EU Limits Embryonic Stem Cell Research Patentability

EU Limits Embryonic Stem Cell Research Patentability

Grant O'Shea is a JD candidate at Osgoode Hall Law School and is enrolled in Professor Mgbeoji’s Patents class in Fall 2011. As part of the course requirements, students are asked to write a blog on a topic of their choice.

While reading a news article on the recent European Court of Justice decision, Oliver Brüstle v Greenpeace e.V. (Case C-34/10), regarding the patentability of the products of embryonic stem cells, a quote from Jurassic Park came to mind. In it, Ian Malcolm criticizes that the evolution of our scientific knowledge outpaces our understanding and appreciation of the moral and social issues pertaining to it.

“I’ll tell you the problem with the scientific power you're using here: it didn't require any discipline to attain it. You read what others had done, and you took the next step. You didn't earn the knowledge for yourselves, so you don't take any responsibility for it. You stood on the shoulders of geniuses to accomplish something as fast as you could, and before you even knew what you had, you, you've patented it, and packaged it, you've slapped it on a plastic lunchbox, and now you're selling it.”
- Dr. Ian Malcolm, Jurassic Park

The current state of biotechnology, where discoveries, and inventions are made by manipulating and extracting elements from early human life, carries with it its own moral issues. Consequently, we are at times faced with the decision of where to draw the line. At what point does something become so potentially offensive or amoral that it justifies prohibition and is undeserving of patent protection?

In Oliver Brüstle v Greenpeace e.V. (Case C-34/10), the highest court in the European Union decided to limit the patentability of embryonic stem cell research. The case was brought forward initially by Greenpeace in the Bundespatentgericht (German Federal Patent Court) and was later appealed to the Bundesgerichtshof (German Federal Court of Appeal), which forwarded the decision to the European Court of Justice.

The Court of Justice made three main declarations pertaining to embryonic patents. First, any ovum becomes an embryo immediately following fertilization. They extended the definition to also include any cell that is made capable, regardless of its derivation, of beginning development towards a human life is an embryo. Second, scientific research and discoveries, for which patents are sought, fall within the scope of EU agreements permitting a ban on “immoral” industrial/technological patents that negatively affect bodily integrity, which includes patents on embryos. Finally, any invention is excluded from patentability if it involves removing elements from an embryo that result in the destruction of that embryo. This applies whether or not the removal is explicitly included or mentioned in the patent application itself.

The court emphasizes that this is not geared toward hindering scientific research; instead, it is only for the purposes of patentability. I perceive their reasoning to fall nicely in line with the concerns of Ian Malcolm, quoted above. It appears that the concern is not leading edge research itself, but the commercial motivation behind it. There is a common theme in the law establishing that compromises, actions, or behavior driven solely by financial gain do not win the sympathies of the court and are not legitimate excuses for dangerous or potentially immoral conduct. It is not surprising that the court is unwilling to grant a monopoly on technologies that exploit and destroy early human life.

However, there are substantial repercussions that may derive from this decision. The patentability of research is one of the significant motivators behind the crucial funding that is required for it to be carried out. European researchers may now experience significant hurdles in receiving funding for their embryonic or stem cell research. They may be encouraged to go as far as to abandon stem cell research for alternatives that are more profitable for investors.

Stem cells have shown significant promise to help with a wide range of medical problems. If the incentives for research are diminished, it could significantly undermine future medicine because research will be stunted. For example, the patent under dispute in this case was ultimately aimed at treating Parkinson’s disease. Likewise, a recent study shows promise in using stem cells to inhibit rejection of organ transplants. This would greatly increase the quality of life for those who have received transplants. It may be ill-advised to jeopardize future research in this field.

The effects of this decision will likely extend beyond Europe; patents granted abroad on stem cell research may now be unenforceable in Europe. Therefore, the profits biotech patents generate in the European market may no longer be significant, because researchers, hospitals, and other related companies will no longer need to acquire licenses for any processes involving stem cells. This could also affect funding abroad because the European market is not available to foreign stem cell patent holders, which results in less return on their investments.

Ultimately, cases like this may be seen as an indication of a current trend in patent law. With growing awareness about, and concern over the application of patents in the fields of biotechnology, such as stem cell research or DNA sequences, it will not be unexpected to see a more universal reform. This is not necessarily a bad thing. I do not think that this would be an insurmountable obstacle for researchers in the biomedical field to overcome. Necessity is the mother of invention; if a clear line were drawn on these morally problematic areas, it would probably not be long before an act of inventive genius allowed researchers to sidestep and avoid offending societal moral reservations and thus reestablish the patentability of stem cells. Until then, validity of such patents will be left to the defense or admonition of those who in Jurassic Park are referred to as “blood-sucking lawyer[s]”.