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Date of decision
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07 February 2001
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Case number
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T 0226/98
- 3.3.1
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Application number
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87306882.9
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Title of the application
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Morphologically homogenous forms of famotidine and processes for
their preparation
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Applicant name
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RICHTER GEDEON VEGYESZETI GYAR R.T.
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Opponent name
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Yamanouchi Pharmaceutical Co., Ltd.
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Keywords
Main request: clarity (no) - obscurity of delimiting feature
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Catchwords:
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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).
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