21 August, 2015

Patentability of Genes, Genetic Material and Embryos in Singapore

Patentability of Genes, Genetic Material and Embryos in Singapore

The debate as to whether genes can or should be the subject of patent protection has continued since the inception of the Human Genome Project. Ultimately, the heart of the debate has focused on whether discovery of a gene is sufficient to claim an invention and whether gene patents encourage or stifle research and the clinical use of genomics. It is timely to review the more liberal stance taken in Singapore to the patenting of genes and genetic material as compared to other jurisdictions, such as the USA and Australia.

Section 13(2) of the Singapore Patents Act (SPA) states that inventions which would encourage offensive, immoral or anti-social behaviour if published or exploited are not patentable. The obvious intention of this section is to prevent the grant of patent rights for inventions which the general public would regard as abhorrent or from which the public need protection. In some cases, merely because an invention may have an offensive use, the fact that it has a legitimate use would not prevent it from being patentable under Section 13(2).

Section 13(3) of the SPA states that for the purposes of Section 13(2), behaviour shall not be regarded as offensive, immoral or antisocial only because it is prohibited by any law in force in Singapore. Thus, whilst a particular law may prohibit the use of an invention in Singapore but this does not necessarily exclude it from patentability on the basis of Section 13(2). For example, this may apply to a product manufactured in Singapore for export to a country where such legal restraints do not apply.

The issue of morality under Section 13(2) is always considered when assessing inventions relating to genes, genetic material and embryos. The stance taken in Singapore, with respect to assessing inventions relating to genes per se, can be traced back to Howard Florey Institute [Relaxin], V8/94 Relaxin, OJ EPO 6/1995. In this case, it was held that the patenting of a single human gene had nothing to do with patenting of human life and that an Examiner should proceed to assess whether an invention relating to a gene per se meets the requirements of novelty, inventive step and industrial applicability, and not raise a morality issue against the invention.

Inventions relating to transgenic animals will also be considered in a similar manner. Paragraph 14 of the Bioethics Advisory Committee’s (BAC) Consultation Paper on Human-Animal Combinations for Biomedical Research, acknowledged that:

"…transgenic animals are already widely used in research. Besides enabling scientists to understand the causes of diseases, and to develop more effective treatment for these diseases, they have also been used to test the safety of new products and vaccines and to study the possibility of producing organs for transplantation that will not be rejected. As transgenic animals are not thought to raise any new ethical difficulties, they are not considered further in this Consultation Paper. "

In the absence of local laws prohibiting the creation of such transgenic non-human mammals together with the scientific and medical benefits arising from such research involving the use of these transgenic non-human mammals, mere offence to a section of the public that would consider the invention distasteful, is not enough for Section 13(2) to apply under Singapore patent practice.

With respect to human embryos, the use of human embryos for commercial or industrial purposes is not patentable under the UK Patents Act Schedule A2 and European Directive 98/44/EC. However, there are no specific provisions governing the patentability of human embryos and their products under Singapore patent law.

The use of human embryos is governed under the Singapore Human Cloning and other Prohibited Practices Act which prohibits the use of human embryos after 14 days of its fertilisation. In particular Section 7 recites as follows:

No person shall develop any human embryo, that is created by a process other than the fertilisation of a human egg by human sperm, for a period of more than 14 days, excluding any period when the development is suspended.

Section 8 recites:

No person shall develop any human embryo outside the body of a woman for a period of more than 14 days, excluding any period when the development is suspended.

Accordingly, methods for generating human embryonic stem cell lines as well as methods where human blastocysts are generated from fertilised human oocytes are not excluded from the Human Cloning and Other Prohibited Practices Act. However, such inventions will be generally be considered on a case by case basis.

However, human reproductive cloning is prohibited in Singapore. The Bioethics Advisory Committee (BAC) issued a report in 2001 stating that (at paragraph 39, page 31):

"There is consensus from all sectors in opposing reproductive cloning. The BAC is of the view that the implantation of a human embryo created by any cloning technology in a womb, known as reproductive cloning, or any other treatment of a human embryo intended to result in its development into a viable infant, should be prohibited. There are strong public policy reasons for this position. These include: (a) the view that human reproductive cloning goes against moral ideas that holds that a human being is not to be treated as a means to an end, but only as an end. This translates into the fear that a whole human being may be brought into existence for a utilitarian purpose; (b) that the social and legal implications of reproductive cloning are very serious, including issues of identity and responsibility; and (c) the fear that it will result in a reduction in biodiversity."

Following the BAC report, the Human Cloning and Other Prohibited Practices Act and as such, reproductive cloning of human beings will not be allowed under any circumstances.

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