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 - 10 March 2025 - is below:

GERMANY - STOP PRESS

Düsseldorf Regional Court finds Pfizer and BioNTech’s Comirnaty mRNA vaccine to infringe.

On 5 March 2025, the Düsseldorf Regional Court held that Pfizer and BioNTech’s mRNA vaccine Comirnaty infringed Moderna’s modified mRNA patent, EP 3 590 949, and that  Moderna had revoked its permission to use its patents for mRNA vaccines during the Covid-19 pandemic via a press release on 7 March 2022. Pfizer and BioNTech were ordered to provide financial information for the calculation of reasonable compensation and damages. More detailed analysis will follow in a subsequent update.

USA - STOP PRESS

PTAB invalidates mRNA patents.

In a reversal of fortune for Moderna, also on 5 March 2025, the US Patent Trial and Appeal Board (PTAB) invalidated two of Moderna’s mRNA vaccine patents that were alleged to be infringed by Pfizer and BioNTech. The written decisions remain sealed but further analysis will follow when we obtain access to the judgment.

UK

Court of Appeal Dismisses Tesla's FRAND Claims Against Avanci 5G Patent Pool. 

On 6 March 2025, the Court of Appeal dismissed Tesla’s appeal against the Patent Court’s judgment in June 2024 setting aside the service of the claim form in relation to Tesla’s claims for the UK court to set the FRAND rate for a licence to the Avanci 5G patent pool. Tesla claimed for declaratory relief against Avanci, the administrator of the patent pool, and for FRAND determinations against Interdigital as both an individual member of, and representative for, the entire Avanci 5G platform.

Phillips LJ and Whipple LJ dismissed Tesla’s appeal, while Arnold LJ in his dissenting judgment would have allowed Tesla’s claims against Avanci and against Interdigital as an individual member of the Avanci pool to proceed.

Arnold LJ was sympathetic to the commercial reality Tesla finds itself in, and recognised the utility of a FRAND declaration against the Avanci platform. However, Phillips LJ and Whipple LJ considered that Tesla’s claims were bound to fail as there is no contractual obligation on either Avanci or the members of the Avanci 5G patent pool to grant Tesla a pool licence on FRAND terms.

In dismissing all of Tesla’s claims, the Court ultimately found that the undertakings given to ETSI by SEP owners, whilst giving Tesla a right to bilateral FRAND licences which each owner, did not entitle it to a right to a pool licence on FRAND terms or indeed on any terms at all. The Court held that on no sensible interpretation of the ETSI undertakings could the obligation to grant a pool licence be based. The fact that the SEP owners have voluntarily put their patents on the Avanci platform does not change this.

UK

Court of Appeal allows Lenovo’s appeal for a declaration of an interim licence.

On 28 February 2025, the Court of Appeal granted Lenovo a declaration that “a willing licensor and a willing licensee in the situation of the parties would agree to, and actually enter into, a short-term cross-licence”. As a result, if Ericsson does not enter into the short-term cross-licence that the Court of Appeal has deemed to be FRAND, it will be deemed by the UK Court to be an unwilling licensor. 

The Court of Appeal’s decision in  Panasonic v Xiaomi [2024] EWCA Civ 1143 set the precedent for such declarations being granted. The main issue in Lenovo v Ericsson was whether the different circumstances of Ericsson and Lenovo were sufficient for the Court of Appeal to come to a different conclusion.  In considering this, the Court of Appeal mirrored the central question it had posed in Panasonic : “what is the point of Ericsson pursuing the Brazilian, Colombian and US proceedings, and attempting to exclude Lenovo’s products from those commercially important markets, with all the massive attendant effort and expense for both parties?”. Ericsson argued that the US proceedings would enable it to achieve a FRAND determination more quickly than the UK, and that being paid an interim payment in the UK sooner was not an advantage as such revenue could not be recognised under generally accepted accounting principles. 

Arnold LJ was unconvinced by these points and decided that nothing prevented him from reaching the same conclusion as in Panasonic: Ericsson was simply pursuing foreign proceedings to achieve a better outcome than a determination by the English courts would provide. Despite having not itself invoked the jurisdiction of the English Court, Ericsson’s conduct was held to be a breach of its good faith obligation under clause 6.1 of the ETSI IPR policy. Once Lenovo had undertaken to enter into the FRAND licence set by the English Court, Ericsson’s “coercion” was no longer justified. 

It was noted that comity was an even more important issue here than in Panasonic since Ericsson had not given an undertaking to be bound by the findings of the English Court.  However, the Court held that the declaration sought did not offend the principle of comity, noting that it is “less intrusive into the jurisdictions of foreign courts and tribunals than a global FRAND determination”. 

With respect to setting the financial terms of the interim licence to which the Court believed Lenovo was entitled, the Court of Appeal simply split the difference between two potential interim licence sums derived by Lenovo and being a “nine-figure dollar sum” based upon Ericsson’s October 2023 overall licence offer and an “eight-figure dollar sum” based upon Lenovo’s own January 2025 overall licence offer). 

UK

Court of Appeal refuses permission to appeal in Halozyme v Comptroller.

In our previous Weekly Update, it was reported the High Court’s dismissal of Halozyme's appeal against the UK IPO Hearing Officer's decision to refuse two SPC applications relating to recombinant human hyaluronidase (RHH) in combination with trastuzumab and rituximab, respectively. The issue in the case was whether RHH was an “active ingredient” within the meaning of Art. 1(b) of the SPC Regulation. The High Court agreed with the IPO Hearing Officer that it was not and so Halozyme’s SPC applications were refused.

Subsequently, Halozyme sought permission to appeal the High Court's decision to the Court of Appeal. This application was refused by the Court of the Appeal on the papers on 27 February 2025. It is therefore the end of the road for Halozyme in the UK. A CJEU referral on the issue relating to Halozyme’s SPC application in Czechia is still pending (C-456/24). 

UK

Patents Court considers claim for damages in Lufthansa v Astronics and Panasonic.

On 21 February 2025, Mr Justice Leech handed down a lengthy judgment  in the damages inquiry which followed Morgan J’s judgment of July 2020 (upheld by the Court of Appeal in 2022), where Astronics, Safran and Panasonic were all held to have infringed Lufthansa’s patent for an aircraft passenger in-seat power supply system.

Lufthansa elected for an account of profits rather than damages and, in response the Defendants maintained that Panasonic had made little or no profit from the acts of infringement decided in the earlier judgment. They argued that the liability judgment only found infringement in the acts carried out by Safran and other seat assemblers in connecting the Components to each other and not in respect of the sale or commercial exploitation of those assemblies by the other Defendants.

A significant part of the inquiry involved determining whether Astronics could have developed and supplied a non-infringing alternative (NIA) to the patented system. On the evidence before the Court, Leech J ultimately rejected the Defendants’ counterfactual argument, concluding that although a proposed alternative product could have been developed, this product would in any case have infringed the patent.  Leech J came to this conclusion on both a standard basis and using the doctrine of equivalents.  Leech J further observed that, if a NIA was possible, it was striking that there was no explanation to the Court as to why the same had not in fact been developed in the face of the threatened proceedings.

The Court also had to consider how to apportion the profits made by the Defendants from the infringing activities the Court had found, determining the extent to which the profits were attributable to the patented features versus other non-infringing features. Several procedural issues were addressed during the inquiry, including unresolved issues from the liability trial, the risk of double recovery given concurrent claims in other jurisdictions, and whether sums paid by Astronics in Germany should be reduced by any indemnity owed or paid to Panasonic.

Overall, the decision is a comprehensive review of English law and its application to the determination of damages flowing from patent infringement, particularly in a complex factual situation where the infringing product was a component of a more complex product and the patentee is seeking to recover damages in respect of secondary or convoyed goods.

While summarising such a comprehensive judgment, which was by its nature quite confined to the particular facts of the case, is not straightforward the Court ultimately concluded that its task was (i) to identify the gross profits made on the Defendant's respective sales, (ii) deduct from that overheads and tax attributable to the sales, and then (iii) apportion the resultant profits so as to recognise the relevant contribution of the Patent (as opposed to other factors that had lead to the generation of the profits).  For Astronics and Panasonic, the Court concluded that their net profits were US$ 34.0 million and US$ 56.8million respectively and that Lufthansa was entitled to 13% of those profits as a result of the infringements.  For Safran, whose involvement arose from the provision of seats into which the infringing power supply products had been incorporated, the Court concluded that the power supply had not those seats more attractive nor lead to the selling of more seats and so damages only arose from the additional labour costs it had charged in respect of fitting the power units, which the Court provisionally assessed as US$81,000.

KOREA

Introduction of New Drug Data Protection System.

On 21 February 2025, the Ministry of Food and Drug Safety (MFDS) implemented a new system for protecting clinical data submitted for an original drug’s marketing authorisation (MA), replacing the previous drug re-examination system (which only provided de facto data exclusivity). 

On the same day the MFDS also amended the Regulation on Safety of Pharmaceuticals, etc. to identify specific categories of drugs that are subject to the data protection system as delegated by the Pharmaceutical Affairs Law, and published a Q&A booklet with details regarding the new system.

In the Q&A booklet, the MFDS clarifies that the new system applies to (i) drugs for which an MA is issued on or after 21 February 2025, and (ii) original drugs that have orphan drug status as of 21 February 2025 or new drugs approved less than six years before 21 February 2025.  This means that original orphan drugs that received an MA after 21 February 2015 are now protected under the new system until the 10th anniversary of their MA date, regardless of whether such drugs did not previously receive a re-examination period or whether the re-examination period has already expired.  The data protection period for original orphan drugs approved in Korea is published on the MFDS website (in Korean).

The periods of data protection under the new system can be summarized as follows:

We thank Kim & Chang for this update.

SWEDEN

Court Upholds Validity of Takeda's SPC for Lisdexamfetamine in STADA v. Takeda.

On 21 January 2025, the Stockholm District Court (Patent and Market Court or PMC) decided in favour of Takeda in its judgment. Takeda markets a product under the name Elvanse®, which contains lisdexamfetamine, a prodrug that requires activation in vivo by enzymatic and/or chemical transformation. STADA had requested that the Court declare Takeda’s SPC for lisdexamfetamine to be invalid on the basis that dexamfetamine rather than lisdexamfetamine was the active ingredient.  STADA argued that the “product” within the meaning of the SPC Regulation was dexamfetamine and not lisdexamfetamine and the SPC had been granted in breach of Art. 2, 3(a), 3(d) and 13 of the SPC Regulation.

Each of these arguments turned on Art. 1(b) of the SPC Regulation, which defines “product” as “the active ingredient or combination of active ingredients of a medicinal product”. Referring to the jurisprudence of the CJEU including Forsgren (C-631/13), Santen (C-673-18), Teva v MSD and MSD v Clonmel (C-119/22 and C-149/22), the PMC noted that the concept of “active ingredient” within the meaning of the SPC Regulation should be understood in the same way as the definition of “active substance” in Art. 1(3)(a) of the Medicinal Products Directive.  This was consistent with the explanatory memorandum to the draft SPC Regulation, which indicated that the concept of “product” had been chosen by the Union legislator as a common denominator between the patent system and the pharmaceutical regulatory system. The PMC shared Takeda’s view that the starting point, when assessing whether a product constitutes an active ingredient, must be how the substance in question has been defined with regard to its function in the medicinal product according to the medicinal product regulatory system.  Taking these considerations into account, the PMC agreed with Takeda that lisdexamfetamine was the active ingredient of Elvanse®, and therefore the “product” under Art. 1(b), and dismissed STADA’s claim.

This contrasts with the decision of the German Federal Patent Court on 4 June 2024, which declared the German SPC to be invalid on the basis that dexamfetamine rather than lisdexamfetamine was the “active ingredient” and therefore the “product” according to Art. 1(b).

UPC

Düsseldorf Local Division grants Order for Bifurcation.
(UPC_CFI_468/2024 & UPC_CFI_687/2024).

On 4 March 2025, a procedural order  was issued by the Düsseldorf Local Division relating to an infringement action filed by GlaxoSmithKline Biologicals SA against multiple Pfizer entities and related claims and counterclaims for revocation.  The Court decided to refer the counterclaims for revocation to the Milan Central Division while proceeding with the infringement action.

On 5 August 2024, the Claimant had filed a patent infringement action against the Defendants in respect of EP 4 183 412. The mention of the publication of the grant of the patent in suit was published on 14 August 2024 and on the same day, six of the Defendants and two other Pfizer entities filed a revocation action with the Milan Central Division. The remaining Defendants filed counterclaims for revocation on 14 November 2024. 

By Preliminary Order of 14 February 2025, the Judge-Rapporteur informed the Parties that the Panel intended to take an earlier decision under r. 37.2 RoP as to how to proceed with the counterclaims for revocation under Art. 33(3) UPCA. The Parties were invited to submit observations.

The Claimant and the Defendants agreed that the counterclaim(s) for revocation should be referred to the Central Division. However, they disagreed on whether to proceed with the infringement proceedings in the event of a referral. The Claimant sought to proceed and requested the Court to set a timely date for the oral hearing, even if the oral hearing would then place before the oral hearing on the Counterclaim for revocation in Milan. The Defendants request a stay of the proceedings pending a final decision in the revocation action. They based their request primarily on the alleged high likelihood of invalidity of the patent in suit but regardless argued that the issue of validity should be addressed first anyway.

The Local Division exercised its discretion to refer the counterclaim for revocation to the Central Division and decided to proceed with the infringement action, rather than stay.

On the issue of bifurcation, the Local Division acknowledged that in general there are advantages in having the infringement action and the counterclaim for revocation being heard together by the same panel but found that the circumstances of this case call for a different decision. In particular, the Local Division found that a referral of the Counterclaim for revocation was appropriate for reasons of efficiency. This was because the Revocation action and the Counterclaim for revocation were essentially based on the same prior art documents and other grounds for invalidity such as added matter, lack of technical contribution and lack of sufficiency. The Defendants themselves had stated that the Counterclaim for revocation (only) updated and amended the grounds in the Statement for revocation because since the filing of the Revocation action the B-specification of the patent in suit has been published and the English Patents Court handed down a judgement by which two further related patents were held to be invalid and not infringed. The Local Division therefore considered that the Central Division would already be familiar with the subject matter of the counterclaim for revocation.

On the issue of whether to stay the infringement action in light of the referral, the Court reiterated that it may stay the infringement proceedings pending a final decision in the revocation proceedings and shall stay the infringement proceedings where there is a high likelihood that the relevant claims of the patent will be held to be invalid  (r. 37.4 RoP, emphasis added). However, in this case, the Court considered that a stay of the proceedings would not be appropriate at this stage. The Local Division found that the question of whether there is a high likelihood of invalidity would require a detailed examination, taking into account the entire content of the file and for this reason, given the stage of the proceedings, it did not appear effective to deal with the issue of invalidity at this point in time. 

However, the Panel did reserve the right to reconsider the possibility of staying the infringement proceedings at a later stage, perhaps if it becomes more apparent during the course of the proceedings that invalidity of the patent is highly likely.