You canât patent a naturally occurring DNA sequence â but you can patent an altered product made from that sequence. In simple terms, thatâs the ruling by the US Supreme Court in a long-awaited decision on the validity of patents for the breast cancer genes BRCA1 and BRCA2.
Widely billed as a decision on whether human genes can be patented in the US, the ruling actually applies to all DNA, from whatever species. While it is a landmark decision, experts consulted by 51¶ŻÂț predict that its impact on human medicine may be less than anticipated.
Still, the ruling may have far-reaching, unintended consequences on other sectors of the biotech industry -â for instance, on companies using genetically engineered bacteria to make industrial enzymes.
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âThey didnât seem to grapple with the broader implications,â complains Hans Sauer, a specialist in intellectual property with the in Washington DC. âThereâs no doubt in my mind that this is going to have a disruptive effect.â
The case was brought by a coalition of organisations including the American Civil Liberties Union against of Salt Lake City. Myriad Genetics has used broad gene patents to operate a monopoly over testing for the two BRCA genes, which when mutated can cause inherited forms of breast cancer.
It was such a test that led to movie star Angelina Jolieâs high-profile decision to have a double mastectomy to reduce her risk of developing the disease.
Limited impact
In a unanimous ruling, the Supreme Court decided that simply isolating a natural DNA sequence is not a patentable invention. However, it upheld Myriad Geneticsâs claims on complementary DNA, or cDNA, made from the BRCA genes. These are sequences produced in the lab from the RNA that is the intermediate step between gene and the protein it codes for. cDNA lacks the non-coding âintronsâ found in the full sequence of a gene.
âcDNA is not a âproduct of nature,â so it is patent eligible,â wrote Justice Clarence Thomas, in the opinion released today.
As you donât need to make cDNA to offer a diagnostic test, campaigners for womenâs health hope that other companies will now leap in, and bring down the cost of testing for BRCA1 and BRCA2. âWe expect to launch a test rather soon,â says , managing director of GeneDX, a genetic-testing company in Gaithersburg, Maryland.
Yesterdayâs problem
It should also become easier for companies like GeneDX to offer diagnostic panels including dozens of genes, to analyse genes that can trigger epilepsy, for example, or to look for specific mutations involved in tumours, helping to design individualised cancer therapy.
Bale estimates that about 8 per cent of the genes her company tests for are covered by gene patents that require her to pay royalties. But the fact that the rest are not protected by patent illustrates why the rulingâs impact on medicine may not be so large. For the most part, broad patents on entire natural human gene sequences are a thing of the past. The BRCA patents were due to expire in 2015 anyway, and most other similarly broad patents are also coming to the end of their lives.
Viewed from that perspective, the Supreme Court ruling is âa referendum on yesterdayâs problemâ, suggests , a specialist in biotechnology law at the University of North Carolina, Chapel Hill.
Wider industry
Still, Sauer is concerned about companies working outside of human medicine that have been operating for 30 years under the assumption that a natural gene sequence can be patented.
Last month, researchers led by of Colorado State University in Fort Collins identified 8703 US patents covering naturally occurring gene sequences that are still in force.
More than half covered genes used outside of human medicine, in applications including agriculture, food and beverage manufacturing, industrial enzymes and bioenergy (Nature Biotechnology, ).
Some companies in these sectors wonât be too worried by the ruling â the genetically modified crops made by giants like Monsanto, for instance, are covered by entire suites of patents on different aspects of the technology.
But Sauer fears that some companies, including those making industrial enzymes using natural bacterial genes spliced into E. coli, may find that their intellectual property has suddenly become worthless. âPeople have arranged their affairs around such patents,â he notes.
Hear from Mary-Claire King, who discovered BRCA1, in âCourt ruling on genes is a âvictory for common senseââ
