EP 4 185 356 B1 relates to a nasal canula.
The patent was not opposed at the EPO.
Brief outline of the case before the UPC
Fisher & Paykel Healthcare Limited lodged a revocation action against Flexicare (Group) Limited before the CD-CFI Milan.
In the order UPC_CFI_480/2025, the CD Milan refused to admit AR2A-13A into the proceedings.
This will be the topic of the present blog.
The claimant’s-Fisher & Paykel Healthcare-point of view
In their rejoinder to the reply to the defence to the application to amend the patent, F&P stressed that AR2A-13A were late filed and should be disregarded.
They maintained that the defendant, Flexicare, had not lodged a specific request to the Court to AR2A-13A into the proceedings, contrary to the requirements of Rule 30.2 RoP.
F&P argued that Flexicare should have foreseen F&P’s clarity objections and prepared the AR in a manner complying with the EPC.
The defendant’s-Flexicare-point of view
During the Interim Conference, Flexicare argued that that the subsequently introduced AR were directly responsive to NEW objections made by F&P in their reply, and they did not introduce any issues that had not previously been discussed by the parties.
Therefore, it would be proportionate to allow them into the proceedings, and proceedings’ efficiency would not be affected by allowing the amendments into the proceedings.
Legal background
According to R 49.2(a) RoP UPC, the defence to revocation may inter alia include an application to amend the patent. The application shall contain, inter alia, an explanation as to why the amendments satisfy the requirements of Art. 84 and 123(2+3) EPC, R 50.2 RoP UPC, R 30.1(b) RoP UPC. Any subsequent request to amend the patent may only be admitted into the proceedings with the permission of the Court, R 50.2 RoP UPC, R 30.2 RoP UPC. R 30.2 RoP UPC also applies to an intended amendment of an amendment (CD 4Paris, UPC_CFI_255/2023, order of 27 February, 2024, Meril v Edwards, margins 16 to 27).
The Decision of the CD-CFI Milan
The court concluded that the subsequent application for AR2A-13A is admissible, but not allowable.
While there is no explicit request to allow auxiliary requests 2A-13A into the proceedings, the court regarded the introduction of new AR as an implicit request.
The request was deemed admissible. Flexicare stated that the AR were introduced as a precaution and in direct response to the clarity issues raised by F&P in their reply. This explanation rendered the request admissible.
The request to allow AR2A-13A into the proceedings was held not allowable and was therefore rejected.
The explanation for the newly introduced AR, i.e. that these AR were introduced as a precaution and in direct response to the new objections of lack of clarity raised in F&P’s reply, is no basis to allow the subsequent AR into the proceedings.
The CD CFI Milan, held that subsequent AR shall only be allowed into the proceedings on an exceptional basis.
While it is true that the clarity objection to which Flexicare reacted with the subsequent AR were only submitted in F&P’s reply, Flexicare should have and could have foreseen the F&P’s clarity objection.
Clarity is one aspect that specifically needs to be addressed in an application to amend the patent, especially with regard to amendments based on the description, not on dependent claims.
As F&P pointed out in the rejoinder to the reply to the defence to the application to amend the patent, the EPO’s Guidelines for Examination F.IV, 4.14.1, specifically deal with the clarity of the wording of claims directed to one entity or a combination of entities.
Flexicare’s explanations during the Interim Conference dis not change the court’s assessment.
While it is true that the subsequent amendments did not introduce any new issues not previously discussed by the parties but reacted to the F&P’s objection, the parties’ discussions on the correct interpretation of the added feature “the aperture fluidically connects the gas tube to the manifold” show that the scope of the first set of AR2-13 might be seen as broader. Flexicare argued that the skilled person would understand this feature in the sense that such fluidic connection between the gas tube and the manifold occurs via the defined aperture, [only] when the gas tube is attached to the manifold via the connector as introduced in feature 1.2. F&P disagreed with this claim construction and stressed that the respective feature simply requires a connection. Thus, the subsequently added feature, introduced by AR2A-13A, which specifically require the nasal cannula to comprise a gas tube, can be seen as further limiting the claim.
In the court’s view, it is specifically the goal of R 50.2, 30.2 RoP UPC to make sure that (limiting) amendments are not introduced into the proceedings “in little steps”, but in a straightforward manner.
Flexicare’s argument that the proceeding’s efficiency would not be affected did not lead to a differing assessment. . The court must respect the preclusive nature of R 50.2, 30.2 RoP UPC. The fact that the other party and the court might have enough time to consider the subsequent amendments before an oral hearing are not a sufficient reason for allowing subsequent amendments.
Comments
The present decision calls for a series of comments, all not favourable to the UPC.
At least at the EPO, when AR are deemed admissible, they cannot be deemed not allowable for purely formal reasons. They can only be deemed not allowable for substantial reasons. Admitting AR but declaring them not allowable for formal reasons, is nothing more than sophistries of small-minded judges, since at the same time, they trample on the right to be heard.
That the RoP UPC have been devised by a self-co-opted group of lawyers and judges behind the back of the ratifying parliaments, and have introduced a big haste in the proceedings, is not speaking in favour of those.
Using the RoP to dismiss AR filed in reply to NEW objections of the claimant in revocation, is odd to say the least. Where is the right to be heard, enshrined in the EPC, cf. Art 113(1) EPC, respected with this way of dealing at the UPC. NEW objections were raised, which changed the legal and factual framework of the case.
The present decision implies that proprietors, when filing AR in reply to an action for revocation, should urgently get a crystal ball so as to be aware of possible new objections raised by the claimant in revocation in reply to those AR.
It is also rather odd that the CD-CFI Milan calls the Guidelines to support its point of view whilst the BA-EPO make clear that what matters is the EPC as such and its Implementing Regulations, and not the interpretation of EPC by the EPO in the Guidelines. The part of the Guidelines quoted is very limited in its saying, and do certainly not allow to disregard the right to be heard.
To sum it up, the present decision is anything but convincing and I would have preferred never to have had to read such absurdities. Should the patent eventually be revoked, the present decision is a first step for a denial of justice at the UPC.
There could be a way for proprietors to hold up the UPC in its haste: file a request for limitation at the EPO. Such a request for limitation is opened to any proprietor and in my opinion neither R 50.2 nor R 30.2 RoP UPC can hinder a proprietor to file such a request.
Comments
Leave a comment