Short Summary
This procedural order concerns a revocation action regarding European Patent EP4185356 before the Court of First Instance of the Unified Patent Court, Central Division Milan. The defendant (patent proprietor) sought to introduce auxiliary requests 2A to 13A into the proceedings in response to clarity objections raised by the claimant. The Court held that while the application was admissible, it was not allowable, rejecting the request because subsequent amendments are only permitted on an exceptional basis and the defendant should have foreseen the clarity objections.
Detailed Summary
This case concerns a revocation action filed by Fisher & Paykel Healthcare Limited (claimant) against Flexicare (Group) Limited (defendant) regarding European Patent EP4185356, which relates to a nasal cannula with a connector and manifold arrangement.
Procedural History:
On 29 May 2025, the claimant lodged a revocation action. On 1 August 2025, the defendant filed its defence to the statement of revocation along with an application to amend the patent, proposing 13 auxiliary requests. Auxiliary request 2 introduced the additional feature that 'the connector attaches to the manifold via an aperture formed in the manifold, wherein the aperture fluidically connects the gas tube to the manifold.' Auxiliary requests 3 to 13 contained similar features with slight wording variations.
On 1 October 2025, the claimant replied, arguing that the scope of auxiliary request 2 was unclear because the claim did not specify whether the gas tube was part of the claimed subject matter or how the aperture was supposed to provide a connection. On 31 October 2025, the defendant filed its rejoinder, maintaining that auxiliary requests 1 to 13 were admissible and allowable, and additionally filed auxiliary requests 2A to 13A, which required the nasal cannula to comprise a gas tube connected to the connector. The defendant argued these new requests were introduced as a precaution in direct response to the claimant's new clarity objections.
On 28 November 2025, the claimant objected that auxiliary requests 2A to 13A were late-filed and should be disregarded, arguing the defendant had not made a specific request under Rule 30.2 RoP and should have foreseen the clarity objections. During the Interim Conference on 18 December 2025, the defendant argued the subsequent auxiliary requests were directly responsive to the claimant's objections and would not affect proceedings' efficiency.
Legal Framework:
Under Rule 49.2(a) RoP, a defence to revocation may include an application to amend the patent, which must explain why the amendments satisfy Articles 84 and 123(2), (3) EPC. Under Rules 50.2 and 30.2 RoP, any subsequent request to amend may only be admitted with the Court's permission. Rule 30.2 RoP is a strict preclusion rule, and the patentee shall introduce all amendments with the initial application to amend. Only in exceptional circumstances shall subsequent amendments be allowed, reflecting the principle of parity of arms.
Court's Decision:
The Court held that the application to allow auxiliary requests 2A to 13A was admissible, treating the introduction of new auxiliary requests as an implicit request. However, the Court ruled the request was not allowable and rejected it. The Court reasoned that while the clarity objections were raised in the claimant's reply, the defendant should have and could have foreseen them, particularly because clarity is a specific aspect that must be addressed in an application to amend, especially when amendments are based on the description rather than dependent claims. The Court noted that the EPO's Guidelines for Examination specifically address clarity of wording for claims directed to entities or combinations of entities.
The Court further reasoned that the subsequent amendments could be seen as further limiting the claim, and it is precisely the goal of Rules 50.2 and 30.2 RoP to ensure that limiting amendments are not introduced 'in little steps' but in a straightforward manner. The defendant's argument regarding proceedings' efficiency was rejected, as the Court emphasized that subsequent amendments are only allowed on an exceptional basis and the preclusive nature of these rules must be respected.
Final Order:
The request dated 31 October 2025 to allow auxiliary requests 2A to 13A into the proceedings was rejected. The order was issued on 15 January 2026 by the full panel consisting of Presiding Judge Andrea Postiglione, Legally Qualified Judge Anna-Lena Klein, and Technically Qualified Judge Kerstin Roselinger.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before Milan (IT) Central Division- Section. Understanding the court's reasoning in Fisher & Paykel Healthcare Limited vs Flexicare (Group) Limited is valuable context for structuring arguments or assessing risk in similar proceedings.
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