This matter originated in opposition proceedings launched by Bresagen and New England Biolabs against F.Hoffman-La-Roche. In that matter the Delegate found, inter alia, that the invention as defined in the claims lacked novelty. The Delegate also found that the claims did not comply with section 40 of the Patents Act in that they were not fairly based on the specification. In particular, the Delegate held that the term "thermostable" in the claims was defined too broadly in the specification. F. Hoffman-La-Roche appealed the decision to the Federal Court and amended the specification to narrow the definition in an attempt to comply with section 40. The Federal Court referred the matter back to the Delegate to determine whether or not the claims were fairly based on the specification, as amended.
The relevant amendment appears as follows: "As used herein, the term "thermostable enzyme" refers to an enzyme which
The Delegate disagreed. He pointed out that the definition of "thermostable enzyme" as set out in the specification described a specific enzymatic reaction. DNA polymerase is the only enzyme disclosed in the specification which is able to catalyse this reaction. In his view, the claimed DNA polymerase was thus clearly encompassed in the dictionary definition of "thermostable enzyme" provided in the specification. Furthermore, the Delegate held that there was nothing in the specification or in the evidence to suggest that the word "thermostable" would have had a different meaning when used as an adjective for "enzyme" and for "polymerase".