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 - 04 October 2024 - is below:

UPC

First Court of Appeal Affirmation of a Preliminary Injunction.

On 25 September 2024, the Court of Appeal upheld the Düsseldorf Local Division’s decision to grant a preliminary injunction (PI) in Ortovox v Mammut (UPC_CoA_182/2024). The dispute relates to an Ortovox patent protecting a transceiver device for avalanche search and rescue and began as a PI granted against Mammut ex parte, was upheld by the Düsseldorf Local Division in an inter partes review, and has now once again been upheld by the Court of Appeal.

 This marks the first occasion that a granted PI has been upheld by the UPC Court of Appeal.

The main action (infringement and revocation) proceedings continue at the Düsseldorf Local division, with a hearing scheduled for 26 November 2024 (case ID: ACT_2379/2024 UPC_CFI_16/2024).

The main substance of the decision relates to claim interpretation, the Court of Appeal once again emphasising their own test, first set out in 10x Genomics v Nanostring and later reaffirmed in VusionGroup v Hanshaw, that the claims are the decisive basis for determining the scope of protection but the description and drawings must also be used to interpret the claims. At first instance, the Düsseldorf Local Division had stated that the file wrapper should generally not be used in claim interpretation. Ortovox had maintained arguments relating to the file wrapper in the appeal proceedings, thereby giving the Court of Appeal an opportunity finally to settle this question. However, the Court of Appeal avoided it: “It is therefore not necessary to clarify the question of whether statements made in the grant procedure are to be used for the interpretation of the patent claims.” Practitioners will therefore have to continue to wait for clarity on this issue from the Court of Appeal, with existing conflicting case law from Local Divisions on the matter.

On novelty, the Court of Appeal considered four prior art documents and found that the independent claims were likely to be novel over each of them. In their reasoning, we continue to see language reminiscent of the EPO’s approach to novelty, with statements regarding a lack of “direct and unambiguous disclosure” of features in the prior art.

On inventive step, there was no mention of the EPO’s problem and solution approach, similar to the 10x Genomics decision from the Court of Appeal and various Local Division main action decisions handed down have seen over the last couple of months. The Court of Appeal did not set out any formulaic test for inventive step, instead taking a more holistic approach, and in so doing, found the patent inventive over all prior art cited.

On the issue of the weighing of interests of the parties (a consideration specific to PIs), the Court of Appeal considered a number of factors. Regarding the assessment of undue delay, they stopped short of settling another conflict present in the UPC Local Divisions of whether there should be a set period of time for a patent proprietor to start a PI action, and, if so, how long (the Munich Local Division has proposed two months whereas the Düsseldorf Local Division has proposed one month). Rather, the Court of Appeal simply stated that any period of delay is “to be measured from the day on which the applicant has or should have had such knowledge of the infringement that he is in a position to make a promising application for interim measures” (i.e. when there is enough evidence of infringement). As the Court considered that this period started on 28 November and the PI application was filed on 1 December, there was no finding of undue delay.

On the topic of irreparable harm, The Court found that irreparable harm is not a necessary condition for the ordering of a PI. The Court stated that Rule 211.3 merely refers to possible damage in the sense that it must be taken into account when weighing up interests if it would occur. The Court added that even ex parte PIs do not necessarily require irreparable damage – the Court can order a PI according to r. 212.1 RoP without first hearing the defendant "in particular" if a delay would probably cause irreparable damage to the applicant.

CANADA

Supreme Court grants permission to appeal in paliperidone palmitate method of treatment appeal.

Following our update in February 2024, on 19 September 2024, the Supreme Court has granted Pharmascience leave to appeal the Federal Court of Appeal's decision upholding the validity of the Janssen patent relating to paliperidone palmitate (INVENGA SUSTENNA). Pharmascience had submitted that the dosage range for the maintenance dose required skill and judgment, meaning it was an unpatentable method of medical treatment. The Court of Appeal had held that the assessment of whether a dosing regime is a method of medical treatment cannot be based exclusively on whether it is fixed or not, rather the question is whether the invention requires the exercise of professional skill and judgment.

UK

Moderna vaccines judgment will be considered by Court of Appeal.

On 25 September 2024, Mr Justice Meade gave a mixed result in the parties’ applications for permission to appeal the Judge’s decision of July (itself a mixed decision, holding one Moderna patent invalid and the other Moderna patent valid and infringed by Pfizer and BioNTech’s Comirnaty vaccine).

Meade J refused Moderna's application for permission to appeal the invalidity decision relating to obviousness and insufficiency. It was determined that there was no reasonable prospect of success given the obviousness grounds were factual in nature. As a result, the ground relating to added matter was also refused.  In contrast, Pfizer and BioNTech were given permission to appeal the decision that Moderna’s other patent was valid. This ground raised issues on novelty and the law of individualised disclosure. 

UK

Janssen Biotech refused permission to appeal for ustekinumab.

On 26 September 2024, Mr Justice Meade refused Janssen Biotech permission to appeal his decision against the validity of its patent for the use of ustekinumab for treating ulcerative colitis. The Judge had previous held the patent invalid for being obvious (reported in our July update), underlining the difficulty of overturning first instance decisions on inventive step, always so dependent on the evidence before the Judge.