Insulet Corporation v. A. Menarini Diagnostics S.R.L., Decision of the Court of First Instance of the UPC Local Division Milan concerning EP 4 201 327, 22 November 2024, Case No. UPC_CFI_400/2024, Order no. 56587/2024
On 22 November 2024, the Milan Local Division (“LD”) dismissed Insulet Corporation’s (“Insulet”) application for a preliminary injunction (“PI”) on the basis that it was more likely than not that the patent in issue is invalid. The court found that auxiliary requests to amend a patent are inadmissible in proceedings for provisional measures.
On the same day, the Milan seat of the Central Division separately rejected Insulet’s application for provisional measures against Eoflow. At the time of writing, this decision was not available and will not be addressed in this note.
Background
Insulet is the proprietor of a European patent with unitary effect, EP 4 201 327 (“the patent”), entitled “Fluid delivery device with transcutaneous access tool, insertion mechanism and blood glucose monitoring for use therein”. It relates to so-called ‘insulin patch pumps’ – disposable, wearable, tubeless insulin management systems for the automated delivery of insulin in diabetic patients. Insulet has developed a closed loop, cloud-connected insulin delivery system known as the Omnipod 5 insulin patch pump.
Menarini Diagnostics S.R.L (“Menarini”) is the exclusive European distributor of the EOPatch insulin patch pump, developed and manufactured by the South Korean company Eoflow, and marketed in Europe under the trade name GlucoMen Day Pump.
On 8 July 2024, Insulet filed an application for provisional measures (a PI) against Menarini, asserting that the offering for sale and sale of the EOPatch and GlucoMen Day Pump infringes the patent. The Milan LD found that the matter was not suitable to be heard without hearing the defendant, and scheduled the hearing for 15 October 2024.
Menarini lodged its objections to the PI application on 6 August 2024 arguing that it is more likely than not that the patent is invalid, denying infringement and arguing there was no urgency and the balance of interests weighed against granting the PI due to a risk to patient health if such measures were granted.
On 26 August 2024, Insulet filed its reply, which included four auxiliary requests to amend the patent. On 16 September, Menarini filed its rejoinder, objecting to the admissibility of the auxiliary requests on the basis that they were filed in breach of Rule 263 RoP and Articles 84 and 123 EPC, and that they were not patentable.
Two weeks later, on 30 September 2024, Insulet lodged an application under Rule 263.3 RoP to unconditionally limit its claim to those auxiliary requests. The judge-rapporteur invited Menarini to comment on this application. Menarini argued that provisional measures cannot be granted on the basis of amended claims, and that an application under Rule 263.3 RoP is only available in main proceedings. Menarini also challenged the validity of the proposed amendments.
The oral hearing took place on 15 October 2024.
The Decision
The Milan LD set out the requirements for a PI to be granted (Article 64 UPCA and Rule 211 RoP). The applicant must demonstrate that:
1. The applicant is entitled to initiate proceedings;
2. The patent is valid; and
3. Its rights are being infringed or that such infringement is imminent.
In addition, urgency and the balance of interests are taken into account. The balance of interests must favour the applicant.
The requirements are cumulative (as per the Lisbon LD in Ericsson v. ASUSTek, CFI 317/2024, order of 15 October 2024), meaning that the absence of one is enough to warrant the dismissal of the application.
Validity
The court noted that the fact that an applicant files auxiliary request does not in itself gives rise to any doubts regarding validity, but are instead indicative of legal caution (10x Genomics v. Curio, Dusseldorf LD, UPC CFI no. 463/2023, order 30 April 2024).
In the present application, the Milan LD found that there is an insufficient degree of certainty that the patent is valid (10x Genomics v. NanoString, UPC CoA no. 335/2023, order 26 February 2024). Specifically, it found that claim 1 of the patent as granted appears to be lacking novelty in the light of the prior art, a US patent referred to as US 2009/0124994 (“US 994”).
Admissibility of the auxiliary requests
The court then went on to consider the admissibility of the four auxiliary requests.
Rule 30 RoP provides that the proprietor may include an application to amend the patent in the defence to a counterclaim for revocation. Rule 30.2 RoP provides that any subsequent request to amend the patent may only be admitted with the court’s permission.
The Milan LD found that auxiliary requests to amend a patent pursuant to Rule 30.2 RoP are not admissible in proceedings for provisional measures (Lisbon LD in Ericsson v. ASUSTek, CFI 317/2024, order of 15 October 2024).
Auxiliary requests to amend a patent are expressly only permitted in the defence to a counterclaim for revocation (Rule 30.2 RoP) or in the defence to a revocation action (Rule 50.2 RoP). As such, they may only be lodged in main proceedings before the court which has jurisdiction to issue a final decision on validity. If, as is the case with proceedings for provisional measures, the court is not competent to decide on validity, the Milan LD said that the proprietor has no right to limit the patent.
The court went on to say that this approach is also consistent with the need for expediency of proceedings for provisional measures, and noted that third parties other than those on the receiving end of a PI application must have clarity and certainty regarding the scope of a patent.
The court also said that the application provided for by Rule 30.2 RoP (amendment of the patent) is distinct and different from the amendment of legal claims under Rule 263 RoP (see below).
The court therefore dismissed the auxiliary requests.
Application to unconditionally limit claim to auxiliary requests – Rule 263.3 RoP
Rule 263 RoP provides that a party may, at any stage of the proceedings, apply to the court for leave to change its claim or amend its case. Rule 263.3 RoP provides that leave to limit a claim in an action unconditionally shall always be granted.
Insulet argued that the auxiliary requests were an attempt to amend its case under Rule 263.3 RoP. However, the Milan LD found this application to unconditionally limit its claim to the auxiliary request to be inadmissible.
The Milan LD agreed with earlier UPC case law where the court held that the phrase “amend its case” in Rule 263 RoP refers to any modification to the case by introducing a new claim or changing its claim, even in the context of provisional measures. However, the phrase “claim limitation” in Rule 263.3 RoP is a different type of request.
The court said that Insulet was attempting to use a different instrument to introduce a request to amend the patent, which is governed by Rule 30.2 RoP, and which, in this case, it had already found to be inadmissible.
Security for costs & interim costs
Menarini sought security for costs in the amount of EUR 200,000 on the basis that Insulet is a US company and the US is not party to any international treaty with Italy (where Menarini has a registered office), the EU or the UPC, which would allow for the enforcement of a decision regarding the reimbursement of its costs. The court dismissed this application, noting that security for costs provisions are not intended to protect against the difficulties of enforcing a cost decision abroad, and that there was no evidence that Insulet would be unable to or unwilling to pay. The application was therefore dismissed.
Finally, the court made an interim costs award in favour of Menarini of EUR 117,465, based on Menarini’s undisputed legal expenses to date.
Comment
This decision highlights the UPC’s overarching aims of ensuring procedural efficiency and ensuring legal certainty for third parties.
The order is here.
