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 - 14 February 2025 - is below:

USA

Federal Circuit Injunction upheld against Samsung Bioepis and Formycon for aflibercept biosimilar product.

On 29 January 2025, the Federal Appeal Court handed down two judgments upholding the decision of the District Court to grant preliminary injunctions against Samsung Bioepis (SB) and Formycon. The judgments form part of a series of actions by Regeneron against other biosimilar companies (Bx), including Mylan, Amgen and Celltrion, which were consolidated in April 2024. Regeneron holds various patents concerning the VEGF antagonist aflibercept, including US 11,084,865 (US 865), which claims a VEGF antagonist formulations suitable for intravitreal injection. Aflibercept is used for the treatment of several angiogenic eye diseases and is sold by Regeneron under the brand name EYLEA®.

SB, Formycon and the other Bx filed abbreviated Biologics License Applications (aBLAs) requesting approval to market EYLEA® biosimilars. Regeneron responded by filing actions for patent infringement and motions for preliminary injunctions. The West Virginia District Court granted the request for preliminary injunctions against SB and Formycon in June 2024. This decision was in part based on the District Court’s finding that US 865 was valid and infringed in expedited trial proceedings involving Mylan earlier that month.

On appeal, SB and Formycon argued that the District Court had no personal jurisdiction over the dispute as there was no evidence that SB intended to market its biosimilar product in West Virginia. SB sought unsuccessfully to argue that the only state with jurisdiction would be the state in which SB makes its sale to Biogen (with whom SB had entered into a US distribution agreement). Formycon argued, also unsuccessfully, that it only intended to sell its product to a third party, who would commercialise the product in the US. However, citing Acorda v Mylan 817 F. 3d 755 (Fed. Cir. 2016), the Federal Circuit deemed the appellants’ aBLAs and service of their Notices of Commercial Marketing, combined with the steps taken to establish distribution channels covering West Virginia (even if they were not themselves intending to make direct sales in West Virginia) were sufficient to meet the minimum contacts standard for personal jurisdiction.

SB and Formycon’s appeal also relied on its claim that US 865 was invalid for obviousness-style double-patenting. However, the Federal Circuit dismissed this ground on the basis that they had put forward no authority in support for their contention that the distinctiveness of a patent can be defeated if the later patent requires only an “additional property” beyond what the reference patent requires, or for its claim that the narrower stability limitation of US 865 over the reference patent was an obvious additional property. The fact that the reference claim reads onto the claims of the later patent does not automatically render the later patent obvious.

The final ground of appeal (argued only by SB, although Formycon raised other substantive obviousness arguments that are not dealt with in this summary) concerned whether Regeneron had established a causal link between the infringement and irreparable harm that would be suffered without injunctive relief. SB’s arguments were based on its claim that it would offer a non-infringing product, and that the District Court was wrong not to conduct a causal-nexus enquiry in circumstances where the comparison of the products is relatively non-complex. The Federal Circuit rejected both of these submissions on the basis that: (i) SB had provided no evidence of any intention to sell non-infringing product under its aBLA; and (ii) the causal-nexus enquiry is not always necessary in an injunction analysis involving products which are essentially identical in the eyes of the consumer.

For these reasons, the Federal Circuit dismissed the appeals, upholding the preliminary injunctions.

EPO

Enlarged Board of Appeal gives its preliminary opinion in G1/24 on the interpretation of patent claims.

Readers may recall that in June 2024 in appeal proceedings relating to one of Philip Morris’ “heat-not-burn” patents a referral was made to the Enlarged Board of Appeal (EBA) relating to (1) the interpretation of patent claims for the purpose of assessing patentability; (2) if and when the description and figures in a patent may be considered when interpreting a patent claim; and (3) the extent to which a patent’s description can serve to interpret a term used in the claims. 

The EBA’s preliminary opinion is short and states that matters relating to (1) above will need to be discussed, presumably at the oral hearing in these proceedings set for 28 March 2025. The EBA, however, recognises the need for consistency in the principles of claim interpretation in both pre-grant examination and in any post-grant proceedings within the EPC. On (2) the EBA is clear that it is currently of the opinion that the description and the figures can be referred to in the course of claim interpretation. At present, the EBA considers that the question referred relating to point 3 above is inadmissible.

UPC

Court of Appeal diverges from CJEU’s position on the independence of in-house representatives
(UPC_CFI_164/2022) / (UPC_COA_563/2024).

Irides Weekly Update 18 October 2024 reported the Paris Central Division’s decision in Suinno Mobile & AI Technologies Licensing Oy v Microsoft Corporation that a procedural application by Suinno was inadmissible due to the lack of independence of the UPC representative who had filed it.  This finding turned on the parallel interpretation of Art. 48(5) UPCA and Art. 19(5) of the CJEU Statute. Both provisions refer to the “independent exercise of [representatives’] duties”, and it is settled CJEU case law that the phrase as used in Art. 19(5) precludes an in-house lawyer from representing their employer before the EU courts.

The Court of Appeal has now considered the issue, and handed down its decision on 11 February 2025. It rejected Suinno’s appeal on the basis that it agreed with the Paris Central Division that the claimant’s  r. 262 RoP application had lacked adequately separate representation, but it did not uphold the Central Division’s parallel interpretation of independence more generally.

Art. 48 UPCA requires that parties be represented in most types of UPC proceedings. The Court held that the implication of Art. 48 is that a natural person may not self-represent, and since there is no distinction in the text between natural and legal persons it follows that a corporate party must use a UPC representative who is as distant as they would be were the party a natural person. The Court further clarified that this requirement precludes a natural person who has “extensive administrative and financial powers within the legal person” from acting as representative, “whether as a result of holding a high-level management or administrative position or holding a significant amount of shares in the legal person”.  In this case, Suinno’s representative was its managing director and main shareholder and was found to have extensive administrative and financial powers within Suinno.

Importantly, however, the Court of Appeal separately considered what is meant by a representative’s “independent exercise of duties” (as contemplated by Art. 48(5) UPCA). On this point it diverged from the CJEU’s interpretation, which precludes any in-house lawyer from representing their employer on the basis that they lack independence. Instead the Court interpreted Art. 48(5) as excluding “any representative who fails to act independently, whether employed or not” but held that the mere fact of a representative being employed by their client is not sufficient to undermine their independence.  

An in-house representative is nonetheless bound by the Code of Conduct for Representatives (CoC), which includes a requirement to “act towards the Court as an independent counsellor by serving the interests of his or her clients in an unbiased manner without regard to his or her personal feelings or interests” (Art. 2.4.1 CoC). The Court of Appeal also cited r. 291 RoP, under which the Court may exclude a representative whose conduct is incompatible with the proper administration of justice, and made clear that in addition to the possibility of exclusion a representative who sees a risk that they cannot fulfil their overriding obligations under the UPCA, CoC and RoP is obliged to withdraw from the proceedings.

On its divergence from the CJEU case law, the Court held that while the UPC is subject to the same obligations under Union law as any national court of the contracting member states (Art. 1 UPCA), it is not an EU Court as such but as a common court is treated as if it were an EU national court, and in the same way as those national courts is not bound by the CJEU’s interpretation of Art. 19(5) CJEU Statute. It instead falls to the UPC to provide an autonomous interpretation of Art. 48(5) UPCA as it has done in this case.

EU

SEP Regulation Withdrawn.

The European Commission has withdrawn its proposed Regulation on Standard Essential Patents (SEPs), citing no foreseeable agreement as to the ultimate adoption of the regulation and signalling a potential reassessment of the Commission’s approach. The Regulation, adopted by the European Parliament in February 2024, included provisions requiring compulsory registration and essentiality checking of SEPs, compulsory non-binding aggregate royalty-setting mechanisms for technology standards, and non-binding royalty rate determinations that must be completed before a patent owner can seek legal redress in EU national courts or the UPC. It also proposed the creation of a new Competence Centre at the EUIPO to manage all these functions.

The proposal sparked heated debate between SEP holders and product manufacturers that implement the relevant standards. Many implementers supported the regulation, believing it would bring  transparency to the SEP licensing landscape.  However, many major SEP licensors strongly opposed the proposals, arguing they would increase costs for innovators, create administrative burdens and delay licensing negotiations. Concerns were also raised about the feasibility of the initiative given the vast number of patents requiring evaluation and doubts about whether the proposed evaluation mechanisms were sufficiently robust.

The proposals therefore faced significant opposition, with many SEP licensors warning that it would harm Europe’s innovation ecosystem and global competitiveness.  Key figures, including USPTO Director Kathi Vidal and UPC Court of Appeal Judge Rian Kalden, have publicly expressed concerns about the proposals. Vidal highlighted the potential for increased administrative costs, while Kalden questioned the necessity of the regulation, given the relatively low volume of SEP disputes in court.

The Commission will now consider alternative approaches to address SEP licensing concerns.

UPC

Mannheim Local Division issues less redacted Order in Panasonic v OPPO action. 
(UPC_CFI_210/2023).

On 6 February 2025, the Mannheim Local Division issued an updated version of its Order mentioned in Irides Weekly Update 29 November 2024.  The updated Order can be found here.

CHINA

New Guidelines on AI-related patent applications in China.

On 31 December 2024, the China National Intellectual Property Administration (CNIPA) issued new guidelines on AI-related patent applications. Those seeking AI-related patents in China now have some clarity that an inventor of such a patent must be a natural person or persons, and not an AI system. In addition, the guidelines provide that applications generated autonomously by AI systems without human contribution will not be allowed. However, this does not mean that patent applications assisted by AI or AI algorithms or models themselves will not be allowed. There is also now guidance on the level of disclosure required in such patent applications. It will be interesting to see how these guidelines are put into practice in order to provide greater certainty to patent applicants and third parties.