The Wisconsin Alumni Research Foundation (WARF) has had three of its patents in relation to stem cells (and in particular, methods of isolation) upheld by the United States Patent and Trademark Office (USPTO). In so doing the USPTO rejected an obviousness challenge in respect of one of the patents. This successful defence of stem cell related patents brings sharply into focus the myriad of issues raised regarding the patentability of stem cells, e.g. the issues of morality and whether something so fundamental should be patentable at all. USPTO's decision also highlights the differences between the approaches in the US, the UK and Europe. Despite objections, the US has given a clear indication that it is receptive to such patents.
WARF's European patent application which relates to human embryonic stem cells (EP O 770 125) has suffered the opposite result, with the European Patent Office (EPO) refusing it on moral grounds under Article 53(a) of the European Patent Convention (EPC). WARF has appealed this decision to the Technical Board of Appeal, which has in turn referred four questions to the Enlarge Board of Appeal, which has requested submissions from third parties as to how the questions should be answered.
The United Kingdom Intellectual Property Office (UKIPO) has submitted a detailed submission on behalf of the UK setting out its arguments against refusing an application on moral grounds. The UKIPO argues that the EPO should not refuse to grant a patent on moral grounds where there is no clear consensus among its contracting states on the morality of patenting stem cell research, as the result would be to deny patent protection in those states where such technology is morally acceptable and therefore patentable. As well as the EPC, the EPO takes guidance from the "Biotechnology Directive" (98/44/EC) on what is and is not to be considered morally acceptable, and in particular Rules 15 and 24 of the Directive. This approach differs from that set out in a Practice Note issued in April 2003 by the UKIPO and helps to explain the difference in approach between the UK and Europe. Broadly, the EPO will not grant patents relating to stem cells where it was necessary to use a human embryo to obtain those cells.
The UK's approach is that it will grant patents in respect of pluripotent stem cells (i.e. those that do not have the ability to develop into a full human being) but will not grant patents in respect of totipent stem cells (i.e. those that do have the ability to develop into a full human being). This is not absolutely contrary to EPO's position, but the EPO's position on pluripotent cells is unclear. The UKIPO has also suggested that given the enormous potential of stem cell research to deliver new treatments for a broad range of illnesses, encouraging development of such treatments by making patent protection available would on balance not be contrary to morality. Naturally, this is all subject to the normal patentability requirements and despite the moral argument being less of a problem for WARF in the UK, it may still struggle to satisfy the novelty and inventiveness requirements.
Current debate in the UK is focused on the Human Fertilisation and Embryology Bill which has created widespread discussion on, amongst other issues, the ethics of using human and animal cells for the benefit of future patients. Pressure from religious groups in particular has led to some minor concessions from Government and the outcome of the bill may more clearly establish the boundaries of morality in the UK in respect of research of this nature. We shall examine the contents of the Human Fertilisation and Embryology Bill in future editions of our IP e-bulletin.