Analysis: EU patent ruling threatens global stem cell research
In a recent decision, the European Union Court of Justice, sitting in Grand Chamber, has ruled on three questions concerning interpretation of Article 6(2)(c) of EU Directive 98/44/EC on legal protection of biotechnological inventions:
1) What is meant by the term “human embryos”?
2) Does “industrial or commercial purposes” include any form of commercial exploitation (in particular, scientific research)?
3) Is an invention that does not teach the use of human embryos unpatentable if it uses a product or process (e.g., embryonic stem cells) whose production necessitates the prior destruction of human embryos?
Combining the answers to these questions showes that the Court ruled that any process or product that at any stage involves removing a totipotent stem cell from an embryo and thereafter destroying the embryo cannot receive patent protection.
The court’s decision inspired the frustrated inventor of the patent at issue, to say:
"It means that fundamental research can take place in Europe, but that developments that follow from that cannot be implemented in Europe. It means European researchers can prepare these things but others will pick the fruits in the U.S. or Asia."
The problem facing medical research and thus the future of our health care is that research, development, and market introduction of genetic therapies are considered too expensive to attract corporate investment in the absence of effective IP protection. The main international accord on patent rights is the TRIPS agreement (Trade-Related aspects of Intellectual Property Rights), which actually controls international trade, but has resulted in considerable harmonization of patent laws among the countries signatory to the World Trade Organization.
TRIPS requires that patents that are valid and enforceable in one WTO country are valid and enforceable in any other WTO country, save for a few exceptions. One of these exceptions is that inventions which are contrary to “ordre public” (public policy) or morality may be excluded from patent protection.
This presents the difficulty that morality and “ordre public” varies between nations and supranational groups like the EU. Now that the EU Court of Justice has ruled that inventions requiring or based on embryonic stem cells are against public policy in the EU, US and other patents which protect stem cell therapies based on embryonic stem cell lines are no longer enforceable in the EU.
Let’s look at the consequences. The patent application at issue was filed in Germany, where the Embryonenschutzgesetz (Embryo Protection Act) defines and controls illegal uses of a human embryo. However, in concentrating on what is illegal rather than on what is legal, Germany appears to have allowed genetic therapies which are based upon pluripotent stem cells. These are the descendants of totipotent stem cells (which may not be used in Germany, as they have the potential to develop into an individual), but have essentially all the therapeutic capacity of totipotent cells.
As a result, we are faced with a curious antinomy. Germany allows the use of pluripotent stem cells for genetic therapy, but the EU allows no aspect of such therapies to receive patent protection. It appears that patents issued by other countries will not be enforced, given the TRIPS bows to local morals. Given the reluctance to invest in genetic therapies without IP protection, Germany will not be able to develop a vertically integrated genetic therapy capability, which is not good.
Worse, perhaps, is that medical doctors in Germany will be able to practice genetic therapy unrestricted by non-EU patents and licensing arrangements. This raises the prospect that, e.g., embryo-based US genetic therapies protected by US patents will not protected anywhere in Europe. For that matter, if a process is developed to regress an adult stem cell to the totipotent stage, it will also lack IP protection in Europe.
One can imagine a situation where going to Europe and receiving an unprotected course of genetic therapy could be much less expensive than receiving such treatment in the US! In effect, then, this decision by the EU Court of Justice significantly reduces patent protection on genetic therapies developed in non-EU countries – not only within the EU, but worldwide.
Given this position, will non-EU companies feel that investment in such therapies is economically sound? I believe there will be a move away from R&D on genetic therapies which present any risk of losing IP protection. In the long run, alternate therapies will probably emerge to take the place of embryonic stem cells. In the interim, however, I, among many others, could face health dangers without being able to reach out for the hope of effective genetic therapies. This seems a non-optimal solution to the moral challenges facing society.