› patent relating to the large scale production of proteins and polypeptides in cell culture for a therapeutic use
› infringement
› validity
Patents
› infringement
› construction of claims
› meaning of “medium containing glutamine” and “cumulative”
› where two allegedly infringing processes
› where one process accepted to infringe integer
› second process does not infringe on preferred construction
› infringement of integer also considered on alternate constructions to that found
› infringement found for some batches on alternate constructions
Patents
› infringement - whether cell culture would reach a maximum possible viable cell density within a percentage range if maintained under a first set of culture conditions
› infringement not found
Patents
› validity
› inventive step
› whether use of a medium with the characteristics specified involved an inventive step
› common general knowledge alone and in combination with three prior art documents
› all but one of the asserted claims lack an inventive step
Quick Take
1Where a patent specification defines 'medium' by reference to a deliberately formulated solution of nutrients, and defines 'cumulative' amounts as components 'added' over the course of cell culture, the claims do not encompass components incidentally present from inoculum carry-over, cell secretions, or contamination — the medium characteristics are assessed solely by reference to the formulated batch and feed media.
2A patentee seeking to prove infringement of a claim integer requiring a hypothetical cell growth outcome (here, that viable cell density would reach 20–80% of the maximal possible density absent a culture condition change) bears the onus of establishing that outcome on the balance of probabilities; mathematical extrapolation from limited data points using curve-fitting, without supporting experimental evidence and contrary to trends in the underlying biological data, may be insufficient to discharge that onus.
3In assessing inventive step for biopharmaceutical process claims, where the common general knowledge included routine media optimisation techniques and the prior art disclosed media formulations that, with routine modification, would satisfy the quantitative medium characteristics of the claims, most claims lacked an inventive step — but a claim requiring a specific combination of characteristics (here, claim 2 requiring a glutamine-to-asparagine ratio below 2 plus two additional characteristics) may involve an inventive step where the prior art did not directly teach that particular combination.
