Reshaping Bio-patents: Measures to Restore Trust in the Patent System

Abstract

Recent events have convincingly shown that public opinion is very sensitive to possible unfair use of the patent system in the field of genetic inventions. Witness the strong reactions evoked by the grant of three patents covering the breast cancer gene, its mutations and the diagnostic and therapeutic applications based on the gene’s sequence by the European Patent Organization and by the restrictive license policy of the patent holder Myriad Genetics.The first part of this paper will analyze the objections which have been put forward against the patenting of biological material over the years. Initially, objections to deny biological material patent protection mainly related to the specific nature of living organisms, the lack of novelty, inventive step or industrial applicability, the impossibility of description and the non-reproducibility of the method of making. However, in recent years, new objections have been raised against bio-patents and a clash between patents and social and ethical concerns appears to have materialized.The second part will examine measures and tools which might help to remove the public reserve with regard to the current use of bio-patents. Instruments that will be examined are the toughening of patent standards, the implementation of an origin and informed consent requirement, a renewed look at the scope of protection, the monitoring of patent proprietor’s licensing practices and the creation of patent pools and of compulsory licences for public health. We claim that such tools, either internal or external to patent law, should be used in order to reduce the negative social impact and to restore trust in the patent system.