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 - 09 August 2024 - is below:

CJEU

CJEU provides a Reasoned Order on interpretation of Art. 3(d) of SPC Regulation.

On 16 July 2024, the Court of Justice of the European Union (the CJEU) handed down its judgment on the correct interpretation of Art. 3(d) of the SPC Regulation. The CJEU had to address the question of which marketing authorisation (MA) must be regarded as the first MA for a medicinal product where the product was covered by a prior MA that had since been withdrawn.

The conditions required to obtain an SPC according to Art. 3 of the SPC Regulation can be paraphrased as follows:

a) the product is protected by a basic patent in force;

b) a valid MA in respect of the product has been granted;

c) the product has not already been the subject of an SPC; and

d) the MA referred to in point (b) is the first MA for that product.

 Background

Genmab is the holder of EP 3 284 753, in force in Hungary, which covers the active ingredient ofatumumab. On 21 April 2010, Genmab was granted an MA for Arzerra, its first medicinal product containing ofatumumab, which was indicated for the treatment of chronic lymphocytic leukaemia (the Prior MA). On 27 February 2019, Genmab withdrew that MA. On 29 March 2021, Genmab was granted an MA for Kesimpta for the treatment of multiple sclerosis, with ofatumumab as the sole active ingredient (the Subsequent MA).

On 7 July 2021, Genmab applied to the Hungarian National Intellectual Property Office (the Hungarian IPO) for an SPC covering ofatumumab, which the Hungarian IPO rejected on the basis that the Subsequent MA was not the first MA for ofatumumab as required by Art. 3(d) of the SPC Regulation. The Hungarian IPO held that the Prior MA should be regarded as the first MA even though it had been withdrawn and was no longer in force when the SPC application was lodged.

Genmab appealed to the Budapest High Court submitting that, for the purposes of Art. 3(d), the first MA can only mean an MA in force on the date the SPC application is lodged, relying on the word “valid” in Art. 3(b). The Budapest High Court stayed proceedings and referred the following question to the CJEU: “Must Article 3(b) and (d) of [the SPC Regulation] be interpreted as meaning that [an MA] predating the [MA] appearing in the application for [an SPC] and referring to the same product must be regarded as the first [MA] for the purposes of [the SPC Regulation], even where that prior [MA] was withdrawn prior to the submission of the application for the [SPC]?”

 The CJEU's reasoned order

The CJEU held that the legislative history of the SPC Regulation indicates that the condition laid down by Art. 3(d) is an objective chronological criterion. As such, the first MA for the product refers to the earliest MA which was granted for that product, regardless of whether or not that MA is still in force. It was clear from the wording of Art. 3(d) that account must be taken of all MAs granted for that product before the date of lodging the SPC application.

The CJEU relied on the following:

i. Art. 8 of the SPC Regulation requires that an SPC application must "contain the number and date of the MA referred to in Art. 3(b) … and, if it is not the first MA for the product in question, the number and date of that first MA". According to the CJEU, if only the MAs that were in force were to be taken into account in order to determine which is the first MA for the product in question, Art. 8 would have required that such information also be provided.

ii. Despite it being common for the same product to be granted several MAs, the EU legislature decided that it is the first MA for the product that is taken into account when assessing whether an SPC should be granted. In support of this reasoning, it is the first MA for the product that is used to calculate the period of 6 months during which the holder of the basic patent must submit an SPC application.

iii. The objective of the SPC Regulation is to protect research leading to the first MA of an active ingredient, not to protect all research giving rise to the grant of a patent and any MA in respect of a medicinal product. If the latter were true, a company could tactically withdraw a prior MA in order to be granted an SPC for the latest marketed version of its product.

Conclusion

Art. 3(d) of the SPC Regulation must be interpreted as referring to the earliest MA granted for a product. This applies even in the situation where a prior MA was granted for the product but withdrawn before the SPC application was submitted.

UK

Patents Court finds Janssen Biotech’s patent, for the antibody ustekinumab for treating ulcerative colitis, invalid for obviousness over prior art.

On 30 July 2024, Mr Justice Meade handed down a decision in a revocation action brought by Samsung Bioepis against Janssen Biotech's patent, EP 3 883 606, which claims the antibody ustekinumab for treating ulcerative colitis (UC). Samsung alleged that the patent was anticipated or made obvious by the prior art, which included an abstract and poster by Prof Ochsenkühn and a set of slides reporting a phase III study of ustekinumab induction therapy in UC (the Sands Slides).

The anticipation attack was based on the Ochsenkühn poster. The Ochsenkühn abstract had been published on 16 January 2018, however there was a dispute between the parties about the disclosure of the poster, which presented more data than the abstract. Samsung alleged that the poster was presented at a conference between 2 and 5 June 2018. Janssen submitted that Samsung had failed to prove that the poster presented at this time was the same version as the poster Samsung relied on in the proceedings. Prof. Ochsenkühn gave evidence on behalf of Samsung, proving his attendance at the conference with a selfie containing a partial view of the poster, and explaining that although there were some formatting differences, these were immaterial. Meade J found for Samsung on this factual issue, concluding that the pleaded poster was part of the state of the art in June 2018, prior to the relevant priority date. However, Meade J held that the Ochsenkühn poster did not anticipate the patent; the study it disclosed was a retrospective analysis of a small number of patients with UC and was from an unblinded single centre study with no control group or placebo. The data therefore did not demonstrate to the necessary standard that ustekinumab was effective for UC as claimed and the patent was not anticipated.

Samsung also alleged obviousness over the three pieces of prior art. Meade J rejected the obviousness case over the Ochsenkühn abstract and poster. Although the work reported in the Ochsenkühn abstract and poster looked superficially impressive, the problems in the methodology and results meant it would not provide the skilled person with confidence about the treatment of UC so as to render the patent obvious: the documents would provide the skilled person with only a hope of success, not a reasonable expectation. Moreover, the attack involved illegitimate mosaicking with the Sands Slides. However, the Sands Slides contained positive results for the induction phase of a phase III clinical trial for the use of ustekinumab in UC and proved that ustekinumab had an effect in treating UC. This would give the skilled person a high degree of confidence, albeit not a certainty, that ustekinumab would also work in the maintenance phase. Meade J therefore found the patent invalid for obviousness over the Sands Slides.

In relation to the obviousness finding, Meade J noted that it would be concerning if the patent system made it hard for patentees to conduct clinical trials without compromising their chance to try to obtain a patent over a second medical use. However, in this case Janssen had filed a US patent application before the Sands Slides and the problem had only arisen because it later submitted claims that were not entitled to the earlier priority date. He therefore considered the problem to be case-specific rather than a general problem inherent to the process of filing for clinical approval and publicising trial protocols.

UPC

Hague Local Division issues PI and finds no unreasonable delay in seeking preliminary measures.

On 31 July 2024, the Local Division of The Hague issued a preliminary injunction in the Netherlands, Germany, France and Italy in Amycel v Spyra Szymon Spyra (UPC_CFI_195/2024), a dispute concerning Amycel’s patent EP 1 993 350 (the Patent). The Patent protects a hybrid strain of Agaricus bisporus mushrooms, which is stated to have improved commercial characteristics. Amycel alleged the Defendant infringed the Patent with a mushroom strain sold under the name "Cayene".

The Court rejected the Defendant’s argument that the application for provisional measures should be dismissed for unreasonable delay under r. 211.4 RoP on the basis that Amycel had learnt of the allegedly infringing acts in late July 2023 but did not file its application until 3 May 2024. It held that unreasonable delay only exists if the applicant behaved in “such a negligent and hesitant manner” in requesting provisional measures after becoming aware of the infringement that “from an objective perspective, it must be concluded the Applicant is not interested in promptly enforcing its rights”. Amycel provided a timeline of the steps it took in the intervening period, including conducting genetic testing and analysis of the Cayene strain and preparing reports to file with its application, as well as entering into negotiations with the Defendant to reach an out-of-court settlement. The Court deemed this explanation plausible and found that Amycel acted diligently as a prudent patentee to anticipate the defences raised by the Defendant by performing experiments before starting proceedings.

The Court also dismissed the Defendant’s invalidity arguments. In particular, the Defendant argued the Patent contravened Art. 53(b) EPC, which excludes from patentability “plant or animal varieties”, on the grounds that a mushroom strain should be equated to a plant variety. However, the Court reiterated the exclusions under Art. 53(b) should be interpreted narrowly and therefore the exclusion does not encompass organisms other than plants and animals, such as mushrooms which belong to the fungi kingdom.

On infringement, the parties agreed the Patent should be interpreted in such a way that it is sufficient to establish that Cayene and the claimed strain, BR06, are “genetically identical”, however the parties disagreed as to the level of identity that must be established to meet this threshold. The Court held that the claim should not be interpreted as requiring 100% identity (as the Defendant had argued) supported by evidence from Amycel that even duplicates/replicates of the same strain do not show 100% identity due to inevitable sequencing errors in DNA analysis. A lower threshold of 99.88% was therefore applied. Based on the genetic analysis reports, the Court found on the balance of probabilities that the strains were genetically identical and the Patent was infringed by the sale or offering of Cayene spawn.

UPC

Paris Local Division rejects order for disclosure.

Also on 31 July 2024, the Paris Local Division of the UPC rejected a request for information under r. 191 RoP in the case of Abbott v Dexcom (UPC_CFI_425/2023).

Abbott Diabetes Care (Abbott) commenced patent infringement proceedings against three Dexcom companies in November 2023. On 17 June 2024, Abbott filed a request for details of Dexcom’s entire product distribution chains, including those in a number of additional contracting member states. Dexcom requested that the Court reject the request or, in the alternative, delay the communication of information until any finding by the Paris Local Division that the patent is valid and infringed, limit the information to the specific Dexcom defendants and order that it should be provided under a confidentiality regime.

Consistent with a previous decision of the Düsseldorf Local Division (UPC_CFI_7/2023), the Court held that a request under r. 191 may be admissible either at the final stage of proceedings or in ongoing proceedings, even before a decision on infringement should this be necessary for the investigation of the case at that stage. Abbott’s request was therefore admissible. However, the Court stressed that a request for information will only be granted where it is reasonably necessary for the purpose of advancing the applicant’s case in accordance with Art. 67(1) UPCA and r. 191.

Dismissing Abbott’s request, the Court noted that Abbott chose to sue only certain Dexcom distributors despite being aware of the existence of distributors acting in other contracting member states where the patent is in force. Abbott’s request, covering distributors it had deliberately chosen not to sue, was therefore disproportionate and not sufficiently related to the present case.