Life Sciences

Insulet v Menarini Diagnostics (UPC CFI NO. 400/2024)

Decision date:

22 November 2024

Court
Milan LD
Patent
EP 4 201 327

Full decision available here:

Osborne Clarke summary

  • Insulet filed an ex parte application for provisional measures against Menarini for alleged infringement of its patent relating to an insulin patch pump. Insulet claimed that Menarini infringed through offering and selling pumps of which it is an exclusive European distributor for the South Korean company EOPatch. Insulet requested a preliminary injunction, as well as ancillary measures including a declaration of origin and distribution channels, identification of all parties involved and delivery up. The requirements for an ex parte order were not met and the Milan LD allowed Menarini to submit responses and attend a hearing.
  • With respect to preliminary injunctions, an applicant is required to provide reasonable evidence to satisfy the court with a sufficient degree of certainty (that is, more likely than not) that: i) it is entitled to initiate the proceedings under Article 47 UPCA; ii) the patent is valid; and iii) its rights are being infringed or that infringement is imminent. In this case, the court held that Insulet did not establish with a sufficient degree of certainty that the patent was valid.
  • Menarini successfully argued to a sufficient degree that the patent lacked novelty and therefore the court considered it more likely than not that the patent was invalid. As such, the preliminary injunction was refused.
  • Insulet had filed four auxiliary requests to amend the patent but the Milan LD followed previous UPC case law and held that the auxiliary requests in proceedings for provisional measures are not admissible prior to the main proceedings. The court rejected the assertion that the amendments were amendments to Insulet's case and therefore fell within Rule 263 RoP. Amendments to the case under Rule 263 RoP refer to modifications to the case: for example, the introduction of a new claim or the substitution of the original claim. In contrast, an application to amend a patent is governed by Rule 30 RoP and such a request can only be made in the main proceedings in a defence to a counterclaim for revocation or in a defence to a revocation action.

Issue

Provisional measures
Preliminary injunction refused

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