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French Thumb Their Noses At EC Genomics Patenting Directive

LONDON -  When the European Commission threatened recalcitrant countries with legal action for failing to implement the EU's Biotech Directive in January, the genomics industry breathed a sigh of relief. 


This is because the Biotech Directive mandates that the European Patent Office's clarity on genomics patents would apply to all patent infringement and validity cases in the courts of European countries.


And, the industry assumed, no country would wish to risk the ignominy of being taken to the European Court of Justice for failing to implement the directive after the Commission's warning. 


However, these threats have resulted in little movement to implement the directive.  On the contrary, in the face of an overwhelming tide, Francehas chosen to implement its own bioethics bill, which directly contradicts the Biotech Directive, and the remaining eight foot-dragging countries, which include Germany, the Netherlands,and Austria,are showing little sign of picking up their heels.  The Commission seems more likely to implement its threat of bringing legal action against those countries for failing to implement the directive.


The French Bioethics Bill is particularly contrary to the Biotech Directive. Unlike the Biotech Directive, which allows the patenting of isolated gene sequences where some utility is shown, the Bioethics Bill forbids the patenting of gene sequences.  The French bill will allow the patenting of a specific technical application of a function of an element of gene sequence.


But the French government has made no attempt to suggest that the two pieces of legislation are compatible.  In fact, French Health Minister Professor Matthei, a sponsor of the bill, suggests that the best way forward would be for the Biotech Directive to be interpreted in accordance with the Bioethics Bill.  


The absurdity of this suggestion is clear: a European Directive which was duly passed after over a decade of negotiations, and which was unsuccessfully challenged in the highest

European Court,
should now be effectively scrapped and replaced with the French Senate's view.


Where now after the French "Non"?


The French position is particularly surprising as Francehas no discretion over whether to implement the Biotech Directive, still less to implement conflicting legislation.  Once a directive has been adopted, the European member states are obliged to implement it. 


It will be interesting to see how the stand-off between the European Commission and France,and the foot-dragging countries will end.  In the meantime, it seems that there is a two-tier Europe: those countries such as the United Kingdom, Spain, and Finland, where the Biotech Directive is now law and is being applied by the courts and those countries where national laws still prevail. Given the uncertainty of the state of the law in the "no Directive" states, the owners of genomics and proteomics patents may think twice before putting their patents on the line.

Alex Wilson is a senior assistant and Robert Burrows is an assistant in the BioPharma group of the UKlaw firm Bristows.

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