|The Federal Circuit had previously held that claims to the composition combining brimonidine and timolol were invalid as obvious.
During claim construction arguments before the district court, Sandoz argued that the “wherein” clauses did not limit the claim but only stated the intended result of the invention. If the “wherein” clauses were not limiting, then the claim would be invalid as obvious as it would be limited to the composition alone, which the Federal Circuit had previously found to be obvious.
The District Court disagreed, holding that the specification emphasized the benefits of the combination as satisfying a need to improve efficacy without increasing adverse effects, and that Allergan had relied on those disclosures during prosecution to overcome prior art.
The Federal Circuit affirmed.
In upholding the District Court’s analysis, Federal Circuit distinguished its own precedent with regards to “wherein” and “whereby” clauses, finding that in those instances where the clause was not a claim limitation, the clause was neither necessary or relevant to the examiner’s approval.
This is not inconsistent with the majority of cases where a “wherein” clause stating the purpose or results of an otherwise fully defined invention is held to not limit the claim. However, as Chief Judge Prost noted in a concurrence, “[g]iven the specificity, clarity, and material limits the ‘wherein’ clauses add to the scope of claim 1 on their face,” Sandoz’s position that the “wherein” clauses did not limit the claim “deserve[d] rigorous scrutiny from the start.”
Allergan thus serves as a reminder that a patent claim that includes a statement of purpose or intended results, that in other contexts may not be the subject of dispute, must always be considered in the context of that particular claim and be evaluated to assess whether it is relevant to the scope of the claim.