Context: In the summer, there was hope that the Unified Patent Court’s (UPC) Court of Appeal (CoA) would soon decide whether an application for provisional measures (i.e., a party moving for a preliminary injunction (PI)) may prevail on the basis of an amended version of the patent claim language (July 26, 2024 ip fray article). The Dusseldorf Local Division (LD) had allowed automotive supplier Valeo to amend claims in a PI proceeding. But a CoA decision on this question has yet to come down.
What’s new: Yesterday (November 22, 2024), the Milan LD as well as the Milan seat of the Central Division (CD) adjudicated parallel cases over an insulin pump, with Insulet’s case against the Korean device maker (EOflow) being filed with the CD and the one against the Italian distributor (Menarini) with the LD. Through overlaps in the panel composition, the two divisions minimized the risk of divergent decisions. The LD decision is already published, and it denies the PI motion because the patent-in-suit (EP4201327 on a “fluid delivery device with transcutaneous access tool, insertion mechanism and blood glucose monitoring for use therewith”) is deemed to be likely invalid (PDF). The court rejected any claim amendments, be it in the form of auxiliary requests or an unconditional amendment.
Direct impact: Presumably, Insulet will appeal this decision and try to revive the PI request at least on the basis of its proposed narrower claim versions.
Wider ramifications: This is another opportunity for clarification unless the parties settle or the CoA disagrees with the court(s) below on the likelihood of invalidity of the patent in its granted form and therefore never reaches the amended claim language.
In its granted form, the patent-in-suit appeared to be non-novel over a prior art reference presented by the defendant. The decision stresses that the PI movant must convince the court that it will prevail on the merits in a main proceeding, that that the balance of interests (which particularly requires urgency) favors an injunction.
Given the fast-track nature of PI proceedings, the Milan LD considers auxiliary requests to amend patent claims inadmissible. Only two statutory bases exist in the Milan LD’s view: Rule 30.2 of the UPC’s Rules of Procedure (RoP) (defense to revocation counterclaim) and Rule 50.2 RoP (defense to stand-alone revocation claim). Those rules are in line with Art. 138 of the European Patent Convention (EPC) according to which a patent may be limited by amending the claims “before the competent court or authority relating to the validity of the European patent.” Of course, the UPC as a whole is a competent court on validity. But a PI proceeding is not a revocation proceeding, not even by way of a counterclaim.
While the Dusseldorf LD allowed Valeo’s patent claim amendment because Rule 263.2 RoP has scope for amendments of the “claim” in a litigation, particularly if such an amendment narrows the scope of the dispute, the Milan LD believes that Rule 263.2 is not an additional opening for claim amendments that are governed by Rules 30.2 and 50.2. Instead, Rule 263.2 would only apply to changes to a litigation claim such as withdrawing a request for an injunction against one of the accused products (that is ip fray‘s own wording and hypothetical example).
There are good policy reasons for the Milan LD’s position. It is about legal certainty for third parties. They should be able to rely on what they see in the patent register. If what they see there appears invalid to them, they may take their chances and make/sell a product anyway. If they then had to face a PI proceeding in which the patentee suddenly asserts some narrower (thus more defensible in the validity context) claim language, they would be disadvantaged. Also, in the revocation contexts there is a possibility of the patent actually being narrowed at the end of those proceedings. Not so in a PI proceeding where the claim scope will remain unchanged: only in the subsequent main lproceedings would there be a possibility of the patent actually being narrowed by the court.
The decision invokes the principles of proportionality, flexibility, fairness and equity, and in that regard also takes into consideration the fact that defendants have very limited time in PI proceedings to develop their argument.
Given that the CoA has not yet resolved the question, the order cites to Court of First Instance (CFI) decisions. The first one to be quoted is last month’s denial by the Lisbon LD of a PI in Ericsson v. ASUS (October 25, 2024 ip fray article). It is worth noting that the question did not have to be resolved in that case as the patent was deemed likely valid (and infringed) anyway (the PI was denied on non-technical grounds):
“A request (to amend the patent) would be inadmissible in preliminary injunction proceedings. The legal framework of the UPCA and the RoP for provisional measures does not expressly allow for such a possibility, in contrast to rule 30 RoP, which applies to actions on the merits. Furthermore, an analogous application of rule 30 RoP is not admissible. An auxiliary request to amend a patent claim in provisional measures is incompatible with the nature of such proceedings which are: summary proceedings; not on the merits; likelihood of the judgement on validity and infringement; urgency. Additionally, these proceedings require the lodging of a main case in which the outcome may differ. Therefore, the provisional nature of such action is inconsistent with the contemplated request.”
The second citation is to a February 27, 2024 decision by the Paris seat of the CD in Meril v. Edwards (PDF):
““The expression ‘amend its case’ contained in rule 263 RoP […] seems to be interpreted in connection of the previous expression ‘change its claim’, as they constitute a hendiadys which relates to any modification to the case by the means of the introduction of a new claim or the replacement of the original one (‘change its claim’), as the expressed reference to a counterclaim seems to evoke, or of the submission of new or different grounds of the claim (‘amend its case’). It follows that the request to replace the original application to amend the patent with a new set of amendments appears to be outside the scope of said rule 263 RoP, as it does not pertain to a claim.”
Rule 263 can apply to PI proceedings, but only in terms of changing the litigation claim, not the patent claim.
There was hope that the dispute between Abbott and SiBio could result in clarification, but in that one, the defendant appears particularly focused on saving litigation expenses. In Insulet v. Menarini (and the parallel Insulet v. EOflow case), there is now a greatly increased likelihood of clarification, but no one should hold their breath.
Panel: Presiding Judge Pierluigi Perrotti, Judge-rapporteur Alima Zana, Judge Anna-Lena Klein (originally from Munich, though not assigned to a Munich UPC division) and Technically Qualified Judge Uwe Schwengelbeck (who also sits on the Federal Patent Court of Germany).
The denial of the PI is a win for Bird & Bird’s Dr. Christopher Maierhoefer (“Maierhöfer” in German), Dr. Claus Becker, Jonathan Hechler, Giovanni Galimberti, Edoardo Bàrbera and Evelina Marchesoni.