EPO Rejects Patent for Manipulating Embryonic Stem Cells

The European Patent Office (EPO) has refused to grant a patent claim covering the manipulation of embryonic stem cells.

Claim 1, the claim under examination, reads:

A cell culture comprising primate embryonic stem cells which

(i) are capable of proliferation in vitro culture for over one year,

(ii) maintain a karyotype in which all chromosomes normally characteristic of the primate species are present and are not noticeably altered through culture for over one year,

(iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and

(iv) are prevented from differentiating when cultured on a fibroblast feeder layer.

Rule 28 of the European Patent Convention (EPC) prohibits the granting of a patent relating to: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; and (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

Here, the patent claim requires the destruction of human embryos. The EPC held that the use of human embryos for industrial or commercial purposes are excluded from patentability, while inventions for therapeutic or diagnostic purposes applied to the human embryo and useful to it is patentable.

Although the claim was not allowed, the EPC stated that this ruling does not relate to the patentability in general of inventions relating to human stem cells or human stem cells cultures. Instead this decisions holds unpatentable inventions concerning products (here: human stem cell cultures) which can only be obtained by destroying human embryos.

This decision is in direct contrast to American patent law which would likely allow such patent claims.