Stem Cell Research and EU Patent Law – Round peg, square hole?

The pace at which science evolves is staggering. Biotechnology is a perfect example of the leaps that science takes – 100 years ago, we would have struggled to know what a stem cell was! But can EU patent law keep up, Laura Mole and Paul Gershlick explore.

The evolution of law and science

The European Patent Convention (the "Convention") was brought into force to try and harmonise patent law in Europe. But whilst the Convention was a valiant attempt, it failed to consider the pace at which biotechnology was evolving. In an attempt to bottle the gap that biotech had opened in the law, the Biotechnology Directive 1998 (the "Directive") was approved. The Directive sought to deal with these more advanced areas of science. One of the key aims of the Directive was to encourage biotechnology through patentability.

"One of the key aims of the Directive was to encourage biotechnology through patentability."

Human embryos

Article 6(2)(c) of the Directive excludes patentability for inventions which use human embryos for industrial or commercial purposes. This presented a particular problem for up and coming stem cell research which used embryogenesis. With no definition of "human embryo" to guide those in charge of interpreting the Directive, stem cell patents were (for the most part) approved. But, as stem cell research evolved, it was not long before the interpretation was challenged by the case of Brüstle v Greenpeace.

Brüstle had been granted a patent for isolated and purified neural progenitor cells established through human embryonic stem cells. Greenpeace challenged the patent, arguing that the research could not be patented under Article 6(2)(c). The case was referred to the European Court of Justice ("ECJ"). The ECJ decided that not only was any fertilised human ovum incapable of patentability, so was any unfertilised ovum in which the artificial process of cell division had commenced the process of development into a human being.

An end to embryonic stem cell patents?

The Brüstle case was, to some, an ignorant judgment. Had one of the key purposes of the Directive been forgotten - to effectively harmonise protection of biotech inventions in the EU to encourage investment in biotechnology? To prevent a form of research which had the potential to change lives being patented seemed like a step backwards.

Would anything change?

Enter the International Stem Cell Corporation ("ISCC") v Comptroller General of Patents case. ISCC applied for two UK patents for stem cell research concerning the creation of synthetic cornea from retinal stem cells. The UK Patent Office rejected the patents based on the ruling in Brüstle – you could not patent anything which was capable of commencing the process of development of a human being.

"The Brüstle case was, to some, an ignorant judgment."

ISCC argued that their patents were different. The research they sought to patent used pluripotent stem cells isolated from parthenotes derived through the process of "parthenogenesis". These parthenotes were incapable of development into a human being – the exclusion to patentability in Brüstle did not therefore apply to this particular type of parthenotes.

The judge found himself in difficulty. Was the definition of a "human embryo", and exclusion to patentability, limited to a process which commenced the development of a human being? The question was referred to the ECJ.

Potential

There is little argument over the potential stem cells could bring to the treatment of human illness. The judge mentioned this in the ISCC case when he said, "Stem cells have the potential to revolutionise the treatment of human disease. Because of their capacity to differentiate into almost any type of adult cell, human stem cells open the door to a wide variety of new therapies and other medical applications. For instance, cardiac muscles could be used to alleviate ischaemic heart disease, pancreatic islet cells for treatment of diabetes, liver cells for hepatitis and neural cells for degenerative brain diseases such as Parkinson's. Other potential applications include the treatment of burns, eye disease, spinal cord injuries and certain forms of cancer."

Why is a bar to patentability a problem?

The answer is simple. The commercial case is often that no patent means no investment and without investment there can be no research. Clinical trials are a good example of costly research which requires heavy investment. Pharmaceutical and life sciences companies recoup this expenditure through patents.

"If academics cannot patent stem cell research in Europe, the research (and the benefit) will simply go elsewhere."

If academics cannot patent stem cell research in Europe, the research (and the benefit) will simply go elsewhere. America and Asia are pioneers in stem cell technology. Just like big pharma companies are looking with a less favourable eye on India due to the recent patent case involving Novartis' Glivec drug, so will funders look at Europe less favourably due to Brüstle.

Be proactive

What can be done?

• Write to your national patent office and petition them to find in favour of patentability for parthenogenesis based pluripotent stem cell research.

• Keep making applications for pluripotent stem cell patents. If the ECJ does find in favour of patentability, you will want to ensure your patent is at the front of the queue.

• Contact your local industry body and see if they want to join in your petition or start their own.

Summary

The ISCC case has the potential to re-open patentability to stem cell research. The judge left us in no doubt how an English court would have interpreted the Directive. He stated, "I agree with ISCC that if the process of development is incapable of leading to a human being...then it should not be excluded from patentability."

"...but science is allowed to evolve and develop in Europe for the benefit of us all."

This new case presents the ECJ with a chance to enable innovation, and the jobs it brings, to take place in Europe. But, this is not just about European industry; it is also about public health and, most of all, its potential.

The Directive was to encourage and facilitate the development of biotechnology in Europe through patentability. So let it do that. Let the exclusion do what it was meant to do. Protect that fundamental line in the sand, where the integrity of human life is protected, but science is allowed to evolve and develop in Europe for the benefit of us all.