European court clarifies requirements for patenting human stem cells

Since the rise of the biotech industry there has been a discussion on the (im)possibility of patenting human stem cells. In 2011, the Court of Justice of the European Union (the Court) delivered a judgment on this subject (see article "Gebruik van menselijke embryo's en het octrooirecht (https://cms.law/nl/NLD/Publication/Gebruik-van-menselijke-embryo-s-en-het-octrooirecht) " (in Dutch)). On December 18th, the Court again delivered a judgment on this subject, further clarifying its earlier statements.

What is the history of the case?

In 1998, the European Union adopted the Biotechnology Directive. This directive states that biotechnological inventions are in principle patentable. An exception is made for the human body. The directive provides that the human body –in any stage of its formation and development– is not patentable. This includes human embryos. In addition to that, the directive provides that inventions must be excluded from patentability where their commercial exploitation offends against public order or morality.

Several years ago, Greenpeace filed a lawsuit against a scientist who applied for a patent on an invention that made use of human stem cells (the so-called Brüstle case). The Court then ruled that "embryo" should be defined broadly. If human stem cells have the potential to develop into an embryo, and thereby into a human being, an invention dependent on these stem cells is not patentable. Despite this apparently clear judgment, the scope of the term "embryo" turned out to be not so clear, as time went by.

What happened in the new case?

The company International Stem Cell Corporation (ISC) was unable to patent the production of synthetic corneas because the English patent agency was of the opinion that these corneas were produced by using stem cells from human embryos. The agency used the Brüstle case to support its position. ISC did not concur with the patent agency and was of the opinion that the Brüstle case was not applicable to the current situation since there were no human embryos involved. The stem cells used by ISC where multiplied by using parthenogenesis (asexual reproduction). ISC used a technique whereby unfertilized eggs were multiplied by using chemical and electrical techniques. According to ISC, it is impossible that stem cells generated this way will ever develop into human embryos.

What does the Court say?

The Court emphasizes again that the term "embryo" should be defined broadly. Each human egg must, when fertilized, be regarded as a human embryo. Furthermore, the unfertilized egg must also be regarded as a human embryo when this organism is capable of developing into a human. In the case of ISC, however, the organism is incapable of developing into a human being. Unfertilized eggs multiplied by using parthenogenesis can never develop into a human being. The exception of the Biotechnology Directive is therefore not applicable, meaning that an invention using this kind of stem cells, may be patented.

The implications of this judgment

After the Brüstle case, many wondered whether it meant the end to medical research in the European Union using human stem cells, since the biotechnological inventions relating thereto could not be patented anyway. People feared that biotech companies would conduct their research in the United States or other countries with a more liberal approach to these matters. This judgment clarifies the current situation and provides that within certain limits it may very well be possible to obtain a patent for inventions that are dependent on human stem cells. We will have to wait and see if medial companies will make use of the new possibilities offered.