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Latest ECJ Stem Cell Ruling Strips Security from Researchers Dr David Martin, Mathys & Squire LLP
In October 2011 the Court of Justice of the EU (ECJ) issued a new ruling meaning that human embryonic stem cell-related inventions are deemed to be no longer patentable in EU Member States. Without adequate patent protection scientists and researchers in the biotech industry will have less incentive to invest time in stem cell research with far reaching implications on their work in Europe.
In making its ruling the ECJ has taken a broad interpretation of the term ‘human embryo’ (EU Directive 98/44/EC – 6 July 1998) to include any cell that is able to commence the process of development of a human being. The ECJ’s interpretation of ‘human embryo’ includes all unfertilised cells that contain a transplanted mature human cell nucleus such that division and development may be stimulated by parthenogenesis.
Accordingly, EU Member States will now be required to refuse patent protection for inventions that benefit in any way from the destruction of a human embryo on the grounds that said destruction is ‘contrary to public order or morality’. The ruling would appear to extend existing patent exclusions to include human embryonic stem cell lines and even donated cell bank material. Whilst decisions of the ECJ are not binding on the European Patent Office (EPO), I would expect the EPO to use this ruling as the basis of an internal practice policy so that, going forward, the EPO’s current and somewhat varied interpretation of ‘human embryo’ will become more harmonised and in line with the ECJ ruling.
The decision, issued on 18th October 2011, follows a case originally filed by Greenpeace against Professor Oliver Brüstle, a neuropathologist and expert in stem cell research from the University of Bonn, Germany, who was awarded a patent in 1999 relating to neural precursor cells used to treat neurological diseases such as Parkinson’s.
In recent years we have seen considerable investment in developing embryonic stem cell-based therapies in Europe. Understandably the ECJ decision has left the scientific community in dismay while threatening to drive a crucial area of research overseas as researchers and companies seek to protect their investments.
Investment often represents many years of research to bring an invention to market. In the case of stem cell research, because much work is needed to move from the laboratory to clinical application, that investment is even greater. And, even once researchers make that all important breakthrough, being a medical application, they still have to overcome the hurdles of testing, patient trials and ultimately licensing for use in humans – all of which require enormous resources of time and money.
Researchers need to have the security that, at the end of all this, their efforts are going to be rewarded and that they will recoup the costs of developing and commercialising the new medical treatment. Patents play an essential role in protecting inventions from unlimited use by competitors, who could potentially reap the rewards without spending a penny on research and development. Inadequate patent protection will therefore dramatically reduce the incentive that scientists and researchers have to invest in a crucial area of medical research.
It is important to note that the ruling is limited to embryonic stem cells that necessarily cause the destruction of a human embryo. As it stands, patent protection is not excluded for non-embryonic stem cells, such as induced pluripotent stem cells (iPS cells) and other adult stem cells, though more research is needed to demonstrate their clinical utility. Nonetheless, I fear that the ECJ’s ruling could drive research away from Europe, to parts of the world where there is a more permissive approach to what can and cannot be patented. This will not only mean we lose the economic benefits of this vital work from our shores, but could create a ‘brain drain’ as the most talented scientific minds in the field take their work elsewhere. At a time when Europe’s economies are stumbling, and we are told that innovation, entrepreneurship and the ‘knowledge economy’ is vital to our future, the decision to limit protection for medical R&D gives a distinct advantage to our global competitors.
Yes, there are emotional, ethical and moral concerns associated with patenting and commercialising materials derived from human embryos. But in reaching this decision, EU institutions have gone against the advice of patent experts across Europe who have recommended a more fluid position. The research community is likely to feel its impact for many years to come.
The biotechnology sector relies heavily on patents and intellectual property rights. As in any research-based industry, the protection of research is a significant challenge.
Questions & What is a patent?
A patent is an exclusive right granted for an invention that is a process or a product that provides a new way of doing something, or offers a new solution to a problem. Patents have a maximum life span of twenty years. It provides its holder, for a limited period, the right to exclude others from making, using or selling the patented invention except with the consent of the patentee. A key issue in biotech firms is what type of inventions can be patented, without doubt biotechnology presents new challenges to the patent system – as shown in this ECJ Ruling and different countries will take different approaches.
What do the terms ‘patent pending’ and ‘patent applied for’ mean?
They are used by a manufacturer or seller of an article to inform the public that an application for a patent for that item has been made. It is against the law to use the term falsely to deceive the public.
What are the advantages of applying for a European/PCT patent?
The main advantage of the European Patent is that it allows the applicant to obtain patent rights in one or more of the European Patent Contracting (EPC) states by making a single application. This may be considerably cheaper than making a separate application in each EPC member state.
When should I apply?
As long as the invention is a secret and not disclosed to the public, you can apply at any time. It is up to you to decide the best time to apply. However, professional advice from a patent attorney would help you understand the risks and implications of filing too early or too late (risking someone else might have the same idea and file an application before you).
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