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What qualifies as a human embryo?

Dr. Réka Berekméri-Varró: Three years after the Brüstle-decision of the Court of Justice of the European Union (CJEU), the interpretation of the term “human embryo” may become narrower as a result of a new case pending before the CJEU. The biotech sector is facing a new potential milestone.

Biotechnology has undergone rapid developments in the recent past. This is particularly the case in the healthcare sector, where biological products and therapies are used in ever more therapeutic areas, for example for the treatment of autoimmune diseases and cancers.

Research and development in the biotech sector require a considerable amount of high-risk investment; therefore, only adequate legal protection can make them profitable. EC Directive 98/44 on the legal protection of biotechnological inventions lays down the principles of the patentability of inventions that – besides ensuring the profitability of investments through legal protection – also protect human dignity and integrity.

A biotech invention – as with other types of invention – is patentable if the object of the invention is a novelty, involves an inventive step and is capable of industrial application, provided that it is not excluded from the scope of patentable inventions.

According to the Directive, the human body is not patentable at any stage of its formation or development, and the simple discovery of one of its elements cannot constitute a patentable invention. However, an element isolated from the human body, or otherwise produced using a technical process may constitute a patentable invention. The Directive also provides that inventions are considered unpatentable where their commercial exploitation would be contrary to “ordre public” or morality.

There are several examples mentioned in the Directive that are considered contrary to public order or public morality. According to Article 6 (2) c) of the Directive, the use of human embryos for industrial or commercial purposes is, for example, excluded from patentability.

This provision also restricts the patentability of procedures involving human embryonic stem cells in the territory of the European Union. It is essential, therefore, to clarify what should be understood under the term “human embryo”. Human embryonic stem cells are considered to be capable of contributing to the treatment of several, currently incurable diseases.

Article 6 (2) c) was examined three years ago by the CJEU in the Brüstle case concerning a patent claimed by a researcher – one Mr. Brüstle – concerning processes that allowed nerve cells to be obtained from embryonic stem cells. The German Federal Patent Court had declared the patent invalid by stating that it violated the national legislation implementing Article 6 (2) c).

Mr. Brüstle appealed against the decision and the highest court in Germany referred the case for a preliminary ruling, claiming that the outcome of the application for annulment depended on the question of how the term “human embryo” should be interpreted; in particular, whether the term covers unfertilized human ova stimulated through certain chemical and electrical techniques. The CJEU gave an affirmative answer to that question and stated that the term “human embryo” should be interpreted broadly. Many researchers did not agree with the Brüstle-decision, claiming that it hindered embryonic stem cell research in the European Union.

However, the interpretation of the term “human embryo” may become narrower as a result of the ongoing case No C-364/13. According to the Opinion of the Advocate General, released in mid-July, unfertilized human ova whose further development has been stimulated through certain chemical and electrical techniques do not qualify as human embryos, and therefore may be treated as a patentable invention as long as they are not capable of developing into a human being. If, however, an ovum is genetically manipulated to become capable of developing into a human being, it must be considered as a human embryo, and thus will be excluded from patentability.

The Advocate General’s Opinion is not binding on the CJEU, but only proposes a legal solution to the case. The decision of the CJEU will hopefully create a balance between the desired stimulation of the biotechnological industry and the protection of human dignity.