Irides: Weekly patent litigation update

This edition features updates from: the European Patent Office (EPO), France, the European Union (EU), the United States of America (USA) and the Unified Patent Court (UPC).

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.
 

EPO

The EPO Enlarged Board of Appeal adopts an approach to claim construction consistent with national courts and the UPC - “the description and drawings shall always be consulted”

In case G 1/24, the Enlarged Board of Appeal (EBA) had been asked to answer the following questions:

Question 1

Is Art. 69(1), second sentence, EPC and Art. 1 of the Protocol on the Interpretation of Art. 69 EPC to be applied to the interpretation of patent claims when assessing the patentability of an invention under Art. 52 to 57 EPC?

Question 2

May the description and figures be consulted when interpreting the claims to assess patentability and, if so, may this be done generally or only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation?

Question 3

May a definition or similar information on a term used in the claims which is explicitly given in the description be disregarded when interpreting the claims to assess patentability and, if so, under what conditions?”

The EBA handed down its decision on 18 June 2025, with the following Order:

“The claims are the starting point and the basis for assessing the patentability of an invention under Articles 52 to 57 EPC. The description and drawings shall always be consulted to interpret the claims when assessing the patentability of an invention under Articles 52 to 57 EPC, and not only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation.” (emphasis added)

In doing so the EBA found the “strictly formal” answer to the first question should be “no” but, regardless of the lack of any “entirely satisfactory” legal basis for claim interpretation in these provisions, it did not need to invent from scratch new principles of claim interpretation. Rather, the decision is based on an existing body of case law from which the applicable principles of claim construction could be extracted.

From the applicable case law, the EBA identified principles that should be adhered to, which are stated in the Order above.  The first point, that the claims are the starting point and basis, was considered to be a settled point in the case law, whereas the second point, the consultation of description and drawings, had given rise to divergence.

In assessing the second point, favouring the line of case law that suggests the description and drawings should be consulted, and thus answering the second question emphatically “yes” on both accounts, the EBA emphasised that harmonisation of the EPC with national courts was desirable. The use of the description and drawings to construe the scope of a claims is a principle of claim construction applied in proceedings in many of the national courts throughout Europe, for example in the “purposive construction” approach applied by the English Courts.

Furthermore, the EBA drew attention to the current case law of the UPC, as exemplified in the Order of the UPC Court of Appeal of 26 February 2024 in NanoString Technologies v 10x Genomics. Wording from the second headnote of this decision aligns very closely with the Order made by the EBA. The third question was considered by the EBA to be encompassed within the second question and so, given the findings on the second question, this was deemed inadmissible. However, given the Order states that the description shall always be consulted, it is clear that definitions provided in the description should not be disregarded, although it remains unclear whether such definitions should always be adopted in claim construction.
 

FRANCE

French Court of Appeal implement CJEU decision on SPC’s for the first time.

In two recent judgments the French Court of Appeal has considered the issue of entitlement to an SPC for a combination product. The cases relate to two SPCs that were sought by Janssen: (1) chloride ripilvrine and tenofovir Alafenamide; and (2) chloride rilpivrine, emtricitabline and tenofovir alafenamide. These were sought on the basis of Gilead’s MA for Odefsey (which is used to treat HIV and which contains emtricitabine, rilpivrine and tenofovir alafenamide as APIs).   The basic patent relied on for both SPC applications related to a new form of rilpivrine and disclosed various formulations for its use in the treatment of HIV.  The SPC applications had been rejected by the French Patent Office, INPI. On appeal, the Court considered the long line of CJEU case law which relates to Art. 3(a) of the SPC Regulation and combination medicines, including in the Merck decisions (C-119/22 and C-149/22) from December last year. Considering this case law the Court sought to answer two questions: (1) does the product fall under the invention of the basic patent?; and (2) is the product specifically identifiable in the basic patent?

On the first question, the Court looked at whether the combination of active ingredients is a necessary feature for solving the technical problem disclosed by the basic patent. INPI had argued that there were no examples to the combinations of active ingredients and no tests to demonstrate that a combined or synergistic effect had been carried out. However, at paragraph [0107] there was some generalised teaching about the synergistic effect of combinations in HIV therapy and the Court held that the patent therefore demonstrated that the combination of the active ingredients has a combined effect that “goes beyond the simple addition of the effects of the active ingredients taken separately.” The combinations therefore fell under the invention of the basic patent.

On the second question, INPI had considered that the combination of hydrochloric ripilvirine with one or more antiretrovirals was not specifically identifiable as there were a large number of combinations that could be made on the basis of the claims and the description of the basic patent. It was therefore for the SPC applicant to show that the person skilled in the art could, with the knowledge of the patent and their common general knowledge, understand the product in question was specifically identifiable. Reference was made by the applicant to aspects of the patent to support that the product in question was specifically identifiable. Further, while tenofovir alafenamide was not included in the claims of the patent, tenofovir was included in the description and it was possible from the description and the common general knowledge for the skilled person to know that it was nucleotide reverse transcriptase inhibitor with anti-HIV activity. Based on these arguments, the Court found the products to be specifically identifiable.

Given these findings the appeal was allowed.
 

EU

Medical Device Coordination Group issue new guidance on the safe making available of Medical Device Software apps on online platforms.

The Medical Device Coordination Group (MDCG) have this week published 2025-4 guidance on the safe making available of Medical Device Software (MDSW) apps on online platforms.

The MDCG working group is comprised of representatives from all Member States and deals with key issues including medical devices, new technologies and clinical investigation. The guidance was issued to assist the European Commission and Member States in implementing the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) and the result of growing availability of health-related apps to ensure safety, regulatory compliance and transparency.

The guidance clarifies the role and responsibilities of App Platform Providers (APP) in bringing MDSW to the EU markets, under the MDR/IVDR and Digital Services Act (DSA) and introduces guidance for intermediary service providers and also provides information on what should be provided by medical device manufacturers when making available their MDSW Apps. 

The guidance clarifies that where a manufacturer uploads a MDSW app this corresponds to the “placing on the market”, when the MDSW app is available this corresponds to “making available on the market”, this includes all commercial activity whether in return for payment or free of charge.

The guidance sets out two roles and the requirements that must be met for each under the DSA, these are:

• APP as in Intermediary service provider: this is where the app platform acts as an online marketplace by facilitating the connections between the MDSW manufacturer and patient. In these circumstances the platform providers are not considered the distributor or importer under the MDR/IVDR, however they are subject to requirements under the DSA which include:
  • Notification of illegal content: reporting and addressing illegal content;
  • Transparency and compliance: ensuing that the online platform is designed to allow traders to comply with their obligations, such as compliance and product safety and assess whether information about the trade in reliable, complete and available to users; and
  • Accountability: Very Large Online platforms (VLOP) must comply with risk assessment framework obligations.
• App platform providers as distributors and importers: this is where a manufacturer makes a MDSW app available to an APP who then provides the product directly to the user (e,g. by transfer or ownership). This applies if the activity is commercial or non-commercial. It is also noted that if the manufacturer is based outside of the EU and the app providers is EU based, then the APP will assume the role of the importer. In this case the DSA does not apply, however the APP is subject to the rules of the MDR/IVDR which includes:
  • Ensuring compliance; and
  • Cooperation and authorities.

The guidance also highlights the “information obligation”, which should be provided and made available to patients on the platform. Manufacturers are responsible for ensuring that the regulatory guidance is complied with even where distributed through intermediary service providers.  In accordance with DSA, platforms should clearly display contact details, product identification and branding such as trade mark and logo. Further, the APP should create a separate library for MDSW app which should be separate from health apps. Where traders are used then providers should assess the platform and information before allowing them to offer the service and randomly check to ensure that they meet the requirements. VLOPs are also subject to further requirements under the DSA.
 

USA

US Court of Appeals upholds Cardiovalve’s patent for heart valve implants.

On 9 June 2025, the United States Court of Appeals for the Federal Court made its decision regarding the patentability of Cardiovalve’s patent (US 10,702,385). Cardiovalve’s patent related to the use of a prosthetic valve support to facilitate minimally invasive implantation of a prosthetic heart valve.

The appellant, Edwards Lifesciences, had petitioned for an inter partes review (which was instituted), during which Cardiovalve filed motions to amend (including a substitute independent claim 11) which were granted by the Patent Trial and Appeal Board (Board). The appellant appealed the Board’s decision on the basis that substitute claim 11 was anticipated or obvious over the cited prior art, “Goldfarb”, raising arguments based on construction of the claims and interpretation of Goldfarb.

Having reviewed the Board’s “legal conclusions de novo and its fact findings for substantial evidence”, the US Court of Appeals considered the evidence supported the Board’s determinations and that some of the appellant’s arguments as to the disclosure of Goldfarb were “unavailing” and “largely speculative”. The Court therefore affirmed the Board’s decision to grant the motions to amend.
 

UPC

The Düsseldorf Local Division confirm 10x Genomics Preliminary Injunction decision as patent is held to be infringed
(UPC_CFI_140/2024)

On 16 June 2025, the Düsseldorf Local Division granted 10x Genomics a permanent injunction against Curio Bioscience in Germany, France, and Sweden. This decision follows the court's previous decision in April 2024 granting 10x Genomics a Preliminary Injunction (PI) following a finding that claim 14 of its patent had been infringed.

In December 2023, the Claimant, 10x Genomics, Inc., filed an application for a preliminary injunction against the Defendant, Curio Bioscience Inc., on the basis of alleged infringement of claims 1 and 14 of its European patent (EP 2 697 391 B1) which claimed a "method and product for localised or spatial detection of nucleic acid in a tissue sample". Following an oral hearing, in its order dated 30 April 2024, Court found infringement of claim 14 (but not claim 1) and issued a PI on that basis, preventing the defendant from offering, marketing, using, or possessing the product of the infringed claim in Germany, France and / or Sweden. In doing so, the court found the patent's validity to be 'sufficiently certain' for the purposes of granting provisional measures.

During the May 2025 merits hearing to which this latest judgment pertains, the claimant sought inter alia a permanent injunction on the basis of indirect infringement of claim 1 (notwithstanding the court's previous decision that it was not infringed) and direct infringement of claim 14. In response, the defendant did not expressly challenge the patent's validity (having had its validity arguments dismissed by the court at the PI hearing) and instead concentrated its technical arguments on non-infringement.

At the oral hearing, the claimant argued that the specification and, in particular, the embodiments covered by claims 7 and 9 were key to the interpretation of claim 1, such that claim 1 was infringed. In addressing this argument, the court referred to Art. 69 EPC in conjunction with the Protocol on its interpretation, affirming that while the claims are 'not only the starting point but also the decisive basis for determining the scope of protection of a European Patent', the description and drawings must always be taken into account as aids to the interpretation of the claim and not only to resolve any ambiguities in the claim. However, it also noted that adequate protection for the patentee must be combined with sufficient legal certainty for third parties.

On the facts of the case, the court did not consider that subclaims 7 and 9 supported a different construction to that which the court had previously found for claim 1. Accordingly, claim 1 was held to be not infringed, but infringement of claim 14 was upheld and a permanent injunction was granted prohibiting the Defendant from offering, placing on the market, utilising or either importing or stocking for the above purposes, products falling within claim 14 of the patent. Recall of products, destruction of products, provision of sales information, damages and costs were also ordered by the court.
 

UPC

Patent Mediation and Arbitration Centre public consultations on draft rules.

The UPC is in the process of setting up its Patent Mediation and Arbitration Centre (PMAC). The PMAC has two seats: in Ljubljana, Slovenia, and Lisbon, Portugal and aims to provide a framework for resolving patent disputes through mediation, arbitration and other appropriate dispute resolution processes. The PMAC has said it expects to be operational by early 2026. The PMAC has published its draft mediation and arbitration rules which deal with issues from requesting ADR proceedings and appointing a mediator/arbitrator to specific rules for FRAND disputes. The PMAC has launched a public consultation seeking feedback on the draft mediation rules by 21 July 2025 and by 4 August 2025 for the draft arbitration rules.
 

UPC

Phased roll out of UPC Case Management System Announced.

The UPC has announced that it will introduce a new Case Management System (CMS), with roll-out taking place in two phases. From July 2025, the first phase focusing on opt-out functionalities and Representatives' registration will begin. This is intended to allow users to gain familiarity with the new system prior to its full roll-out. The second phase, from September 2025, will see the full CMS become operational for all users. Until September 2025, the current CMS will continue to be used for the filing of cases, applications and protective letters. Users should look out for an upcoming dedicated webpage from the UPC with relevant materials, FAQs and user guides about the new CMS roll-out.