Legal Problems Raised by Patents on Human Stem Cell-Based Inventions
A non-expert audience may be surprised by the mere idea that inventions based on human stem cells can be patented. But the starting point is clearly that living material is patentable. Both US law, especially since the Supreme Court’s decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and EU law, where article 5(2) of Directive 98/44 on the legal protection of biotechnological inventions,  OJ L213/13, reads ‘An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element’, have adopted this starting point quite a while ago. The fact that there is no exclusion in principle for living material does however not mean that any living material can be patentable in any circumstances.
This contribution looks therefore at how the conditions for patentability apply to human stem cell based inventions and in a second stage it considers the application of the morality clause to them.
In order for an invention based on human stem cells to be patentable the inventions needs to satisfy the requirements of novelty, inventive step and capability of industrial application. Novelty is always an issue when the invention is based on existing (human stem) cells, but the issue can be overcome if certain conditions are met. Inventive step similarly raises issues, but issues that can be overcome. Real issues arise in relation to the requirement of capability of industrial application. This requirement is traditionally somewhat undervalued, but potentially it can be crucial in an area such as patents for human stem cell-related inventions. In the United Kingdom, this potential was recently demonstrated in Eli Lilly and Company v. Human Genome Sciences, Inc, (2008) R.P.C. 29.
And then finally attention turns to the thorny issue of the application of the morality clause in this area. The current approach is seen as unsatisfactory and an alternative approach is put forward.
KeywordsStem cell Inventions Legal Morality exception Patentability
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