Now that the dust has settled after a decade of uncertainty IPcopy surveys the scene to try and determine what the state of play is on patenting of human pluripotent stem cells in Europe.
It seems an age ago when the debate first erupted following the grant of European Patent No. 0695351 to the University of Edinburgh which inadvertently included a claim to a human being (oops!); a matter quickly rectified following an opposition filed by German Greenpeace and several other parties with proclaimed moral and ethical interests in this area. In fact the ‘Edinburgh Patent’ was actually more about methods for obtaining purer colonies of embryonic stem cells, rather than the cells themselves. Before long the debate on the ethical position of using human embryos as a source of material for deriving human embryonic stem cells (hESCs) had snowballed and the issues considered during the earlier Edinburgh case were played out in full in Jamie Thompson’s Wisconsin Alumni Research Foundation patent application (published as EP-0770125-A) which related to the derivation of the first hESCs.
Across the Atlantic at around this time in the US, the Bush Administration had placed restrictions on use of NIH funds for research into derivation of new hESC cell lines. So by the middle of the last decade the debate on the ethical aspects of human embryo research and stem cells derived from human embryos was raging. Indeed, in 2007 Hollywood movie actor and Parkinson’s disease sufferer, Michael J. Fox, went as far as to provide the keynote speech to the US Bioindustry Organisation’s annual convention on the issue of human stem cell research.
The patentability issues were settled, in Europe at least, as a result of two fortuitous scientific developments: Shinya Yamanaka’s discovery of a method to make induced pluripotent stem cells (iPSCs) from human differentiated cells, and Robert Lanza’s publication of a non-destructive method for deriving hESCs. Both of these technical leaps that occurred late in the last decade underpinned the reasoning of the decision of the Court Of Justice of the European Union (CJEU) in the final landmark case: Oliver Brüstle v. Greenpeace (C-34/10). Yamanaka’s group had showed that pluripotency was not the unique preserve of hESCs and Lanza’s that that you could pluck cells from a human blastocyst without destroying it in the process. A neat way out was provided for the judges considering the patentability of Brüstle’s claimed neural stem cells that had been derived from a hESC line. The judgement said amongst other things that inventions that require prior destruction of human embryos or their prior use as base material are excluded from patentability in the EU. This remains the case even if the actual step of derivation is not part of the patent claims. In addition, the term ‘human embryo’ should also be considered broadly when looking at inventions in this technical area. The CJEU decision was confirmed in late November 2012 by the German Courts who had initially referred the case.
The subsequent doom and gloom for the hESC researchers and related regenerative medicine industries in Europe has faded now that the European Patent Office (EPO) has interpreted the CJEU decision and adopted a new pragmatic approach. In fact, for researchers currently active in the field of hESC and human iPSC research the situation is actually fairly favourable and is summarised as:
1. Patent applications claiming methods and products that encompass human pluripotent cells are patentable in Europe as long as the earliest filing date is later than 30 November 2007 which is the date Yamanaka published his paper on human iPSCs (Cell, Volume 131, Issue 5, 861-872, 30 November 2007).
2. Patent applications that claim methods and products using hESC lines are patentable if the earliest fling date is later than 10 January 2008 which is when Lanza’s group published their process for non-destructive derivation of hESCs (Cell Stem Cell. 2008 Feb 7;2(2):113-7. Epub 2008 Jan 10).
For the currently pending applications or the few granted patents that have their earliest filing dates before both of these dates it would seem that prospects for enforcement within the EU at least are at best challenging. It may be that this clears the path for newer human stem cell therapies and inventions to be exploited in Europe without the worry of some older legacy patents being enforced. Perhaps it could be said that the European hESC industry v.2.0 was born on 10 January 2008.
From an objective stand point it would seem strange to play out such an important philosophical debate though the medium of patent law, when surely the ethical aspects of research should be considered by national governments who choose to license and fund this area. This author wonders why, for the sake of argument, British taxpayers’ money can be used to promote research into hESCs in the UK, but the products of that research are denied patent protection because they are considered immoral by an EU body. The clash between national and perceived European interests is quite striking especially in an area where views on morality are far from harmonised across Europe. For bodies such as the EPO Enlarged Board of Appeal and the Court of Justice of the European Union it is dangerous to assume that they can opine on what is acceptable for all of Europe, irrespective of the diverse cultural backgrounds and beliefs that exist within this corner of the World. If this is a foretaste of what we can expect from pan-European decision makers entrusted with the new EU unitary patent and unified patent litigation process then there may be interesting times ahead.