Patent decision

BL number

O/316/12

Concerning rights in

GB0621068.6 & GB0621069.4

Hearing Officer

Dr L Cullen

Decision date

16 August 2012

Person(s) or Company(s) involved

International Stem Cell Corporation

Provisions discussed

Section 76A(1), Schedule A2, PA77

Keywords

Excluded fields (refused)

Related Decisions

None

Summary

Patent applications GB0621068.6 & GB0621069.4 relate to methods where parthenogenesis is used to activate a human oocyte (i.e. stimulation of a human oocyte, without fertilisation by a sperm cell) to produce a parthenogenetically-activated oocyte or “parthenote”. GB0621068.6 concerns the production of human stem cells from such parthenotes, whilst GB0621069.4 concerns human synthetic corneas and corneal tissues derived from such parthenotes.

Stimulation of the human oocyte can be achieved using chemical or electrical parthenogenesis techniques. The stimulated human oocyte divides in a manner analogous to that of a fertilised human embryo, to produce a parthenogenetically-derived structure analogous to the blastocyst stage of normal embryonic development, from which stem cells can be obtained. These stem cells can then be used to obtain corneal tissue

The applicant argued that a parthenogenetically-stimulated human oocyte is not “capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so” because they have an inherent biological limitation that prevents those activated oocytes from developing into a viable human being. When an oocyte is caused to divide by parthenogenetic stimulation, the absence of the paternal copy of the maternally-repressed genes prevents normal development of the parthenogenetic “embryo” to term - in particular, there is no development of the placental tissue.

The hearing officer found that on the basis of the judgment in CJEU case C-34/10, Brüstle, which addressed a number of questions concerning inventions relating to human embryos and human embryonic stem cells, that a parthenogenetically-derived structure analogous to the blastocyst stage of normal embryonic development did fall within the definition of a “human embryo” for the purpose of Paragraph 3(d) of Schedule A2 of the Patents Act 1977, which implements Article 6(2)(c) of European Directive 98/44/EC on the legal protection of biotechnological inventions. A parthenogenetically-stimulated human oocyte is considered, on the basis of the Brüstle judgment to be capable of commencing the process of development even if it is not able to complete this development.

The claimed methods of producing stem cell lines and the claimed stem cell lines (GB0621068.6), and the claimed methods of producing synthetic corneas or corneal tissue and the claimed synthetic corneas or corneal tissue (GB0621069.4), were found to constitute uses of human embryos for industrial or commercial purposes, and are thus excluded from patentability under Paragraph 3(d) of Schedule A2 of the Act.