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 - 24 March 2025 - is below:

UK | STOP PRESS

Two out of three of DSM’s microbial oil patents found invalid.

On 20 March 2025, the Patents Court gave judgment in a three patent case between DSM IP Assets (the patentee) and Mara Renewables Corporation and Algal Omega 3 Ltd.  All three patents were considered at a single trial and the lengthy judgment covers all three. The patents relate to products or processes for oils containing high levels of polyunsaturated fatty acids (PUFAs), notably an omega-3 PUFA called docosahexaenoic acid (DHA). DSM had brought claims in respect of each patent, alleging infringement of each, with Mara/AO3 consequently counterclaiming for invalidity on a variety of grounds.

Mara/AO3 were successful in revoking EP 2 576 801 (for the use of pH 8 and other steps to demulsify a lysed cell composition during the microbial oil extraction process) as the patent was found invalid for obviousness.  The Judge, Mr Justice Mellor, also had to decide the correct approach to claim construction of the numerical pH limit in the claims.  Mara/AO3 were also successful in revoking EP 3 530 740 (for a high percentage DHA oil), with the judge finding it invalid for added matter, obviousness and insufficiency. DSM’s remaining patent EP 2 921 155 (use of a protease enzyme in the microbial oil extraction process) was found valid and thus infringed until its date of expiry in May 2023. A copy of the decision can be found here.

USA

“Substantial weight” given to secondary indicia of nonobviousness insufficient to save two Moderna mRNA vaccine patents from a PTAB finding of unpatentability.

On 5 March 2025, the Patent Trials and Appeals Board (PTAB) ruled two Moderna patents unpatentable in the ongoing dispute with BioNTech/Pfizer over mRNA vaccine patents (IPR2023-01358, IPR2023-01359). The patents, directed to lipid nanoparticles comprising betacoronavirus spike protein-encoding mRNA and methods of administering such compositions to subjects in order to elicit an immune response were challenged at the PTAB by BioNTech/Pfizer following Moderna’s patent infringement action in Massachusetts Federal District Court. Both decisions considered the same key issues, followed the same reasoning and arrived at the same outcome.

The focus of the validity challenges was on the question of obviousness, with one of Moderna’s own earlier-published patent applications (Schrum) playing a central role in both cases. The PTAB found that the challenged claims of both Moderna patents were obvious in light of Schrum read in combination with a second prior art document incorporated in its entirety by an express reference; and the combination of Schrum and a third prior art document.

Considering whether the person of ordinary skill would have had a reasonable expectation of success, the board pointed out that the independent claims of both patents were broad and that there was no need to show “reasonable expectation of success concerning features or results that the claims do not require”. Amongst other things, it was not necessary to show that there was a reasonable expectation of clinical efficacy that might satisfy the FDA, which would have been a “much higher benchmark” than what was in fact required by the claims. Also unhelpful to the patentee’s case were some of their own FDA submissions which cited preclinical studies in a way that supported a reasonable expectation of success. This is a good example of the well-known tension in the field of therapeutics between submissions to regulatory authorities (citing the state of the art as evidence that the proposed intervention will be safe and effective) and to the patent office (where patentees often try to argue the claimed invention yielded “unexpected” results even in the face of the same literature).

On the issue of secondary indicia of non-obviousness, despite accepting that there was a nexus between the challenged claims and the objective evidence of non-obviousness (in the form of the parties’ Spikevax and Comirnaty vaccines) and affording “substantial weight” to the demonstrated long-felt unmet need, failure of others, industry praise and commercial success relating to these products; the board nevertheless noted that the patentees’ objective indicia of non-obviousness were outweighed by the very strong prima facie case that the patents were obvious over the cited art and ultimately held all challenged claims unpatentable.

GERMANY

Düsseldorf Court finds for Moderna in latest instalment of Covid Vaccine case.

As reported in our previous Weekly Update, the Düsseldorf Regional Court has ruled that Pfizer and BioNTech (hereafter Pfizer) is liable for damages for infringing one of Moderna’s mRNA patents. The patent in question, EP 3 590 949, relates to ribonucleic acids containing N1-methyl-pseudouracils and their uses (the Patent) and has already been the subject of litigation in the UK, Ireland, the Netherlands and Belgium.

The action was started in Düsseldorf in August 2022 with Moderna alleging that Pfizer’s mRNA vaccine Comirnaty (used against Covid-19) infringed the Patent. As in other jurisdictions, Moderna did not request an injunction to remove Comirnaty from the German market but sought damages in respect of sales made from 8 March 2022, the day after Moderna released its ‘Updated Patent Pledge’. The Updated Patent Pledge specified that Moderna would not enforce its Covid vaccine patents against vaccines which were destined for 92 low and middle income countries. This was in contrast to its earlier public pledge made in October 2020 that it would not enforce its Covid vaccine patents for the duration of the pandemic.

In its defence, Pfizer argued that this earlier pledge bound Moderna until the World Health Organisation declared the pandemic at an end in May 2023. However, the German Court disagreed ruling that Moderna’s Updated Patent Pledge had the effect of revoking the earlier pledge and consequently, Moderna’s consent to use its patents. As a result, the Court held that Pfizer is liable to pay Moderna damages and reasonable compensation and also ordered Pfizer to provide comprehensive financial information to enable the level of damages to be calculated.

The Court also rejected Pfizer’s request to stay the proceedings pending a final decision on the validity of the Patent from the EPO. Perhaps unsurprisingly, the Court considered the Patent’s validity to be sufficiently certain given it had been upheld by the Opposition Division in May 2024.  The fact that Pfizer and the other EPO opponents had appealed this decision to the Technical Board of Appeal did not change this.

The decision of the German Court is aligned with that of Mr Justice Meade which was handed down in July 2024 and which also found Pfizer had infringed the UK designation of Patent and was liable for damages. Pfizer has appealed the UK decision and has also indicated that it will appeal in Germany so this is by no means the end of the story.

UK

CJ Medical Limited Found to Infringe Patent in Claim against Well Lead Medical.

On 7 March 2025, HHJ Hacon handed down his decision in an infringement action relating to EP 3 760 143, a patent which claims a device for removing stone fragments (such as fragments of kidney stones and gallstones) from a patient using suction via a sheath inserted into the urinary tract.  Well Lead Medical Co., Limited, the claimant and patentee, alleged that CJ Medical Limited, the defendant, infringed claims 1 (the device) and 3 (the device with the addition of a flexible, deflectable tip) of the patent by the marketing of their product (the Seplou Sheath), while CJ Medical denied infringement and claimed the patent was invalid. 

Considering validity, HHJ Hacon decided that the first piece of prior art (disclosing a sleeve placed over a flexible endoscope) could not be combined with one of a number of patents referred to in a given passage therein (disclosing a pressure regulating mechanism), as pleaded by CJ Medical. The was no evidence on whether the other patents cited but not pleaded made alternative disclosures that would have been relevant to the skilled person’s analysis, nor had the experts considered them. In the absence of the combined disclosure of a pressure regulating mechanism, the patent was considered inventive over the first piece of prior art.

HHJ Hacon found that claim 1 of the patent lacked inventive step over the other cited prior art (a Chinese utility model with the same inventor as the patent), but that claim 3 was inventive as it was not obvious at the priority date to secure a flexible deflectable tip to the distal end of the sheath.

Turning to infringement, as a preliminary point of construction, the judge determined that the requirement for the sheath lumen and the side arm lumen to have “the same” diameter means what it says, subject to a limited manufacturing tolerance of +/- 5%. Claim 3 was found to be infringed by CJ Medical’s Seplou Sheath, in size 14 (the product being available in 5 sizes), as the diameter of size 14’s sheath was “the same” (a 0.2% difference) as the diameter of the lumen of the side arm, thus infringing on a normal construction of the claim.

The judgment also addressed and dismissed allegations of added matter and on the method of treatment or diagnosis exception to patentability. Regarding the latter, the judge concluded that the patent does not fall within the prohibition of methods of treatment by surgery (its claims concerning products only, not processes), finding that the policy behind the treatment provision is to prohibit the patenting of certain kinds of methods identified, and was not intended to restrict the patenting of any sort of product.

UPC

Munich Local Division considers jurisdiction and validity of opt-out withdrawal
(UPC_CFI_339/2024) and (UPC_CFI_235/2024)

The Munich Local Division rejected two objections of Roku Inc. and Roku International B.V. (Roku) regarding the incompatibility of the Agreement on a Unified Patent Court (UPCA) with European primary law. It also rejected Roku’s objection that the Sun Patent Trust (SPT) lacked authority to bring a claim in the UPC, and that the Munich Local Division, as the division of the UPC indicated by SPT to hear the claim, lacked jurisdiction.

In relation to UPC_CFI_339/2024, all of Roku’s grounds of objection were found to fall outside of the remit of the provisions covered by r. 19(1) RoP and/or were unfounded.

The Court determined that the question of UPC compatibility with primary law of the European Union is not included in the list of grounds for an objection and is not directly relevant to the question of the UPC's jurisdiction. An objection pursuant to r. 19(1) RoP is not designed as a "general" review procedure of the UPCA, and does not serve the purpose of reviewing the UPCA for conformity with Union law. A referral to the CJEU, as requested by Roku in the alternative was also not appropriate as there is no need for an indirect examination of the alleged illegality of the UPCA under Union law.

The Court also ruled that an objection pursuant to r. 19(1) RoP cannot be successfully based on an alleged violation of the right to a lawful judge, pursuant to art. 47(2) of the Charter of Fundamental Rights of the European Union (EU CFR) or art. 6(1) sentence 1 of the European Convention on Human Rights (ECHR). Insofar as Roku’s objection was to be understood as meaning that statutory judges have been "withdrawn" from the parties by the improper establishment of the UPC, the validity and applicability of the UPCA is not admissible subject matter of this oppositions. If Roku was alleging violation of the statutory judge by the claim being brought before a Local Division, rather than the Central Division, the court did not agree, as the prerequisites for the jurisdiction of the central chamber were not apparent. The appointment of individual panels of a (permanent and previously established by law) court does not in itself affect the right to a statutory Judge - only if the Judge specifically appointed to make a decision is not independent and/or not impartial can this be a violation of these provisions.

The Court found the "legitimacy of the plaintiff" ground to be unfounded, with SPT having successfully withdrawn its “opt-out”. The Court found that if a plaintiff’s representative has declared withdrawal from the "opt-out", it is not necessary to prove in, or with, the statement of claim the authorisation of the representative. Proof of a power of attorney must only be submitted if the authorisation is disputed. Here, it had not been necessary for proof of authorisation for SPT’s representative filing the withdrawal of the opt-out to be enclosed with the statement of claim or application for withdrawal.

Finally, insofar as Roku’s final ground of objection was based on r. 19(1)(b) RoP (lack of jurisdiction of the division of the UPC indicated by the applicant), the court found it has jurisdiction over action for patent infringement pursuant to art. 33 para 1 UPCA. Such actions can be brought before the division of a Contracting Member State in whose territory the actual or threatened infringement has occurred. The unlawful use of the patent alleged by SPT is said to have taken place in the Germany and so within the jurisdiction of the Munich Local Court. Further, for jurisdiction to be assumed, it is not necessary for an infringement to have actually occurred or threatened to occur. Rather, the assertion that an act of infringement justifying jurisdiction has taken place, and that this cannot be ruled out from the outset, is sufficient. Whether a harmful event has actually occurred or threatens to occur is a question of the merits of the action.

The fact that the alleged infringing act of the second defendant predated the entry into force of the UPC is also irrelevant to the question of jurisdiction. The jurisdiction of the UPC also covers infringement actions to the extent that they are based on acts of use which are alleged to have taken place before the UPCA entered into force.

Similar reasons were given when determining the equivalent objections in UPC_CFI_235/2024.