Invention and the Human Embryo

Directive 98/44/EC on the legal protection of biotechnological inventions, implemented by the EPC 2000, provides that uses of human embryos for industrial or commercial purposes shall be considered unpatentable. Patent law must be applied to respect morality and fundamental principles recognized in EU law safeguarding dignity and integrity of the person. In contrast, the embryo’s “special status” acknowledged by the scientific community does not accord it any protection on the basis of human dignity. Instead, the widely accepted 14-day rule, triggered by entry into a stage of canonical embryogenesis, sits within the regulatory framework to provide what is generally considered an acceptable level of respect for human embryos.

My central theme is that the law cannot rationally prohibit from patentability all uses of preimplantation embryos in innovation and permit as well as fund embryonic stem cell research that “uses” embryos and permit methods of assisted reproduction to be conducted commercially that discriminate between human embryos, leading to their deprioritisation and/or destruction. That the industrial fertility sector provides the largest source of human embryos used in stem cell research serves to emphasise the irrationality.

The prohibition against inventions involving use of human embryos is out of kilter with the regulation of stem cell research, the trajectory of stem cell science and its translation into new health care technologies for the clinical setting. On the basis that it is legitimate to incorporate extra-legal ethical principles into patent law, I argue for an interpretation of the exclusion that incorporates the 14-day rule to strike a finer balance between investor and society interests presently skewed by according full moral status to the preimplantation embryo bestowed by the convenient language of dignity.