T 0226/98 (Famotidine/RICHTER GEDEON) vom 07.02.2001

Main request: clarity (no) - obscurity of delimiting feature

1. In a claim related to a product as such (here: famotidine form "B"), the feature "as a pharmaceutical product" for defining a pharmaceutical standard of purity renders said claim unclear in the absence of a generally accepted quantitative definition for the purported standard of purity. Nor can this expression be considered to be a commonly accepted functional feature as no clear definition can be derived therefrom (see point 7.2 of the reasons).
2. As purity standards are likely to change with time for a number of reasons (e.g. new manufacturing process, new or improved analytical tools, change of criteria for obtaining a marketing authorization), it remains obscure what is considered to be the required product quality when defined by the feature "as a pharmaceutical product" (see point 7.3 of the reasons).