The Sometimes Limiting Effect of “Wherein” Clauses

Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey.

Summary: A “wherein” clause can be limiting if it is material to patentability.

Allergan Sales, LLC and Allergan, Inc. (collectively, “Allergan”) sued Sandoz, Inc. and Alcon Laboratories, Inc. (collectively, “Sandoz”) alleging that Sandoz’s Abbreviated New Drug Application (“ANDA”) for a generic version of Allergan’s Combigan^® drug infringed three of Allergan’s patents. The district court granted Allergan a preliminary injunction, and Sandoz appealed.

The independent claims at issue recited both an efficacy “wherein” clause (“wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day”) and a safety “wherein” clause (“wherein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily”). The district court construed the “wherein” clauses as limiting.

Sandoz appealed and argued that the “wherein” clauses merely stated the intended results of administering Combigan^® and the recited results were not material to patentability. The Federal Circuit noted that the shared specification of the patents at issue demonstrated that the increased efficacy and safety of Allergan’s claimed methods were material to patentability. Allergan also relied on the efficacy and safety of the claimed methods when responding to the Examiner’s rejection during prosecution. Furthermore, the Examiner explicitly relied on the “wherein” clauses to explain that the claims in the patents at issue were novel and non-obvious over the prior art.

The only issue in dispute regarding the grant of a preliminary injunction was whether the “wherein” clauses were limiting. Thus, the Federal Circuit affirmed the district court’s grant of Allergan’s motion for preliminary injunction.

Judge Prost issued a concurring opinion. While she agreed with the affirmance of the district court’s decision, she believed the plain language of the claim compelled a rejection of Sandoz’s position that the “wherein” clauses were mere statements of intended results.

Editor: Paul Stewart

Written by: Benjamin Ho & Nicole R.Townes