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 - 12 July 2024 - is below:

UK

Moderna successfully upholds one of two patents relating to its mRNA vaccine.

As mentioned in last week’s Stop Press, on 2 July 2024 Mr Justice Meade handed down his decision in the technical trial in Moderna v Pfizer & BioNTech, a dispute over various patents that were asserted against Pfizer/BioNTech’s Comirnaty COVID-19 vaccine. Pfizer/BioNTech had effectively admitted infringement of EP (UK) 3 590 949 (EP 949) and EP (UK) 3 718 565 (EP 565), the two patents asserted by Moderna, so the trial focused on Pfizer/BioNTech’s counterclaim for revocation.

EP 949

EP 949 relates to a modified form of mRNA in which the uracil bases are replaced with N1-methyl-pseudouridine (m1Ψ). Moderna sought to defend claims to mRNA with 100% of the uracil bases replaced by m1Ψ, and which comprised a “polyA tail” (a chain of predominantly adenine nucleotides). Pfizer sought to argue that EP 949 was invalid for anticipation by patent application WO 2007/024708 A2 (UPenn), and for obviousness over UPenn or a paper by Katalin Karikó (Karikó 2008).

The Judge rejected Pfizer/BioNTech’s novelty attack based on UPenn. m1Ψ was not individually disclosed or, even if it was, it was only one compound in a long list suggested by UPenn, with no particular indication that it was preferred, and would need to be combined with one of a number of mRNAs disclosed in a different example in order to anticipate EP 949. In relation to an alternative anticipation argument, the Judge held that the proposed route involved a process of research and deduction and there was no direction to replace 100% of the uracil bases in an mRNA strand.

On obviousness, the Judge rejected Pfizer/BioNTech’s argument that, having read UPenn, the skilled person would have explored other nucleotide modifications, which would lead them to m1Ψ, describing the approach proposed by Pfizer/BioNTech’s expert as “one of blind trial and effort”. It was also at odds with the common general knowledge (CGK), which taught away from the use of m1Ψ. Karikó 2008 overlapped significantly with UPenn and did not contain any material differences.

Therefore, it would not have been obvious for the skilled person to go from the prior art to the invention of EP 949, and the validity of the patent was upheld.

EP 565

EP 565 relates to a betacoronavirus mRNA vaccine with the spike (S) protein or a subunit as the antigenic polypeptide and formulated in a lipid nanoparticle. Pfizer/BioNTech sought to advance cases that EP 565 was anticipated and obvious over Moderna’s WO 2015/164674 (WO 674) application, and invalid for added matter.

The Judge first had to resolve a number of outstanding issues in relation to disputed CGK. As to whether betacoronaviruses were considered viable vaccine targets at the priority date, the Judge was convinced that they were in light of a “substantial body of materials” submitted by Pfizer/BioNTech as evidence. The CGK also indicated that (i) there was unlikely to be any difficulty in applying lipid nanoparticles in the context of mRNA vaccines and (ii) the spike (S) protein or subunit had been used as the target antigen and had elicited neutralising antibodies with protective effect in test animals.

The Judge rejected Pfizer/BioNTech’s anticipation attack, noting that it required the skilled person to make choices to combine selected, different parts of the teachings of EP 565 in ways which were not taught. WO 674 did not provide a sufficiently clear and unambiguous teaching of all the features of EP 565. However, the Judge noted that the application for EP 565 as filed also lacked a sufficiently clear and unambiguous teaching of all the necessary features of the patent as granted, and therefore found the patent invalid for added matter.

On obviousness, the case mainly revolved around Example 20 of WO 674, which disclosed a “key vaccine” for MERS-CoV (another betacoronavirus) comprising an mRNA encoding the MERS-CoV spike glucoprotein as an antigen. Moderna sought to argue that the skilled team would not choose to work with MERS-CoV, as there would be many other vaccine targets to work on, but this argument failed in light of the Judge’s findings on CGK. The Judge held that Example 20 of WO 674 provided a clear pointer towards a goal that would be attractive: progressing a vaccine against betacoronaviruses such as MERS-CoV. EP 565 was therefore also invalid for obviousness over WO 674.

UK

Moderna’s patent pledge examined by Court.

As mentioned in last week’s Stop Press, on 2 July 2024 Mr Justice Richards handed down his decision in Moderna v Pfizer & BioNTech. The trial dealt with the effects of (i) a statement made by Moderna in October 2020 (referred to in the judgment as the Pledge) that they would not enforce their COVID-19-related patents against those making vaccines to combat the pandemic for the duration of the pandemic and (ii) Moderna’s statement in March 2022 (the March 2022 Statement) that the non-enforcement of the patents would apply only to vaccines destined for 92 low- and middle-income countries. Moderna did not seek injunctive relief in the proceedings, but sought damages or an account of profits for any acts of infringement by Pfizer and BioNTech that took place from the date on which the Pledge was updated in March 2022.

The Judge rejected Moderna’s argument that the Pledge was not intended to provide consent to companies such as Pfizer/BioNTech that were already manufacturing COVID-19 vaccines prior to the date of the Pledge. On an objective reading of the Pledge, this was incorrect and Moderna was held to have given consent for Pfizer/BioNTech to manufacture their COVID-19 vaccines. Citing United Wire v Screen Repair Services [2001] RPC 24, the Judge explained that although the consent was not contractual, it was sufficient for Pfizer/BioNTech’s actions not to constitute infringement under section 60 of the Patents Act 1977.

However, the Judge rejected Pfizer/BioNTech’s case that the “pandemic period” according to the Pledge continued until 5 May 2023, when the Emergency Committee advised the WHO that COVID-19 no longer constituted a public health emergency. The Pledge gave little guidance on when the pandemic could be said to come to an end but in any case the Pledge was identified in the text as a “forward-looking statement” that was neither a promise nor a guarantee so Moderna had reserved the right to change its mind.

The effect of the March 2022 Statement was to withdraw Moderna’s previous consent. Contrary to Pfizer/BioNTech’s submissions, the Judge held that (i) Moderna’s actions did not constitute a “waiver of rights” under US federal law, and (ii) even if the Pledge had been a “waiver of rights”, it would not have rendered Moderna’s consent irrevocable. There was also no unilateral contract between the parties under the law of Massachusetts as (i) the Pledge did not constitute an offer which Pfizer/BioNTech could accept by conduct and (ii) even if there was an offer capable of acceptance, Pfizer/BioNTech’s conduct was incompatible with acceptance and Pfizer/BioNTech had not provided any consideration. There was therefore no bar to Moderna revoking their consent through the March 2022 Statement.

Pfizer/BioNTech is therefore liable for infringing acts carried out in the UK after March 2022.

CAMBODIA

Department of Industrial Property (DIP) introduces online patent register.

The Department of Industrial Property in Cambodia has recently made its official patent and industrial design database publicly available, granting open access to almost 5000 patent database entries and over 1200 industrial design records with filing dates from 2006. A further 400 patent records are not currently available on the open database but are intended to be uploaded imminently.

UPC

Second UPC merits decision given by Paris Local Division.

The UPC handed down its second merits decision on 4 July 2024, with the Paris Local Division issuing a ruling in the matter of DexCom, Inc. v Abbott Laboratories (UPC_CFI_230/2023). This follows its first merits decision handed down on 3 July 2024 (as reported in last week’s Irides Weekly Update here).

DexCom had brought an infringement action against Abbott Laboratories and nine other Abbott group companies in relation to its patent EP 3 435 866, which concerns technology for remotely monitoring blood glucose levels in diabetes patients. The defendants counterclaimed for revocation of the patent, based on added matter, lack of novelty and lack of inventive step.

DexCom argued that the UPC did not have jurisdiction to hear the defendants’ counterclaim for revocation of the German part of the patent as the scope of the counterclaim should be identical to the scope of the infringement action. In its infringement action, DexCom had requested the exclusion of infringing acts that are the subject of a pending action before the Mannheim Regional Court against defendants 1, 2 and 8 based on the German part of the patent. Defendant 8 has also filed a revocation action in relation to the German part before the German Federal Patent Court.

DexCom’s position was that a counterclaim for revocation from defendants 1, 2 and 8 was not possible under Art. 33(3) of the UPC Agreement (UPCA) and, in relation to defendant 8, the UPC did not have jurisdiction based on Art. 31 UPCA and Art. 71c(2) and Art. 29(3) of Regulation (EU) No 1215/2012 (Brussels Recast). For the remaining defendants, DexCom argued lack of jurisdiction under Art. 31 UPCA and Art. 71c(2) and Art. 30(2) Brussels Recast.

Jurisdiction

The court dealt with jurisdiction as a preliminary issue and found that it had jurisdiction to rule on the entirety of the patent, including the German part.

Concerning the scope of the revocation action, the court held that it should not be limited to the scope of the infringement claim (i.e. excluding the German part) for the following reasons:

• The application for revocation was supported by defendants other than defendants 1, 2 and 8, i.e. not only those defendants who were involved in the parallel national proceedings in Germany. It would be contrary to the principle of a fair trial for the other defendants to be blocked from defending themselves by means of a counterclaim for revocation of the entire European patent, given that they had been sued for infringement in all territories in which the European patent is in force; and
• There is no provision in the UPCA that limits a party bringing a counterclaim to the parts of the patent asserted against it by the claimant in the infringement action, or to limit a revocation action to what is asserted in the main infringement action. The fact that DexCom had excluded certain acts of infringement was therefore irrelevant.
• While there is a general principle that the parties are to define the subject matter of the dispute (reiterated in Art. 76(1) UPCA), thereby allowing the claimant to exclude certain acts of infringement in a UPC action in order to avoid the parallel jurisdiction between the UPC and national courts during the transitional period under Art. 83, this principle cannot restrict a defendant in its challenge to the validity of the European patent being asserted against it.

Concerning the argument that the UPC lacked jurisdiction due to the pending nullity action in Germany, the court held that this was not a case of lis pendens as the parties and subject-matter of the UPC action were not identical to the German proceedings. The revocation action in Germany only concerned the German part of the patent and only involved one of the defendants in the UPC action (defendant 8). As a result, the court did not consider that it was obliged to decline jurisdiction in favour of the German court under Art. 29 Brussels Recast. Instead, the UPC and German actions were “related actions” under Art. 30(2) Brussels Recast, allowing the court the discretion to decide whether to decline jurisdiction or not. Given that the German Federal Patent Court would not issue a final decision until after a decision in the present UPC proceedings (the German oral hearing is scheduled for 29 January 2025), the UPC held that it was neither efficient nor expeditious to decline jurisdiction or to stay proceedings pending the German decision.

The UPC therefore decided to maintain jurisdiction to rule on the validity of the entire patent, including its German part.

Validity

The court also resolved a preliminary issue on interpretation of the patent, confirming that Art. 69 of the European Patent Convention is the basis for claim interpretation and adopting the principles laid down by the Court of Appeal in 10x Genomics and Harvard v Nanostring (UPC_CoA_335/2023), (see Weekly Update 9/2024 here for a summary of this case), namely that the patent claim is the decisive basis for determining the scope of protection while the description and drawings may be used as explanatory aids for interpretation. These principles were also confirmed in SES-Imagotag v Hanshow (UPC_CoA_1/2024), reported in Irides Weekly Update 20/2024 here.

Having construed the claims based on these principles, the court found the patent invalid for lack of inventive step (the patent having survived novelty and added matter attacks), a view which was in agreement with the Preliminary Opinion issued by the German Federal Patent Court on the German part of the patent. This was based on the selection of one of four data transmission protocols (to which the patent did not ascribe any particular or surprising effect) being deemed obvious over the prior art in combination with the CGK.

The court also found that DexCom’s auxiliary requests to amend the patent did not cure the validity issues (the first request was deemed to not involve an inventive step and the second request was found to add subject matter).

Consequently, the patent was revoked in its entirety in all contracting UPC member states, with DexCom’s claims of infringement dismissed given the finding of invalidity. DexCom was also ordered to bear the costs of the proceedings, to be determined in separate proceedings upon request of a party for a cost decision.