tem cell research is advancing at an incredibly fast pace. Technology based on the use of human embryonic stem cells (hESCs) is being employed in an attempt to tackle a wide variety of conditions including vision loss, diabetes, heart disease and skin disorders. However, with such cutting-edge research comes moral considerations, which in turn have implications for the type of technology that is patentable. T e potential ethical implications associated with biotechnological inventions were
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acknowledged as early as the late 1980s, and resulted in the adoption of the Biotechnology Directive 98/44/EC in July 1998. Article 6(2) (c) of the directive—incorporated into the European Patent Convention by rule 28(c)—is targeted at stem cell research, and prohibits the patenting of human embryos.
While the directive provides some clarity on one aspect of stem cell research, it leaves many more questions unanswered. It is no surprise, then, that in recent years the patentability of technology based on hESCs has been the subject of signifi cant
consideration, including by the Court of Justice of the European Union (CJEU), the European Patent Offi ce (EPO) and national courts.
In these decisions, the courts have inevitably tried to strike a balance between, on the one hand, the promotion of potentially benefi cial research by means of patent law, and on the other hand, respect for the fundamental principles of safeguarding the dignity and integrity of the person, objectives that are set out in the preamble to the directive.
What constitutes a “human embryo” under
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