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European Genetics Group Offers Genetic Testing Patent Recommendations

NEW YORK (GenomeWeb News) – The European Society of Human Genetics has issued a broad set of recommendations focused on making patenting laws, regulations, and practices for genetic tests in Europe clearer and more useful, ESHG said today.
The recommendations are the product of a multi-year effort and a series of workshops dating back to 2005 involving members of the ESHG’s Public and Professional Policy Committee and the Patenting and Licensing Committee. Three members of these committees — Ségolène Aymé, Gert Matthijs, and Sirpa Soini — authored a paper detailing the recommendations in the May issue of the European Journal of Human Genetics.
Patents for inventions are basically beneficial for society, if they “drive innovation and promote progress,” ESHG said. “However, 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.”
Many geneticists regard the patenting of genes as a questionable, and even unacceptable practice, because they consider the identification of a gene, a mutation, or a link between a genetic defect and disease to be a discovery and not an invention, and therefore not patentable under the European Patent Commission.
The importance of patents on genes may increase in the future as more tests become phenotype-based, or "exploring at once many potentially involved genes," the authors note in the EJHG paper. Genetic tests also may begin to combine detection of several mutations with metabolite measurements, which could make combinations of patents more common. These trends point to the potential for a more complicated patenting environment to come, in ESHG’s view.
However, the group said it is not proposing an entirely new model of genetic IP protection, but instead it is for working within the existing patenting system to find complementary mechanisms for accessing patents, such as new models for licensing.
ESHG proposed more interaction and dialogue between parties such as service providers, consumers, patent owners, and patients in order to find ways to preserve the patent systems without damaging the quality of care.
There is a need for a balance set by legislators that provides a framework for researchers to be rewarded for their inventions without preventing access to genetic tests for patients, ESHG said.
Many genetic claims that have been granted are too broad, ESHG argued, and these have a negative impact on the development of new innovations. In the future, European regulators should use a scientific advisory committee to assess the scope of genetic patent claims, the group suggested.
The ESHG also proposed reducing the number of patents by prohibiting the patenting of individual mutations in known disease genes and perhaps by considering that establishing a link between a disease and a genetic sequence is merely a discovery, and therefore is not patentable.
Because the US Patent and Trademark Office is “more liberal” in its patenting policy than European and Japanese offices, the ESHG said it endorses efforts of the Trilateral Organization to harmonize the varying approaches. The European Patenting Organization also should reduce its backlog of patents under review, which can cause confusion and other problems, by narrowing the scope of gene patentability, said ESHG. 
The ethical aspects of genetic patenting also should be considered, particularly as attorneys, patent applicants, and patentees sometimes “push the ethical limits of patentability,” ESHG said.
In another recommendation, ESHG said there should be some way to address moral issues currently not addressed under the EPC, and there may be value in establishing an ethics committee to consider issues of major interest.
The EPO also should promote access to information on patents and applications, particularly through the Patent DNA set of the EMBL nucleotide sequence database, ESHG said. 
ESHG also found it is necessary to “define the scope of the research exemption more explicitly,” and it advised genetic labs not to rely on this exemption when offering diagnostic testing.
In addition, ESHG said that the licensing system should be made more efficient in order to encourage scientists to pursue research in different areas and to encourage users to seek new licenses and pay royalties. Licensing costs also should be made more transparent, ESHG argued, with licensing agreements made public.
Because normal market mechanisms do not operate the same way in the genetic testing field, there should be licensing guidelines that do not give the licensor exclusive control over human genetic information, the group said. It also urged the genetic community to “respect the patenting and licensing rules,” once they are accepted, and the group said that research institutes and hospitals should know how to handle licenses and patents.
Models for compulsory licenses that have been adapted in some countries should be adapted by others and made consistent with their system. Alternative licensing models such as patent pools and clearinghouses also should be tested to help overcome intellectual property problems and increase access to genetic tests and new technologies, ESHG said.
“The patenting and licensing system will be more easily accepted by the majority of geneticists and by the public, when the specific sensitivities around genetic testing, and of medicine and health care in general, are taken into account in the light of increasing (and increasingly powerful) diagnostic possibilities coming online,” ESHG concluded.

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