A TRANSATLANTIC patent battle has broken out over a gene that causes about one-third of all inherited breast tumours. If the dispute is not resolved quickly, it could delay the introduction of tests to diagnose the presence of cancer-causing mutations.
Michael Stratton and his team at the Institute of Cancer Research in Sutton, Surrey, first described the gene, called BRCA2, in Nature shortly before Christmas. But rival researchers at Myriad Genetics, a company in Salt Lake City, Utah, now claim that they isolated the gene first. Both Myriad and the London-based Cancer Research Campaign (CRC), which funded Stratton鈥檚 work, have applied for patents on BRCA2, covering the future development of diagnostic tests.
The race to identify BRCA2 entered its final stages on 23 November last year, when researchers at the Sanger Centre, the genome sequencing institute near Cambridge, and their colleagues at Washington University, St Louis, made the DNA sequence of the part of chromosome 13 known to contain BRCA2 available over the Internet. On 5 December, a copy of Stratton鈥檚 paper arrived at Nature鈥檚 London office. Members of Stratton鈥檚 team say that they were working on the gene before the chromosome 13 sequence information was released, but add that the data allowed them to finish their work earlier. 鈥淚t made it a quicker prospect to assemble the complete gene,鈥� says Bruce Ponder of the CRC Human Cancer Genetics Research Group at Addenbrookes Hospital in Cambridge.
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Ironically, Stratton鈥檚 group and that of Mark Skolnick, the researcher at the University of Utah who founded Myriad, used to collaborate in the hunt for BRCA2. But that partnership was dissolved in acrimonious circumstances in 1994 after Myriad filed for a patent on the other major breast cancer gene, BRCA1, which was discovered by Skolnick鈥檚 team. 鈥淲e do not believe pieces of the human genome are inventions; we feel it is a form of colonisation to patent them,鈥� Stratton told 快猫短视频 at the time.
So how does this view square with the CRC鈥檚 BRCA2 patent application? 鈥淚鈥檝e not changed my mind on anything,鈥� says Stratton. 鈥淎lthough I have concerns about the patenting of disease genes, we put in a patent on BRCA2 as a holding measure.鈥�
Gordon McVie, the CRC鈥檚 scientific director, explains that it is the usual policy of CRC Technology, the campaign鈥檚 commercial arm, to apply for patents. But he adds that the main motivation behind the CRC鈥檚 BRCA2 patent is to ensure that future diagnostic tests are made available at an affordable price.
鈥淲e would not want to see the pricing of diagnostic tests determined purely by profit considerations,鈥� he says. Given that Myriad, which had already signalled its intent to patent BRCA2, was known to be hot on the gene鈥檚 scent, McVie argues that the CRC had no alternative but to file a patent. If it had not patented, says McVie, the CRC would not be able to influence the price of diagnostic tests.
The outcome of the BRCA2 patent dispute will depend, in part, on which application was filed first. The CRC patent was filed at the UK Patent Office in late November, almost immediately after Stratton鈥檚 team isolated BRCA2. Myriad refused to say when it filed its application. 鈥淚t鈥檚 standard patent protocol not to disclose date of invention, date of patent filing, or the inventors,鈥� says Peter Meldrum, Myriad鈥檚 president.
Both sides say that they wish to end the dispute without resorting to a legal battle that could take several years to complete, but it is so far unclear how the conflicting claims can be reconciled. Emma Plummer, a business manager with CRC Technology, notes that the dispute will probably have to be resolved before diagnostic tests teach the market.
Nevertheless, McVie vows not to let the dispute impede basic research on the gene. 鈥淏RCA2 is going to be made freely available to other academic scientists,鈥� he promises. 鈥淭here is not a monopoly situation. That is important.鈥�
By contrast, many cancer researchers complained that Myriad was initially reluctant to provide clones of BRCAl, after its earlier patent application. 鈥淚 did not find it easy to obtain a full-length clone,鈥� says Sofia Merajver of the University of Michigan in Ann Arbor. 鈥淭he cooperation was not especially flowing.鈥�