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UPC CFI 454/2023

Nov 30, 2023·EP2196231 · System for ambulatory drug infusion comprising a filling apparatus for flexible containers

Action number: ACT 589997/2023

Case details
Status
Case Closed (Patent upheld as granted)
Action
Revocation
Category
Main revocation action
Parties
Claimants
Representatives
Respondents
Representatives
Division
Paris CD
Technology
  • Instruments
    Medical technology
Language
English
First decided
Feb 20, 2024
Last decision
Dec 18, 2024
How this compares
The court's record for this kind of case, counted in first-instance rulings. A figure in brackets is the number of rulings a rate rests on.
Patent revokedMedian days to first decision
All UPC37% (34/91)124
Paris CDLockedLocked
Judge Paolo CatallozziLockedLocked
Judge Tatyana ZhilovaLockedLocked
Judge Giorgio CheccacciLockedLocked

At the UPC: Tandem Diabetes Care Group (18 cases)·Roche Group (29 cases)

This dispute contains 9 other proceedings

UPC CoA 120/2025·UPC CFI 11/2025·UPC CFI 88/2024·UPC CFI 455/2023·UPC APP 3514/2024 and 4 more

1 other defendants litigating the same or a related patent

UPC CFI 325/2024

Start a free trial to see how each one ended.

More cases: Paris CD·2023

Decisions
  • 2024-12-18
    Revocation ActionPublic

    Summary: The Paris Central Division dismissed Tandem Diabetes Care's revocation action against Roche's EP 2 196 231 B1 (ambulatory drug infusion system), maintaining the patent as granted and ordering the claimants to bear the costs of proceedings, finding the grounds for invalidity (including lack of inventive step over prior art Diaz/Robertson/Glejboel) were not proven.

    Show the legal issues (3)
    • revocation action lack of inventive step
    • standstill clause breach as admissibility issue
    • ambulatory drug infusion patent validity
  • —
    revocation

    Summary: a) dismisses the revocation action filed by [redacted] and against [redacted] b) maintains the European patent EP n° 2 196 231 B1 as granted; c) orders that the costs of the proceedings shall be borne by the claimants.

Documents
Document titleDatePublic
Final order anonymized - 18.02.20252025-02-19Not public
Outcome of the Order2025-02-18Not public
rule 3532025-02-18Public
rule 3532025-02-18Not public
Acknowledgement-of-change-of-a-representative2025-02-14Not public
Acknowledgement-of-change-of-a-representative2025-02-14Not public
Comments on Rectification Merits Decision2025-01-30Not public
Comments on Rectification Merits Decision2025-01-30Not public
preliminary order2025-01-23Not public
preliminary order2025-01-23Not public
Receipt2025-01-20Not public
2025-01-20 Application to rectify decision R 3532025-01-20Not public
Final order anonymized - 18.12.20242024-12-19Not public
Headnote-and-Keywords2024-12-18Not public
DecisionOutcome2024-12-18Not public
decision2024-12-18Public
decision2024-12-18Not public
Application-RoP293-Receipt2024-12-13Not public
Formal-checks_Notification-of-positive-outcome2024-12-13Not public
Application-RoP293-Receipt2024-12-13Not public
Formal-checks_Notification-of-positive-outcome2024-12-13Not public
Application-RoP2932024-12-11Not public
Notification Pursuant to Rule 293 RoP (Change of Representative)2024-12-11Not public
Application-RoP2932024-12-11Not public
Notification Pursuant to Rule 293 RoP (Change of Representative)2024-12-11Not public
Outcome of the Order2024-11-27Not public
closing workflow2024-11-27Public
Receipt2024-11-27Not public
Confirmation of appointment - anonymized2024-11-20Not public
Outcome of the Order2024-11-20Not public
Confirmation of appointment - case 589997/20232024-11-20Not public
Confirmation of appointment - case 589997/20232024-11-20Public
Receipt2024-11-15Not public
Annex E12024-11-15Not public
Application2024-11-15Not public
Annex E12024-11-14Not public
Request for access to audio recording2024-11-14Not public
Hearing Reference2024-11-06Not public
Hearing Reference2024-11-06Not public
Order Rule 333 - 04.11.20242024-11-04Not public
Outcome of the Order2024-11-04Not public
rule 3332024-11-04Not public
rule 3332024-11-04Public
Final order - 30.10.20242024-10-31Not public
Interim-Procedure-Closure2024-10-30Not public
Summon-Oral-Hearing2024-10-30Not public
rule 1082024-10-30Public
rule 1082024-10-30Not public
Template-Order2024-10-30Not public
Hearing-Dates2024-10-30Not public
Comments on definitions2024-10-29Not public
Comments on definitions2024-10-29Not public
Exhibit KAP 152024-10-29Not public
2024-10-29 Submission Roche2024-10-29Not public
Acknowledgement-of-lodging2024-10-29Not public
Exhibit KAP 142024-10-25Not public
2024-10-25 Application to review order R. 3332024-10-25Not public
Final order - RoP1052024-10-25Not public
Final order - RoP3332024-10-25Not public
Outcome of the Order2024-10-25Not public
closing workflow2024-10-25Public
Outcome of the Order2024-10-21Not public
rule 3332024-10-21Public
rule 3332024-10-21Not public
Acknowledgement-of-lodging2024-10-21Not public
rule 92024-10-18Public
rule 92024-10-18Not public
Template-Order2024-10-18Not public
rule 92024-10-18Not public
Receipt2024-10-18Not public
Application to review2024-10-18Not public
Application for a stay2024-10-18Not public
Order Rule 105 - 10.10.20242024-10-14Not public
rule 1052024-10-10Not public
rule 1052024-10-10Public
Hearing Reference2024-09-11Not public
Hearing Reference2024-09-11Not public
Fix-Interim-Conference-Date2024-09-04Not public
rule 352024-09-04Public
rule 352024-09-04Not public
interimConferenceDecision2024-09-04Not public
writtenProcedureClosure2024-09-04Not public
Outcome of the Order2024-07-29Not public
rule 302024-07-29Public
Receipt2024-07-01Not public
Receipt2024-07-01Not public
Auxiliary Request 29.pdf2024-06-28Not public
Auxiliary Request 28.pdf2024-06-28Not public
2024-06-28_new_auxiliary_requests_Roche_signed2024-06-28Not public
Auxiliary Request 27.pdf2024-06-28Not public
Auxiliary Request 30.pdf2024-06-28Not public
2024-06-28_request_for_confidentiality_R_262_2_signed2024-06-28Not public
Acknowledgement-of-lodging2024-06-28Not public
2024-06-28_rejoinder_Roche_signed2024-06-28Not public
2024-06-28_rejoinder_Roche_signed2024-06-28Not public
Hearing-Dates2024-06-27Not public
rule 282024-06-27Public
Outcome of the Order2024-06-27Not public
time extension2024-06-27Public
Availability oral hearing2024-06-26Not public
Availability oral hearing2024-06-26Not public
2024-06-26 Brief Roche regarding availability2024-06-26Not public
Receipt2024-06-25Not public
2024-06-25 Request to extend deadline2024-06-25Not public
Exhibit KAP 132024-06-25Not public
Exhibit KAP 132024-06-25Not public
order2024-06-20Public
Acknowledgement-of-lodging2024-05-28Not public
Annex D102024-05-28Not public
Annex D82024-05-28Not public
Reply Tandem2024-05-28Not public
Annex D92024-05-28Not public
Annex D62024-05-28Not public
Annex D72024-05-28Not public
Exhibit KAP 12 - DE2024-05-21Not public
Brief re oral hearing2024-05-21Not public
Availability hearing2024-05-17Not public
Availability hearing2024-05-17Not public
rule 282024-05-14Not public
Hearing-Dates2024-05-14Not public
Preliminary Objection order - case 3514-2024 r2024-05-10Not public
Headnote-and-Keywords2024-05-10Not public
Preliminary_Objection_DecisionOutcome2024-05-10Not public
preliminary objection2024-05-10Not public
preliminary objection2024-05-10Not public
preliminary objection2024-05-10Public
Template-Order2024-05-10Not public
Acknowledgement-of-lodging2024-03-28Not public
Formal-checks_Notification-of-positive-outcome2024-03-28Not public
Exhibit KAP 102024-03-27Not public
Auxiliary Request 052024-03-27Not public
Auxiliary Request 012024-03-27Not public
Auxiliary Request 242024-03-27Not public
Auxiliary Request 122024-03-27Not public
Auxiliary Request 182024-03-27Not public
Exhibit KAP 072024-03-27Not public
Auxiliary Request 132024-03-27Not public
Auxiliary Request 152024-03-27Not public
Auxiliary Request 072024-03-27Not public
Defence to Revocation_amended2024-03-27Not public
Auxiliary Request 202024-03-27Not public
Auxiliary Request 192024-03-27Not public
Auxiliary Request 212024-03-27Not public
Auxiliary Request 232024-03-27Not public
Exhibit KAP 062024-03-27Not public
2024-02-23 Defence to Statement for DNI_signed2024-03-27Not public
Exhibit KAP 112024-03-27Not public
Auxiliary Request 102024-03-27Not public
2024-02-23 Defence to Revocation_signed2024-03-27Not public
Exhibit KAP 092024-03-27Not public
Auxiliary Request 062024-03-27Not public
Reply Roche regarding request for correction - formal checks II2024-03-27Not public
Auxiliary Request 172024-03-27Not public
Auxiliary Request 092024-03-27Not public
Auxiliary Request 022024-03-27Not public
Auxiliary Request 112024-03-27Not public
Auxiliary Request 042024-03-27Not public
Auxiliary Request 222024-03-27Not public
Auxiliary Request 162024-03-27Not public
Auxiliary Request 252024-03-27Not public
Auxiliary Request 262024-03-27Not public
Auxiliary Request 082024-03-27Not public
2024-03-07 Reply Roche regarding request for correction - formal checks_signed2024-03-27Not public
Auxiliary Request 142024-03-27Not public
Auxiliary Request 032024-03-27Not public
Exhibit KAP 082024-03-27Not public
Formal-checks_Request-for-correction2024-03-18Not public
2024-02-23 Defence to Statement for DNI_signed2024-03-07Not public
Auxiliary Request 242024-03-07Not public
Auxiliary Request 152024-03-07Not public
Auxiliary Request 052024-03-07Not public
Auxiliary Request 062024-03-07Not public
Auxiliary Request 022024-03-07Not public
Auxiliary Request 142024-03-07Not public
Exhibit KAP 102024-03-07Not public
Auxiliary Request 222024-03-07Not public
Auxiliary Request 212024-03-07Not public
Auxiliary Request 082024-03-07Not public
Auxiliary Request 132024-03-07Not public
Exhibit KAP 092024-03-07Not public
Exhibit KAP 072024-03-07Not public
Auxiliary Request 172024-03-07Not public
Auxiliary Request 162024-03-07Not public
Auxiliary Request 042024-03-07Not public
Auxiliary Request 102024-03-07Not public
Auxiliary Request 192024-03-07Not public
Auxiliary Request 032024-03-07Not public
Auxiliary Request 202024-03-07Not public
2024-03-07 Reply Roche regarding request for correction - formal checks_signed2024-03-07Not public
Auxiliary Request 092024-03-07Not public
2024-02-23 Defence to Revocation_signed2024-03-07Not public
Auxiliary Request 262024-03-07Not public
Exhibit KAP 112024-03-07Not public
Auxiliary Request 252024-03-07Not public
Auxiliary Request 072024-03-07Not public
Auxiliary Request 122024-03-07Not public
Exhibit KAP 062024-03-07Not public
Auxiliary Request 012024-03-07Not public
Auxiliary Request 232024-03-07Not public
Exhibit KAP 082024-03-07Not public
Auxiliary Request 182024-03-07Not public
Auxiliary Request 112024-03-07Not public
hearing invitation2024-03-06Public
Template-Order2024-03-06Not public
Template-Order2024-03-06Not public
2024-03-04 Reply Roche regarding date for oral hearing on opposition_signed2024-03-04Not public
Availability hearing2024-03-01Not public
Availability hearing2024-03-01Not public
hearing date2024-02-28Not public
Rejoinder to Preliminary Objection2024-02-26Not public
Rejoinder to Preliminary Objection2024-02-26Not public
Formal-checks_Request-for-correction2024-02-26Not public
Acknowledgement-of-lodging2024-02-23Not public
Exhibit KAP 072024-02-23Not public
Auxiliary Request 172024-02-23Not public
Auxiliary Request 012024-02-23Not public
2024-02-23 Defence to Statement for DNI_signed2024-02-23Not public
Auxiliary Request 062024-02-23Not public
Auxiliary Request 232024-02-23Not public
Auxiliary Request 072024-02-23Not public
Auxiliary Request 042024-02-23Not public
Exhibit KAP 062024-02-23Not public
Auxiliary Request 192024-02-23Not public
Auxiliary Request 112024-02-23Not public
Auxiliary Request 132024-02-23Not public
Auxiliary Request 222024-02-23Not public
2024-02-23 Defence to Revocation_signed2024-02-23Not public
Auxiliary Request 022024-02-23Not public
Auxiliary Request 182024-02-23Not public
Auxiliary Request 082024-02-23Not public
Auxiliary Request 212024-02-23Not public
Auxiliary Request 152024-02-23Not public
Auxiliary Request 092024-02-23Not public
Auxiliary Request 052024-02-23Not public
Auxiliary Request 242024-02-23Not public
Auxiliary Request 102024-02-23Not public
Exhibit KAP 102024-02-23Not public
Auxiliary Request 202024-02-23Not public
Auxiliary Request 262024-02-23Not public
Exhibit KAP 092024-02-23Not public
Auxiliary Request 162024-02-23Not public
Auxiliary Request 142024-02-23Not public
Auxiliary Request 122024-02-23Not public
Exhibit KAP 082024-02-23Not public
Auxiliary Request 252024-02-23Not public
Auxiliary Request 032024-02-23Not public
Exhibit KAP 112024-02-23Not public
Receipt2024-02-21Not public
2024-02-20 Request for confidentiality ACT_589997_2023_App_3514_2024_signed2024-02-20Not public
Exhibit KAP 6 - EN_confidential2024-02-20Not public
Exhibit KAP 6 - EN_confidential2024-02-20Not public
Exhibit KAP 05 - DE2024-02-20Not public
2024-02-20 Reply in preliminary objection Roche ACT_5899997_2023 App_3514_2024_signed2024-02-20Not public
Exhibit KAP 05a - EN2024-02-20Not public
2024-02-20 Reply in preliminary objection Roche ACT_5899997_2023 App_3514_2024_signed2024-02-20Not public
Outcome of the Order2024-02-20Not public
request for time extension2024-02-20Public
Receipt2024-02-15Not public
2024-02-15 Request extension time period statement of defence_signed2024-02-15Not public
request for pleadings2024-02-13Not public
commentPreliminaryObjection2024-02-09Not public
Response to Preliminary Objection2024-02-09Not public
Annex PO 01 to Response to Preliminary Objection2024-02-09Not public
Annex PO 03 to Response to Preliminary Objection2024-02-09Not public
Annex PO 02 to Response to Preliminary Objection2024-02-09Not public
preliminaryObjection2024-01-26Not public
Receipt2024-01-23Not public
2024-01-22 request for confidentiality ACT_589997 2023_signed2024-01-22Not public
Exhibit KAP 03 - EN2024-01-22Not public
Exhibit KAP 01 - EN2024-01-22Not public
2024-01-22 preliminary objection Roche ACT_5899997_2023(457596.3)_signed2024-01-22Not public
Exhibit KAP 03 - EN2024-01-22Not public
Exhibit KAP 04 - DE2024-01-22Not public
Exhibit KAP 02 - EN2024-01-22Not public
Exhibit KAP 02 - EN2024-01-22Not public
2024-01-22 preliminary objection Roche ACT_5899997_2023(457596.3)_signed2024-01-22Not public
Exhibit KAP 01 - EN2024-01-22Not public
Exhibit KAP 04a - EN2024-01-22Not public
Acknowledgement of access to case2024-01-02Not public
Notification Of Service2023-12-20Not public
AR Revocation Action - Tandem-Roche - 20.12.20232023-12-20Not public
Letter for Service2023-12-13Not public
Panel-Appointment2023-12-13Not public
epoUploadDocumentsWorkflow2023-12-06Not public
Document from EPO2023-12-06Not public
EPO-Request-for-case-pending2023-12-04Not public
Acknowledgement-of-lodging2023-12-04Not public
Formal-checks_Notification-of-positive-outcome2023-12-04Not public
Annex D12023-12-04Not public
Annex C22023-12-04Not public
Annex A12023-12-04Not public
Amended Statement2023-12-04Not public
Annex D32023-12-04Not public
Annex C12023-12-04Not public
Annex D42023-12-04Not public
Annex A22023-12-04Not public
Revocation Action dated 30 November 20232023-12-04Not public
Annex D52023-12-04Not public
Annex C32023-12-04Not public
Annex A32023-12-04Not public
Annex B12023-12-04Not public
Annex C42023-12-04Not public
Annex A42023-12-04Not public
Annex D22023-12-04Not public
Formal-checks_Request-for-correction2023-12-04Not public
Annex D12023-11-30Not public
Annex A32023-11-30Not public
Annex B12023-11-30Not public
Revocation Action dated 30 November 20232023-11-30Not public
Annex A42023-11-30Not public
Annex D22023-11-30Not public
Annex D32023-11-30Not public
Annex A22023-11-30Not public
Annex C32023-11-30Not public
Annex C22023-11-30Not public
Annex A12023-11-30Not public
Annex D52023-11-30Not public
Annex D42023-11-30Not public
Annex C12023-11-30Not public
Annex C42023-11-30Not public
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.

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.