Stem cell patents
8/09/2009

Stem cell research has been a controversial issue since it first emerged and presents a great legal and moral challenge. There is an ongoing debate on the morality of stem cell research. There are those who argue that stem cell research presents a great opportunity to study processes governing cell division and differentiation (the process whereby an unspecialised embryonic cell acquires the features of a specialised cell such as a heart, liver or muscle cell). Knowing the genetic and molecular controls of such processes will then reveal information about how genetic disorders and other birth defects arise, and assist in the development of new therapies to treat such defects. Stem cells may also be used to test new drugs, an example of this is the use of cancer cell lines used to screen potential anti-tumour drugs. Another possible use of stem cells is cell-based therapy. The U.S. Food and Drug Administration (FDA) has approved an embryonic stem cell clinical trial involving the injection of neural stem cells into paraplegics who have suffered a recent spinal cord injury.

Those opposed to stem cell research argue that embryonic stem cell research could very rapidly lead to reproductive cloning and it could result in human life being devalued. The pro-life movement argues that a human embryo is a human life that is entitled to protection. Would the pro-life movement’s argument hold for embryos that were created but not used for in vitro fertility treatments? In vitro fertilisation (IVF) generates a large number of embryos which, if not used, are slated for destruction. Must researchers, in the interest of morality, stop using such embryos which will be destroyed in any case, or must researchers use such embryos to conduct research that may result in much needed cell-therapies being developed? In many countries abortion has been legalised, thousands of embryos are being destroyed on a daily basis.

Having conducted research on stem cells, companies sponsoring such research consider the financial benefits emanating from such research. In order to have an enforceable right to such results and any products obtained from the research, companies consider the various intellectual property rights that may protect their findings. Obtaining patent rights for one’s invention is one of the ways in which companies protect their intellectual property. Since some view stem cell research as immoral, would a patent protecting stem cell lines or a method of producing same be viewed as immoral.

The South African Patents Act provides that a patent shall not be granted for an invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behaviour. The Registrar of patents may refuse an application if it appears to him that the use of the invention to which the application relates would be expected to encourage offensive or immoral behaviour. Stem cell research may be deemed as immoral by some, but would generating a heart for a person in need of it be immoral simply because stem cell technologies were used to generate it? The National Health Act makes provision for use of stem cells for research and therapeutic purposes within the boundaries of morality.

According to section 57(2) of the National Health Act: “The Minister may, under such conditions as may be prescribed, permit therapeutic cloning utilising adult or umbilical cord stem cells.” Section 57(4) further states that: “The Minister may permit research on stem cells and zygotes which are not more than 14 days old on a written application and if-
a) the applicant undertakes to document the research for record purposes; and
b) prior consent is obtained from the donor of such stem cells or zygotes”.The date of commencement of section 57 is still to be proclaimed.

The National Health Act does not define embryonic, adult and umbilical cord stem cells. However, it is clear that it recognises that there are differences between the different types of stem cells. Embryonic stem cells are derived from embryos that are four or five days old. Accordingly, use of such embryos, usually obtained from eggs that have been fertilised in vitro for use in IVF, for research purposes may be permitted by the Minister subject to compliance with the provisos of paragraphs a) and b). Umbilical cord stem cells are derived from the cord blood of the umbilical cord at childbirth. Use of such cells does not result in the destruction of any embryos. Adult stem cells are found in a tissue or organ capable of renewing itself. Such stem cells are different from embryonic stem cells in that they are thought to be limited to differentiating into different cell types of their tissue of origin, unlike embryonic stem cells which are pluripotent (they are capable of becoming all cell types of the body).

Most researchers prefer using embryonic stem cells to adult stem cells mainly because they can be grown relatively easily. This is very advantageous as a large number of cells are required for stem cell therapy. Researchers have found a means of genetically reprogramming adult stem cells to behave like embryonic stem cells, such reprogrammed adult cells are called induced pluripotent stem (iPS) cells. In the long run, this may result in less use of embryonic stem cells.

Generally, embryonic stem cell research is perceived to be immoral because it involves the destruction of embryos. Use of adult stem cells does not involve destruction of embryos and may well not be perceived as immoral, although some may argue that any kind of stem cell research may encourage cloning of human beings. But, it may be that patents in respect of adult stem cells may be more acceptable. In New Zealand, patents including stem cells within their scope frequently face objection during examination as they may be deemed to be “contrary to morality”.

Recently, the Enlarged Board of Appeal of the European Patent Office (EPO) made a decision in relation to the Wisconsin Alumni Research Foundation stem cell patent application. The EPO decided that “patents could not be granted for inventions which would have necessitated the destruction of human embryos in order to be performed at the filing (or priority) date of the patent application”. The United Kingdom Intellectual Property Office (UKIPO) has confirmed that they will be taking the EPO stance by granting patents relating to human embryonic stem (hES) cells only if “at the filing or priority date, the invention could be obtained by means other than the destruction of human embryos”.

Unlike the EPO, UKIPO makes a clear distinction between pluripotent and totipotent cells. Pluripotent cells only have the potential to develop into all cell types, whilst totipotent cells have the potential to develop into the entire human body. UKIPO will continue granting patents relating to pluripotent hES cells as it does not consider patenting pluripotent hES cells contrary to morality in UK. However, the grant of such patents is subject to the proviso set out above. Totipotent hES cells are excluded from patentability.

The South African Patents Act is based on the UK Patents Act of 1977. As a result, it is more probable that when it comes to hES cell patents, South Africa may follow the precedent set by UKIPO. Accordingly, pluripotent hES cell patents may well not be viewed as contrary to section 24(4)(a) and section 36(1)(b) of the South African Patents Act. It would thus be advisable to direct the claims of a patent application relating to stem cells to pluripotent hES cells and not totipotent hES. Inventions relating to adult stem cells and iPS cells may also be patentable as they are not totipotent.

Kutlwano Hutamo
Candidate Attorney kutlwano-h@adamsadams.co.za