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Methods of human cloning, generation of human embryos and human stem cell lines

8.192 The prohibition of human reproductive cloning was codified into law as the Human Cloning and Other Prohibited Practices Act (HCOPPA) in Singapore as it is almost unanimous from the international community, local scientific and religious groups as well as our general public that reproductive cloning of human beings is abhorrent and should not be allowed under any circumstances. Therefore objections under Section 13(2) should be made over such inventions.

8.193 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 cloningtechnology in a womb, known as reproductive cloning, or any other treatment  ofa 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.”

8.194 Following the BAC report, the HCOPPA was enacted and it came into force in Singapore on 1st October 2004. In the Second Reading of the Bill as it then was, the Senior Minister of State & Health (Dr Balaji Sadasivan) said that:

“There will be no unanimous view on this subject and my Ministry recognises and respects the diversity of views. But in the area of human reproductive cloning, there is almost unanimous agreement from the international community, local scientific and religious groups as well as our general public that reproductive cloning of human beings is abhorrent and should not be allowed under any circumstances.”

8.195 When dealing with applications involving human embryos and cloning, Examiners should consider raising a Section 13(2) objection when the invention encompasses performance of an act that is one of the “Prohibited Practices” in Part III of the HCOPPA.

8.196 Acts that are prohibited by the HCOPPA include:

(i) placing a human embryo clone in the body of a human or the body of an animal even if the human embryo clone did not survive or could not have survived;
(ii) development of any human embryo that is created by a process other than fertilisation of a human egg by human sperm, for a period of more than 14 days (excluding any period when the development of the embryo is suspended);
(iii) development of any human embryo outside the body of a woman for a period of more than 14 days (excluding any period when the development of the embryo is suspended);
(iv) removal of any human embryo from the body of a woman for the purpose of collecting a viable human embryo;
(v) placing any human embryo in a non-human animal;
(vi) placing any human embryo in the body of a human other than in a woman’s reproductive tract;
(vii) placing any animal embryo in the body of a human for any period of gestation;
(viii) placing any prohibited embryo in the body of a woman;
(ix) the import into Singapore or export out of Singapore of any prohibited embryos; and (x) commercial trading in human eggs, human sperm and human embryos.

A prohibited embryo as defined in Section 2(1) of the HCOPPA, includes among others, any human embryo that has been developing outside the body of a woman for a period of more than 14 days (excluding any period when the development of the embryo is suspended) and any human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo.

8.197 Generally, methods of generating human embryonic stem cell lines from human blastocysts will not be objected under Section 13(2) since human blastocystsare less  than 14 days old post fertilization. Methods of producing human stem cell lines from adult tissues are normally also allowed. The patenting of parthenote derived human embryonic stem cell lines was recently considered by the Australian Patent Office (International Stem Cell Corporation [2016] APO52) and the European Court of Justice (International Stem Cell Corporation v Comptroller General of Patents, Designs and Trademarks [2014], C-364/13), and the decision was a blastocyst formed via parthenogenic activation of an unfertilized human oocyte cannot develop into a human being, and therefore are also allowable. Accordingly, such inventions will likely not attract a Section 13(2) objection in Singapore. However, Examiners should still consider the facts of the case when examining such inventions.

8.198 The Human Biomedical Research Act (HBRA) 2015 prohibits certain kinds of human biomedical research activities as a result of ethics concerns. Examiners should consider raising a Section 13(2) objection when the invention fall within “Prohibited human biomedical research” in Section 30 and the Third Schedule of the HBRA.

8.199 The Third Schedule of the HBRA prohibits:

(i) human biomedical research involving the development of particular types of human-animal combination embryos beyond 14 days or the appearance of the primitive streak, whichever is earlier (these particular types are cytoplasmic hybrid embryos; human-animal combination embryos created by the incorporation of human stem cells including induced pluripotent stem cells; and human animal combination embryos created in vitro by using human gametes and animal gametes; or one human pronucleus and one animal pronucleus);
(ii) human biomedical research involving the implantation of any human-animal combination embryo into the uterus of an animal or a human;
(iii) human biomedical research involving the introduction of human stem cells (including induced pluripotent stem cells) or human neural cells into the brains of living great apes (whether prenatal or postnatal); and
(iv) human biomedical research involving the breeding of animals which have had any kind of pluripotent stem cells (including induced pluripotent stem cells) introduced into them.

There are strong ethics reasons for prohibiting such research and therefore, when Examiners encounter applications involving any of the above prohibited research, he should discuss the application with a Senior Examiner and generally consider raising a Section 13(2) objection.

8.200 In addition, any claim which encompasses a human would be objected to under Section 13(2). This is consistent with the patent practice in other major jurisdictions.