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 January 2025 - is below:

SWITZERLAND

Swiss Supreme Court upholds validity of apixaban SPC.

Readers may recall that in March 2024, the Swiss Federal Patent Court dismissed a challenge to the validity of the Swiss apixaban patent. The challenge against the patent was based on a lack of novelty and inventive step, the novelty arguments relating to a formalistic challenge to priority. The inventive step analysis of the Federal Patent Court took account of G2/21 stating that two criteria must be cumulatively fulfilled: (i) the claimed technical effect must be recognised by the skilled person with his/her general technical knowledge and on the basis of the originally filed application as being covered by the originally disclosed technical teaching, and (ii) the skilled person must be able to deduce that the technical effect is embodied by the originally disclosed invention. As these were fulfilled the patent was held to be inventive.

The decision of the Federal Patent Court was appealed and focused on whether or not the patent in suit was entitled to priority; the findings of the Federal Patent Court on inventive step were not challenged.

The issue of priority related to whether or not there had been an intra-company transfer of the patent rights between the priority application and the application as filed given one company in the group had filed the priority application while another had filed the application.  The Federal Patent Court had affirmed the priority claim noting that an implied transfer between two companies within the same group was valid under Swiss law as well as the EPC. The Supreme Court upheld this decision and dismissed the appeal. Interestingly, there was a question on the appeal as to whether or not a challenge to priority could be brought by a third party who has no interest themselves in the patent in issue. While commentary advocating for the prohibition of such third party challenges was referred to by the Supreme Court, it ultimately did not make any finding on this point.

AUSTRALIA

Best method obligations knock out three vaccine patents.

There has been a long running dispute between Boehringer Ingelheim and Zoetis in Australia surrounding whether three patents relating to pig vaccines are valid. On examination, two of the three patents were granted but an appeal followed (together with a cross appeal) and in 2023 and 2024 all three patents were held invalid. Zoetis, the patent owner, then further appealed to the Federal Court of Australia. Late last year that Court handed down its decision which focussed on whether the inventions in the patents had disclosed the best method known to Zoetis for performing the inventions as well as the inventive step of the patents.

As readers may be aware, the best method challenge arises from s. 40(2)(aa) of the Patents Act 1990 and provides that a complete specification must “disclose the best method known to the applicant of performing the invention”. In this sense the word “invention” is held to mean the embodiment which is described and around which the claims are formed. There are a series of cases which provide guidance on the best method requirement (e.g. Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd, Les Laboratories Servier v Apotex Pty Ltd and Firebelt Pty Ltd v Brambles Australia Ltd). The decision in Firebelt focused on the form of the claims in making a finding as to whether the best method had been disclosed. Subsequent cases (e.g. Sandvik) had considered the invention in the specification as a whole. The Firebelt case has never been overruled but has been distinguished on a number of occasions and in its decision in the current case between Boehringer and Zoetis the Federal Court took the opportunity to clarify that the correct approach when considering the best method requirement is to look at the invention disclosed in the specification as a whole. The Court also noted other considerations which could be relevant, including the burden imposed on the skilled addresses by the non-disclosure of the relevant information and the burden on the patent applicant in requiring disclosure of the best method. The question of whether the best method has been disclosed is fact specific to each case. Further, the Federal Court endorsed a previous ruling in a GSK case which states that a patent applicant is not entitled to withhold information that would be necessary for the skilled person to carry out the invention on the basis that that information could be obtained by routine experimentation.

In this case, prior to filing the patents in issue, Zoetis had carried out a number of experiments into investigational vaccine products. Boehringer submitted that since Zoetis had done this and knew there was varying efficacy Zoetis also knew the best method but did not disclose it. This was accepted by the Court. While Zoetis made other arguments on appeal about how it had met the best method requirement and challenging the trial judge’s findings, none of these were successful and it was held that the requirement had not been met and the patents should be invalidated on this ground.

The trial judge’s findings on inventive step, which were based on expert evidence, were not disturbed on appeal. The appeal was therefore dismissed and the patents are invalid.

UPC

Costs awarded against potential intervener. (UPC_CFI_380/2024)

On 23 December 2024, the Milan Central Division handed down a costs decision relating to an application by Menarini Diagnostics s.r.l (Menarini) to intervene in the ongoing dispute over insulin pumps between Insulet and EOFlow (to whom Menarini is the exclusive European distributor). That application was rejected by the Milan Central Division in an order of 1 October (as previously reported here). Insulet subsequently filed an order seeking legal cost compensation against Menarini.

The Judge-Rapporteur rejected Menarini’s objections that (i) it should not have to pay legal costs as it was not a party to the proceedings following the failure of its intervention and (ii) that costs consequences should only follow decisions on the merits. The intervention application had given rise to “sub-proceedings” to which Menarini was a party – and as the unsuccessful party, it should generally bear the costs of those sub-proceedings under Art. 69 UPCA, which states that “Reasonable and proportionate legal costs and other expenses incurred by the successful party shall, as a general rule, be borne by the unsuccessful party”. Further, the intervention application did entail a decision on the merits on the intervener’s legal interest and the nature of its support for one of the parties, as evidenced by the substantive reasons set out in the decision on that application.

Menarini’s argument that Insulet’s costs were incurred voluntarily also failed – there is no distinction between “necessary” and “voluntary” defence under Art. 69 UPCA. Finally, the Judge-Rapporteur rejected Menarini’s contention that it should not have to pay Insulet’s costs because the amount of the costs was “not proven”. The Judge-Rapporteur noted that Insulet’s request for €1,764 seemed “reasonable and proportionate” as required for costs to be awarded under r. 152 RoP and that there was no need under r. 151.1 RoP for a full invoice for legal costs to be presented as part for a costs application.

The Court therefore awarded Insulet its costs as requested.

UPC

Permission to amend patent considered by Hamburg LD in 10x Genomics v Vizgen. (UPC_CFI_22/2023)

On 20 December 2024 the Hamburg Local Division handed down a decision in the ongoing action between 10x Genomics, the President and Fellows of Harvard College (Harvard, the proprietors of the patent-in-suit), and Vizgen, relating to requests by Harvard to amend the patent under r. 30.2 RoP, which notes “Any subsequent request to amend the patent may only be admitted into the proceedings with the permission of the Court”.

Harvard had previously made two requests to amend, submitting 53 sets of auxiliary requests. Following the issuance of the preliminary opinion of the EPO Opposition Division in August 2024, Harvard submitted a third request for amendment with a further two sets of auxiliary requests in October 2024. This third request was rejected by the rapporteur on the grounds that the new version of the amendment could have been made earlier in the proceedings and was inadmissible. Harvard requested that the panel review and overturn the rapporteur’s decision.

The panel rejected the request, holding that contrary to Harvard’s submissions, the assessment of whether a request under r. 30.2 RoP is in time does not depend on the expectations of the patent proprietor as to whether the proprietor could reasonably expect that the filing of the request might cause a delay in proceedings. By the time it submits a response to a revocation claim (or counterclaim), the patent proprietor is already aware of the arguments in that revocation claim – in that respect, the proprietor is already in a position to submit corresponding amendments to the patent, and should generally do so at that stage. Only in exceptional circumstances should the court admit later requests for amendment of the patent under r. 30.2 RoP.

The panel explicitly granted permission to appeal, noting the need for harmonised jurisprudence regarding the admissibility of subsequent requests for amendment under r. 30.2 RoP.