|Parthenogenesis - Bischoff, Steve R, 2010 - Duke University/ISCO|
The significance of the ISCO Euro Court of Justice ruling positively hits on a number of fronts:
1. It is of course clear now that International Stem Cell Corp (ISCO) can be granted European Patents on their Parthenogenesis IP which gives them a distinct commercial position in the Pluripotent field in Europe.
2. Other Parthenogenesis programs can proceed to file & secure IP in Europe as a result of the ruling.
3. Existing Patent Applications that specify Parthenogenesis derivation methods as an "embryonic" cell source now have a clarified legal route to secure IP
4. Existing Patent Applications that specify "Pluripotent" derivation methods as an "embryonic" cell source now have a clarified legal route to include Parthenogenesis derived ES cells as a result of the ruling.
5. The combination of this clarification ruling on an activated unfertilized egg not being a "human embryo" by definition and the previous Non-Destructive language on use of IVF supernumerary pre-embryos clearly indicates a pathway to patent pre-embryo ES methods in Europe. An extracted Blastomere cell from a post fertilization state isn't capable of developing into a human independently and as long as its extraction doesn't do harm the 4-8 cell the pre-embryo can develop into an human, as it's potential is maintained, but only if it continues to correctly divide and post its implantation in the mother's womb will it have a chance to develop. The Non-Embryonic-Destruction ("NED") issue has already been indicated by the EPO's examination documentation on hESC Patent Applications and punctuated recently by Issuing Patents to hESC methods to derive human cells conditional upon NED technology tools being used (see Hadasit Medical / CellCure / BTX hESC RPE Patents).
How does this ruling reflect on Ocata Therapeutics, as they were a primary Licensee to ISCO of their Parthenogenesis IP estate and maintain an interest in hpESCs as a Pluripotent source in their own IP assets?
While ISCO has got a ruling that works well for them, after much effort to get their science understood, the issues for Ocata in Europe are more layered...
As I outlined in the comments above there are directly positive aspects to the outcome in this case which can be extended to the Ocata & the sector, namely:
Pathogenesis is a Patentable Method and Product in Europe as it isn't a technology to create human life. As such anyone wishing to develop innovations using Parthenogenesis can do so with a path to secure IP around their programs. Ocata have covered the use of Parthenogenesis directly in Patent Filings (EPO RPE Apps for instance) and also in the "Pluripotent" manner which covers all sources of ES cells... so this directly and positively relates to Ocata's hESC Apps which include hpESCs and general Pluripotent language in their Apps.
On the issue of NED cell lines and Blastomere this ruling confirms the German Courts findings that the viability of a pre-embryo or capacity to develop into a human is critical to determine when considering whether there is scope for Patentability. The European Court left it to the National Courts to decide, if required, whether there is viability to an embryo. If an embryo for example arrests naturally it therefore has no ability to develop into a human and therefore its use is non-destructive and patentable in Germany for example (as they have done), according to their view of it. This seems logical and correct. If on the other hand a viable embryo is destroyed for its cells - in the case of Blastocyst technology (BioTime, WARF et al) - then there are no grounds for Patentability. If a non-destructive process is used to extract a Blastomere and the remaining pre-embryo remains viable that is also a non-destructive technology and one which the EPO has indicated is ok as a means to derive ES cells and patent the methods related to innovative cell related science (i.e. RPEs... for example). So this all bodes well for Ocata's hESC derivative Methods & Products.
Ocata has edited in their most recent continuation submission to their earliest Blastomere priority related application & paved the way for EPO acceptance as a non-human (mouse) method of NED cell lines (intention to grant was issued Dec 18th 2014). This looks like it will establish the precedent for the later Blastomere priority which is based on Human cell methods. The issues here remain language, ES co-culture methods, NED viability & use interpretations etc at the EPO, irrespective of the European Court of Justice's opinion on Parthenotes. However, this is true generally of the EPO as they are a separate body to the European Institutions. Their most current leaning on the subject can be seen in the recent documentation relating to the mouse patent (below) which includes an acknowledgement of innovation in respect to a Blastomere extraction versus the inefficient & destructive "classical" inner cell mass removal Blastocyst process...
To continue, Ocata also has IP that relates to eggs which includes Parthenogenesis techniques and can win Patents in Europe now either using non-destructive hESC NED lines and/or via hpESCs or other Pluripotent sources.
Further, SCNT as a method to create ES cells would I believe fall within the Parthenogenesis ruling as the techniques involved to "activate" the egg would follow the same argument as ISCO's Parthenotes above...
The use of pre-existing IVF supernumerary for SCNT ES cell lines is less clear as it involves an existing viable fertilized pre-embryo (hundreds of thousands in deep freeze) unless the pre-embryo was deemed unviable post thaw and could serve the purpose of being a home for SCNT ES development.
The issue here is the Egg versus a Fertilized Egg (viable pre-embryo) - if you use an Egg in SCNT Methods and produce ES cells you would need to prove that you are not creating anything viable in terms of human life, as there are issues with regard to germ cell manipulation and cloning.
Bottom line is the ISCO/Parthenotes ruling was v. positive for ISCO primarily but also Ocata and other hpESC/Pluripotent source programs.