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 - 6 December 2024 - is below:

UK

Supreme Court grants permission to appeal in AI action.

The Supreme Court has granted Emotional Perception permission to appeal the decision of the Court of Appeal in Comptroller-General of Patents, Designs and Trade Marks v Emotional Perception AI Ltd [2024] EWCA Civ 825 which was handed down on 19 July 2024. The Court of Appeal found that a patent to an artificial neural network should be assessed in the same way as any other computer implemented invention and rejected Emotional Perception’s patent on the basis that it did not disclose a technical (as opposed to aesthetic) contribution. The Supreme Court is expected to hear the case next year and its decision is likely to have a considerable impact on how AI and computer implemented inventions are handled in the UK. Our previous summaries of the first instance and appeal decisions can be found here and here.

IRELAND

Apixaban appeal allowed and case remitted to the High Court.

On 28 November 2024, the Court of Appeal allowed an appeal by Bristol-Myers Squibb (BMS) against the decision of the High Court in Teva v Bristol-Myers Squibb [2023] IEHC 744 and remitted the matter for rehearing before a different judge of the High Court. The first instance trial concerned the validity of BMS’ compound patent for apixaban, which the judge held to be invalid on the grounds of lack of plausibility.

In considering the 901 page first instance judgment, the Court of Appeal found that the trial judge had failed to make essential findings of fact and to provide reasons why the evidence of one witness was preferred over another. In light of this, the Court of Appeal could not properly assess whether the High Court was correct in its conclusion that BMS’ patent was invalid. It therefore considered that it must remit the case to the High Court for rehearing, confined to the issue of plausibility. Contrary to the approach of the trial judge, who assessed plausibility according to the test established in Teva v Boehringer Ingelheim [2022] IECA 58, the plausibility test to be applied is that set out in the EBA decision G 2/21.

UPC

Paris Central Division revokes VMR’s patent (UPC_CFI_307/2023 & UPC_CFI_308/2023).

In its decision of 27 November 2024, the Paris Central Division has revoked VMR’s patent for a vaporizer (e-cigarette) for lack of inventive step over the cited prior art and common general knowledge. Interestingly, the court allowed late-filed documents from NJOY when considering the case demonstrating that the UPC may sometimes deviate from the “front-loaded” nature of proceedings suggested by the Rules of Procedure (RoP).

The claimant NJOY filed a revocation action against VMR. VMR filed a defence and NJOY submitted new evidentiary documents with its reply to VMR’s defence. VMR objected to this on the basis that NJOY could have filed the documents at the time of its original claim.  Further, VMR argued that NJOY, if it wished to rely on the additional documents, should have applied to amend its case under r. 263 RoP; NJOY had not done so. Following the principles set out in r. 13 and 44 RoP, the Court noted that its proceedings are intended to be “front-loaded” so that the defendant is aware of the factual elements and legal grounds of the claim made against it, and so that matters proceed expeditiously. However, the Court emphasised that these rules are subject to the principle of proportionality set out in the Preamble of the RoP.  The Court also considered it would act counter to the principle of procedural efficiency if excessively detailed statements of fact and additional documents were provided with the initial claim. A third factor, in favour of admitting NJOY’s additional documents, was that it would be unfair to prevent a party introducing a document during proceedings that only became available to that party at a later stage. Taking these points into account, the Court admitted NJOY’s documents.

In relation to the substantive decision, the key integer of claim 1 of the patent referred to a “window” in the shell of the vaporizer. Notably the claim did not specify where the window should be located or its size or shape. The Court was therefore unconvinced by VMR’s argument that the window was to allow a user to see if the removable “cartomizer” was positioned correctly. The Court considered that this would only be true if the claim required the window to be located so as to show the connection of the cartomizer to the rest of the vape and the claim was broader than this. In fact the Court decided that all that was needed was “a window of any shape and size … that in some way allows some portion of the chamber to be visible from outside the shell”.  It was agreed that the starting point prior art “Pan” did not disclose the window feature but, faced with the technical problem of how “to allow a portion of a chamber to be visible from the outside”, the answer was obvious: “providing a non-transparent wall of a chamber with a window … is the most basic approach known to [the skilled person] when confronted with [that] problem”.

CANADA

Federal Court rejects judicial review of Health Canada's patent listing process.

On 20 November 2024, the Federal Court handed down its decision in EMD Serono and Merck Serono SA v The Minister of Health and Apotex Inc. 2024 FC 1848. The Court dismissed Serono’s application for judicial review of the Minister of Health’s decision regarding the listing date for Serono’s patent on the patent register. Serono had argued that the Minister unreasonably delayed listing their patent, resulting in a loss of their patent rights.

In Canada, under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 (PM(NOC) Regulations), the owner of a pharmaceutical patent can prevent generic (or biosimilar) products entering the market once the patent has been listed by the Minister of Health on the patent register. After a patent has been listed, a generic seeking to launch its version of the patented drug must either gain the patentee’s consent or allege that the listed patent is invalid or not infringed. If a generic chooses the latter option, it must serve a Notice of Allegation (NOA) on the patentee, which entitles the patentee to bring an action for a declaration of infringement and prevents the generic from entering the market for 24 months. However, a generic need not address any patents listed after the filing date of its drug submission; the patent register is effectively “frozen” as of the filing date.

Before listing a patent, the Minister must decide whether a patent meets the eligibility requirements under s. 4(2) of the PM(NOC) Regulations, namely that it claims an approved medicinal ingredient, formulation, dosage form or use.

In Serono’s case, its patent to a cladribine regimen for treating multiple sclerosis was granted by the Canadian Intellectual Property Office (CIPO) on 7 March 2023. Serono’s patent list was submitted to Health Canada for review in relation to its multiple sclerosis product Mavenclad nine days later, on 16 March. Health Canada carried out a preliminary analysis of the Serono patent’s eligibility on 21 March and informed Serono that its patent had been added to the register on 23 March. One day earlier, Apotex had filed its regulatory submission for its generic version of Mavenclad. As Serono’s patent was not on the register at the time of the regulatory submission, Apotex did not need to address it by serving an NOA.

The Minister of Health rejected Serono’s request to change the listing date from 23 March to the earlier date of 16 March, when the patent was submitted for review, on the basis that the PM(NOC) Regulations make a clear distinction between submission of a patent list and the addition of patents to the register. In its request for judicial review, Serono argued that the week-long delay between filing and the Minister’s decision to add the patent to the register was unreasonable as the PM(NOC) Regulations do not allow for any discretion to delay. Serono contended that the correct interpretation of the PM(NOC) Regulations was that a generic must address any patents that have been submitted to the register prior to the filing of their regulatory submission.

The Federal Court rejected Serono’s arguments, stating that the Minister’s decision was not unreasonable in light of the facts of the case and the PM(NOC) Regulations. Under the Regulations, the Minister must assess each patent for eligibility before adding it to the register and it is only once this has been done that a generic company is required to address the patent. The court also noted that the day that Health Canada completed the screening and eligibility form for the patent is not necessarily the day on which the Minister determined the patent to be eligible to be added to the list. 

UPC

Milan Local Division rejects PI application (UPC_CFI_400/2024).

On 22 November 2024, the Milan Local Division dismissed Insulet’s application for a preliminary injunction against Menarini. The application for provisional measures concerned the alleged infringement of EP 4 201 327 (EP 327), which relates to a fluid delivery device, by a patch-insulin pump distributed in the EU by Menarini. Finding that the patent is likely invalid, the Court dismissed the application and confirmed that claim amendments are not permitted in proceedings for provisional measures.

The Court set out that for a preliminary injunction to be granted, pursuant to Art. 62.4 and r. 211.2 RoP, the applicant must establish the validity of its patent with “sufficient certainty”, i.e. it must show that the patent is more likely valid than invalid. The Court found that EP 327 appeared to lack novelty over the prior art and was therefore more likely than not invalid.

As part of its reply to Menarini’s validity attacks, Insulet filed auxiliary requests to amend the claims of its patent. The Court dismissed these requests, rejecting Insulet’s argument that they only represented an expression of legal caution and were therefore admissible at any point in the proceedings. Instead, the Court followed previous case law in holding that auxiliary requests are not admissible prior to the main proceedings, as r. 30 RoP and r. 50 RoP only permit claim amendments to be sought in a defence to a claim or counterclaim for revocation.

Further to its auxiliary requests, Insulet also applied under r. 263.3 RoP to unconditionally limit its claim for infringement to the claim scope defined in its previously submitted auxiliary requests. Citing an interpretation of r. 263 RoP established by the Paris Central Division, the Court held that this was not an application to limit a claim within the meaning of r. 263.3 RoP and was instead an attempt to introduce claim amendments outside of r. 30 RoP and r. 50 RoP. The Court held that the application under r. 263.3 RoP was therefore inadmissible.

The Court’s findings in this case reinforce the principle that claim amendments are not permitted in preliminary injunction proceedings at the UPC. This position is consistent with the required urgency with which an application for a preliminary injunction must be brought, and the right of defence, particularly the principles enshrined in r.  263 RoP, which in part establish the front-loading of UPC claims.

Though not an argument advanced by Insulet, Menarini acknowledged that it is possible that claim amendments could be permitted in proceedings for provisional measures in extraordinary circumstances. As the Court in this case did not have to consider such an argument, it remains to be seen under what, if any, extraordinary circumstances claim amendments in proceedings for provisional measures may be allowed.

Menarini also sought security for its costs in the event it is successful in the main proceedings. It argued that there is a significant risk that it would be unable to enforce a costs order were it to be granted one as Insulet is a company incorporated in the US, which is not a party to any international treaty which would allow for enforcement. The Court rejected the application on the grounds that difficulty of enforcement is not sufficient for the granting of security, and further noted that Menarini had failed to make out a positive case that Insulet would avoid paying its costs or that its financial situation would prevent it from doing so.

ISRAEL

Revocation of a single SPC in a European Recognised Country invalidates the IL PTE.

In a recent decision, the Patent Office (ILPO) clarified the way in which Israeli patent term extensions (PTEs) are affected by the revocation of an SPC in in one of the European Recognised Countries (the UK, Germany, France, Spain and Italy).

In Israel, a PTE will be granted if the "Two-State Requirement" is met, which requires a PTE granted in the US and an SPC granted in at least one of the European Recognised Countries. However, the Israeli PTE will be invalidated in the event that the corresponding US PTE or any of the recognised European SPCs are revoked, regardless of whether other SPCs in the European Recognised Countries are upheld.

Following the revocation of the UK patent and SPC for apixaban, the patentee, Bristol-Myers Squibb, tried to resist the resulting revocation of the PTE for apixaban in Israel. The patentee highlighted the fact that SPCs in other European Recognised Countries had not been revoked and that, had there never been an SPC in the UK, the criteria for the Two-State Requirement would still be satisfied. Although the ILPO Deputy Commissioner agreed with the patentee that there was asymmetry in the provisions for PTEs in Israel, they were constrained by the case law requiring a strict interpretation of the statutory language and revoked the PTE.

EPO

Referral to Enlarged Board of Appeal on intervener's rights.

On 11 November 2024, the Technical Board of Appeal (TBA) gave a decision  considering whether a third party, who has intervened during appeal proceedings, may acquire appellant status.

The patent proprietor is a Swedish company Foreo AB, whose EP 163 patent concerns an oscillating handheld skin cleanser. The patent was opposed by a German company Beurer GmbH and, before the oral proceedings at the Opposition Division, a third company Geske GmbH & Co. KG filed an intervention following receipt of a warning letter from Foreo alleging that Geske had infringed EP 163. Geske’s intervention was refused on the basis that the mere existence of a threat was insufficient grounds for intervention under Art. 105 EPC. A second intervention attempt by Geske, made after it had filed a request at the Düsseldorf District Court for a declaration of non-infringement, was also refused since the Düsseldorf case was not considered “pending” at the time of the second intervention. In the meantime, the Opposition Division only considered Beurer’s opposition to EP 163 and decided to uphold the patent. Beurer appealed and Geske filed a third intervention, along with an appeal against the Opposition Division’s decision to refuse its second intervention.  Before the oral proceedings in the appeal, Beurer withdrew its appeal and so the TBA had to decide if the appeal may continue on the basis of Geske’s third intervention and/or the appeal of its decision not to allow its second intervention.

Foreo argued that the intervention should not be allowed on the basis that this was Geske’s “third bite of the cherry” but the TBA disagreed, noting that Geske’s previous interventions had not in fact been heard so it was more akin to three attempts “to have one bite of the cherry”. An issue remained, however, in that neither Art. 105 EPC (Intervention of the Assumed Infringer) nor Art. 107 EPC (Persons entitled to appeal and to be parties to appeal proceedings) contemplated interveners joining at the appeal stage, creating an apparent procedural bar to Geske’s intervention being allowed at the appeal once the sole appellant (Beurer) had withdrawn its appeal.

Having closely reviewed the wording of the EPC and precedent decisions (particularly G 03/04), the TBA decided that “Entitlement to intervene in opposition proceedings and thereby become an opponent is … determined by a legal interest extraneous to the EPO proceedings rather than a period of opposition”.  This legal interest was the risk of an infringement action which an intervener in Geske’s position faced.  The TBA continued that “it finds it appropriate to apply this reasoning also to the appeal stage”. The TBA decided that this would overcome the procedural issues but in view of the importance of the question and the potential conflict with G 03/04, it is being referred to the Enlarged Board of Appeal.