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This discussion paper, prepared by an international group of experts, proposes and ethical framework for gene patenting with recommendations aimed at policy-makers, courts, patent lawyers and patent offices.
The remarkable development and application of new genetic technologies over the past 25 years has been accompanied by profound changes in the way in which research is commercialised in the life sciences. Many thousands of patents which assert rights over DNA sequences have been granted to researchers across the public and private sector.
In general, we acknowledge the benefits that have accrued to society from the patent system, but we ask whether the application of the patent system to DNA sequences is achieving its goals, namely the stimulation of innovation for the public good, and the rewarding of people for useful new inventions.
We note that many patents that assert rights over DNA sequences have already been granted but are of doubtful validity. The effects of many of these patents are extensive, because inventors who assert rights over DNA sequences obtain protection on all uses of the sequences.
In the future, the granting of patents that assert rights over DNA sequences should become the exception rather than the norm. The patent system currently regards DNA sequences as eligible for patenting. However, as computational techniques replace cloning as the main route to identifying genes, we consider that the issue of the eligibility for patenting of DNA sequences needs to be reopened.
Even if DNA sequences are considered eligible for patenting, they must then satisfy the criteria of being novel, inventive and useful. We consider that the application of these criteria to DNA sequences has not been sufficiently stringent. We note, further, that the fact that DNA sequences are essentially just genetic information distinguishes them from other chemical compounds, with regard to the patent system.