Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 24 February 2025 - is below:

UPC

Helsinki Local Division grants permission to extend infringement case to non-UPC territory, Spain
(UPC_CFI_214/2023)

On 8 January 2025, AIM Sport (AIM) filed an application based on r. 203 RoP to amend its case against a number of Supponor companies (Supponor) in relation to its patent EP’ 663, and to add a further defendant under r. 305 RoP. Due to Supponor’s preliminary objection to AIM’s original infringement action, which had originally been allowed at first instance but dismissed on appeal (see the decision of the Court of Appeal in our Weekly Update here), Supponor is yet to submit its defence. After considering the issue, the Helsinki Local Division held that AIM was entitled to amend its claims to extend the infringement case to Spain and Germany and to add an additional UK-based defendant (TGI Sport Virtual UK Limited, previously Supponor UK Ltd) as a new defendant. Other amendments were also allowed but are not covered in this update.

AIM requested that its case should be extended to Spain on the basis that in previous pleadings it had sought a preliminary injunction (but not a separate permanent injunction) for the alleged infringement of the Spanish designation of EP’ 663 and the fact that the Supponor defendant companies (including the Spanish company) were jointly committing the alleged infringing acts. AIM argued that, although a protective letter had been filed in Spain, this did not amount to ongoing proceedings in Spain which would prevent the company from being included in the case. Further, AIM stated that the “Court has jurisdiction and competence to decide upon the infringement claims in Spain”. AIM also requested that its case should be expanded to include TGI Sports Virtual Limited UK as AIM had become aware, after the lodging of the original Statement of Claim, of a draft agreement which showed that the new UK-based defendant was involved in infringing acts in Germany jointly with the other defendants.

In both cases, Supponor argued that AIM had not justified the reasons for its late applications to amend. Supponor explained that information relating to both the UK defendant and the Spanish designation of EP’ 663 were already available to AIM prior to filing its original infringement claim. 

In assessing the issues, the Court noted that the key points to consider when assessing an application to amend are the “presumption of r. 23 RoP that three months are sufficient for defendants to present their defence” and also that “the frontloaded procedure in the UPC must be protected”. As no defence had yet been submitted in the proceedings, AIM agreed that the defendants should have the full three months to lodge their defence should its amendments be accepted. As such, these requirements were not at risk and it was up to the Court to examine the circumstances of the amendments.

In relation to AIM’s request to include Spain in the scope of the infringement claim, the Court allowed the amendment to allow AIM to seek a permanent injunction in relation to the Spanish designation explaining that there was a high likelihood that if the amendments were not allowed AIM would initiate additional proceedings concerning the Spanish designation against Supponor “in the UPC or other courts” which would lead to a risk of “irreconcilable and inconsistent decisions”. Although the Court acknowledged that the amendment could have been made at an earlier stage, it was willing to allow the amendment due to the “unconventional situation” in which the case was re-starting which meant that there was no threat to the frontloaded nature of the proceedings. In making its decision, the Court also referred to AIM’s original Statement of Claim which included the Spanish subsidiary as a defendant and noted that “AIM already sought damages in relation to Supponor Limited’s infringement of the Spanish designation”. (Supponor Limited was one of the original defendants).

The Court also held that, on the basis of procedural economy, the new UK defendant should be included. The Court again noted that, if it did not allow the new defendant to be added to the case, AIM may choose to initiate new proceedings which would result in the risk of irreconcilable and inconsistent decisions. As a result, the scope of the case was also expanded to include claims of infringement by the new UK defendant in Germany.    

Of interest in the judgment was the Court’s lack of discussion regarding the UPC’s jurisdiction over the Spanish designation of EP’ 663 in proceedings on the merits. While the Court noted that AIM had previously claimed damages for infringement of the Spanish designation, it is not clear how this was formulated in the original Statement of Claim nor how the UPC would have decided that it had jurisdiction to determine infringement of a national designation of an EP in a non-UPC territory in the absence of this additional factor.  Additionally, the Court did not explain how a final decision on infringement in the existing unamended claim concerning national ‘UPC’ designations of EP’ 663 under ‘UPC’ law would be irreconcilable or inconsistent with a final decision on infringement of the Spanish designation under Spanish law, which it is assumed the UPC will have to apply in relation to the Spanish designation.  The different national designations are, after all, parallel rights. 

The Court did grant permission to appeal its order, accepting that there was only limited guidance so far from the Court of Appeal on the various issues.

BELGIUM

Brussels Enterprise Court rules on SPC manufacturing waiver.

The Brussels Enterprise Court has held that a manufacturing waiver for a biosimilar is valid without a reference number of the marketing authorisation for export countries. The claimant, Amgen, owns a portfolio of patents relating to denosumab, the active ingredient in Prolia and Xgeva, and processes for its manufacture. Amgen has been granted SPC protection in Belgium in respect of denosumab until November 2025.   

In March 2024, Samsung Bioepis (SB) notified the Belgian Intellectual Property Office of its intention to manufacture biosimilar denosumab in Belgium under the SPC manufacturing waiver (SPC Manufacturing Waiver Regulation No 2019/933) during the period of denosumab SPC protection for the purpose of exporting the product from the EU. Amgen objected to SB’s notification on the grounds that it lacked an MA reference number or equivalent in a country of export. In this section of the notification, SB had stated that such information “will be provided as soon as it is publicly available, in accordance with Article 5(5)(e) of Regulation (EC) No 469/2009 (as amended)”.

After reviewing the relevant legislation, the Court held that SB had complied with the notification requirements for a manufacturing waiver for export as there was no requirement for a manufacturer to provide an MA reference number or the destination of export until this information was publicly available. The decision is therefore consistent with the decision of the Hague District Court in preliminary injunction proceedings brought by Janssen against SB in respect of its manufacturing waiver for a different biosimilar (ustekinumab) as reported in our Weekly Update here.

CANADA

Federal Court reinstates patent held abandoned due to failure to pay maintenance fees.

On 22 January 2025, the Federal Court set aside the Commissioner of Patents’ decision refusing to reinstate Matco’s Patent Application No. 3 086 194 for failure to pay maintenance fees.

Matco used third-party service providers to exclusively manage maintenance payment fees of its patent portfolio. The failure occurred due to a data migration error between Matco’s previous third-party service provider, CPI, and its new provider, Dennemeyer. Data for two patent applications were not imported and, as a result, the maintenance fees were not paid. Matco’s US legal counsel were notified of the error by their Canadian patent attorney, but under instructions to take no further action with regard to annuities payments and maintenance fees. US counsel did not notify the client of this failure until after the 6-month grace period had expired.

Matco requested reinstatement of the patent application but this was refused on the basis that Matco failed to meet the “due care” standard required under paragraph 73(3)(b) of the Patent Act, which requires the applicant to take all measures that a reasonably prudent applicant would have taken given the particular circumstances to avoid the failure. The Commissioner set out several evaluative principles. First, the applicant must provide reasons for the failure. Second, only measures taken before the failure occurred will be considered in the analysis. Third, the grounds of due care must be “clearly established”. Fourth, all parties involved in the maintenance and prosecution of the application must demonstrate due care.

The Federal Court reviewed the Commissioner’s decision on the standard of reasonableness and identified two main issues. First, the Commissioner completely overlooked the fact that, but for the migration error, the maintenance fee would have been paid. This was the proximate cause of the failure and therefore relevant to the due care inquiry. Second, the Commissioner’s assertion that the abandonment of the application could have been avoided had the notice been forwarded to Matco, was not supported by evidence. Given the distinct roles held by the Canadian patent attorney, US counsel and the third-party provider, each entity carried out its own responsibilities with the knowledge it had. For these reasons, the application was allowed and Commissioner’s decision set aside.

The decision favours a broader view of the “due care” requirement under the Patent Act which examines the proximate cause of the failure as well as subsequent acts taken by all relevant parties.

UPC

Court of Appeal addresses representation of lawyers.
(UPC_CoA_635/2024)

Following the Court of Appeal’s Order in Suinno v Microsoft on representation pursuant to Art. 48 UPCA (reported in our Weekly Update here), a further decision was given on this issue on 12 February 2025.

The appeal arose from a third party request for access to pleadings and evidence pursuant to r. 262(1)(b) RoP in the counterclaim action between Meril GmbH and Edwards Lifesciences Corporation. An individual, referred to as Respondent 1, filed the application on both his own behalf and that of SWAT Medical. Respondent 1 is a European Patent Attorney and UPC Representative and the Chair of SWAT Medical’s Board of Directors.

The application was granted at first instance. Meril appealed, and Respondent 1 lodged a statement of response naming himself as the representative. The name of a law firm also appeared on the statement as a Legal Representative of SWAT Medical. Meril contended that neither Respondent 1 nor SWAT Medical was validly represented pursuant to Art. 48 UPCA, and that consequently neither the statement of response nor the original r. 262(1)(b) RoP application had been admissible.

Although noting that Meril’s submission on admissibility was made out of time, the Court of Appeal held that the representation requirement concerns the public policy issue of due process, and the Court is therefore entitled to examine it at any time and of its own motion. In appropriate circumstances the Court may allow a party time to appoint a representative.

Under Art. 48 UPCA and r. 8(1) RoP, a party must be represented before the UPC except in certain specified circumstances. The Court confirmed its decision in Ocado (UPC_CoA_404/2023) that this requirement extends beyond the understanding of ‘Parties’ in Art. 47 UPCA (which is by reference to ‘actions’ but not other applications) and covers a third party applicant under r. 262(1)(b) RoP. The representation requirement exists to prevent private parties from self-representing, to ensure that representatives are sufficiently distanced from their clients (as clarified in Suinno v Microsoft) and to safeguard the proper conduct of the proceedings via the special requirements of representatives under r. 284 and r. 290(1) RoP. The fact that a party is a lawyer or European Patent Attorney does not exempt them from the requirement of separate representation. The Court also confirmed the clarification in Suinno v Microsoft that the additional requirement of independence precludes an individual with extensive administrative and financial powers within a corporate party from representing it before the UPC.

Respondent 1 was precluded both from self-representing in the r. 262(1)(b) RoP application and from representing SWAT Medical, the latter decision being based on the incompatibility of his position as Chair of the SWAT Medical Board with independence. The Court also dismissed the mention of a separate law firm as a representative of SWAT Medical since no particular practitioner had been named. However, as the Court of Appeal has made clarifications on representation since Meril filed its appeal, it granted Respondent 1 and SWAT Medical 14 days to instruct representation and lodge a statement of response.

UPC

Court of Appeal rules non-UPC lawyers can be given access to confidential information.
(UPC_CoA_621/2024)

The Court of Appeal has ruled that where a party makes an application to restrict access to confidential information under r. 262A RoP, the rules of procedure do not require that the information be restricted to the parties’ employees or their UPC representatives within the meaning of Art. 48 UPCA. 

This decision comes in the case of Daedalus Prime LLC v Xiaomi and MediaTek. At the same time as filing its defence to Daedalus’ infringement claim, Xiaomi also filed a r. 262A RoP application requesting that access to certain parts of its defence be restricted. The Hamburg LD provisionally granted protection of the confidential information and restricted access to it to Daedalus’ authorised UPC representatives. In response, Daedalus requested that its managing director and two US attorneys be granted access. The Hamburg LD subsequently extended access to Daedalus’ managing director, but denied access to the two US attorneys. Daedalus requested a review of the subsequent procedural order by the panel. The panel rejected the application for review but granted leave to appeal.

The Court of Appeal did not consider that the wording of r. 262A.6 RoP required that confidential information be restricted only to parties’ employees or UPC representatives. R. 262A.6 RoP requires that access to confidential information only be granted to a total number of persons no greater than necessary in order to ensure compliance with the rights of the parties to an effective remedy and to a fair trial. Whether a particular person may be granted full access must be determined on the basis of the relevant circumstances of the case, including the role of that person in the UPC proceedings, the relevance of the confidential information to the performance of that role and the “trustworthiness” of the person in keeping the information confidential.   

The Court of Appeal held in this instance that granting access to the two US attorneys would not be at odds with r. 262A.6 RoP, as the number of persons to whom access was restricted was not greater than necessary, and the US attorneys’ role in the UPC proceedings was sufficient for them to be granted access. The fact that US attorneys are bound by strict ethical rules of legal professional conduct was a relevant consideration.