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 - 11 October 2024 - is below:

CJEU

CJEU clarifies interpretation of “significant benefit” and “clinical superiority” in Regulation 141/2000.

In its decision of 4 October 2024 (C-237/22 P), the Eighth Chamber of the CJEU dismissed Mylan’s appeal against the General Court’s decision T-303/16. Mylan held a marketing authorisation (MA) for the medicinal product “Tobi Podhaler – Tobramycin” (Tobi Podhaler), an orphan medicinal product comprising tobramycin for the treatment of pulmonary infection in cystic fibrosis patients. During the 10-year period of market exclusivity provided for orphan medicinal products under Regulation 141/2000 (the Regulation), VVB (a Lithuanian manufacturer of generic medicinal products) submitted a MA application for Tobramycin VVB as an orphan medicinal product for the same therapeutic indication as the Tobi Podhaler. VVB relied on a derogation in Art. 8(3) of the Regulation, whereby a second applicant could receive an MA for the same indication as a previous orphan medicinal product if the second medicinal product was “Safer, more effective or otherwise clinically superior” to the previously authorised product. The Commission, following a positive scientific opinion from the CHMP of the EMA, decided that Tobramycin VVB could rely on the Art. 8(3) derogation. The decision was upheld, despite Mylan’s appeal, at the General Court. Mylan subsequently appealed to the CJEU.

Mylan argued that the General Court had incorrectly interpreted the concept of “clinical superiority” and its relation to the concept of the “significant benefit”, which is required for a medicinal product to receive orphan designation under Art. 3(1) of the Regulation. Mylan submitted that, since the concepts of “significant benefit” and “clinical superiority” were based on the same criteria (i.e. greater efficacy, greater safety, or a major contribution to patient care), the General Court had erred in holding that only one of the criteria had to be fulfilled in order for a second medicinal product to be considered “clinically superior” to an existing orphan medicinal product, whereas the overall balance of all three criteria had to be considered in order for a product to be found to have “significant benefit”.

The CJEU did not accept Mylan’s arguments. The CJEU held that Art. 3(2) of Regulation 847/2000, which clarified the definition of “significant benefit” was to be interpreted strictly, and that to satisfy it, a product should be at least equivalent in terms of efficacy, safety and benefit/risk balance to similar products already authorised. However, the wording of Art. 3(3)(d) of Regulation 847/2000 made it clear that any one of the three criteria was sufficient for a product to have “clinical superiority”. The concepts of “significant benefit” and “clinical superiority” were therefore not to be interpreted as interchangeable.

On the facts, the CJEU noted that the orphan designation for Tobi Podhaler had been claimed on the basis of a major contribution for the entire target population, and the EMA had required that its safety and efficacy was at least equivalent to previous formulations of tobramycin. However, Tobramycin VVB claimed a derogation only on the basis of improved safety in a subset of the patient population who suffered from a cough when taking Tobi Podhaler – as such, evidence that the Tobramycin VVB was safer for that particular subpopulation was sufficient to demonstrate “clinical superiority”.

The CJEU also dismissed Mylan’s submission that the General Court had provided insufficient reasoning in determining whether the population who suffered from a cough when taking Tobi Podhaler was large enough to constitute a “substantial portion” of the target population. Mylan’s appeal was therefore dismissed.

UPC

Milan Central Division rejects application to allow exclusive distributor of challenged embodiment to intervene (UPC_CFI_380/2024).

Insulet commenced parallel applications for provisional measures for patent infringement against EOFLOW in the Milan Central Division, and against its exclusive distributor Menarini in the Milan Local Division. Menarini filed an application to intervene in the Central Division case between Insulet and EOFLOW on the basis that the decision would affect its contractual relationship with EOFLOW as well as its customers. Having already denied a request for a Connection Joinder, the Central Division denied this request on the basis that Menarini's legal interest was already protected by way of defence in the parallel proceedings before the UPC Milan Local Division.

In its 1 October decision, the Court noted that intervention in interim injunction proceedings is only available in exceptional cases and that Menarini should not be given the opportunity to present its case to two different UPC Courts. On a separate procedural point, the Court held that an application to intervene may be filed in hard copy (rather than electronically, as required by Art. 44 UPCA, r. 4.1 RoP) as it is not possible for an intervener to open a workflow in the CMS.

STOP PRESS - UK

Two RSV vaccine patents found invalid in Pfizer v GSK. 

On 7 October 2024, Mr Justice Mellor handed down his decision in Pfizer v GSK Biological & Anor. [2024] EWHC 2523 (Pat). The judgment related to the infringement and validity of GSK’s patents EP (UK) 3 109 258 and EP (UK) 2 222 710, both of which relate to a strategy for vaccinating against respiratory syncytial virus (RSV) based on the use of a modified version of the F protein in the envelope of RSV.

The Judge found both patents invalid for obviousness over each piece of pleaded prior art. The Judge was not persuaded by GSK’s secondary evidence to reconsider his conclusion on prima facie obviousness. However, the patents were not invalid for either AgrEvo obviousness or classical insufficiency. The Judge also held that had the patents been valid, they would not have been infringed by Pfizer’s products, and granted the Arrow declaration sought by Pfizer.

A full report will follow in an upcoming Weekly Update.

STOP PRESS - UK

High Court Invalidates Split Poly(A) Tail Patents.

On 8 October 2024, Mr Justice Meade handed down his decision in BioNTech & Pfizer v CureVac [2024] EWHC 2538 (Pat) in relation to two patents owned by CureVac relating to a method of improving protein expression in mRNA molecules by splitting the poly(A) tail sequence. The defendants, BioNTech and Pfizer, disputed the validity of these patents.

The Judge concluded that the patents were invalid on the basis of insufficiency and obviousness. In relation to the insufficiency attack, Meade J concluded that the patents did not disclose the alleged technical contribution, and because the contribution was not plausible across the scope of the claims. An added matter attack by the defendants failed, however, as the features in the claims were found to be disclosed in the PCT application.

A full report will follow in an upcoming Weekly Update.

STOP PRESS - UK

High Court Upholds Enzalutamide Patent.

Also on 8 October 2024, Mr Justice Mellor handed down his decision in three actions that were jointly case managed where Accord Healthcare, Sandoz and Teva sought to revoke a patent and an SPC for the compound enzalutamide owned by the Regents of University of California and Astellas Pharma Europe. The Claimants sought to argue that the patent was obvious over two pieces of prior art. They also argued that the patent did not plausibly disclose a technical contribution. The Court held that the Patent was not obvious and that it did disclose a technical contribution. It was therefore valid.

A full report will follow in an upcoming Weekly Update.

UPC

Munich Local Division allows a patent pool administrator to intervene in infringement and invalidity proceedings in support of the patent proprietor.

On 2 October 2024, the Munich Local Division ruled on an application made by Access Advance LLC (AA) pursuant to r. 313 of RoP to intervene in infringement and invalidity proceedings in support of NEC Corporation, the patent proprietor and Claimant (UPC_CFI_153/2024). NEC has contributed the patent in suit to a pool of HEVC standard essential patents. AA is the administrator of that pool. As administrator, AA is entitled to conduct licence negotiations with implementers of the HEVC standard, to enter into licence agreements for the patents included in the pool, to collect royalties, and to distribute the royalty income to the pool members.

The Defendants, TCL, objected to the application to intervene on the basis, inter alia, that (i) AA has no legal interest in the proceedings, and (ii) allowing the intervention would not prevent a violation of Art. 101 TFEU since AA and the Claimant could exchange confidential information about their respective licence negotiations with the Defendants.

The Court explained that a legal interest within the meaning of r. 313(1) RoP means a direct and present interest in the grant by the Court of the Order or Decision as sought by the party whom the prospective intervener wishes to support, and not a mere interest in relation to the pleas in law put forward, e.g. by reason of being in a similar situation to one of the parties. The Court considered that such a direct legal interest had been established in this case by AA because if the Court finds the patent to be valid and infringed, AA could assert this against the Defendants, demand a licence agreement and collect royalties Moreover, without intervention, AA’s legal position could be compromised with respect to NEC and the other pool members as to whether it decides to retain the patent in the pool (which NEC would advocate) or remove it as being invalid (which would benefit the other members of the pool).

 The Court also rejected the Defendants’ arguments relating to Art. 101 TFEU, finding that allowing the intervention does not increase the risk of anti-competitive conduct. The Court considered that it was unobjectionable if AA or the Claimant obtained information about the other party’s licence negotiations with the Defendants, since the mere receipt of information does not constitute a concerted practice and could happen whether or not the intervention was permitted, nor does it affect trade between member states. The Court also considered that there were serious doubts as to whether AA and the Claimant are competitors in the market of patent licensing because AA derives its legal status solely from the Claimant.

Finally, the Court held that as a party to the proceedings AA must be treated in accordance with r. 315(4) RoP and be allowed to access the court file. However, as the Court had already classified certain information as confidential and established a restricted confidentiality club on the Claimant’s side, AA could not be granted unlimited access to the information. To promote the progress of proceedings the Court decided not to grant access to information relating to the bilateral licence discussions between the Claimant and the Defendants. The Court granted access to the other categories of confidential information on a restricted basis pursuant to r. 262a ROP.