HOW MUCH CLINICAL DATA IS NEEDED IN A PATENT?

The problem of lack of clinical data to support the scope of patent claims in Europe is a similar problem in the US. Generally, broader claims need more supporting clinical data.

Here is an example.


In Europe, Chugai owned a patent entitled “Remedy for Vasculitis”. The patent was based on inhibiting the binding of “IL-6 to the IL-6 receptor.”


A third party opposed the patent based on lack of disclosure sufficient for a person skilled in the art to carry out the invention.


The European patent board explained that vasculitis is a term for “various diseases with unknown causes. . . . The only link between the various diseases was the presence of inflammation.”


The patent taught that IL-6 was involved in inflammation. Two patients, who were “not typical” and represented “extreme cases”, were successfully treated, according to the patent.


The prior art, according to the Board, “cast serious doubt” on whether the patented therapy “could be used to treat any type of vasculitis.” In fact, the prior art showed that inhibiting the binding of IL-6 to IL-6 receptor by an anti IL-6 antibody “does not lead to a prevention or treatment of every type of vasculitis.”


The Board concluded that the patent “does not provide any form of guidance as to which types of vasculitis respond to the administration of an anti IL-6 receptor antibody. There is thus no teaching . . . on how to treat vasculitis in all its forms. As a consequence . . . the subject matter of . . . the [patent claim] is not sufficiently disclosed over the whole scope of the claim.”

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