European Patent Office Nixes WARF Application, Again
(BioWorld Today Via Acquire Media NewsEdge) LONDON - There was a second and final rejection of the University of Wisconsin's infamous WARF human embryonic stem cell patent from the European Patent Organization (EPO) last week.
EPO's highest board of appeal confirmed a decision handed down in June that it would be against the "public order" to grant the patent since it requires the destruction of an embryo to apply the method for preserving pluripotent stem cells in vitro without the cells losing the ability to differentiate subsequently.
EPO was careful to say the decision does not mean human stem cell lines cannot be patented. However, the ruling does not make it clear if products based on banked embryonic stem cell lines that did not involve the destruction of an embryo as the starting point, but do trace their origins to a destroyed embryo, are also unpatentable. Nor is it clear if cell lines based on fetal stem cells also would be considered contrary to public order.
That lack of clarity means the reaction to the decision was mixed. In European countries where embryonic stem cell research is allowed, academic research will be freed up because scientists will no longer need licenses to the WARF patent.
George Schlich, lead intellectual property counsel for Stem Cell Sciences plc, told BioWorld Today the ruling, "probably loosens up the stem cell industry in Europe, because now there is not a dominant patent that controls human embryonic stem cells."
Schlich pointed out that at the time of filing of the Wisconsin Alumni Research Foundation's Patent Application number 96903521.1 in 1995, the only way of obtaining pluripotent stem cells was through the destruction of an embryo. Now it is possible to isolate stem cells without destroying the embryo they come from. In addition, with research into induced pluripotent stem cells, in which adult somatic cells are transformed back into pluripotent cells, and also the use of therapeutic cloning, it is becoming possible to produce human embryonic stem cells through other routes.
Cambridge, UK-based Stem Cell Sciences does not have any WARF licenses, or any products that were originally derived from embryos. Schlich said the decision on the WARF patent, "is helpful for the industry as a whole because it clarifies the position."
Geron Corp., of Menlo Park, Calif., which is a WARF licensee, chose to interpret the ruling as covering only human embryonic stem cells cultured from an embryo, and not human embryonic stem cell lines subsequently derived from those cells.
"Many human embryonic stem cell lines [are] widely available through stem cell banks, obviating the need for researchers to culture the cells from embryonic material. Therefore this decision should not affect patents for later-developed human embryonic stem cell technologies, including technologies developed by Geron to enable scalable manufacture of human embryonic stem cells," the company said in a statement.
David Earp, Geron's chief patent counsel and senior vice president of business development, said EPO's decision is not unexpected, adding, "Given the narrow basis for the decision, it should have a very limited impact on Geron's ability to protect our embryonic stem cell technologies in Europe."
But since some European countries, including the UK, do allow patenting of products based on human embryonic stem cells, the decision will make it more complex to market any cell therapy products based on human embryonic stem cells, and it will not be possible to file for a single European patent for such products.
In contrast to Geron, some legal experts in Europe thought the narrow basis of the decision created uncertainty. Paul Chapman, of the intellectual property lawyers Marks and Clerk in London, said the rejection of the WARF patent fails to clarify the law.
The relevant rule in the European Patent Convention prohibits patents that involve the use of human embryos, "for commercial or industrial purposes."
Chapman said that leaves the door open over the patentability of stem cell technology that makes use of human embryos, but does not necessarily involve the destruction of embryos.
"This uncertainty is likely to have a detrimental effect on a field of research vital to future medical progress," said Chapman. It is not clear if products derived from banked stem cell lines will be patentable, and patent applications are increasingly falling into this grey area. "While some will interpret the decision as a green light for patent applications, which describe methods that don't necessarily involve the destruction of an embryo, this has not been given, and any such claims are likely to be challenged at a future date," Chapman said.
However, Adrian Tombling, patent attorney and life sciences expert at Withers & Rogers LLP in Birmingham, UK, said, "While significant, [the ruling] does not mean the end of stem cell research - far from it. This ruling only affects inventions which involve generating stem cells through the destruction of embryos. As there are now a number of potential alternative methods for obtaining stem cells, [it is] unlikely to hinder research in this area."
But Chapman said he thinks an outright rejection of any product that at any stage involved destruction of a human embryo would have been preferable to the uncertainty that exists now. "While this would pose problems for researchers seeking to protect their inventions in the field, it would at least allow them to move forward commercially with some degree of certainty."
Clarity may come from the fate of a number of Geron patents that have been held up while the WARF issue was considered. "We are optimistic that the EPO will now move to allow the backlog of Geron's European patent applications that have been on hold pending this decision," Earp said.
As far as the UK is concerned, Chapman noted that the UK Intellectual Property Office has for some time been granting patents that refer to human embryonic stem cells and products, but not their method of isolation. It remains to be seen whether or not the UK will be influenced by EPO's ruling, but Chapman said, "[The] decision may have an effect on the potential validity in the UK of already granted patents, adding to the uncertainty left by [EPO's] decision among the UK stem cell community" n
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