European geneticists call for ban on DNA patents
Brussels – To ensure that new genetic tests become available to patients, European human geneticists have called for a ban on patents covering disease genes and related SNPs. Additionally, the group under Prof. Gert Matthijs (Univ. Leuven, Belgium) from the European Society of Human Genetics (ESHG) recommended that EU policymakers should establish binding guidelines for licensing patented DNA, RNA and cDNA sequences to prevent licensors from acquiring “exclusive control over human genetic information”. At the end of April, the scientists issued a broad set of recommendations focused on reshaping EU patenting law to prevent monopolies that hamper the development of innovative genetic tests (Eur. J. Human Gen. 16, 405-411). The geneticists now want to lobby for these claims at the Patent Office, the European Parliament and the European Commission in order to stimulate the incorporation of the recommendations into existing patent legislation.
Multiplex-tests will require costly licenses
The move is driven by the fact that phenotype-based testing, which looks at a huge set of DNA sequences simultaneously, will become widespread in the near future, and would require multiple and costly licences. Overly-broad patents that cover cDNA sequences and the proteins encoded by them could hamper innovation, according to the 23 authors of the recommendations. “As soon as the first monopolies on genetic tests started appearing, we realised patenting had become a major issue,” said Matthijs.
The chair of the group, who has been involved in drafting the guidelines since 2005, hopes that its publication will also have a major impact on the US, where patenting genes was practiced extensively in the course of the Human Genome Project. Patenting of DNA sequences has become difficult since then, however, because the number of relevant genes is limited. Additionally, market exclusivity is a prerequisite for the huge investment needed to develop human therapeutics and diagnostics. Regulators will therefore have to strike a balance between the needs of innovative biopharmaceutical companies and researchers.