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 - 05 July 2024 - is below:

UK - STOP PRESS

Patents Court gives two judgments in mRNA Covid-19 vaccines action.

On 2 July 2024, Mr Justice Meade handed down his 153 page decision in the two Moderna and Pfizer/BioNTech cases relating to Moderna’s patents - EP 3 590 949 (EP 949) and EP 3 718 565 (EP 565) - asserted against Pfizer/BioNTech’s SARS-Cov-2 vaccines (Comirnaty). EP 949 claims mRNA in which one of the usual nucleosides (uridine) is replaced with N1-methyl-pseudouridine whilst EP 565 relates to a betacoronavirus mRNA vaccine formulated in a lipid nanoparticle, and the use of such an mRNA vaccine in a method of preventing and/or treating betacoronavirus disease.

Meade J ruled that (i) EP 949 was valid and infringed (although infringement was not in issue), and (ii) EP 565 was invalid for added matter and obviousness over a Moderna patent application WO 2015/164674.

Also on 2 July 2024, Mr Justice Richards handed down his decision in the parallel action where Pfizer/BioNTech had argued that Moderna had given them consent to use the technology through a public statement (the "Pledge") where Moderna pledged not to enforce its COVID-19 patents during the pandemic. The court examined the interpretation and validity of the Pledge, as well as issues of contract law and waiver under US federal law. The court ultimately concluded that while Moderna had initially given consent through the Pledge, this consent was revocable and had been revoked by a subsequent statement in March 2022.

A full analysis of the decisions will follow next week. 

UK

Patents court rules in favour of Dexcom in its dispute with Abbott over a patent protecting its Continuous Glucose Monitoring devices.

On 28 June 2024, Mr Justice Mellor ruled that Dexcom’s G7 product did not infringe Abbott’s EP 3 730 044 B1 (EP 044), but that EP 044 was invalid for obviousness. By the priority date, there were three well known Continuous Glucose Monitoring (CGM) systems which were non-integrated systems, whereby the sensor was inserted into the skin with an applicator/insertion device. Once inserted, the user then added a separate sensor electronics unit to the sensor and blood glucose readings were taken from the sensor electronics unit by the reader device. In contrast, EP 044 described an integrated system, whereby the sensor and the sensor electronics unit form an integrated unit before the sensor is inserted into the skin.

Dexcom levelled a number of criticisms of Abbott’s sole expert, Dr Schoemaker. Mellor J agreed that Dr Schoemaker was not able to adopt the viewpoint of the mechanical engineer in the skilled team and that this underpinned many of his opinions that something was not obvious, which Mellor J kept in mind.

The issue of infringement resolved to issues of construction of the claims of EP 044. It mainly concerned the interpretation of the integer “coupled to the housing”. Mellor J agreed with Dexcom that the integer should be construed narrowly. He noted that the G7 included two springs: (i) the insertion spring, which causes automatic insertion once the mechanism has been activated by the user pressing the trigger shroud, and (ii) the retraction spring, which causes automatic retraction of the needle. Thus, the G7 is an applicator with automatic insertion and retraction. The consequence was that, although the specification of EP 044 describes automatic (and semi-automatic) insertion, those were not claimed. Accordingly, he agreed with Dexcom that claim 1 was limited to manual insertion in which the force on and movement of the housing is the cause of the insertion of the needle. Therefore, Mellor J ruled that G7 does not infringe EP 044.

Dexcom alleged invalidity of EP 044 on the following grounds: (i) obviousness over prior art citations known as Heller, Ethelfeld and Fennell, (ii) an added matter attack against claim 5 of EP 044, and (iii) two insufficiency attacks. Applying the test in Pozzoli, Mellor J found that EP 044 was invalid for obviousness over Heller. Dexcom submitted that Heller disclosed all the features of claim 1 and a device with those features in combination is a natural result of following the teaching of Heller. Mellor J noted that the disclosure of the use of an integrated sensor and electronics unit is the subject of the invention in Heller. Abbott submitted (and Mellor J rejected) that Dexcom’s case on Heller was classic ex post facto hindsight. Further, Abbott developed 12 steps which they claimed Dexcom’s case required to get from Heller to claim 1. Mellor J found that these steps were part of routine product development by the unimaginative design engineer in the skilled team, not steps at all or inevitable in any practical implementation of Heller. He also concluded that the differences between Heller and claim 1 were minimal and therefore, the patent was invalid.

EPO

Reasons published in Referral to EBA regarding correct approach to claim interpretation.

As previously reported in our weekly update on 24/05/2024, in the case T 0439/22 several questions concerning the use of a patent description when interpreting words in a patent claim which would otherwise be clear to the skilled person given their usual meaning in the art have been referred to the Enlarged Board of Appeal (EBA).

The case was brought to the Technical Board of Appeal (TBA) by the Opponent (Yunnan Tobacco Internation Co.) against a decision of the Opposition Division to maintain Philip Morris’ patent EP 3076804 relating to a cartridge for a smoking device. The Opponent’s objections to the referral were heard on 10 April 2024, and the TBA confirmed in its Interlocutory Decision handed down on 24 June 2024 that the requirements for an EBA referral were met. First, the TBA held that following a review of the conflicting EPO case law, that an EBA decision was required to ensure uniform application of the law. Secondly, and following a review of national law and the recent UPC decisions addressing construction, the TBA noted that claim construction by the EPO has to be seen “within the greater context of the patent system as a whole”. As such, that there is a point of law of fundamental importance that needs clarification.

The following questions are referred to the EBA:

1. Is Article 69(1), second sentence EPC and Article 1 of the Protocol on the Interpretation of Article 69 EPC to be applied on the interpretation of patent claims when assessing the patentability of an invention under Articles 52 to 57 EPC?
2. May the description and figures be consulted when interpreting the claims to assess patentability and, if so, may this be done generally or only if the person skilled in the art finds a claim to be unclear or ambiguous when read in isolation?
3. May a definition or similar information on a term used in the claims which is explicitly given in the description be disregarded when interpreting the claims to assess patentability and, if so, under what conditions?

UPC

Düsseldorf Local Division grants the first permanent injunction against Bette in relation to its dispute with Kaldewei over sanitary tub devices.

On 3 July 2024, the Düsseldorf Local Division comprising Presiding Judge Thomas, Judge Dr Thom as rapporteur and legally & technically qualified Judge Kupecz granted the first permanent injunction in the UPC in Kaldewei v Bette (UPC_CFI_7/2023). EP 3 375 337 B1 (EP 337) claims sanitary tub device (tub and support arrangement) with various features. Kaldewei alleged direct and indirect infringement of EP337 and in the alternative auxiliary requests by "Bette Floor", "BetteFloor Side" and "Bette Ultra" shower trays; and wished to prevent the distribution and offer of the minimum tub carrier called "Flex". Bette counterclaimed for invalidity, citing lack of novelty and inventive step.

As an initial matter, the Court refused a request for a retrospective extension not the deadline of submission of documents, as it was (1) served too late, after the substantive submission for which the party is requesting the extension; and (2) was so late as to jeopardise the proper preparation of the oral hearing by the international panel.

In reaching its ruling on validity, the Court construed the claim considering the skilled person’s understanding i.e. a qualified engineer with five years of experience in the development and manufacture of sanitary products. It applied a somewhat EPO style analysis, identifying the problem of the patent in suit as “specifying a sanitary tub device which can be easily formed in different sizes and has good functional properties”. It concluded that claim 1 was not inventive over DE 197 10 945 C1 (DE 945), because the difference between DE 945 and claim 1 is the use of rigid plastic foam for certain pieces, the use of which by the skilled person was considered to be routine further development. However, the Court concluded that the auxiliary request was new and inventive over DE 945 (as well as other combinations of citations, although it was not shown that the skilled person should combine those citations), as the solutions provided in the prior art differ in their approach to the patent in suit.

It was undisputed that the alleged infringements made use of the teaching of the patent in suit. However, Bette sought to rely on a prior use defence to the infringement allegations. The Court confirmed that a right of prior use was only relevant if acquired and sufficiently evidenced in each of the contracting member states at issue: there is no European right of prior use. There was insufficient evidence to support prior use in all relevant states in this case. As a result, the Court held that Bette directly and indirectly infringed. In determining that there was contributory infringement, the Court noted that a double territorial connection is required. This means that, on the one hand, the offer and/or delivery must take place in the territory and, on the other hand, the invention must also be used in the territory.

The Court ordered an injunction, including recall and a separate order to permanently remove the infringing products from distribution channels (in a more limited form than requested, to reflect that the infringer must have the actual and legal possibilities to do so), a penalty payment, provisional damages, costs and disclosure of information on the committed acts (volume, value, costs, profits, third party identities etc).