Japanese scientists report they have, for the first time, grown mammalian eggs from stem cells and that these artificially created eggs were used to produce healthy offsprings. This advancement is being called the beginning of the end of the long search for the holy-grail of reproductive biology.
What Are Stem Cells?
All stem cells have two important characteristics:
1) They are undifferentiated cells that are capable of renewing themselves, seemingly indefinitely, through cell division, sometimes even after long periods of inactivity.
2) Under certain conditions, these undifferentiated cells can be induced to become tissue – or organ-specific cells with special functions.
Because early stem cell lines were derived from embryos, stem cell research has been mired in controversy causing many states to pass laws specifying what can and cannot be done.
Unlike embryonic stem cells, Induced Pluripotent Stem Cells (IPSCs) are not derived from pre-implantation embryos but are instead derived from certain adult cells that have been re-programmed to assume a stem-cell like state.
Proponents of stem cell research have argued that because of the stem cell's unique regenerative abilities, stem cells offer potentially new methods for treating diseases such as diabetes and heart disease. In light of Thursday’s announcement, many in the scientific community are now saying that infertility can be added to the list.
What Was Achieved?
According to the research paper published in Science, a team of scientists led by Dr. Mitinori Saito created viable mouse eggs in vitro using both embryonic and IPSC cell lines. The viability of these eggs was demonstrated by in vitro fertilization with natural mouse sperm to create healthy, fertile offspring. The details of the research methodology can be reviewed here.
This achievement comes only a year after the same core group of scientists announced that they were able to create mice sperm from stem cells to generate healthy, fertile offspring.
This recent development is being touted as the end of the long-sought holy grail in reproductive biology: to make sperm and eggs in a laboratory dish.
What Was Not Achieved?
It remains to be seen (1) whether Saito’s artificially created mouse sperm can be used to fertilize these artificially created egg cells to produce healthy, fertile offspring and (2) whether this result can be replicated in other mammals, such as humans.
However the implicit possibilities of this work are startling. Based on this study, it is conceivable that researchers may one day be able to create genetic human offspring from the DNA of otherwise infertile couples including same-sexed partners and even deceased individuals.
The Canadian Scramble: Oncomouse v Monsanto
S2 of the Patent Act states that a patent must disclose a “new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”.
While no patent application has yet been filed, this discovery nonetheless raises some interesting questions as to the Canadian patentability of the subject matter disclosed by Saito et al.
On one hand, we have the Supreme Court’s decision in Harvard College v Canada (Commissioner of Patents) (2002 SCC 76) which states that higher life forms are not patentable subject matter; on the other, we have the SCC’s decision in Schmeiser et al v Monsanto (2004 SCC 34) which effectively extended the valid exclusionary rights for a gene and a cell to the actual seed and plants derived from that gene and cell.
Moreover, the majority in Monsanto (para 23) and both the majority (para 162) and the minority (para 3) in Harvard, conceded that a genetically altered egg cell would be patentable because it is “a substance or preparation formed by combination or mixture of various ingredients” thus satisfying s2 of the Patent Act.
But if Saito and his team were to file a patent application for the genes that produced their ground-breaking oocyte cells in Ottawa next month -- how would Canadian law rule on the validity of this request? At what point would the genetically altered egg rise from a mere “preparation formed by combination or mixture of various ingredients” to a “higher life form”? Would the SCC still side-step the question of whether or not patent protection for a gene “extends to activities involving the organism that results from that gene” (para 24)?
Areas for Further Legal Research
Several papers on the patentability of biomedical technology have been featured on this blog including this examination of the state of gene patenting in Canada by Thomas Kurys. Kurys recommended that the Patent Act be amended to include (1) a provision that grants Parliament the power to award compulsory licensing to a third party who can demonstrate an overriding public need to a government administrative body and (2) a research exemption for genetic patents in medical technology. One wonders how his analysis might be applied to this latest development in reproductive biology.
Beatrice Sze is a JD Candidate at Osgoode Hall Law School.