|Merpel doesn't know much|
about stem cells and embryos,
but she knows what pleasure
can be derived from an
unhatched egg ...
"What has happened?
The new Guidelines for Examination in the European Patent Office came out on 20 June 2012, and on the controversial subject of patenting stem cell inventions they follow the ruling of the Court of Justice of the European Union (CJEU) in Brüstle v Greenpeace (Case C-34/10)., noted on this blog by David here.
In essence, the decision and the guidelines both now say that, to be patentable in Europe, a stem cell invention should not be directed to a human embryo (broadly defined), nor should the subject matter of the patent have required the prior destruction of a human embryo, at any time in the past. However, the patentability of inventions relating to adult stem cells, or human induced pluripotent stem cells (where adult cells are ‘reprogrammed’ to take on pluripotent capabilities, such that they can be used as the source of stem cells for therapeutic use) remains unaffected by the new Guidelines. Further, technologies that extract embryonic stem cells without destroying the embryo should not be affected by Brüstle and should also remain patentable at the EPO.
Practical and commercial relevance
This Guideline does not come as a surprise following comments from the EPO President that he was minded to follow the CJEU (even though the EPO wasn't formally bound to do so). Nevertheless it will be seen as a backwards step by many in the industry as EPO practice until Brüstle was to allow patents for embryonic stem cell technologies that could be based on a stem cell line at the time of filing (even though such a stem cell line would have required the destruction of an embryo to establish the line -- which may have been years ago). The new examination guidelines change that - stating "The point in time at which such destruction takes place is irrelevant" (as per Brüstle).
However, the technology in this area is continuing to move forward and it will be interesting to see how the Guidelines are applied at the ‘cutting edge’ and the implications that this may have for filings that do not stipulate a means of obtaining the human embryonic stem cells (hESCs). For example, there is now a means of making human embryonic stem cells that does not require destruction of an embryo: Advanced Cell Technology’s (ACT’s) non-destructive “single-cell blastomere” technology. As indicated above, since this technology is non-destructive it should still be patentable.
The question then arises whether or when (as a scientific matter) this technology, which has only been available for a few years (the landmark Nature paper was published in August 2006), can be used interchangeably with hESCs made using the ‘old’ technology i.e. well established cell lines. If so, patent applications filed for hESC technologies since this non-destructive technology became available may be patentable on the basis that they do not necessarily involve destruction of a human embryo and in which case the impact of the new Guidelines would be restricted (perhaps severely so). In this way the test implemented by the EPO, that the technology that is the subject of the application, necessitates the destruction of a human embryo, may be the silver lining for those working in the regenerative medicine area.
This raises some interesting questions about how one would demonstrate for EPO patentability purposes that the technology is not "exclusively obtained by a method which necessarily involved the destruction of human embryos". In particular:
• What is the threshold for showing that a non-destructive means could be used instead?
• Does this need to be proven and, if so, how (this would be extremely burdensome if the technology of the application has only been validated using hESCs based on a cultured cell line, which would still be acceptable for USPTO purposes)?
• Does it instead just have to be plausible (and could this be established without data)?
• Does this have to be addressed in the specification or is it good enough if it can be established as a matter of fact?Further practical difficulties may arise if it needs to be demonstrated that a non-destructive means could be used, for example, ACT’s single-blastomere technology, if it is patent protected and could only be used under licence (or, would this fall under the experimental use exemption?).
Finally, the question remains unanswered as to how the national courts will treat such patents and how they will deal with the sorts of issues raised above and arising out of Brüstle.
What the Guidelines say about stem cells in brief
The Guideline (below) broadly reflects the Brüstle ruling. The somewhat clumsy wording "product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded" appears to be designed to allow for stems cell inventions related to cells produced by processes that do not necessarily require the destruction of an embryo, although it raises a number of questions, as we state above. The stipulation that the inventions must not have required the destruction of an embryo at any time in the past is altogether clearer. This means that an invention must not even employ stem cell lines that required the destruction of an embryo at any point in history, even though working the invention itself requires no such destruction (and regardless of whether or not such method is part of the claim).
The Guideline at Chapter II-15 of Part G says (including bold text):
"(c) Uses of human embryos for industrial or commercial purposes:
A claim directed to a product, which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28(c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant.
When examining subject-matter relating to human embryonic stem cells under Art. 53(a) and Rule 28(c), the following has to be taken into account:
(a) the entire teaching of the application, not only the claim category and wording, and
(b) the relevant disclosure in the description in order to establish whether products such as stem cell cultures are obtained exclusively by the use, involving the destruction, of a human embryo or not. For this purpose, the disclosure of the description has to be considered in view of the state of the art at the date of filing.
Since Scott and Paul have been kind enough to send this piece the IPKat's way, even though it was really meant for elexica, this Kat hopes that readers will be kind enough to let them have their thoughts on this significant development.The exclusion of the uses of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (EU Dir. 98/44/EC, rec. 42)".