Assessing Contribution Over The Prior Art On a Biotech Patent Case

It is not always easy to assess what the contribution of the invention is on a complex biotech case. How this is an important issue to think about because it will determine the scope of claims that should be drafted or the arguments that can used when defending claims.

Often biotech inventions can be seen at different ‘resolutions’.  If X has been found to treat Y and information was available about the mechanism through which X acts then this could be claimed in the following ways:

-          X for use in a method of treating Y

-          X or a substance that works in the same was as X for use in a method of treating Y

-          X for use in a method of treating Y or a condition with the same basis as Y

The different claims reflect possible extrapolations of X and Y.  Which of these claims can be obtained will depend on how close the prior art is and the extent to which the claims would be considered sufficient and supported.

Where the invention concerns the finding that an SNP in a gene causes a certain condition, the following contributions could be considered:

-          the invention shows involvement of the gene in the condition

-          the invention shows that changes to the gene expression or activity are relevant to the condition

-          the invention shows that the gene is naturally polymorphic and that the polymorphisms are relevant to the condition

-          the invention shows that modulation of the gene activity or expression can be used to treat the condition

-          the invention shows that countering the in vivo effect of the SNP can be used to treat the condition.

Thus claims to diagnosis and treatment of the condition could be possible. The different diagnostic claims might be allowing the following lines:

Method of diagnosing condition Y in an individual by determining whether the individual possesses polymorphism Z in gene A.

Method of diagnosing condition Y in an individual by determining whether the level or activity of protein B [encoded by gene A] is altered in the individual.

You may also wish to see related articles Biotech Patents in Europe and Top 10 Observations on Antibodies.