Genetically modified organisms

8.201 Inventions relating to transgenic plants and transgenic non human animals generally do not raise ethics alarms in Singapore. As acknowledged in paragraph 14 of the Bioethics Advisory Committee’s (BAC) Consultation Paper on Human Animal Combinations for Biomedical Research:

“… 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.”

8.202 This appears to be the case even if the genome of such transgenic non-human animals contains human genes. The Bioethics Advisory Committee’s Ethics Guidelines for Human Biomedical Research (June 2015) stated that:

“Transgenic animals are animals in which the genome has been modified to include human genes. They have been widely used in laboratory research into the understanding and treatment of diseases for many years. In its Human-Animal Combinations Report and in preparing these Guidelines, the BAC has not explicitly considered transgenic animals but insofar as these Guidelines are relevant they should apply. However, to the extent that research involves the use of transgenic mice or other small mammals in laboratory conditions, and subject to observance of provisions for laboratory animal welfare, the BAC does not foresee any ethical difficulty in the continued use of such animals.”

8.203 Therefore, in the absence of laws prohibiting the creation of such transgenic nonhuman animals coupled with the scientific and medical benefits arising from such research involving the use of these transgenic non-human animals, mere offence to a section of the public, in the sense that that section of the public considers such inventions distasteful, is not enough for Section 13(2) to apply. Section 13(2) will apply only if the general public would regard the grant of patent rights for such inventions as abhorrent.

8.204 In contrast to the ethics position on the germline genetic modification of non-human animals, the position is less clear with regards to germline genetic modification of humans. There have been recent international delilberations on germline editing of genes in humans for the treatment of serious genetic diseases. In the Ethics Guidelines for Human Biomedical Research (June 2015), it was acknowledged that such germline genetic interventions are still at the experimental stage and there is insufficient knowledge to assess the potential long term consequences of such interventions. Accordingly, when the invention encompasses germline genetic modification of humans, the case should be discussed with a Senior Examiner.

8.205 Inventions relating to genetic manipulations that can cause public safety concerns or serious environmental hazards should also be discussed with a Senior Examiner. If it is determined that publication of the invention may be prejudicial to public safety under Section 33(2) of the Patents Act, the Examiner should inform and consult Patents Registry for further advice. An objection under Section 13(2) may also be warranted in such situations.