Authorities have gone too far in allowing claims on DNA
For more than 30 years legal authorities around the world have been arguing about the patentability of DNA. The next round takes place on April 15 when the US Supreme Court hears a challenge to patents held by Myriad Genetics on the two most important genes in which mutations make women susceptible to breast cancer, BRCA1 and 2.
All legal systems hold that a product of nature such as a gene is not patentable in itself. The crucial question for the Supreme Court to decide is whether the steps carried out by Myriad in isolating and characterising the BRCA genes were sufficiently inventive to justify patent protection. Although the arguments in the Myriad case are too finely balanced for the FT to come down firmly on either side, the principles raised about protecting intellectual property in the life sciences are clear.
Most important is to make sure that invention really has taken place when issuing patents based on natural products, from human genes to plant varieties. Whether or not Myriad did enough to justify its BRCA patents, in general the US Patent and Trademark Office has been far too lenient in granting gene patents for little more than discovering existing DNA sequences.
Altogether about 4,000 of the 23,000 human genes are covered by at least one active US patent – an absurdly high number. Many of these were granted during a great DNA patent rush as the human genome project reached completion in the late 1990s. But analysis published this week by US researchers in the journal Genome Medicine shows that the over-reach is even worse than people had realised, because thousands of patents cover shorter stretches of DNA that together account for almost the whole human genome.
Whatever the outcome of the Myriad case, the US Patent Office must never again issue so many patents on routine discoveries that demonstrate neither utility nor inventiveness. It can learn here from the European Patent Office which has been more demanding when assessing gene patents.
Although many of the DNA patents granted in the 1990s will soon expire, the issue remains critical for the life sciences. Researchers are moving on from finding conventional genes. Discoveries about the “non-coding regions” of the genome that control the activity of genes will soon pour out of the world’s laboratories – and it is essential that these DNA sequences are not patented en masse.
As the cost of reading DNA plummets through the $1,000 level for a whole human genome (3bn biochemical letters of genetic code), DNA diagnosis will expand exponentially. Personalised medicine, in which an individual’s treatment is tailored to his or her genetic make-up, may depend on sequencing thousands of genes – and potentially contravening thousands of patents. On Wednesday, for example, scientists released 80 new genetic markers that indicate how likely people are to develop certain cancers, including ones that refine the risk of breast cancer in carriers of BRCA mutations. Governments must ensure that such technology can benefit patients without getting bogged down in a morass of competing patent claims.
A more general lesson can also be learnt from the way the boundaries of gene patenting have been pushed out. Industries based on science and technology support a large service industry – including lawyers, patent specialists and patent offices – whose interests are served by extending the scope of patents and then arguing about them in the world’s law courts. The time has come for governments to push back against excessive expansion and make sure that patents continue to serve the interests of protecting invention and promoting innovation.
Editorial, Financial Times