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 - 15 December 2023 - is below:

EPO

TBA considers standard of proof required to show claimed therapeutic effect of a pharmaceutical in EPO proceedings

On 8 December 2023, the Technical Board of Appeal (TBA) handed down its decision in T 2036/21 which concerned N.V. Nutricia’s patent EP 2 170 104 relating to food composition for prodromal dementia patients (the Patent).  

In its earlier decision of T 694/16, the Board of Appeal considered the Patent to meet the requirements of sufficiency of disclosure and novelty but remitted the case to the Opposition Division for further prosecution on the basis of auxiliary request 4 (AR4). Claim 1 of AR4 related to a composition for use in the prevention or delay of the onset of dementia in a person having specific "characteristics" of a prodromal dementia patient. The OD subsequently considered the subject matter of AR4 to involve an inventive step and therefore upheld the patent as valid.  

On appeal to the TBA, the appellants relied upon passages from two prior art documents reporting on a clinical trial which included statements that no overall difference was observed between patients in the active and control groups, in support of their argument that claimed composition was not suitable for preventing or delaying the onset of dementia in prodromal patients and thereby did not confer the claimed therapeutic effect. The TBA criticised this approach in which the appellants had cherry-picked statements from the documents out of context, and held that if read in their entirety, the skilled person would understand that whilst the claimed effect was not detected in the clinical trial, possibly because the clinical trial was not designed and adequately powered to do so (it investigated a different endpoint), this did not necessarily mean that the claimed composition is unsuitable to achieve the claimed therapeutic effect. 

The TBA considered the crucial point to be decided is whether further evidence is available which makes it credible that the claimed composition is suitable for preventing or delaying the onset of dementia in a prodromal patient. Even if the tests aimed at assessing an endpoint of a clinical trial do not yield a statistically significant outcome, other results may still be taken into account to evaluate the efficacy of a treatment, which in some cases may provide valuable information in relation to the endpoint for which no significant results were observed. The TBA reiterated that the principle of free evaluation of evidence applies, according to which the competent EPO body is able to make a decision in light of its conviction arrived at freely, taking into account the available evidence and on the footing that one set of facts is more likely to be true than the other. It is not a prerequisite to perform a statistical analysis of the results and to determine a specific confidence interval, as may be required in biomedical research and by health authorities granting MAs. 

Following this approach, the TBA concluded that the results in the prior art documents made it credible that the claimed composition prevents or delays the onset of dementia in a patient of claim 1 of AR4, and furthermore that patients at the earliest stage of prodromal disease benefit the most from the treatment. On inventive step, the TBA was of the view that the skilled person would only get to the invention from the prior art with the benefit of hindsight, therefore whilst the claimed therapeutic effect is rendered plausible by the disclosures in the prior art documents, the invention is not obvious over them.

NETHERLANDS

Dutch Court considers validity of Moderna’s mRNA patents

On 6 December 2023, the District Court of the Hague handed down a judgment in a patent infringement action brought by Moderna, the owner of EP (NL) 3 590 949 (EP 949), against Pfizer and BioNTech in relation to BioNTech’s Comirnaty vaccine.  EP 949 relates to mRNA technology and the modification of mRNA to enhance its properties, focussing on the production of mRNA with a specific modification, N1-methyl-pseudouridine (m1Psi), which is intended to reduce the immune response and improve protein production.  Pfizer and BioNTech counterclaimed for revocation of EP 949 on the basis of lack of novelty, obviousness, and added matter. They also asserted that Moderna's Patent Pledge, which exempts COVID-19 vaccine makers from patent enforcement, negates any infringement or tort claims.

Pfizer and BioNTech had entered into a collaboration agreement in 2018 to develop mRNA-based influenza vaccines.  Three of the defendants were Dutch-based entities of the Pfizer group, but there was also a US Pfizer entity (Pfizer Inc.) and two German BioNTech entities, one of which was the MA holder for Comirnaty and the other its parent company.

The court initially dealt with a jurisdictional challenge, concluding that it had jurisdiction to hear the claims against the non-Dutch entities (Pfizer Inc. and the BioNTech entities) as well as the Dutch entities because the alleged infringing acts occurred or may occur in the Netherlands.  Pfizer Inc. and BioNTech argued that they would not be engaged in the manufacture, distribution or sale of Cominarty in the Netherlands, but the court held that to the extent that Pfizer Inc. and BioNTech are facilitating and profiting from infringing acts taking place in the Netherlands, the court had jurisdiction.

The court then addressed the issue of novelty over WO 708, an earlier patent application that also deals with modified nucleotides in mRNA. Moderna argued that EP 949 is novel because selections from three lists were required to reach the claimed invention.  In response, the defendants successfully argued that the lists are actually interdependent and the law on selections from lists therefore did not apply.  The skilled person would infer from WO 708 all the features of the claims of EP 949. The court also found that the substitution of 'comprising of' with 'consisting of' in relation to one of the auxiliary requests did not confer novelty. Nor did the addition of the words  "for use as a medicament" in a different auxiliary request help the patentee.  This was on the basis that a medical use can only confer novelty if this use is not credible from the prior art in light of the common general knowledge.  In this case, the medical use was sufficiently clear from the prior art.

On this basis, the court concluded that EP 949 was not novel and therefore also not infringed.  It was not necessary for the court to consider the further submissions before it.  

Moderna, as the unsuccessful party in both the claim and the counterclaim, was ordered to pay the costs of the proceedings. Pfizer and BioNTech, had each claimed €250,000 for the costs of the proceedings, including disbursements. However, the court decided not to award this amount as both Pfizer and BioNTech, had conducted joint and identical defences and their claim to have different interests was not substantiated. Instead, the court awarded €250,000 to the defendants in totality. 

UPC

The Unified Patent Court has introduced a new method for downloading documents on the CMS

On 5 December 2023, the UPC announced the new functionality available on the CMS which allows for multiple documents for a given case to be downloaded at once. In addition, the UPC also announced that a further functionality is now available on the CMS to correct and update representative data.  A guide on the use of the functionality is available here.