7. The requirement of sufficiency of disclosure in the biotechnology field
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  7. 7. The requirement of sufficiency of disclosure in the biotechnology field
  8. 7.2. Level of disclosure required for medical use
  9. 7.2.7 Disclosure for some side effects
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7.2. Level of disclosure required for medical use – credible effect

Overview

7.2.7 Disclosure for some side effects

In T 2444/18 the board said that it it had been rendered credible that a mixture of isoleucine, leucine and valine might reduce certain side effects of sorafenib. The board agreed, however, with the opponent's view that this teaching could not be extended to different side effects for the following reasons. Even if admitted, the disclosure of document D10 (post-published evidence) on the potential utility of BCAAs against one further side effect would not remedy the absence of a substantiated general concept that would allow the teaching of example 1 to be extended to all conceivable side effects. The patent proprietors also argued that the wording of claim 1 "for use in reducing a side effect" required only one side effect to be reduced. The board arrived at a different conclusion. Claim 1 of the main request did not specify a particular side effect. If BCAAs as defined in claim 1 were administered to a patient to reduce or prevent a side effect other than bleeding, e.g. tinnitus, this was an alternative embodiment covered by claim 1. The therapeutic efficacy of BCAAs in preventing or treating tinnitus (and other side effects not covered by example 1) was not supported by evidence and was not rendered credible in the application as filed.

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