31 May WARF stem cell patent faces long and winding road
Madison, Wis. – Does the Wisconsin Alumni Research Foundation’s European stem cell patent application have a realistic chance for approval?
The foundation’s stem cell patent is controversial enough in the United States, where critics charge it is overly broad and is suppressing scientific research. While that is a contention WARF dismisses, pointing to the more than 300 academic licenses it has issued for stem cell research, the critics’ claims could influence Europe’s eventual decision.
To assess WARF’s chances in Europe, WTN Media contacted attorney Robert Anderson, a partner in the London-based international business law firm Lovells. The firm employs more than 3,000 people, including 1,600 attorneys, and has offices in every major European jurisdiction and key financial centers in the United States and Asia.
Not exactly WARF speed
WARF’s application seeks patent protection for a purified preparation of primate and human embryonic stem cells. The European Patent Office’s Examining Division rejected the application in 2004, in part because the method of producing cells used a human embryo as starting material for the cell culture and required the destruction of that embryo, which is prohibited by the European Patent Convention.
WARF appealed that ruling, and Andrew Cohn, its government and public relations manager, does not expect a decision on the appeal for a “minimum” of 18 months. Anderson’s explanation of European patent law reveals why: there are many issues to resolve.
Anderson, who graduated from Edinburgh University with a bachelor of science degree in chemistry, including chemical pharmacology, said rules pertaining to the patentability of stem cells have their origin in a directive issued by the European Parliament/Council on the legal protection of biotechnological inventions. According to Anderson, the European rules contain certain exclusions from patentability, and the seemingly contradictory rules that are relevant to the WARF case are as follows:
Rule 23d, which says that European patents will not be granted with respect to biotechnological inventions that use human embryos for industrial or commercial purposes.
Rule 23e (I), which states that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute a patentable invention.
And Rule 23e(2), which appears to throw a wrench in the works. It states than an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, “even if the structure of that element is identical to that of a natural element.”
The consequence of these rules, Anderson said, is that there is nothing that expressly prohibits the patenting of all stem cells per se. However, the position may be somewhat different in relation to “totipotent” and “pluripotent” embryonic stem cells.
“There are likely to be real difficulties in patenting totipotent stem cells because these have the potential to develop into all the cells necessary for human development,” he said. “That being so, the argument is that they are excluded by Rule 23(e)(1) as a `stage’ in the formation and development of the human body. It can be argued that Rule 23(e) (1) relates only to the human body as such, and that a stem cell is not `the human body’ at any stage of its development.”
Anderson said pluripotent stem cells, which are capable of differentiating into all cell types that make up the human body but which are not capable of giving rise to a human being, are arguably not excluded from patentability on this particular ground.
The issue in the WARF case relates to Rule 23d(c), he said. At the time WARF filed the application, it was not possible to produce the stem cells that are the subject of the claims of the patent without making use of human embryos.
“The European Patent Office initially took the view that, although the patent did not seek protection for human embryos, since human embryos are used at some stage in producing the stem cells which were the subject of patent protection, the invention concerned the use of human embryos,” he said. “This is the position that was adopted by the EPO in the Edinburgh University case.”
The patent office said that the exclusion should be looked at broadly, and the fact that embryos were used to produce the stem cells was enough to place it within the exclusion. While on appeal, Edinburgh University has maintained its request for a patent in the original form, but it has hedged its bet with an amendment to exclude embryonic stem cells from the claims.
The counter argument made by the patent office in the Edinburgh case is that Rule 23 should be construed more narrowly, as “solely directed to excluding patent protection for the embryos, themselves.” The fact that embryos are used at some stage in the process is irrelevant if the claims of the patent seek protection for something else, in this case primate embryonic stem cells. Anderson said WARF is “running a similar counter argument in their case.”
In relation to other exclusions under the European Patent Convention, Anderson said the approach has been to use a narrow interpretation. But the fact that these particular exclusions have their origin in the directive on biotechnological inventions may make the matter more complex.
“The water is also, to some extent, muddied here because the European Patent Convention is published in English, French, and German,” Anderson said. “The texts use slightly different words and are equally valid.”
For example the French text of Rule 23 suggests that the invention may be excluded if the object of the invention involves the utilisation of human embryos, not merely the means by which the invention is achieved.
In addition to these specific exclusions, there is a general exclusion of inventions that are “contrary to morality.” According to Anderson, this argument was made in the Harvard Oncomouse case, when the European Patent Office decided that, in such cases, there was no hard-and-fast rule.
The EPO said “one had to look at all the circumstances and try and adopt a balance between the benefits of the invention and the undesirable aspects,” Anderson noted. “In that case, they thought that the benefits of the Oncomouse in relation to cancer research far outweighed the unfortunate consequences for the mice involved.”
There is a dispute as to whether the “balance” argument is applicable in the case of inventions related to human material.
In terms of jurisdiction, there is yet another complication. Although the European Patent Office is the usual route in which patents are pursued, a number of European states have made it possible instead to file in individual national patent offices. National attitudes differ and national patent offices might take a different approach than the EPO.
“Certainly the indications are that patents directed to pluripotent embryonic cells may well be permitted by the UK patent office, but this may be subject to further review by the courts,” Anderson said.
Speaking for WARF, Cohn did not dispute Anderson’s take on the foundation’s patent application or European patent rules – “What he [Anderson] said sounds find to us,” Cohn said – and he declined to characterize the European patent rules as contradictory. In general, he suggested, “patent rules are very technical and very difficult.”
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