Irides: Weekly global patent litigation update

This edition features updates from: Brazil, CJEU, Unified Patent Court (UPC) and the European Patent Office (EPO).

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world.
 

Brazil

Senate Issue Proposals Targeting Anti‑Suit and Interim Licence Interference in Patent Enforcement.

A notable proposal has been made to amend the central legislation governing patent law in Brazil (Statute #9,279 of 14 May 1996). The proposal is to add a provision expressly empowering a judge to impose financial penalties where the Court identifies that a request was made to a foreign authority with the aim of preventing the filing of a lawsuit in Brazil or otherwise interfering with the enforceability of a Brazilian Court decision. The proposal sets out the justification for this change in the law by reference to the “proliferation of requests for anti-suit injunctions (ASIs) and interim license injunctions” in other Courts around the world and has, therefore, clearly been precipitated by actions of parties in recent global (F)RAND disputes.

Readers may be aware that Brazil is a jurisdiction where SEP-holders are able to obtain injunctions against implementers. Injunctions have been granted in a number of high profile cases (e.g. Ericsson v Apple, Samsung v ZTE) and have been a factor in the decisions made in other Courts in parallel proceedings in these global (F)RAND battles (including the interim licence decisions of the Court of Appeal of England and Wales, as recorded in the senate’s proposal). It therefore appears that the Brazilian legislature is reacting to this new global dynamic, by creating new powers. The measure is yet to be enacted. 
 

CJEU

Danish Court refer SPC Manufacturing Waiver questions on scope of export exemption. [Janssen v Samsung Bioepis C‑371/26]

The Danish Maritime and Commercial Court has made a referral to the CJEU seeking guidance on the scope of the SPC manufacturing waiver. The referral has arisen in the context of the ongoing multi-jurisdictional dispute between Janssen and Samsung Bioepis (SB) concerning the manufacture of ustekinumab. The reference comes against a broader backdrop of parallel proceedings between the same parties, including a case currently before the Dutch Supreme Court, as well as cases concerning the same issue between different parties elsewhere across Europe. 

Background

During the SPC term, SB made an SPC manufacturing waiver notification to Janssen in Denmark in which it stated that the purpose was for “export and storing” and that the export country MA number would be provided as soon as publicly available. SB sought only to rely on the export waiver as opposed to the stockpiling waiver. A week later, the notification was updated to state that the export country was to be the UK (although still no MA number was provided). SB then manufactured ustekinumab in Denmark from January 2024 for export to the UK following expiry of the UK SPC in July 2024. The product was stored for a period in Denmark pending UK SPC expiry, and was also sent to Italy for fill & finish before going to the UK. 

Issues

Janssen argued that SB’s acts did not fall within the export exemption because SB’s manufacture in Denmark did not take place for the purpose of a specifically planned and immediately imminent export to the UK, and instead was for general and unlimited storage within the EU, pending possible later export. Janssen argued that the export waiver permits only such acts which are strictly necessary for the export, and SB’s storage exceeded that.

Tied to this, Janssen argued that the SPC Regulation contemplates that at the time the notification is made, the MA in the export country should have granted. Therefore, to make a valid SPC manufacturing waiver notification, the MA number must be provided at the time the notification is made (i.e. this is the same point as was in issue in the UK in Regeneron v Alvotech, see here and in which Meade J came to the opposite conclusion).

Questions referred

The 4 questions referred to the CJEU are (in essence): 

1. Must the export waiver be interpreted as meaning that it does not cover the making of a product or a medicinal product containing that product - for the purpose of storing it in the member state of making for an indefinite period and without any restriction, in order to place that product potentially on the market of one or more third countries in the future?

2. Must the expression ‘any related act that is strictly necessary … for the actual export’ be interpreted as not covering the storage of a product (or a medicinal product containing that product) in the member state of making, where the export itself does not take place immediately following the making of that product but is deferred to a separate and future point in time (e.g. because placing that product in the third country market) first requires the expiry of IPRs and/or depends on the issue of a MA (or equivalent) in the third country)?

3. Must the export waiver be interpreted as meaning that a maker cannot rely on the exemption if, at the time of the notification, the maker has not (yet) obtained a MA (or equivalent) in the intended third country of export?

4. Must the export waiver be interpreted as meaning that a maker cannot rely on it if, at the time of making, the maker cannot place the product (or a medicinal product containing that product) on the market of the intended third country without infringing IPRs there? 

The decision also notes the existence of parallel proceedings in Italy, although details of those proceedings are not yet publicly available. Together with the pending appeal in the Netherlands, the reference underscores the extent to which disputes concerning the manufacturing waiver are now emerging across multiple jurisdictions. The CJEU’s eventual ruling is therefore likely to play a central role in harmonising the approach and providing greater certainty on the limits of permissible activity during the SPC term.

UPC

Hamburg Local Division restricts UPC jurisdiction over UK patent parts despite EU anchor defendants. [Infoblox v Nuxu UPC_CFI_360/2026]

On 8 June 2026, the Hamburg Local Division partially granted the Defendants’ preliminary objection under r.19.1(a) RoP concerning the UPC’s international jurisdiction over a US-based defendant in respect of infringement in a non-UPC member state, in this case, the UK.

The Claimant alleged infringement of the same European patent in Germany, France, Finland and the UK by three defendants, a US parent company and two German entities. Although the Defendants did not dispute jurisdiction against the German entities, it argued that for the US defendant, the Claimant failed to plead sufficient facts to establish jurisdiction. The Court accepted that it had jurisdiction over all three Defendants by virtue of both Art. 7(2) BR and Art. 8(1) BR with respect to the German, French and Finnish designations. However, the Claimant failed to plead sufficient facts with respect to the US defendant regarding the UK national designation, that could only be obtained under Art. 8(1) BR, i.e. via an anchor defendant. The Court firstly acknowledged that it did in principle have jurisdiction that could cover acts in non-UPC and non-EU territories (Kodak v Fujifilm). However, under Art. 8 BR, the place and effect of the infringing acts of the anchor defendants, in this case the German entities, are relevant. The Claimant must plead a close connection based on joint or coordinated infringement of the same national part of the patent in that specific country. In this case, the Claimant failed to allege any facts showing the US entity and the anchor defendants jointly infringed the UK designation of the patent. The Court therefore dismissed the action against the US defendant insofar as it concerned the UK national part of the patent, while maintaining jurisdiction for Germany, France and Finland.
 

EPO

The Board of Appeal highlights risks of unreasoned auxiliary request (Hoya Lens v Zimmer T 0079/24).

The Opposition Division decided that European patent No. 3 056 545 could be maintained in its original form. In its reply to the statement of grounds of appeal, the respondent proprietor relied on a number of auxiliary requests.

The Board of Appeal (TBA) considered the main request, finding that it lacked inventive step over the prior art document D3. For the majority of the auxiliary requests, the patentee did not provide any further arguments regarding inventiveness over D3 in addition to those submitted for the main request. As such, each of the requests were found to lack inventive step. As regards auxiliary requests 24 to 35, the TBA took a strict approach to admissibility. The opponent-appellant argued that those requests should not be admitted into the appeal proceedings because they were insufficiently substantiated, contrary to Art.12(3) RPBA. Although the opponent had not addressed each auxiliary request individually in its statement of grounds of appeal, TBA held that, where the patent was maintained at first instance, an opponent-appellant is not required to address every auxiliary request separately, provided it explains why the decision should be set aside. The TBA emphasised that it is for the proprietor to present in its reply a complete and substantiated appeal case, including an explanation of how each auxiliary request overcomes the objections relevant to the decision under appeal.

The proprietor had not provided a substantiated explanation in its rejoinder of how the amendments addressed the inventive step objection over D3 but at the oral hearing declared that they had a different line of defence specific to the amendments made in auxiliary requests 24 to 35. This did not cure the deficiencies in their written submissions and the TBA exercised its discretion not to admit the requests pursuant to Art. 12(3) and 12(5).
 

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