Purdue Pharma LP et al. v. Collegium Pharmaceutical, Inc. (15-cv-13099).

Judge Saylor issued a claim construction order in this case, which involves three patents relating to abuse-deterrent and low-toxicity versions of oxycodone. The claims relating to deterrence of abuse required the inclusion of an irritant in an amount sufficient to impart an irritating sensation.  Collegium first sought to require the irritant be something deliberately added to the composition for the purpose of causing irritation – in other words, that would not cover ingredients added for other purposes that happened to also be irritants.  This construction was denied as improperly importing an element of intent into the claims, although Judge Saylor did note that, during prosecution, Purdue had disclaimed instances where the other recited  ingredients (drug, release carrier, excipient) could also serve as the irritant, thus reducing the broadness of the scope from that sought by Purdue.  Judge Saylor refused to find the term “effective amount” indefinite, finding that the term has a customary usage to a person of ordinary skill in the art and that examples were provided in the specification, providing an objective baseline through which the term would be understood.  Finally, with respect to reduced toxicity, Judge Saylor rejected Collegium’s arguments that “removing” a particular impurity should be limited to removing only that particular impurity and removing it completely, as being inconsistent with the usage of the term in the specification.

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