European Commission to monitor biotech patents 8/8/05. By the Public Health Genetics Unit The European Commission has released its second report on the implementation of the Directive on the legal protection of biotechnological inventions (98/44/EC).

The report, 'Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering, details how the Directive has been implemented in Member States, noting that 21 countries have transposed it into national law and four have not: Italy, Luxembourg, Latvia and Lithuania.

The report also addresses two issues raised in the Commission's first report [PDF 236KB] on this topic (published in 2002): the scope of patents on gene sequences or partial gene sequences that have been isolated from the human body and the patentability of human pluripotent embryonic stem cells and of cell lines obtained from them. Rather than take action at this time, the Commission reports that it has decided to monitor continuing developments in both these areas.

On the first issue, Members States have differed by providing either a broad or limited scope of patent protection for human gene sequences.

Most States provide 'absolute product protection', which covers the original disclosure in the patent application and possible future uses of the sequence. But two countries, France and Germany, have chosen a more restricted scope of protection. According to a statement by EuropaBio , the European Association for Bioindustries, these States have chosen to limit the patent protection to only the specific use disclosed in the application. In addition, France has banned the patenting of human gene sequences.

Instead of judging whether or not these States have correctly implemented the Directive, the Commission has decided to monitor the economic consequences of their actions. EuropaBio has expressed its disappointment that the Commission has not sought better harmonisation in implementing the Directive. "Industry requires predictable rules across all Member States in order to attract the large R&D investments to meet societal needs," stated Bo Hammer Jensen, Chair of EuropaBio's Intellectual Property Working Group.

Inconsistency between the Member States is also clear in the second issue discussed in the report, that of the patentability of cell lines from human pluripotent stem cells. The Commission recognises that Member States differ significantly in their attitudes towards embryonic stem cell research. Due to these differences, the rapidity at which the field is progressing and the fact that the Directive allows Member States to refuse patents on the grounds of order public or morality, they have decided "…it is premature to give further definition or provide for further harmonisation in this area."

The Commission have launched an international study, Stem Cell Patents: European Patent Law and Ethics , to examine the ethical and legal aspects of stem cell patenting.

Article courtesy of the Public Health Genetics Unit .