Irides: Weekly patent litigation update

This edition features updates from: The Unified Patent Court (UPC), Spain, Australia and the European Union (EU).

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.
 

UPC

Düsseldorf Local Division sets out the infringement test for second medical use claims.

[UPC_CFI_505/2024]

On 13 May 2025, the Düsseldorf Local Division handed down the UPC's first decision specifically addressing infringement of second medical use claims. The proceedings concerned EP 3 536 712 (EP 712) which is owned by Regeneron with Sanofi the exclusive licensee. EP 712 relates to the use of PSCK9 inhibitors to reduce elevated lipoprotein(a) (Lp(a)) levels in a defined patient group. Regeneron and Sanofi alleged that Amgen's PCSK9 inhibitor, evolocumab marketed as Repatha®, infringed EP 712. Amgen counterclaimed, arguing EP 712 was invalid and should be revoked.

Claim 1 was structured in paragraph 81 into the following features "A pharmaceutical composition comprising a PCSK9 inhibitor, the PCSK9 inhibitor is an antibody or antigen-binding fragment thereof that specifically binds PCSK9, for use in reducing lipoprotein(a) (Lp(a)) levels in a patient who is diagnosed with or identified as being at risk of developing a cardiovascular disease or disorder or a thrombotic occlusive disease or disorder prior to or at the time of administration of the composition, is not on a therapeutic statin regimen at the time of administration of the composition, and exhibits a serum Lp(a) level above 30 mg/dL".

Claim Construction

PCSK9 inhibitors were known to lower low-density lipoprotein (LDL-C) and administered to patients with high cholesterol. The Court found that the skilled person would therefore interpret the claim to exclude the use of PCSK9 inhibitor solely for that purpose. However, the claim does not exclude the use of PCSK9 inhibitors for other purposes, including to lower LDL-C, as long as it also is used to achieve the claimed therapeutic effect of reducing elevated Lp(a) serum levels. Further, the requirement for the patient to exhibit a serum Lp(a) level above 30 mg/dL meant that objectively the patient has such levels. This means that, without specifying when it is done or how or by whom, patient Lp(a) levels are measured at some point before treatment is started.

Infringement

The Court held that there are no separate statutory provisions regarding infringement of second medical use claims, nor is it harmonised across the UPC member states. The Court noted it was necessary to obtain a balance between a fair protection for the patent proprietor and a reasonable degree of legal certainty for third parties. For such purpose-limited product claims, the Court held that the relevant test for infringement was:

1. Objective element: The alleged infringer must offer or place the medical product on the market in such way that it leads, or may lead, to the claimed therapeutic use; and
2. Subjective element: The infringer must have known, or reasonably should have known, that the medical product was being used, or may be used, to the claimed therapeutic use.

The Düsseldorf Local Division stressed that this must be assessed by analysing all the relevant facts and circumstances of the case. Relevant factors may include: the extent or significance of the allegedly infringing use; the relevant market including what is customary on that market; the market share of the claimed use compared to other uses; what actions the alleged infringer has taken to influence the respective market, either ‘positively’ encouraging patented use, or ‘negatively’ by taking measure to prevent the product from being used for patented use.

The Claimants sought to argue that s. 5.1 of the Summary of Product Characteristics (SmPC) for Repatha® established infringement as it reported on a clinical trial where "Repatha reduced unbound…Lp(a)” by around 25%. Although the court agreed that the SmPC of a product is important, it held it was not decisive. Ultimately, the Court was not satisfied on the evidence before it that physicians were prescribing Repatha® for the claimed use, or that there was a likelihood of this happening. The Court was also not satisfied that the Defendants were aware, or should have been aware, that their product was being used to lower Lp(a) levels in patients with high levels. Therefore the Court held that neither the objective or subjective elements of the test for infringement had been satisfied.

Validity

The Court was clear that the known use, in this case lowering LDL-C levels, could not take away from the novelty of the claimed second medical use as this would ignore the notional novelty of second medical use claims afforded protection by Art. 54(4) EPC. None of the prior art relied on by the Defendants directly and unambiguously disclosed the use of an anti-PCSK9 antibody for lowering Lp(a) levels. On inventive step, although the prior art may give the skilled person some motivation to consider PCSK9 inhibitors to lower Lp(a) levels, the documents disclosed multiple compounds that had this effect, and there were technical reasons teaching away from the motivation to use PCSK9 inhibitors at the priority date. Amgen's attacks on priority, added matter and sufficiency also failed.

EP 712 was therefore found valid but not infringed.
 

SPAIN

Spanish Supreme Court dismisses Teva appeal and upholds BMS’ patent for apixaban as valid.

On 24 April 2025, the Supreme Court found the apixaban compound patent (ES 2 329 881 (ES 881)) valid, upholding the Barcelona Appeal Court decision. ES 881 contains claims to apixaban alone and to apixaban for the treatment of thromboembolic disorders. Its validity was challenged by Teva.

Plausibility of compound claims

The Court reviewed G-2/21 in light of T-116/18 and considered it to be aligned with the ab initio implausibility standard. This standard was applied to the question of whether it was plausible that apixaban itself was as a factor Xa inhibitor, based on the disclosure of the application as filed, rather than the large number of compounds originally in claim 1 of the application.

The Court adopted the Appeal Court’s finding of fact that apixaban was among the 74 most preferred compounds of the application which would all have excellent potency against factor Xa. Given this, the skilled person would have no reason to doubt that the inventors had prepared, tested, and found excellent results for apixaban. Putting this into the words of the test from G- 2/21, the skilled person would consider the technical effect of apixaban (inhibiting factor Xa) to be encompassed by the technical teaching of the application and embodied in the same originally disclosed invention.

The Court noted the judgments from the Dutch, French and Norwegian courts supporting this conclusion, and took no account of the English Court of Appeal judgment as it did not apply the test in G-2/21.

Plausibility of medical use claims

The Court held that paragraph 77 of G-2/21 was only relevant to second medical use claims, whereas the relevant claims of ES 881 were first medical use claims. Further, it was common general knowledge that factor Xa inhibitors could treat thromboembolic disorders.

Priority

Teva’s appeal on lack of priority was rejected as inadmissible.
 

AUSTRALIA

Australian Federal Court dismiss Sanofi’s appeal and allow Amgen’s functional claims to proceed to grant.

On 23 April 2025, the Federal Court (AFC) handed down its decision in Sanofi v Amgen In (No 3) [2025] FCA 387), dismissing Sanofi’s appeal against the Patent Office's decision to allow five Amgen patent applications (the Applications) relating to antibodies binding to PCSK9. Inhibiting PCSK9 enhances the liver’s ability to reduce LDL (informally known as “bad cholesterol”).

The Court held that the Applications contained three types of claims – “epitope claims” to antibodies binding to certain epitopes of PCSK9, “residue claims” to antibodies binding to certain amino acid residues of PCSK9, and “competition claims” to antibodies which compete for binding to PCSK9 with a structurally defined antibody.

Sanofi challenged the decision to grant the Applications on the basis of “Failure to Define the Invention”, “Failure to Define a Method of Manufacture”, “Lack of Fair Basis”, “Lack of Clarity”, “Failure to Describe the Invention Fully” and “Lack of Inventive Step”. Some particularly interesting points in the Judgment are set out below.

To succeed on appeal Sanofi had to satisfy the Court that Applications contained one or more claims which would be “clearly invalid” if the Applications proceeded to grant.

Failure to Define the Invention

Sanofi argued that the claims were invalid as they did not define antibodies with reference to their amino acid sequences or fragments thereof. However, the Judge disagreed this was necessary and said that it was only essential that the skilled person would be able to determine if a given antibody fell within or outside the claims. On the evidence provided, the Judge held that the functional limitations were sufficient to allow the skilled person to determine if a given antibody would fall within the scope of the claims.

Fair Basis

Sanofi argued that the claims lacked fair basis since they claimed a scope broader than was disclosed by the specification and omitted essential features disclosed in the specification. The Judge disagreed – the example antibodies disclosed in the specification did not need to exemplify every possible antibody which was claimed in order for the claim to be fairly based. The fact that the number of antibodies falling within the claim could be much greater than the number of reference antibodies disclosed in the Applications was not relevant, under the law applied (see further discussion below).

Inventive Step

Finally, the Judge held on inventive step that although the skilled person may have been motivated to try to generate antibodies with the aim of disrupting the interaction between PCSK9 and LDL receptors, they would not have done so with the requisite expectation of success. As such, the Patents did not lack inventive step. This is in contrast to the findings of the UPC, which invalidated a European patent within the same family as the Patents in its first revocation decision, as reported previously here.

Applicable Law

A final point to note is that the decision of the Federal Court applied the law in Australia as it was prior to the enactment of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), which changed the patentability requirements in Australia and brought them closer in line with sufficiency requirements in other jurisdictions. As such, this decision may not necessarily be determinative of the Australian Courts’ future positions on the validity of functionally-limited antibody claims.
 

UPC

Düsseldorf Local Division finds Grundfos pump patent infringed. [UPC_CFI_41/2025]

The Düsseldorf Local Division delivered its decision on 8 May 2025 regarding Grundfos’ patent infringement claim against Chinese manufacturer Hefei Xinhu Canned Motor Pump Co, Ltd (Hefei Xinhu). Grundfos’ patent is to a heating circulation pump unit involving means that automatically detect whether an external control is connected. If detected, the system automatically switches from internal to external speed control. Ultimately the Court found that the patent was valid and infringed, ordering the recall and destruction of the infringing products and an injunction against Hefei Xinhu.

In doing so, the Court clarified the interpretation of functionally defined features (e.g. "means for switching") in claims and addressed procedural limitations on introducing new prior art after the counterclaim. The Court also affirmed that injunctions following trial can be enforced without a need to provide security where there was no argument as to why security would be required.

Construction 

In construing a functional claim feature, “means for switching” the court considered that the claim defined the “means” functionally rather than structurally and that this was allowable provided the function is clearly defined and the skilled person can implement it. The Court considered that the ‘means’ must be “capable” of determining connection of an external control and initiating the switch-over, but how this is done is left to implementation by the skilled person.

In doing so the Court construed this feature very broadly, finding that any mechanism that automatically triggers the switch is sufficient to meet this feature. Hefei Xinhu argued that the claim was insufficiently disclosed in the patent, on the basis that the description includes examples like a ‘microswitch’ or ‘sensor’ and that these generic examples of components would leave the skilled person implementing the invention with undue difficulties even in the light of their common general knowledge. Despite its broad construction, the Court disagreed.

New Prior Art

Having found the patent valid in the light of the prior art originally cited by the Defendant, the Court addressed new prior art and new attacks raised late in the procedure (specifically in the reply to the revocation counterclaim) under r. 263 RoP. It found that if a defendant introduces new prior art only in the reply to the revocation counterclaim (to argue lack of novelty or inventive step), this constitutes an extension of the original revocation action. 

The Court stated that such late-submitted prior art or attacks can only be admitted if a) the defendant convincingly shows that the documents could not reasonably have been submitted earlier, and b) the admission does not unduly prejudice the claimant’s ability to conduct the case.

Furthermore, the Court stated that even if the prior art was already part of the case, any new arguments or combinations based on this also amounts to an extension and is subject to the same strict test. 

Following these tests the Court rejected late-filed prior art documents put forward by Hefei Xinhu, along with new inventive step combinations. 

Relief 

Having found that the patent was valid and infringed, the Court ordered recall of the infringing products, finding this proportionate and rejecting arguments about excessive cost or impact on third parties (e.g. installers, building owners) as Grundfos had a legitimate interest in clearing the market of infringing products. The Court also ordered the destruction of infringing products, finding that Hefei Xinhu had not sufficiently demonstrated that the products could be made non-infringing. Finally, the court awarded €64,000 in provisional damages, reflecting likely lost revenue/licensing fees, with the exact damages to be determined in further proceedings. No security pending any appeal was ordered as Hefei Xinhu did not request it or show grounds for it, and the Court found no significant risk of unjust harm to the defendant from immediate enforcement.

UPC

Boehringer Ingelheim's application for provisional measures against Zentiva rejected.
[UPC_CFI_11/2024]

On 8 May 2025, the Lisbon Local Division rejected Boehringer Ingelheim’s (BI) application for a preliminary injunction against Zentiva for lack of an imminent threat of infringement. The patent in question, EP 830843 B1, protects the use of nintedanib or nintedanib esylate for treating fibrotic diseases and is due to expire in December 2025.

Zentiva had obtained two Marketing Authorisations (MAs) for generic nintedanib products in August 2024 and sought a Prior Evaluation Procedure (PEP) necessary for public reimbursement of its product which was approved on 6 December 2024. It was agreed that it is customary for generic pharmaceutical companies in Portugal to request a PEP before the expiration of a patent, but BI argued that the PEP was requested prematurely, more than a year before the patent expires. BI therefore sought a PI on the basis that Zentiva was now free to sell its generic products to both private hospitals and public hospitals.

The Court cited the decision of the Düsseldorf Local Division in Novartis/Genentech v Celltrion and noted that it must be established on a case-by-case basis that the potential infringer has carried out acts that make it more likely than not that the Defendant intends to offer or place the product on the market before the patent expires. Imminent infringement must then be assessed from the point of view of the concrete likelihood that, in light of the circumstances of the case, the Defendant is more likely than not to commit an act of infringement.

On the evidence before it, the Court was not satisfied that there was evidence of imminent infringement. While Zentiva obtained a PEP, it had not offered or marketed the products and had not participated in tenders for public hospital sales.
 

EU

HMD withdraw antitrust complaint over alleged SEP abuse.

HMD, the Finnish smartphone manufacturer (partly owned by Qualcomm and Google) has withdrawn its complaint lodged with the European Commission’s (EC) Directorate-General for Competition. The complaint had related to VoiceAge EVS’s enforcement of its Standard Essential Patents relating to the Enhanced Voice Services (EVS) standard. Notably:

1. The complaint was lodged over two years ago and the Directorate-General to date had still not to date initiated any formal investigation, notwithstanding that the Commission’s best practice is for investigations to commence within 12 months of lodging; and
2. The Commission had filed an amicus curiae brief in the ongoing dispute between the companies at the Munich Higher Regional Court (case no. 7 O 116/19, VoiceAge EMS v HMD) in relation to how to apply the CJEU’s decision in Huawei v ZTE. HMD’s appeal in that action is currently pending following a decision in VoiceAge’s favour.

This comes as VoiceAge has had success in another German action where on 30 April 2025, the Munich I Regional Court granted VoiceAge a SEP injunction against OPPO (case no. 7 O 10630/21, VoiceAge EVS vs. OPPO and OROPE).