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 - 31 January 2025 - is below:

UK | STOP PRESS

Xolair formulation patent found valid and infringed.

On 30 January 2025, the Patents Court has found that the patent protecting Novartis and Genentech’s high concentration liquid formulation of Xolair was valid and infringed by Celltrion’s Omlyclo biosimilar. Celltrion had challenged the patent for lack of novelty (including the unusual ground of anticipation by equivalents), obviousness, lack of inventive step and added matter. A copy of the decision can be found here. A fuller report will follow next week.

UPC

Düsseldorf Local Division assumes long-arm jurisdiction over EP (UK) patent.
(UPC_CFI_355/2023). 

In a decision handed down on 28 January 2025, the Düsseldorf Local Division had to determine whether it had jurisdiction over infringement of the EP(UK) patent. The UPC decided that it does.

This decision marks an important development in of cross-border jurisdiction within the UPC system. It remains to be seen, however, whether the court’s conclusion would change if a UK revocation action had been filed, as the UPC suggested this may have impacted the assessment.

In this action, Fujifilm had filed an infringement action against Kodak concerning a European patent that was designated in both Germany (the only Contracting Member State in which the EP was in force) and the UK. Kodak counterclaimed for revocation, challenging the validity of the EP(DE) but not the EP(UK).

Since the revocation action sought only the revocation of the EP(DE), the issue of the UPC's jurisdiction over revocation claims concerning patents in non-Member States did not arise. On this basis the court held that it did not therefore need to await the outcome of C-339/22 BSH Hausgeräte, in contrast to the contemporaneous Order in the parallel Mannheim Local Division proceedings (see below).

However, the Court decided that it had jurisdiction over the infringement claim regarding the EP(UK). It based this decision predominantly on the application of the Brussels Recast Regulation rather than the UPCA. The Court emphasised that the exclusive jurisdiction provision in Art. 24(4) does not apply to infringement. The Court went on to find that the Brussels Regulation applies even in disputes between Member and non-Member States citing the CJEU’s ruling in Owusu (C-281/02). Additionally, the Court referred to Art. 71b(1) of the Brussels Recast Regulation, which ensures that the UPC, as a common court for Contracting Member States, has jurisdiction equivalent to that of national courts under the same regulation.

The Court rejected Kodak's argument that the UPC’s jurisdiction should be limited to Contracting Member States. Since Germany as a Member State had jurisdiction over patent infringement actions involving third states, there was no jurisdictional barrier to the UPC deciding the claim for infringement of the EP(UK). The Court also considered Art. 34 UPCA, which governs the territorial scope of UPC decisions and found that it does not prevent the Court from hearing cases related to patents in non-Member States.

The Court nevertheless dismissed the infringement claim regarding EP(UK) due to its finding that the EP in force in Germany was invalid. Despite deciding that the validity of the EP(UK) was not in issue and that the UPC had no jurisdiction to decide the validity of the EP(UK), the Court determined that the validity of the patent was a prerequisite for granting injunctions or other remedies based on infringement. The defendants argued that the EP(UK) was invalid for the same reasons as the EP(DE), and the Court found that the claimant failed to distinguish any differences in the validity assessments between the UK and Germany. Consequently, the infringement action could not succeed, as the patent was invalid under EPC law.

UK

Touchlight Genetics Defends Entitlement Claim Made by Founding Scientist.

On 27 January 2025, Michael Tappin KC, sitting as a Deputy Judge of the High Court, handed down his decision in the case of Dr Vanessa Hill v Touchlight Genetics. The dispute surrounded ownership of the patent protected production process for Touchlight’s flagship “doggybone” DNA (dbDNA) technology. Dr Hill, a founding shareholder and former Chief Scientific Officer of Touchlight, sought a declaration of entitlement to patents stemming from an international patent application filed by Touchlight in 2010. Dr Hill contended that she devised the dbDNA production process (referred to by the parties as the “Close-Ended Process”) prior to her employment by Touchlight, and that whilst some of her invention rights were passed to the company under a service agreement in 2008, she had kept the Close-Ended Process when operated at mesophilic (as opposed to thermophilic) temperatures for herself.  

Touchlight’s position was that the Close-Ended Process had been devised after Dr Hill’s service agreement took effect, and that even if it was devised beforehand, the rights to the technology would in any event and without segregation of thermophilic temperatures, have been assigned to Touchlight under that agreement. Further, Touchlight contended that Touchlight’s reliance on Dr Hill’s conduct gave rise to an estoppel that prevented her from asserting any rights she might have had to the inventions.  Finally Touchlight argued that Dr Hill’s claim was barred under the provisions of Art. 23 of the Community Patent Convention as enacted into UK law by s. 37 Patents Act 1977 which provides that an entitlement claim started more than 2 years after the date of grant of a patent can only succeed if the patentee knew that it was not entitled to the patent.

Following a trial that took place over three weeks in November and December 2024 and which focussed largely on fact evidence and contemporaneous documents, the Court held that it was more likely than not that the Close-Ended Process had been devised after Dr Hill’s service agreement came into effect.  This finding was sufficient for Touchlight to succeed. However the Judge went on to consider Dr Hill’s service agreement and, applying conventional principles of English contract law, and in particular the requirement for the Court to ascertain the objective meaning of the language which the parties have chosen in which to express their agreement, held that all aspects of the Close-Ended Process had been transferred to Touchlight as part of the service agreement. 

Having made these findings on the date on which the Close-Ended Process had been devised and on the effect of the service agreement, the Court did not rule on the issues of estoppel and the limitation period in s. 37 but did make certain findings in relation to them.  Of interest to patent lawyers was the Judge’s finding that the burden of proof lay with Dr Hill to show that Touchlight knew it was not entitled to the patent.   Finally, on the s. 37 limitation issue, Dr Hill had contended that this time bar was only in respect of orders to transfer patents and did not bite on her claim to be registered as one of the proprietors of the patent.  However, having regard to Art. 23 CPC, the Judge stated that he had “considerable sympathy” with Touchlight’s submission that s. 37 applied more broadly than orders for transfer.

UPC

Mannheim LD considers the applicable law for infringing acts before and after the entry into force of the UPCA
(UPC_CFI_365/2023)

On 22 January 2025, the Mannheim Local Division gave a pre-hearing Order in a dispute between Fujifilm and Kodak. Of particular interest is that the Order flags two interesting and fundamental issues that will be decided at the oral hearing to be held between 11 and 13 February 2025.

First, the panel has postponed determination of whether the UPC has jurisdiction to grant a permanent injunction covering the UK, being a non-contracting third state, until after the CJEU renders its decision in C-339/22 BSH Hausgeräte. This is in apparent contrast to the approach of the Local Division in Düsseldorf in the parallel case between the same parties.

Second, the UPC will decide whether national law or the UPCA should be applied to infringing acts which occurred prior to 1 June 2023.

The infringement dispute concerns Kodak’s process free plates (SONORA X, SONORA XTRA-2 and SONORA XTRA-3) which Fujifilm allege infringe its patent EP 3 511 174. The earlier embodiment, SONORA X, was only marketed and distributed prior to the UPCA coming into force. To determine whether national law or the UPCA applies to such acts of historic infringement, it will be necessary to consider whether Art. 28 of the Vienna Convention on the Law of Treaties (VCLT) intended the UPCA to have retroactive effect. Art. 28 states “[u]nless a different intention appears from the treaty or is otherwise established, its provisions do not bind a party in relation to any act or fact which took place or any situation which ceased to exist before the date of the entry into force of the treaty with respect to that party”.

For infringing acts committed after the entry into force of the UPC Agreement on 1 June 2023, the UPC must decide whether national law or the UPCA should apply, and if national law can still be invoked by a party where the UPCA would lead to diverging and disadvantageous results.

NETHERLANDS

Judgment of the Court in The Hague regarding the use of dimethyl fumarate (DMF) for treating multiple sclerosis (MS).

On 22 January 2025, the District Court of the Hague issued its decision in Biogen v Sandoz, Neuraxpharm and Mylan. The Court revoked EP (NL) 2 653 873, finding it invalid for lack of inventive step, or, in the alternative, invalid on grounds of insufficiency (considering this squeeze in detail).  Biogen, which markets DMF under the brand Tecfidera®, had claimed that the generic manufacturers infringed its patent EP 873 (a patent for a 480mg day dosage of DMF, or MMF, for the treatment of MS), by marketing generic DMF products.

Inventive step

In its reasoning, the Court formulated the objective technical problem of the patent to be the provision of an “alternative treatment of MS”. It found that the skilled person would know from the prior art and from their common general knowledge that the efficacy (and effectiveness) of DMF is dose-dependent. Therefore, they would have a reasonable expectation of success that this technical problem could be solved in an obvious way by testing lower doses of DMF than 720 mg a day (the dosage which was disclosed by the prior art). In general, a lower dose with the same effect is more favourable, as less active substance is needed and there are fewer side effects. This would therefore give the skilled person, upon reviewing the prior art, an incentive to investigate lower doses. As part of that search, the skilled person would have tested a dose of 480 mg per day, in a routine dose ranging study.

In the Court’s view, the skilled person would also understand that when considering the prior art and the effects of the different doses of DMF, there may have been a under-evaluation, within the prior art study, of the effects of 360 mg DMF per day. The disease was significantly more active in the 360 mg per day test group than in the other groups. The skilled person would therefore realise that higher disease activity shown in the study by the 360 mg per day group is very likely to have influenced the results (these results being that a 360 mg per day dose showed no statistically significant effect compared to the placebo group, and only the 720 mg per day dose did). The skilled person would consequently not rule out the possibility that a dosage lower than 720 mg per day, or even the dosage of 360 mg per day itself, may be effective.

The Court therefore concluded that the invention was obvious, as there would be an incentive for the skilled person to test (routinely) whether a lower dose than 720 mg DMF per day, including 480 mg, is effective in treating (RR)MS.

Insufficiency

The Court held that if Biogen’s argument on inventive step was followed (i.e. if the Court agreed there would be no incentive for the skilled person to test routinely whether a lower dose than 720 mg DMF per day (including 480 mg) is effective in treating (RR)MS)), the patent would then be insufficient. This is because a skilled person would consequently not consider it credible that a 480 mg dosage was effective for the treatment of MS, as the efficacy of this dosage is not made clear from the patent application, and would need further explanation or evidence i.e. clinical data.

The Court briefly touched upon whether recent case law on post-published data (G2/21) now suggests that when considering the sufficiency of a second-medical-use claim, there must always be some positive evidence in the application that the therapeutic effect occurs, or if it suffices that there must merely be no doubt of that therapeutic effect. However, the Court did not explore this question further in the present case, due to its view on insufficiency i.e. that the skilled person would doubt whether a dosage of 480 mg per day would be effective in the treatment of (RR)MS.

UK

Court of Appeal refuses to depart from CJEU case law on Art. 3(d) of the SPC Regulation.

On 28 January 2025, the Court of Appeal gave a further strong indication that when it comes to interpretation of the SPC Regulation, as transposed into UK law following Brexit, the courts of England and Wales with align with previous decisions of the CJEU (Decision here).

The case in question related to an SPC application by Merck Serono SPC for their medicinal product MAVENCLAD which contains the active ingredient cladribine, for relapsing remitting multiple sclerosis. This active ingredient had been the subject of MAs before, in the 1990s and 2000s, for use in hairy cell leukaemia. As such, following the CJEU’s decision in Santen, the most recent MA was not the first authorisation to place the product on the market. The SPC application had therefore been refused by the UK IPO and the first appeal rejected by the High Court as the application did not comply with Art. 3(d) of the SPC Regulation. However, of note, Merck’s SPC application had been made at a time when the prevailing CJEU case law was Neurim, a decision which would have permitted Merck’s SPC application to be granted.

There was only one ground of appeal before the Court of Appeal, namely that Santen had been wrongly decided and the Court should therefore depart from it. Departure from retained CJEU case law following Brexit is something which is open to the Court of Appeal (and Supreme Court) in certain circumstances. The Court of Appeal took a two-step approach, first considering if they could depart from Santen; and second, if the Court could depart from it, would it do so.

On the first step, the Court considered the statutory position that the Court of Appeal can depart from retained EU law except where there is post-transition case law which modifies or applies that retained EU case law and which is binding on the Court of Appeal. The Court held that in its decision in the Newron case in 2024, relating to Art. 3(b) of the SPC Regulation, the Court chose to follow Santen (and not Neurim) and in doing so created a precedent it could not depart from. It did not matter that Newron was on Art. 3(b) and not Art. 3(d). Further, any arguments from Merck that the Court of Appeal can in some limited circumstances (not relevant to retained EU law) depart from its own decisions and therefore it should do so in relation to Newron were dismissed.

On the second step, whether the Court should depart from Santen if it could, the Court was clear that it should not. In the leading judgment from the Court, Lord Justice Birss considered Neurim to be the outlier case in a series of CJEU case law and that Santen had brought clarity where Neurim had created more questions. He acknowledged the policy objective behind the decision in Neurim but said that judicial interpretation cannot achieve that objective it should be done by  legislation.

It is notable that all three Lord Justices– Lord Justice Birss, Lord Justice Arnold and Lord Justice Lewison - gave reasons for the dismissal of the case. It is of particular interest that Lord Justice Arnold made a point specifically that while the relevant aspects of the SPC Regulation in the UK remained unamended as compared to the regulation of SPCs in Europe the UK courts should continue to interpret the UK legislation in harmony with the CJEU (unless convinced that the CJEU’s interpretation is wrong).

UK

Court of Appeal reverses on amendment to case to include request for interim licence.

On 28 January 2025, the Court of Appeal’s gave its decision in Alcatel/Nokia v Amazon on the question of whether Amazon was entitled to amend its case to include a declaration that a willing licensor and licensee would enter into an interim licence covering Nokia’s global video codec patent portfolio and an order for specific performance requiring Nokia to grant such a licence (Decision here). Nokia’s portfolio includes standard-essential patents (SEPs) subject to RAND commitments and non-essential patents (NEPs) relevant to video streaming and device functionality.

Nokia had sued Amazon in Brazil, Germany, the US, and other countries, alleging infringement of its SEPs and NEPs by Amazon’s video streaming services and devices. While the UK action initially concerned only NEPs (where Alcatel were the claimant), Amazon later sought declarations of non-infringement and revocation of two Nokia SEPs, arguing that a RAND licence for SEPs should extend to all of Nokia’s video codec patents, including NEPs. With negotiations stalled and Amazon facing injunctions abroad, it sought to amend its case to include interim relief in the form of a licence pending a final determination of RAND terms.

The High Court refused Amazon’s request, holding that its claim had no real prospect of success. The Court of Appeal, led by Arnold LJ, found that Amazon’s case had a real prospect of success, particularly in light of Panasonic v Xiaomi, where it was declared that a willing licensee in the position of Panasonic in the circumstances of that case would grant an interim licence . Nokia’s attempts to distinguish Panasonic v XIaomi were dismissed on the basis that the factual distinctions were arguably immaterial.

The Court also rejected Nokia’s arguments that it had complied with its RAND obligations, that an interim licence would serve no useful purpose, and that granting it would interfere with foreign Courts. It criticized Nokia’s reliance on a Munich I Regional Court ruling that found Amazon unwilling to take a FRAND licence, noting that the decision of that court was based on EU competition law rather than Nokia’s contractual RAND commitments. English Courts take a different approach to assessing RAND compliance, placing less of a burden on implementers like Amazon to prove willingness. Ultimately the court found that it was arguable that the decision did not show that Nokia was acting in good faith for the same reasons as in Panasonic v Xiaomi.

The Court concluded that unless Amazon’s application was expedited before the RAND trial, it would be rendered meaningless. Consequently, the Court of Appeal allowed Amazon’s appeal, permitting it to amend its pleadings and pursue its claim for an interim licence.

UK | STOP PRESS

Court of Appeal to hear Lenovo v Ericsson appeal on 18 February 2025.

Further to our Weekly Update here, Lenovo have sought permission to appeal to the Court of Appeal. This was granted on 8 January 2025 and an expedited hearing of the appeal has been listed for 18 February 2025.  We therefore expect further guidance from the Court of Appeal on the grant interim licence relief in FRAND disputes shortly thereafter.

NETHERLANDS

Attorney General delivers opinion supporting validity of BMS’ apixaban compound patent at the Supreme Court.

In May 2022, the first instance Court refused to grant BMS a preliminary injunction on the basis that the patent would not survive proceedings on the merits for lack of plausibility within the inventive step assessment. Following the decision of the Enlarged Board of Appeal in G2/21, BMS again sought a preliminary injunction in May 2023, which was refused by the first instance Court. BMS appealed this decision, and in August 2023 the Court of Appeal granted a preliminary injunction ruling that the invention in the patent is plausible. Sandoz and Teva appealed to the Supreme Court. There are also parallel merits proceedings, with the first instance Court finding the patent valid in October 2024 [as set out in our Update here].

A hearing at the Supreme Court was held in December 2024, and Advocate General van Peursem delivered his opinion on 25 January 2025. The opinion analyses the test set out in G2/21. It explains that the only requirement in the test is that the skilled person can deduce/derive (in Dutch afleidbaar) that the claimed technical effect is encompassed by the technical teaching – and not, as Sandoz and Teva submitted, that the skilled person understands that the claimed effect is actually achieved by the invention. Following this reasoning, technical teaching should not be understood as information teaching the skilled person how the problem is actually solved, but instead how the problem can be solved using technical means.

In applying this test, the Advocate General notes its abstract nature, and that the EBA indicated that it should be concretised in the specific circumstances of the case. Here this meant that the criteria of G2/21 would be met if the technical effect was expressly and specifically identified as the primary objective of the patent.  As the effect was so identified, the Advocate General concluded that the G2/21 criteria were satisfied.