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UPC CFI 380/2024

Jul 3, 2024·EP4201327 +1 more: FLUID DELIVERY DEVICE WITH TRANSCUTANEOUS ACCESS TOOL, INSERTION MECHANISM AND BLOOD GLUCOSE MONITORING FOR USE THEREWITH

Case details
Status
Case Closed
Action
Provisional measures
Category
Provisional Measures
Parties
Claimants
Reps: Marc Grunwald (Peterreins Schley)
Respondents
Reps: Mirko Weinert (Hoyng Rokh Monegier)
Division
Milan CD
Judges
Technology
Packaging & Conveying
Language
English
Decisions
  • 2024-11-22
    PI deniedApplication for provisional measures

    The Milan Central Division rejected Insulet Corporation's application for a preliminary injunction against EOFLOW Co., Ltd. for alleged infringement of EP 4 201 327 (insulin pump). The Court held that the applicant had not established with sufficient certainty that the patent was valid (particularly claim 1 which appeared to lack novelty or inventive step over the prior art). The auxiliary request to amend the patent under R. 30.2 RoP was inadmissible in provisional measures proceedings given the requirement for expediency and the adversarial principle. Insulet was ordered to bear the costs; value in dispute EUR 2,500,000; cost ceiling EUR 400,000.

    Legal issues:Provisional measures (R. 206 RoP; Art. 62 UPCA)Validity of patent in provisional measures proceedingsAdmissibility of patent amendment in provisional measures (R. 30.2 RoP)Claim interpretation (R. 263.2 RoP)
Documents
Document titleDatePublic
Case Closure Formal Check2025-05-02Not public
Outcome of the Order2025-02-15Not public
ORDER 11 February 20252025-02-15Public
Receipt2025-01-31Not public
Rejoinder Cost Fixation Proceedings2025-01-31Not public
Rejoinder Cost Fixation Proceedings2025-01-31Not public
Exhibit PS C-62025-01-31Not public
ORDER2024-11-27Public
ORDER2024-11-27Public
ORDER2024-11-27Not public
ORDER2024-11-22Public
ORDER2024-11-22Not public
Template-Order2024-11-22Not public
Template-Order2024-11-22Not public
Outcome of the Order2024-11-22Not public
Outcome of the Order2024-11-22Not public
Outcome of the Order2024-11-22Not public
Outcome of the Order2024-11-22Not public
Headnote-and-Keywords2024-11-22Not public
Measures_DecisionOutcome_Notification.pdf2024-11-22Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
39640/2024/OH/MIL-CTL/UPC2024101609AM2024-10-17Not public
Receipt2024-10-15Not public
HRM 422024-10-14Not public
Filing revocation action2024-10-14Not public
Outcome of the Order2024-10-09Not public
ORDER 262A 9 OCTOBER2024-10-09Public
Outcome of the Order2024-10-09Not public
ORDER 9 OCTOBER 20242024-10-09Public
Response R. 262A Application2024-10-09Not public
240916_UPC_CFI_380-2024_Objection_PI_redacted_A2024-10-08Not public
Exhibit HRM_18_redacted_A2024-10-08Not public
Exhibit HRM_05_redacted_A2024-10-08Not public
ORDER 8 OCTOBER 20242024-10-08Public
Receipt2024-10-08Not public
241007_RoP 262A_signed2024-10-07Not public
241007_RoP 262_signed2024-10-07Not public
HRM40-Legal_Opinion2024-10-07Not public
HRM39-Second_Affidavit_Kim_Confidential2024-10-07Not public
HRM35-Declaration_of_Marco_Antonio_Sicurani2024-10-07Not public
HRM41-Letter_by_Unita_Organizzativa_Stazione_Unica_Appaltante_Regionale2024-10-07Not public
HRM40-Legal_Opinion2024-10-07Not public
241007_Rejoinder_PI_signed2024-10-07Not public
241007_Rejoinder_PI_signed2024-10-07Not public
HRM34-Extended_European_Search_Report2024-10-07Not public
HRM36-Framework_Agreement-Friuli_Venezia_Giulia2024-10-07Not public
HRM36-Framework_Agreement-Friuli_Venezia_Giulia2024-10-07Not public
HRM41-Letter_by_Unita_Organizzativa_Stazione_Unica_Appaltante_Regionale2024-10-07Not public
HRM39-Second_Affidavit_Kim_Confidential2024-10-07Not public
HRM35-Declaration_of_Marco_Antonio_Sicurani2024-10-07Not public
HRM37-Ancona_decision2024-10-07Not public
HRM33-Prof_Pott 2nd_report2024-10-07Not public
HRM37-Ancona_decision2024-10-07Not public
HRM38-Applicant_Annual_Reports2024-10-07Not public
Headnote-and-Keywords2024-10-01Not public
ORDER 1 OCTOBER 20242024-10-01Public
Outcome of the Order2024-09-28Not public
ORDER 27 September 20242024-09-28Public
ORDER 27 September 20242024-09-28Not public
Receipt2024-09-27Not public
Receipt2024-09-27Not public
Exhibit PS 7a2024-09-26Not public
Application for leave to change claim2024-09-26Not public
Exhibit PS 222024-09-26Not public
Exhibit PS 7a2024-09-26Not public
Exhibit PS 202024-09-26Not public
Exhibit PS 292024-09-26Not public
Exhibit PS 192024-09-26Not public
Statement of Reply2024-09-26Not public
Exhibit PS 182024-09-26Not public
Statement of Reply (redacted)2024-09-26Not public
Exhibit PS 212024-09-26Not public
Exhibit PS 26a2024-09-26Not public
Exhibit PS 282024-09-26Not public
Exhibit PS 272024-09-26Not public
Exhibit PS 242024-09-26Not public
Exhibit PS 262024-09-26Not public
Exhibit PS 232024-09-26Not public
Exhibit PS 302024-09-26Not public
Exhibit PS 252024-09-26Not public
Reply to Confidentiality Request2024-09-25Not public
Headnote-and-Keywords2024-09-24Not public
Outcome of the Order2024-09-24Not public
ORDER2024-09-24Public
Response to R. 313 Order2024-09-24Not public
240924_UPC_CFI_380-2024_comment_on_intervention_RoP314_signed2024-09-24Not public
ORDER2024-09-23Not public
ORDER2024-09-23Public
ORDER2024-09-23Not public
ORDER2024-09-17Not public
Receipt2024-09-17Not public
240916_UPC_CFI_380-2024_RoP_262A_signed_2024-09-16Not public
240916_UPC_CFI_380-2024_RoP_262_signed_2024-09-16Not public
Acknowledgement-of-lodging2024-09-16Not public
HRM28 - Babiker et al. (2022)2024-09-16Not public
HRM16 - Webpage OMNIPOD2024-09-16Not public
HRM18 - Affidavit Richard An_confidential2024-09-16Not public
240916_UPC_CFI_380-2024_Objection_PI_signed2024-09-16Not public
HRM05 - Affidavit_Jesse Kim_confidential2024-09-16Not public
HRM22 - Statement Mr. Borghesi_Oct232024-09-16Not public
HRM07 - Feature Analysis Claim 1 EP 4 201 327 C02024-09-16Not public
HRM12 - US7144384B2 (Gorman)2024-09-16Not public
HRM06 - US Appeal Court2024-09-16Not public
HRM17 - Menarini Cease and Desist Declaration2024-09-16Not public
HRM13 - Insulet SEC Annual Report 20232024-09-16Not public
HRM21 - Statement Ms. Romanzi2024-09-16Not public
HRM18 - Affidavit Richard An_confidential2024-09-16Not public
HRM09 - WO2010_055504A1 (Yodfat)2024-09-16Not public
HRM18 - Affidavit Richard An_confidential2024-09-16Not public
HRM32 - FDA_Recall Omnipod2024-09-16Not public
HRM27 - Statement Mr. Dijkers2024-09-16Not public
HRM30 - Kulzer et al. (2022)2024-09-16Not public
HRM08 - US2009124994A1 Roe2024-09-16Not public
HRM24 - Statement Ms. Argyrakopoulou2024-09-16Not public
HRM29 - Berget et al. (2019)2024-09-16Not public
HRM10 - Sclater et al. - Mechanisms and Mechanical Devices Sourcebook -part 12024-09-16Not public
HRM05 - Affidavit_Jesse Kim_confidential2024-09-16Not public
HRM14 - Insulet Internat. Ltd. Annual Report 20222024-09-16Not public
HRM21 - Statement Ms. Romanzi2024-09-16Not public
HRM25 - Statement Mr. Frenoy2024-09-16Not public
240916_UPC_CFI_380-2024_Objection_PI_signed2024-09-16Not public
HRM31 - Park et al. (2022)2024-09-16Not public
HRM15 - Macrotrends2024-09-16Not public
HRM19 - Statement Mr. Park2024-09-16Not public
HRM17 - Menarini Cease and Desist Declaration2024-09-16Not public
HRM20 - Statement Dr. Trada2024-09-16Not public
HRM23 - Statement Mr. Borghesi_Mar24 (Borghesi II)2024-09-16Not public
HRM26 - Statement Dr. Vervoort2024-09-16Not public
HRM05 - Affidavit_Jesse Kim_confidential2024-09-16Not public
HRM11 - Irby 1999 - Optimization and Application of a Wrap-Spring Clutch to a Dynamic Knee-Ankle-Foot Orthosis2024-09-16Not public
240916_UPC_CFI_380-2024_Objection_PI_signed2024-09-16Not public
HRM04 - opinion Prof. Pott2024-09-16Not public
HRM20 - Statement Dr. Trada2024-09-16Not public
HRM10 - Sclater et al. - Mechanisms and Mechanical Devices Sourcebook -part 2.pdf2024-09-16Not public
Response to R. 333 Application2024-09-16Not public
ORDER REVIEW2024-09-13Not public
summons2024-09-11Not public
ORDER2024-09-11Public
Acknowledgement-of-lodging2024-09-10Not public
240906_S12123-24-01_Application_to_review_signed2024-09-06Not public
Hearing-Dates2024-09-04Not public
ORDER2024-09-04Not public
Hearing-Dates2024-09-04Not public
ORDER2024-09-04Not public
ORDER2024-09-04Not public
Template-Order2024-09-04Not public
ORDER2024-09-04Not public
Template-Order2024-09-04Not public
240903_RoP340_rejoinder_EOFlow_signed2024-09-03Not public
Rejoinder re Connection Joinder2024-09-03Not public
240902_RoP340_comments_on_preliminary_order_signed2024-09-02Not public
Insulet v. EOFLOW - UPC_CFI_380/2024 - Central Division Milan2024-08-30Not public
ORDER2024-08-28Not public
Receipt2024-08-27Not public
Exhibit PS 182024-08-27Not public
Exhibit PS 24a2024-08-27Not public
Exhibit PS 252024-08-27Not public
Exhibit PS 202024-08-27Not public
Exhibit PS 7a2024-08-27Not public
Exhibit PS 232024-08-27Not public
Exhibit PS 23a2024-08-27Not public
Exhibit PS 212024-08-27Not public
Exhibit PS 192024-08-27Not public
Additional Submission2024-08-27Not public
Exhibit PS 222024-08-27Not public
Exhibit PS 242024-08-27Not public
Receipt2024-08-26Not public
HRM02 - LD Milan Procedural Order 12 July 20242024-08-26Not public
240826_RoP340 request of connection joinder_signed2024-08-26Not public
HRM03 - Objection Menarini 6 August 2024 (redacted)2024-08-26Not public
HRM01 - Application for provisional measures 8 July 2024 - Insulet vs. Menarini2024-08-26Not public
Notification Of Service2024-08-23Not public
Receipt for EOFLOW2024-08-23Not public
Acknowledgement of access to case2024-08-22Not public
Panel-Appointment2024-07-11Not public
Letter for Service2024-07-08Not public
ORDER2024-07-08Public
Panel-Appointment2024-07-08Not public
ORDER2024-07-08Public
ORDER2024-07-05Not public
ORDER2024-07-05Not public
Panel-Appointment2024-07-03Not public
Application-For-Measures-Receipt2024-07-03Not public
Formal-checks_Notification-of-positive-outcome2024-07-03Not public
Application-For-Measures-Acknowledgement2024-07-03Not public
Exhibit PS D62024-07-03Not public
Exhibit PS 172024-07-03Not public
Exhibit PS 112024-07-03Not public
Exhibit PS 82024-07-03Not public
Exhibit PS 52024-07-03Not public
Exhibit PS 32024-07-03Not public
Exhibit PS D 52024-07-03Not public
Exhibit PS 102024-07-03Not public
Exhibit PS D 22024-07-03Not public
Exhibit PS 22024-07-03Not public
Exhibit PS 72024-07-03Not public
Exhibit PS D12024-07-03Not public
Application for Provisional Measures2024-07-03Not public
Exhibit PS 132024-07-03Not public
Exhibit PS D42024-07-03Not public
Exhibit PS D32024-07-03Not public
Exhibit PS 22024-07-03Not public
Exhibit PS 42024-07-03Not public
Exhibit PS 162024-07-03Not public
Exhibit PS 32024-07-03Not public
Exhibit PS 142024-07-03Not public
Exhibit PS 12024-07-03Not public
Exhibit PS 122024-07-03Not public
Exhibit PS 152024-07-03Not public
Exhibit PS 62024-07-03Not public
Exhibit PS 92024-07-03Not public
Plain-English summary

Insulet Corporation (US), maker of OmniPod insulin pumps, applied for a preliminary injunction against EOFLOW Co. Ltd (South Korea) based on EP 4 201 327 (a patent for a fluid delivery device used in insulin pumps). The Milan Central Division denied the PI, finding that prior art US'994 disclosed all features of claim 1 with sufficient certainty to cast serious doubt on the patent's validity. Insulet's auxiliary request to amend the patent in PI proceedings was held inadmissible, and Insulet was ordered to bear costs.

Accepted arguments
What the court agreed with — by party.

  • Patent EP 4 201 327 claim 1 is likely not novel in view of prior art US'994

    RespondentLegal basis: Art. 54 EPC

    Note: Court found that US'994 discloses all features of claim 1 of the patent at issue (fluid delivery device with rotating nut/clutch mechanism), negating validity with sufficient certainty to deny the PI.

  • Auxiliary request to amend patent under R. 30.2 RoP is inadmissible in provisional measures proceedings

    RespondentLegal basis: R. 30.2 RoP; R. 263.2 RoP

    Note: Court held that the expedient nature of PI proceedings, combined with adversarial principle and right of defence, makes patent amendments under R. 30 inadmissible; 'amend its case' in R. 263.2 refers only to pleadings, not patent claims.

Rejected arguments
What the court did not agree with — and why.

  • US'994 contains unworkable embodiments and should not be read to disclose all features of claim 1

    ClaimantLegal basis: Art. 54 EPC; general principles of claim interpretation

    Reason: Court applied the principle that patent descriptions must be interpreted to make the invention workable; US'994 Fig. 4 and Fig. 5 disclose two distinct workable embodiments, and the keyhole feature does not render the device non-functional.

  • Court should permit patent amendment as auxiliary request to cure any validity defect

    ClaimantLegal basis: R. 30.2 RoP; R. 263.2 RoP

    Reason: Patent amendment under R. 30.2 RoP is inadmissible in PI proceedings; R. 263.2 RoP's 'amend its case' refers only to pleadings amendments.

Key legal principles
Doctrines and rules cited in the reasoning.
PI applicant must cumulatively prove entitlement, validity, and infringement to sufficient degree of certainty (R. 211.2 RoP)Patent amendment under R. 30.2 RoP is inadmissible in provisional measures proceedings due to expediency requirement and adversarial principleR. 263.2 RoP 'amend its case' means pleadings amendment only, not amendment of patent claimsPatent descriptions must be interpreted to make the invention workable rather than unworkableInsufficient validity showing is grounds for denial of PI even without deciding infringement

Browse other cases on this principle.

Prior art relied on
References cited and the role they played.
  • US'994 (US patent cited as prior art against EP 4 201 327 claim 1)Novelty-destroying
Claim construction notes

The court construed claim 1 of EP 4 201 327 as covering a fluid delivery device with a drive mechanism comprising a drive wheel, lead screw, plunger, threadable nut, and clutch configured to allow the nut to pass through when disengaged and grip the nut when engaged so the drive wheel rotates the nut to advance the plunger. The court found US'994 discloses two embodiments (Figs. 4 and 5) that between them cover all these features.