LONDON—The Human Genetics Commission  (HGC), an independent group that advises the U.K. government, issued a plea today to health and research institutions to develop a coherent policy on intellectual property, particularly patents on diagnostic tools. The message came in a new report, "Intellectual Property and DNA Diagnostics ," launched at a press conference—the swan song of the soon-to-be-disbanded HGC. The report found that doctors and researchers in U.K. public institutions have mostly ignored biotech companies' patents on numerous genetic tests, leaving patent-holders unsure how much their intellectual property (IP) is worth. IP owners who say their claims are being ignored often don't even try to sue the mammoth National Health Service, according to the report, partly because they don't know where to begin.
The HGC report made several recommendations: First, Research Councils U.K. and other funding agencies should review their licensing requirements. The Department of Health needs to find a way to monitor how IP involving biomarkers affects diagnostics, and NHS should be given governmental support in managing these issues. Finally, the report recommends that data should be gathered on what kind of impact IP has on innovation to bring clarity to what is now a heated and often confused debate on the value of patents.
One panellist at the press conference spoke of the need to minimize the nuisance factor of patents in health care. The patenting of DNA-based tests is "unacceptable, unenforceable, and detrimental," said Gail Norbury, commissioning and governance director of genetics laboratories at Guy's Hospital here.
The U.K. public health system has so far been able to "muddle through" by working around IP issues, said science policy expert Michael Hopkins of the University of Sussex, but it does so at its own peril. "The clock is running on multiple infringement suits. Back royalties can be claimed and those are accumulating. We can't keep muddling."
In the meantime, said Berwyn Clarke of the biotech company Lab21 in Cambridge, the United Kingdom should be concerned that its biotech companies might move to countries where they can more easily assert their IP rights. Because of the strength of NHS, he said, "the U.K. should be the best in world [for developing and clinically testing diagnostic tests], but at the moment it's one of the worst [places] to develop a business."
Hopkins says that Europe is less protective of IP for diagnostic tests than the United States. He cited a 2009 survey  that found that only 4% of E.U. public sector labs have had to withdraw genetic testing because of IP claims, compared with 25% in the United States. Seven times more gene patents have been filed in the United States than in Europe. The U.S. market is so large and lucrative, and patents so much easier to enforce, he told ScienceInsider, that many U.S. companies haven't found it worth their while to assert their rights overseas. That could change, however: "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 some returns on their R&D investments, especially as many U.K. regulatory agencies are strengthening their evidence demands. But because IP issues affecting diagnostic tests are case-specific, he couldn't envision a single law or approach resolving the matter.
Many hospitals and research labs devise their own "homebrew" tests, avoiding royalty payments to those who hold key patents. For instance, AstraZeneca holds a patent on a genetic test for non-small cell lung carcinoma. In the United Kingdom, Clarke said, 21 labs test for this marker, but only two use the test approved by U.K. regulators. Some "are of higher quality than others," Clarke said, "and mistakes do get made." Clarke, who advocates standardization of tests, suggests that NHS should be more concerned about this.
Norbury disagrees: Multiple tests, including homebrews, can be used to cross-check results, she said. And homebrew testing makes it possible for patients to get a second opinion even if hospitals aren't willing to buy the company-backed test. She also sees nothing wrong with workarounds that evade royalties. "People find a way around things; how are you going to prevent people copying CDs?" The public health sector, she feels, shouldn't have to worry about patent-holders nipping at its heels.
But many agree that the current system is broken. It's time, said Alastair Kent, a panel member and chair of the HGC's Monitoring Group on Intellectual Property, to "shed light rather than generate heat and dust."