Written description in chemical and pharmaceutical patents

The written description requirement in the chemical and pharmaceutical industries is based on a unique, everevolving factual situation necessitating the application of what would otherwise be a technology-neutral statute. In light of the range of issues presented, drafting, prosecution and enforcement strategies have become more complicated and exacting, with the courts providing a rather ambiguous guide as to what will be sufficient. As the Federal Circuit recently warned, an issue involving written description “must be decided on its own facts” and “the precedential value of cases in this area is extremely limited” (Noelle v Lederman, 355 F 3d 1343 (Fed Cir 2004)).

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