ACT_589997/2023

System for ambulatory drug infusion comprising a filling apparatus for flexible containers

RevocationMain Revocation ActionParis CDRevocation Action—

Overview Decisions Reasoning Documents Timeline

Coverage: Partial.Reasoning extracted with partial coverage — some sections may be incomplete.

Plain-English summary

Tandem Diabetes Care sought revocation of Roche's EP 2 196 231 (ambulatory drug infusion system with filling apparatus for flexible containers). The Paris Central Division rejected all invalidity attacks, finding that neither Diaz nor Robertson (alone or in combination), nor Glejboel combined with those references, disclosed the key feature requiring the support structure to limit container expansion (feature 1.3iii). The court also held that breach of a standstill agreement does not bar proceedings but may give rise to contractual liability, and maintained the patent as granted.

Accepted arguments

What the court agreed with — by party.

Breach of a standstill clause does not deprive the breaching party of the right to sue, but may give rise to contractual liability
Claimant
Note: The Paris Central Division rejected any jurisdictional/admissibility challenge based on breach of a standstill clause, holding such breaches do not divest the party of the right to bring an action.
Claim 1 feature 1.3iii (support structure limiting expansion of flexible container) is not disclosed by 'Diaz'
RespondentLegal basis: Art. 56 EPC
Note: The court found that Diaz's reservoir casing performs a protective function and the gap shown in figures is intended to remain even when filled, so the limitation feature is not disclosed.
Robertson (container for solid medicaments/pills) is not a relevant combination with Diaz (liquid drug delivery)
RespondentLegal basis: Art. 56 EPC
Note: The court found the skilled person would be unlikely to consult Robertson (a box for pills) to improve Diaz (a liquid medicament delivery system), and in any event Robertson does not disclose the missing feature.

Rejected arguments

What the court did not agree with — and why.

Lack of inventive step over Diaz combined with Robertson
ClaimantLegal basis: Art. 56 EPC
Reason: Neither Diaz nor Robertson discloses feature 1.3iii (the support structure limiting container expansion), and the combination of the two references cannot supply this missing element; the skilled person would have had no motivation to combine the two documents.
Lack of inventive step starting from Glejboel combined with Diaz and/or Robertson
ClaimantLegal basis: Art. 56 EPC
Reason: Neither Glejboel, Diaz, nor Robertson discloses feature 1.3iii, so this combination also fails to establish obviousness.

Key legal principles

Doctrines and rules cited in the reasoning.

problem-solution approach for inventive step standstill clause breach does not bar action but may give rise to contractual liability motivation to combine prior art references required for obviousness

Browse other cases on this principle.

Prior art relied on

References cited and the role they played.

Diaz (unspecified publication, liquid drug delivery system)Obviousness combination
Robertson (unspecified publication, container for solid medicaments)Obviousness combination
Glejboel (unspecified publication)Obviousness combination

Claim construction notes

The court interpreted claim 1 of EP 2 196 231 as requiring a support structure that limits the expansion of the flexible container (feature 1.3iii). This feature was critical to the inventive step analysis: the court found that Diaz's reservoir casing, which surrounds the reservoir to protect medication, does not disclose this limiting function because the casing in Diaz is intended to leave a gap even when the reservoir is full.