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 - 22 November 2024 - is below:

GERMANY

Court seeks guidance from the CJEU on the interpretation of the Orphan Drug Regulation.

By decision dated 25 October 2024, the Munich Regional Court has made a referral to the CJEU on the correct interpretation of Regulation (EC) No 141/2000, which concerns Orphan Medicinal Products (the Orphan Drug Regulation). The referral relates to Article 8 of the Orphan Drug Regulation, which gives the marketing authorisation holder of an orphan drug 10 years of marketing exclusivity. The referral was made in the context of proceedings between Alexion Pharmaceuticals and Amgen and the enforceability of Alexion’s marketing exclusivity rights to its orphan drug Soliris. 

Readers will recall that Soliris (eculizumab) is approved as an orphan drug for the treatment of four rare diseases. However, only two of these rare diseases still benefit from orphan drug marketing exclusivity.  Previously, Alexion had applied to the Munich Regional Court for a preliminary injunction to prevent potential cross-label use of Amgen’s eculizumab biosimilar Bekemv, even though Bekemv had been authorised solely for those diseases for which Alexion’s orphan drug marketing exclusivity had expired.  The preliminary injunction was granted at first instance but this decision was overturned on appeal by the Munich Higher Regional Court in February 2024.

The current main proceedings deal with essentially the same issue as the preliminary injunction proceedings. However, in this case rather than reach a decision, the court has decided to suspend the proceedings and refer three specific questions to the CJEU. The exact form of the questions can be found in the decision itself but essentially the court asks whether holders of orphan drug marketing exclusivity can enforce these rights against third party competitors under civil law, relying either on Article 8 or the “overall objective” of the Orphan Drug Regulation.  If the answer is yes, then the court asks whether these claims arise directly from European law or whether their scope and form is governed by national law.  The commentary from the German court on the correct interpretation of the Orphan Drug Regulation suggests that they consider it does provide a legal basis for enforcing  orphan drug marketing exclusivity rights. However, whether or not the CJEU agrees with this interpretation remains to be seen. 

UK

Patents Court refuses to order short term licence in Lenovo v Ericsson. 

On 19 November 2024, Richards J handed down his decision in the ongoing proceedings between Lenovo and Ericsson. Lenovo had applied for a declaration that a willing licensor and a willing licensee would agree and enter into a short-term cross-licence that would expire once either the English Court, or the Court of the Eastern District of North Carolina (where parallel proceedings between the parties are ongoing) determined final FRAND terms.

The Judge was careful to differentiate the case from that of Panasonic v Xiaomi (Panasonic CA), where both parties had given undertakings to the English Court to accept the FRAND court-determined cross-licence – in this case, while Lenovo had given such an undertaking to the English Court, Ericsson had not. Unlike in Panasonic CA, therefore, the English court would not necessarily be determining FRAND terms of a licence that the parties were certain to enter into. The Judge therefore attached less weight to Lenovo’s undertaking when considering if Ericsson’s actions in seeking injunctive relief in other jurisdictions had been contrary to its FRAND commitment.

On the other hand, the Judge attached more weight to the negotiations between the parties – in particular, the Judge cited a brief from the US Office of Unfair Import Investigations which had indicated that Ericsson had made an offer in the FRAND range in October 2023 as suggesting that Ericsson was not seeking supra-FRAND rates through its litigation strategy, and so was not acting in bad faith despite seeking injunctive relief in other jurisdictions.

The Judge also disagreed with Lenovo’s argument that their proposed short-term licence was a “normal” FRAND licence, as (i) Lenovo’s proposed licence contained a “true-up” provision meant that it did not determine a price payable for the exploitation of IP for a particular period and (ii) there was insufficient evidence that such short-term licences were typical or prevalent in the industry. Unlike in Panasonic CA, only one party had proposed short term licence terms, and there was no possibility of “splitting the difference” between two proposed rates to arrive at a FRAND level for any such licence.

Unlike Panasonic CA, where the declaration had been granted with the aim of causing Panasonic to reconsider their position, here the Judge did not consider that making the declaration sought by Lenovo would have utility beyond attempting to influence foreign courts.

The Judge was not satisfied, therefore, to the requisite high degree of assurance needed for making a declaration at an interim stage of the proceedings that the statement in the declaration would be correct in fact and law, nor that making such a declaration would serve a useful purpose. Lenovo’s application was therefore refused.

UPC

Munich Local Division gives main action decision and grants injunction in heart valve dispute.

On 15 November 2024, the Munich Local Division of the UPC handed down its decision in Edwards v Meril, a dispute relating to Edwards’ patent EP 3 646 825 which was upheld by the Paris Central Division in amended form in a decision of 19 July 2024. The patent claims a prosthetic heart valve comprising struts arranged into hexagonal cells, and was allegedly infringed by Meril’s Myval extra-large heart valve.

In finding the patent infringed the panel adopted a purposive interpretation of the term “parallel” in the patent, noting that it “must not be understood in a strictly mathematical sense” on the basis of evidence in the figures of the patent and Edwards’ expert evidence.

The panel dismissed Meril’s request for a re-scheduling or stay of the infringement hearing pending the appeal of the validity decision. Meril submitted that certain of their invalidity arguments had not been addressed by the Paris Central Division – the Court disagreed, and found there were no substantive or formalistic grounds for the requested re-scheduling or stay.

Although Meril contested that their product’s struts were arranged in overlapping octagons rather than hexagons, the panel held, based on experimental evidence submitted by Edwards, that the cells in the Meril valve behaved more like hexagons when the valve was being deployed. The patent was therefore infringed.

The panel rejected Meril’s claim to a compulsory licence, noting that the BGH had previously found Meril to be an unwilling licensee. Meril had also not made sufficient efforts to engage in licensing discussions with Edwards following the BGH decision, leading to a strong presumption against Meril’s entitlement to a compulsory licence.

The panel also were unconvinced by Meril’s argument that there was public interest in having its product available on the market – it was not sufficient that it would be advantageous for a physician to have a variety of treatment methods at their disposal and that Meril’s product had some superior features to the Edwards product. Any public need was therefore held to be sufficiently met by Edwards’ product. Either Meril would have had to demonstrate that their product was the only available treatment method, or that it resulted in a notable enhancement in patient care.

The panel did not find it appropriate to allow a grace period for Meril to adapt its infringing products, and granted an immediate injunction, damages (final quantum to be determined), and costs against Meril.

UPC

Munich Local Division refuses request for antitrust information.

Also on 15 November 2024, the Munich Local Division refused Meril’s request to seek information from the European Commission regarding the Commission’s investigations into Edwards’ alleged violations of EU antitrust law, on the grounds that:

• Meril’s request was filed late, coming after the oral hearing in the case where the Court had disallowed post-hearing submissions and requests;
• Granting the request could jeopardise the Court’s planned date for announcement of its decision; and
• The Court had already asked for an update on the Commission’s proceedings at the oral hearing, and there was no suggestion that the situation had changed since then.

UPC

Munich Central Division grants access to unredacted documents.

On 4 November 2024, the Munich Central Division handed down a decision granting a third party applicant access to unredacted pleadings and evidence. The applicant, UK patent attorney firm Mathys & Squire LLP, had made an earlier application for these documents but, following submissions from the Claimant, had only been provided with redacted copies. The applicant therefore made an application under r. 262.3 RoP for unredacted copies. Reasons cited by the applicant in support of its application included that the redacted information had been made public elsewhere, that there is a public interest in having full access to pleadings and evidence, and that the applicant had specific professional reasons for requesting access, including to better understand how the concept of a “value of an action” might operate in proceedings before the UPC.  

The Court not only found that the formal requirements for an application under r. 262.3 RoP had been met but that the claimant, in failing to respond to the application by way of any further submissions, had failed to give legitimate reasons as to why the previously redacted information should remain confidential. The court therefore concluded that the interests of the applicant in having access to the information outweighed the interests of the Claimant in keeping it confidential and allowed the application.