WTN gives analysis of issues facing WARF stem cell patent applications in Europe
Joe Vanden Plas gives a discussion of the patent issues confronting WARF in Europe.
To assess WARF's chances in Europe, WTN Media contacted attorney Robert Anderson, a partner in the London-based international business law firm Lovells.
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.
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.
Rule 23e(2) 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."
Anderson: 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. 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.
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.
To assess WARF's chances in Europe, WTN Media contacted attorney Robert Anderson, a partner in the London-based international business law firm Lovells.
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.
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.
Rule 23e(2) 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."
Anderson: 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. 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.
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.
posted by Lawrence B. Ebert at 6:54 AM
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