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DNA SEQUENCES


Recent European decisions have provided much to think about for practitioners concerned with DNA sequences. Caroline Pallard and Bart Swinkels investigate.


Before grant


Industrial application is one of the requirements of a European patent (EP). Subsequently,


the


EC Biotech Directive 98/44 provided more explanation of the concept of industrial application of DNA sequences: the industrial application of a DNA sequence must be disclosed in the application. A DNA sequence without indication of a function is not a patentable invention. If a protein is to be produced, its function should be defined in the application.


Several EP case law decisions issued on industrial application of DNA sequences-related inventions shed new light on the concept of ‘function’ when applied to a protein/corresponding DNA sequence.


T0870/04


Te European Patent Office Board of Appeal held that the requirement of industrial application was not met. It held that the only practicable use suggested is to use the BDP1 phosphatase to find out more about its natural function. Tis kind of activity could not be considered as industrial application, but rather research.


Terefore, even if the structure and function of a protein is disclosed, the requirement of industrial application is not necessarily met if:


• The function is complex and not fully understood


• No disease has been identified that is linked to an excess or deficiency of the protein and


• No other uses have been disclosed. T898/05


Te board held that the requirement of industrial application was met. It provided a new definition of function when applied to a protein: “Te function of a protein can be seen at different levels. Tese include:


i) Te biochemical activity of the protein or molecular function (protease, etc.)


ii) Te function of the protein in cellular processes or cellular function (apoptosis, etc.)


iii) Te influence of those cellular processes within a multicellular organism or biological function (cancer, immune response, etc.).”


It is concluded that the elucidation of one of these functions may result in an invention fulfilling


the requirements of industrial


application even if other functions are not yet elucidated. In this specific case, the molecule and cellular functions were not disclosed. However, the biological function of the protein disclosed in the application (immune response) provides an “immediate concrete benefit” derivable from the application.


Terefore, even if the structure of a protein is disclosed without a molecular function, the requirement of industrial application may be met.


www.worldipreview.com Life Sciences Intellectual Property Review 2011 57


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