Pfizer Inc. v. Alkem Labs. Ltd.

Failure to raise a claim-construction issue precludes a party from arguing claim differentiation.

October 15, 2015

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Pfizer Inc. v. Alkem Labs. Ltd., Civ. No. 13-1110-GMS, 2015 U.S. Dist. LEXIS 94327 (D. Del. July 21, 2015) (Sleet, J.)

Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine); U.S. Patents Nos. 7,384,980 ("the '980 patent") and 7,855,230 ("the '230 patent")

Nature of the Case and Issue(s) Presented: The parties conducted a bench trial on the infringement of one claim from each patent.  The patents cover the pharmaceutical composition for Toviaz, a drug to help treat symptoms of an overactive bladder.  

Sandoz, the only defendant challenging infringement, argued that Pfizer’s expert failed in his expert report to opine on the standard for one of skill in the art, and thus was precluded from offering opinions as to claim construction. Sandoz further argued that the doctrine of claim differentiation required the scope of the claims to be narrowed to support a finding of non-infringement.

Pfizer argued that Sandoz had waived any argument as to the scope of testimony for its expert by failing to raise the issue at the pre-trial conference. As for claim differentiation, Pfizer argued that Sandoz failed to offer any contrary claim constructions in order to invoke an argument on claim differentiation.
The district court found that Sandoz had waived any argument as to the expert’s testimony and failed to offer claim-construction proposals to raise an issue of claim differentiation.

Why Pfizer Prevailed: The district court found that Sandoz had waived any argument as to the scope of Pfizer’s expert’s testimony.  The court noted that Sandoz had raised the issue in its pre-trial briefing, but failed to address the issue when the court asked about it during the pre-trial conference.  

The district court rejected Sandoz’s argument on claim differentiation because Sandoz had failed to raise a claim-construction issue.  The court noted that there may have been a colorable argument on claim construction, but Sandoz did not offer any expert testimony on how one of skill would read the claim or ask the court to construe the claim.  Thus, the record did not support a claim-differentiation argument.

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