Australasian Science: Australia's authority on science since 1938

Stem Cell Research Loses European Patent Protection

By Martin Pera and Debra Yin Foo

The European Court of Justice has ruled that research involving the removal of a stem cell from a human embryo at the blastocyst stage – and therefore entailing the destruction of that embryo – cannot be patented. The ruling removes a key commercial incentive for biotechnology and pharmaceutical companies to back stem-cell research in Europe.

"The decision by the European Union Court of Justice will slow or halt the translation of advances in stem cell research into treatments for patients.

“Though the ruling does not affect Australia directly, we have to recognise that progress in this field depends on international collaboration, particularly in clinical trials. European stem cell scientists are leaders in the field, and everyone will suffer if there are barriers to such collaboration.

“Engagement of the pharmaceutical and biotechnology sectors is critical to bringing stem cell therapies to the clinic. Such engagement depends on the ability to protect intellectual property.

“Clinical trials of cell therapeutics derived from embryonic stem cells are already underway in the United States for spinal cord injury and macular degeneration, and more are on the way. These trials depend on private sector investment and technological capability. The ruling will make it very difficult to pursue similar work in Europe."

Professor Martin Pera is Program Head of Stem Cells Australia and Chair of Stem Cell Sciences at the University of Melbourne.

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"This is a disappointing decision and goes against a purpose of the patent system. The patent system rewards innovation and encourages dissemination of information by disclosure of the invention in a patent. For that disclosure, the applicant receives a period in which they can exploit the invention at the exclusion of others. This gives some certainty to a company associated with the granting of a patent.

“With limited and reduced protection of the research and discoveries surrounding an invention, companies, not only in Europe, will be discouraged from publishing their findings and inventions and hence will keep that information secret. We need to have systems that encourage the dissemination of information, particularly in the area of embryonic stem cell research. Suitable replacements for embryonic stem cells are not certain, and research in this area should be encouraged and shared.

“If there is no system to protect inventions in Europe then companies may also decide not to file in other countries, such as the US, which would otherwise disclose their inventions to the public. Once disclosed and published with no protection in Europe, others are able to commercialise the invention in Europe without reward to the patentee. There would be many negative flow-on effects for both companies and individuals.

Finally, the judgment is binding on EU member states, and the European Patent Office (EPO) is also expected to bring its practice into line with the judgment. In practice this means that the validity of any patents relating to uses of human embryonic stem cells that have already been granted in the EU can now be challenged on the ground of exclusion from patentability, although they will remain in force until such a challenge is made.

With regard to the examination of pending applications, we expect that the EPO and countries of the EU will revise their current practice in line with the judgment. Therefore, we think that chances of obtaining patent protection for pending applications are, at best, very slim.

We escaped a bullet with the gene debate and I hope that this backward approach to patenting of ES cells, especially for the new technologies, will not have the impact that we all are concerned about.”

Dr Debra Yin Foo is the Partner in charge of the Biotechnology Department at Phillips Ormonde Fitzpatrick Intellectual Property Attorneys.

Source: AusSMC