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ESHG Issues Gene Patenting Guidelines


The European Society of Human Genetics issued recommendations in late April that would continue to allow genetic researchers to patent their innovations, including genetic tests, while at the same time ensuring that those innovations do not restrict a patient's ability to access such tests.

The ESHG, recognizing that genetics introduces a new set of ethical challenges for the existing patenting system, suggested in its guidelines that geneticists and governments work together to use new mechanisms within the existing framework to reward innovation without restricting patient access.

The ESHG's recommendations include establishing an ethics committee to assess the scope of patents and limit the granting of broad patents; more interaction among US, EU, and Japanese patent authorities to align their patent systems; prohibiting patents for disease genes; and promoting new models for licensing to promote research.

"The argument that a cDNA does not exist in nature, and thus makes its sequence patentable, is often viewed as a legal twist that does not convince most geneticists," wrote Ségolène Aymé, Gert Matthijs, and Sirpa Soini, members of ESHG's Public and Professional Policy Committee and the Patenting and Licensing Committee, in a paper published in the May issue of the European Journal of Human Genetics.

Although in most areas the "patenting system works satisfactorily," genetics clearly introduces new ethical considerations. Thus, "it must be recognized that in some instances patents can also be problematic; this is the case in the field of genetics, and particularly in the area of genetic testing," the authors assert.

Under the European Patent Commission, DNA, RNA, genes, and other components of the human genome are patentable. The European Patent Office allows innovators to patent DNA sequences if "the specification must enable the invention to be performed to the full extent of the monopoly claimed."

Turna Ray

PGx & Molecular Dx Notes

Agendia announced plans to deepen its relationship with Agilent by codeveloping new in vitro diagnostics in the area of cancer. According to the terms of the deal, Agilent will supply Agendia's products on microarrays through 2011. Agilent has been manufacturing the components for Agendia's assays since 2003.

Compugen says it has discovered and tested a potential blood-based small-cell lung cancer biomarker that it has named CGEN-438, a splice variant of the delta-like protein 3 precursor, DLL3. CGEN-438 is reportedly secreted into the bloodstream.

Since its clinical trials met their primary endpoints, Third Wave Technologies submitted applications to the US Food and Drug Administration for clearance of two molecular tests for human papillomavirus.s


$10 million
Amount NIH will fund for studies relating genetic variations to biological mechanisms or disease causality.

Funded Grants

Metabolomics Network for Drug Response Phenotype
Grantee: Rima Kaddurah-Daouk, Duke University
Began: Dec. 14, 2006; Ends: Nov. 30, 2010

The team is looking to integrate metabolomics and pharmacogenomics "to achieve a deeper understanding of the drug-response phenotype and to accelerate the establishment of genotype-phenotype correlations for drug response," according to the abstract. The scientists contend that adding metabolomic data will enhance prediction of individual variation in response to treatments.

Selectable Biomarkers for Pathogenic Burkholderia
Grantee: William Hickey, University of Wisconsin, Madison
Began: Jul. 1, 2007; Ends: Jun. 30, 2009

Hickey and his group will use these funds to determine whether cyanuric acid amidohydroase can be used as a biomarker for human pathogens in the Burkholderia family. Having a biomarker to identify the pathogenic forms of this organism would enable other molecular genetics approaches to understanding it, the scientists say.

The Scan

Study Links Genetic Risk for ADHD With Alzheimer's Disease

A higher polygenic risk score for attention-deficit/hyperactivity disorder is also linked to cognitive decline and Alzheimer's disease, a new study in Molecular Psychiatry finds.

Study Offers Insights Into Role of Structural Variants in Cancer

A new study in Nature using cell lines shows that structural variants can enable oncogene activation.

Computer Model Uses Genetics, Health Data to Predict Mental Disorders

A new model in JAMA Psychiatry finds combining genetic and health record data can predict a mental disorder diagnosis before one is made clinically.

Study Tracks Off-Target Gene Edits Linked to Epigenetic Features

Using machine learning, researchers characterize in BMC Genomics the potential off-target effects of 19 computed or experimentally determined epigenetic features during CRISPR-Cas9 editing.