition gene, or BRCA.
Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer.
Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer.
The mutations are most common in people of eastern European Jewish descent. Myriad sells the only BRCA gene test.
The legal issues centre around whether the genes that Myriad patented, called BRCA1 and BRCA2, are natural phenomena.
The US Supreme Court is to rule on whether
scientists and corporations can patent human genes and stop other
researchers from working on them without their permission
But the US Court of Appeals for the Federal Circuit has twice ruled that genes can be patented and the case landed in the Supreme Court.
Myriad argues that its patents are for genes that have been 'isolated', which makes them products of human ingenuity and, therefore, patentable.
The American Medical Association, the American Society of Human Genetics, the March of Dimes and James Watson, among others, have filed briefs asking the court to invalidate Myriad's patents on BRCA1 and BRCA2.
On the other side are Myriad and industry groups such as the Biotechnology Industry Organization (BIO) and the Animal Health Institute.
They say that if gene patenting is ruled invalid, companies - with no guarantee they could profit from their discoveries - would stop investing in genetics research, to the detriment not only of patients but the economy.
The ACLU is arguing that isolating the DNA
molecules doesn't stop them from being DNA molecules, which they say
aren't patentable
'This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications,' he said.
'What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes,' said Karuna Jagger, executive director of Breast Cancer Action.
The ACLU is arguing that isolating the DNA molecules doesn't stop them from being DNA molecules, which they say aren't patentable.
'Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself,' said Christopher A. Hansen, the ACLU's lawyer in court papers.
'A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter.'
The Obama administration seems to agree. Artificially created DNA can be patented, but 'isolated but otherwise unmodified genomic DNA is not patent-eligible,' Solicitor General Donald Verrilli said in court papers.
Previously the high court unanimously threw out patents on a Prometheus Laboratories, Inc, test that could help doctors set drug doses for autoimmune diseases like Crohn's disease, saying the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review. The court will rule before the end of the summer.