LONDON -The Human Genetics Commission (HGC), an independent group that advises the British government issued a plea today for health and research institutions to develop a coherent policy on intellectual property, including patents on diagnostic tools. The message came in a new report, "Intellectual Property and DNA Diagnostics," launched at a conference-the song Press swan HGC soon-to-be-dissolved. The report found that doctors and researchers in U.K. public institutions have mostly ignored biotechnology companies for patents on numerous genetic tests, leaving holders of patents uncertain how their intellectual property (IP) is a value. Intellectual property owners who say their demands are ignored, often do not even try to continue the National Health Service mammoth, according to the report, in part because they do not know where to start.
The HGC report made several recommendations: First, the research councils U.K. and other funding agencies should review their license conditions. The Ministry of Health needs to find a way to monitor how intellectual property affects involving biomarkers and diagnostics NHS should receive government support in managing these issues. Finally, the report recommends that the data should be collected on what kind of IP impact on innovation to bring clarity to what is now a heated and often confused about the value of patents debate.
One speaker at the press conference spoke about the need to reduce the nuisance factor of patents in health care. The patenting of the DNA-based tests is "unacceptable, unworkable and damaging," said Gail Norbury commissioning and director of governance genetics laboratories at Guy's Hospital here.
the UK public health system has so far been able to "wade" in working on issues of intellectual property, said the expert Michael Hopkins University political scientist Sussex, but it does so at their own risk. "the clock is running on multiple infringement suits. Back royalties may be claimed and those who accumulate. We can not keep tangle. "
Meanwhile, said Berwyn Clarke biotechnology company Lab21 in Cambridge, UK should be concerned that its biotechnology companies could move to countries where they may easier to enforce their intellectual property rights. due to the strength of the NHS, he said, "the UK should be the best in the world [for developing and clinically testing diagnostic tests], but at the moment it is one of the worst [places] to develop a business. "
Hopkins said that Europe is less protective of intellectual property for diagnostic tests than the United States. He cited a 09 survey which revealed that only 4% of E.Ü. the laboratories of the public sector had to withdraw genetic tests due to intellectual property claims, compared to 25% in the US. Seven times more gene patents have been filed in the United States and Europe. The US market is so vast and lucrative, and patent so much easier to apply, he said Science Insider, many American companies have not found it worth their while to assert their rights to foreign. That could change, though: "It's just a matter of when someone gets hungry enough"
economist Stuart Hogarth of Kings College London agrees that companies are getting itchy to start getting. returns on their R & D, especially as many UK regulators to strengthen their evidence requirements. But because the intellectual property issues that affect diagnostic tests are specific to the case, he could not consider one law or approach to address the issue.
many hospitals and research laboratories are developing their own tests "homebrew", avoiding royalty payments to those who hold key patents. for example, AstraZeneca holds a patent on a genetic test for non-small cell carcinoma of the lung. in the UK, Clarke said, 21 laboratories test for this marker, but only two are using the test approved by regulators UK. some "are better than others," Clarke said, "and mistakes are made." Clarke, who advocates the standardization of tests, suggests that the NHS should be more concerned about this.
Norbury disagree: the multiple tests, including homebrew, can be used to cross check the results, she said. And homebrew tests allows patients to get a second opinion, even if hospitals are not willing to buy the test of sustained business. She also sees nothing wrong with workarounds beyond royalties. "People find a way around things, how do you prevent people from copying CDs?" The sector of public health, she feels, should not have to worry about patent holders nipping his heels.
But many agree that the current system is broken. It is time, said Alastair Kent, a committee member and President of HGC's Monitoring Group on Intellectual Property, "to shed light rather than generate heat and dust."
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