The patent claim was for a compound for extending the functional life of pancreatic islet cells. The patent comprised no experimental data supporting the drug’s claimed therapeutic effect, but it did contain a technical explanation of its effect and an experimental methodology by which this could be verified.
Held: Plausibility can be demonstrated in the specification without experimental evidence, if there is no substantiated doubt about the theoretical case made for the efficacy of the invention.
The Board was concerned with the circumstances in which the specification could be sufficient without experimental data: ‘The Boards of Appeal have indeed dealt with cases where, in the context of the assessment of inventive step, there could only be an invention if the application made it at least plausible that its teaching did indeed solve the problem it purported to solve and in which to establish plausibility the disclosure of experimental results in a patent application, or, under certain circumstances, by post-published evidence, was considered necessary (see decision T 716/08 of 19 August 2010, points 14 to 16 for a summary of the case law) . . The board re-emphasises in this context however that this case law considers the establishment of plausibility only relevant when examining inventive step if the case at hand allows the substantiation of doubts about the suitability of the claimed invention to solve the technical problem addressed and when it is thus far from straightforward that the claimed invention solves the formulated problem.’
T 0578/06
European
Cited by:
Cited – Warner-Lambert Company Llc v Generics (UK) Ltd (T/A Mylan) and Another SC 14-Nov-2018
These proceedings raise, for the first time in the courts of the United Kingdom, the question how the concepts of sufficiency and infringement are to be applied to a patent relating to a specified medical use of a known pharmaceutical compound. Four . .
Lists of cited by and citing cases may be incomplete.
Updated: 18 October 2021; Ref: scu.668612