Are Human Embryonic Stem Cells now patentable in Europe?

by Simona Varani

This month, the European Court of Justice (ECJ) rendered a decision in “International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK)” that significantly modified the landscape for human embryonic stem cell (hESC) patenting.

The court decided that prohibitions against patents on hESCs only apply to cells derived from embryos that had the potential to develop into a human being. This left as patent eligible, in Europe, hESCs produced from "parthenotes", oocytes stimulated to divide and produce hESCs without fertilization.

In Europe, the debate on biotechnology patents started in the late 1980s with the aim of clarifying the distinction between what is patentable and what is not, leading to the adoption on 6 July 1998 of EU Directive 98/44/EC on the legal protection of biotechnological inventions. The directive has been implemented by all EU member states and specifically rules out patentability of the use of human embryos for industrial or commercial purposes.

In the following years, both the European Patent Office (EPO) and the European Court of Justice rendered rulings around the use and patentability of human Stem Cells which substantially agreed upon defining as unpatentable human stem cells as well as processes to isolate them which presuppose the destruction of a human embryo, irrespective of the point in time at which such destruction takes place (“Brüstle case" (C-34/10), and Article 6(2)(c) of the EU directive).

The ECJ also decided that a "totipotent" or "pluripotent" human embryonic stem cell falls within the definition of a human embryo, deciding that these cells' capacity to develop into many or all human tissues was sufficient for them to qualify as a "human embryo." Even the use of established hESC lines fell within the scope of that proscription, according to the ECJ, since the production of the claimed product (hESC) "necessitates the prior destruction of human embryos" by "the removal of a stem cell from a human embryo".

The case recently brought to media attention derives from an appeal filed by ISCO Corporation over rejection from the UK patent office of two patent applications directed as use and isolation of human Stem Cells obtained through parthenogenetic activation of oocytes.

ISCO Corporation held that under the law, hESCs were defined as "capable of commencing the process of development which leads to a human being." ISCO Corporation argued that its cells could not undergo such a development process, and isolation of such cells did not require destruction of human embryos Thus, ISCO Corporation argues that these cells should be patent eligible under the Biotechnology Directive (Directive 98/44).

The ECJ concluded that the parthenogenetic human embryos did not have that capability of commencing the process of development of a human being (being limited to development to the blastocyst stage) and thus these embryos and hESC's derived from them did not satisfy the criterion previously relied upon by the ECJ to exclude those cells from patent eligibility. In the judgment, the court states that “the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a 'human embryo', within the meaning and for the purposes of the application of Directive 98/44".

In conclusion: human Stem Cells derived from parthenogenetically activated oocytes are now patentable in Europe, whilst nothing has changed around the use of human embryos and the more traditional hESC isolation technologies.

For more on parthenogenetically activated oocytes and generation of hESC, see for instance

http://www.bedfordresearch.org/articles/deFriedF-S08.pdf

For more information and background on European biotechnology patents see

https://www.epo.org/news-issues/issues/biotechnology.html

For a more detailed rendering of the recent decision, see

http://www.patentdocs.org/2014/12/some-human-embryonic-stem-cells-are-once-again-patent-eligible-in-europe.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+PatentDocs+%28Patent+Docs%29

Image source: AGING, Vol 3, No 5 , pp 494-508