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 - 14 April 2025 - is below:

UK - STOP PRESS

Update on Glenmark v AstraZeneca Appeal.

On Wednesday 9 April, the Court of Appeal granted AstraZeneca an interim injunction against Glenmark, preventing it from launching its generic dapagliflozin product, expectedly until the form of order hearing in the main validity action concerning AstraZeneca’s dapagliflozin patent. In doing so, the Court of Appeal overturned the decision of the High Court which had refused the PI (reported here). More details will follow regarding the decision after written judgment is handed down.

EU

Commission issues full Decision in investigation for alleged abuse of a dominant position in relation to blockbuster multiple sclerosis treatment, Copaxone.

Following our previous update here, on 8 April 2025, the European Commission released its full Decision following its issuing of a fine for misusing the patent system and disparaging a rival product. The Decision can be found here.

Our further analysis of the reasoning will appear in a future update. 

GERMANY

Munich Higher Regional Court provides guidance on FRAND Defence.

On 20 March 2025, the Munich Higher Regional Court handed down its much-anticipated decision in VoiceAge v HMD, rejecting HMD’s appeal against the final judgment of the Regional Court of Munich and providing important guidance on the consideration by the German courts of FRAND defences . Through the case, VoiceAge was enforcing its European patent EP 2 102 619 B1, which relates to the encoding of sound signals and had been declared essential to ETSI’s EVS speech-coding standard.

In parallel nullity proceedings, the Federal Patent Court upheld the patent in a restricted form. HMD and VoiceAge both appealed against the decision but later withdrew those appeals, and therefore the patent is now valid in its restricted form.

The Higher Court upheld the decision under appeal and found that HMD infringed the patent even in its restricted form, and therefore VoiceAge is entitled to the injunctive relief and consequential claims awarded by the first instance court. In doing so, the Court analysed HMD’s FRAND defence and provided important guidance.

Unusually the European Commission intervened in the appeal proceedings by submitting an amicus curiae brief addressing somewhat critically the German courts’ historic approach to FRAND defences and emphasising that in its view the steps laid out by the CJEU in Huawei v ZTE must be strictly followed by EU national courts.

The Higher Court ultimately agreed with that overall submission, although holding that the steps mentioned in the Huawei framework must be observed by the parties as a matter of principle and that strict literal compliance with the steps as a prescribed process may not always be necessary. As such, not every 'footfault' or non-compliance with a step automatically disqualifies a defendant from raising a FRAND defence.

As for step 1 of the Huawei framework, i.e. notice of infringement by the SEP holder, the Court held that this is just a procedural step which could be satisfied by issuing proceedings . Further, if the parties have already begun negotiations, the defendant cannot later raise purely formal errors (or deficiencies) regarding the notice of infringement, as the purpose of the notice is just to provide the defendant with clarity regarding which patent(s) the SEP holder considers to be infringed by the defendant and to give the defendant an opportunity to examine this in more detail to make a sufficiently informed decision. Therefore, the purpose of the notice of infringement is fulfilled if the defendant is made aware of which patent(s) is involved and providing a notice of infringement does not need to be strictly followed in a formal sense.

Regarding step 2 of the Huawei framework, i.e. the implementer's expression of willingness to conclude a licence, the court held that if a SEP holder makes an offer, despite the lack of or insufficient declaration of willingness by the defendant, and the parties then enter into negotiations then the SEP holder cannot invoke in good faith that the FRAND defence does not stand because the defendant did not express willingness to licence before the offer was made by the SEP holder. As such, the defendant's expression of willingness does not need to be strictly explicit – it can be implicit and understood by the defendant's actions.

As regards step 3 of the Huawei framework, i.e. FRAND offer by the SEP holder, the court held that if the first offer by the SEP holder was FRAND compliant, then the defendant’s FRAND defence fails. FRAND is a range, and the defendant must accept an offer from the SEP holder that is within this range – even if the offer was only “just FRAND”. The defendant is not entitled to conditions at the more favourable end of the range. However, this does not mean that a non-FRAND first offer by the SEP holder would automatically lead to the defendant’s FRAND defence taking effect.

Under step 4 of the framework, the defendant is required to provide a counteroffer. As such, the Court held that the defendant’s compliance with steps 4 and 5 of the framework should be considered before the Court has to consider the substance of the FRAND defence in any detail.

In its counter-offer, the defendant must properly respond to the SEP holder’s offer even if that offer is itself not on FRAND terms. Given that the defendant is obliged in good faith to participate constructively in the negotiations and is therefore naturally obliged to submit a counteroffer that is FRAND compliant and not abuse the counteroffer step for mere delay, the Court held that it is only necessary to examine whether the defendant submitted a counteroffer (an improved offer) to the SEP holder and not whether the counteroffer is on FRAND terms. Therefore, step 4 is to be examined in relation to the defendant’s compliance with step 5 of the framework, i.e. providing sufficient security if the SEP holder rejects the defendant’s counteroffer.

In a significant aspect, it appears perhaps because the Court considered that the delay imposed by a judicial examination of the patentee’s FRAND offer, and the dilution of the patentee’s rights that inevitably entails, the Court will not embark upon that exercise at all if the implementer has not provided full security. The Court held that the appropriate amount of security should be based on the SEP holder's last offer rather than on the defendant's counteroffer. The payment of a security deposit by the defendant is a “concretisation” of the defendant’s willingness to take a licence. If the court subsequently finds – possibly with the assistance of expert evidence – that the SEP holder’s offer to be FRAND, the defendant must then accept that offer and conclude an agreement.

Finally, from an implementer perspective, it now appears that irrespective of past conduct, the defendant can prove willingness by providing security. If the last offer by the SEP holder includes a licence to the SEP holder’s global portfolio, the security must cover the licence fee based on the global portfolio and should not be “calculated down” to the patent in suit in isolation and just for the territory of Germany. The rationale behind this is that the security is not for a claim for damages (which would be limited to the patent in suit and the territory of Germany) but for a FRAND licence.

Given the importance of this decision in the context of FRAND/SEP disputes, the Court allowed an appeal to the Federal Court of Justice.

UPC

Munich Court applies the problem-solution approach.
(UPC_CFI_501/2023)

As part of a number of ongoing cases between Edwards Lifesciences Corporation (Edwards) and a number of Meril companies (together Meril), on 4 April 2025 the Munich Local Division rejected Meril’s counterclaim for revocation of Edwards’ patent and held that the Meril defendants were directly infringing the patent in the amended form that had been upheld by the EPO Opposition Division in June 2024. The patent EP 3 669 828 B2 (EP 828) relates to the design of an implantable prosthetic heart valve.

In assessing the validity of EP 828, the Court dismissed Meril’s arguments in relation to added matter, novelty and sufficiency. In considering the inventive step requirements under Art. 56 EPC, the Court applied the problem-solution approach developed by the European Patent Office noting that this would “enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the EPO and the Boards of Appeal”. In doing so, the Court acknowledged that the Court of First Instance and the Court of Appeal had adopted a range of approaches some of which were similar but not identical to the problem-solution approach. The Court also noted that the problem-solution approach was the tool applied by both parties in their briefs. Meril relied on a key piece of prior art (a US patent application referred to as Nguyen) which it then argued the skilled person would combine with other documents and the CGK. The Court held that the Nguyen document was a realistic starting point but found that the technical solution provided was completely structurally different to that disclosed in the patent and did not disclose “the core of the technical teaching”. As a result, Nguyen taught away from the additional features claimed, and no motivation existed to modify Nguyen as proposed by Meril. Nor would (as opposed to could) the skilled person combine Nguyen with another piece of prior art, starting from that other piece of prior art, as there was not no motivation to do so. Thus, Meril’s obviousness attack under Art. 56 EPC failed.

On claim construction, the Court noted that a broad claim should only be construed in a narrower manner on the basis of the description or drawings in exceptional cases. It rejected Meril’s narrower interpretation of claim 1 of EP 828 and held that Meril’s product directly infringed.

Meril also argued that the Munich Local Division did not have jurisdiction over its Italian subsidiary, Meril Italy S.r.l. Edwards had brought the proceedings against three defendants in the Meril group and argued that the Munich Local Division had jurisdiction over all three group companies under Art. 33(1)(b). The second defendant was the Indian parent company of the first and third defendants (German and Italian subsidiaries) and responsible for manufacturing and supplying the infringing product to both subsidiaries as well as offering the product for sale in UPC member states via its website. The first defendant (Meril GmBH) was identified as the “European Headquarters” responsible for the distribution of products in Europe, while the third defendant was responsible for distribution of Meril’s products in Italy.

In considering its jurisdiction, the Court held that Art. 33(1)(b) UPCA allows multiple defendants to be sued at the place of business of one of the defendants, provided that the defendants have a commercial relationship, and the action concerns the same alleged infringement. In relation to non-unitary patents this applies to situations where multiple defendants in different member states are “accused of infringing the relevant national designations of the same European patent by the same product or process”. The Court noted that any alternative view of the legislation would undermine the purpose of the UPC to “overcome the fragmented patent litigation landscape”.

On the facts, the Court held that the requirement for the same alleged infringement was met as the case was considering the same attacked embodiments in relation to the national designations of the same European patent. Further, there was a sufficient commercial relationship between the defendants as both the second defendant (as the parent company) and first defendant (the European Headquarters) were responsible for the Italian defendant. Although Meril Italy’s representatives stated that the infringing product had not been sold in Italy, a search for “Meril Italy” would lead a consumer to the second defendant’s website where they would be able to purchase the infringing product and therefore Meril Italy was held to be offering the product for sale as it uses and benefits from the offer activities on the website.

The Court ordered all three Meril companies to cease and desist from offering, placing on the market, using, or importing the infringing products. A carve-out from the injunction was allowed where a physician has successfully applied for an individual exemption on behalf of a patient. No grace period was allowed in light of the statement of claim having been received 12 months before the oral hearing, with the judgment following 2 months later. In addition, the Court ordered Meril to recall and destroy its infringing products (other than in relation to the individual exemption carve-out) and pay provisional damages of EUR 663,000 to Edwards. Meril were also ordered to provide information on the extent to which the defendants had committed the infringing acts as well as information on distribution channels, to be provided within 3 weeks. 

SOUTH AFRICA

Enzalutamide patent held invalid after patentee failed to establish chain of title.

In a recent case in the Court of the Commissioner of Patents the Regents of the University of California (UC), and its licensee Astellas, sought an interim interdict against Eurolab and Dis-Chem following the launch of an infringing enzalutamide medicine. Enzalutamide is a treatment for certain types of prostate cancer.

The proceedings also involved consideration of an application for groundless threats as well as an application for revocation of the patent. On the latter application, the main issue was on chain of title. The patent was the result of a collaboration between UC and the Howard Hughes Medical Institute. The judge discussed various assignments and purported assignments which were signed by the different inventors and concluded that UC had not established that it had the right to the patent at the date of making the application, that date being held to be the relevant date for when any assignment of rights needs to have been made.

The patent was therefore held invalid and the application for an interim interdict was dismissed. The application for groundless threats was granted.