The limitations of a “wherein” clause
| October 15, 2019
Allergan Sales, LLC v. Sandoz, Inc., No. 2018-2207
August 29, 2019
Prost, Newman and Wallach. Opinion by Wallach
Summary
Appellees (Allergan hereon in) sued Appellants (Sandoz hereon in) asserting that their Abbreviated New Drug Application (ANDA) for a generic version of Allergan’s ophthalmic drug (Combigan®) infringed on their U.S. Patent Nos. 9,770,453: 9,907,801: 9,907,802. The District Court found limiting a number of “wherein” clauses in the Patents’ and granted Allergan’s motion for Preliminary Injection. Sandoz appealed. CAFC affirmed.
As an exemplary claim, independent claim 1 of the ‘453 patent is as follows:
A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate,
wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day and
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 specifications contained a clinical study, referred to as Example II, and it is the results thereof that are reflected in “the disputed “wherein” clauses (i.e., the efficacy and safety of the claimed combination).
Allergan argued that the “wherein” clauses were limiting, whereas Sandoz argued that the “wherein” clauses were not. Specifically, Sandoz argued that the “wherein” clauses “merely state the intended results” and so are not “material to patentability.” Sandoz argued that the only positive limitation in the claim[s] is the administering step. Sandoz relied upon previous cases to argue that “…whereby [or wherein] clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”); Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001).
The District Court and CAFC disagreed. The courts looked to the specification, and to the prosecution history wherein the Applicant had relied upon the results of administering the combination drug to assert patentability over the prior art. It was also noted that the Examiner had explicitly relied upon the “wherein” clauses in his explanation as to why the claims were novel and non-obvious over the prior art in the Notice of Allowance.
The courts differentiated this case from the previous case argued by Sandoz in that, “In Bristol–Myers we expressly noted that the disputed claim terms “w[ere] voluntarily made after the examiner had already indicated . . . the claims were allowable” and such “unsolicited assertions of patentability made during prosecution do not create a material claim limitation.”
Accordingly, “the District Court “f[ound] that the ‘wherein’ clauses are limiting because they are material to patentability and express the inventive aspect of the claimed invention” and the CAFC affirmed.
Take-away
“The specification is always highly relevant to the claim construction analysis and is, in fact, the single best guide to the meaning of a disputed term.” Prosecution history and the Examiner’s express rational for allowance are also highly relevant.
