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 - 7 April 2025 - is below:
 

UK

Court of Appeal grants AstraZeneca permission to appeal its request for a preliminary injunction.

As reported last week, the Patents Court denied AstraZeneca’s (AZ) request for a preliminary injunction (PI) against Glenmark’s dapagliflozin product until the form of order hearing following the recent validity trial in respect of AZ’s patent. The decision by Michael Tappin KC sitting as a High Court Judge was that damages as a result of refusal of an interim injunction would be an adequate remedy for AZ on the basis that “damages are calculable to a reasonably high degree of accuracy”, whether Glenmark were the only generic to enter the market or whether other generics entered the market too and whether or not AZ were to increase its rebates. On the other hand, the Judge considered quantification of the damages payable to Glenmark under the cross-undertaking would be significantly more difficult.

On Monday 31 March, Arnold LJ granted AZ’s application for permission to appeal its PI request to the Court of Appeal and granted expedition in request of that appeal. The appeal hearing will take place on Wednesday 9 April 2025.

AZ also sought a hold-over injunction until the Court of Appeal decision. Glenmark requested that it be allowed to supply 175,000 packs of its generic dapagliflozin product, which were in lorries ready for distribution, to its wholesalers for release into the UK market so as to be able to preserve its first mover advantage, while agreeing to otherwise stay off the market pending the decision on appeal. Arnold LJ noted he wished to preserve the status quo in a way that was least prejudicial to Glenmark’s position as first mover and permitted the Glenmark product which was currently ready for distribution to go to wholesalers, but not to be released for further sale or distribution in the UK. Glenmark undertook to stay off the market pending appeal on that basis.
 

UPC

Düsseldorf Local Division grants ex parte order for inspection at trade fair.

On 26 March 2025, the Düsseldorf Local Division gave its decision in respect of Steros GPA Innovative’s (Steros) application under r. 192 and 199 RoP for inspection and preservation of evidence in respect of its electrolytic polishing machines which were being exhibited at a trade fair in Cologne from 25 March to 29 March 2025. Steros sought an order for a bailiff and expert (a nominated patent attorney) to inspect two products, the DLyte 1D and DLyte 100D. Steros argued that it needed the inspection order as it was otherwise not possible to be obtain the products to examine them to substantiate an infringement claim before the UPC - they are expensive machines (€30k-50k) which are only sold via specific distribution channels by resellers who have a close relationship with the manufacturers and an anonymous purchase would not be possible. 

Steros had previously tested a different product, the DLyte 10D, which it had purchased from a mutual customer and had also examined a DLyte 100D in Turkey. Steros submitted the results of those tests to the Court to demonstrate why it considered they fell within the scope of the claimed invention. Steros argued that publicly available information suggested that the DLyte 1D and DLyte 100D (in respect of which the order was sought) were identical to the tested DLyte 10D in so far as relevant to the claimed invention.

The Court considered that Steros had credibly demonstrated possible infringement by the products in question and that sufficient substantiation for an infringement claim could only be obtained by inspecting the products, including carrying out measurements during operation corresponding to the features of the claim. In respect of the DLyte 100D, the Court noted there was a need to test this product to provide certainty as to whether it corresponds to the version examined in Turkey so as to be able to prove infringement within the UPC contracting member states. The Court therefore granted, on an ex parte basis, the order for inspection (which included performing measurements) and in the event that the inspection and measurements as specified were not possible, an order for physical seizure together with all technical, promotional and commercial documents relating to the products.
 

UPC

Respondent’s request to review ex-parte order for evidence preservation measures dismissed.

Tiru is the proprietor of a patent covering waste incineration technology and, in October 2024, had become aware of a YouTube video showing an incineration furnace installed at a French waste management facility by Maguin. It claimed that Maguin's incineration furnace appeared to infringe the patent and on 17 December 2024, filed two ex-parte requests (against Maguin, the manufacturer and Valinea Energie, the operator of the waste management facility) with the Paris Local Division for preservation of evidence and on-site inspection. Tiru claimed that a visit to the waste management facility by a court expert was necessary to confirm infringement. 

On 23 December 2024, ex-parte orders were granted by the Paris Local Division, limiting the scope of the measures to confirming infringement of the patent. The preservation measures were carried out simultaneously at Maguin's offices and Valinea Energie's site where the incineration furnace was located.

On 12 February 2025, Maguin requested that the Court retract the preservation of evidence measures on the grounds that there was an absence of risk of destruction of evidence, a lack of urgency, and on the basis that Tiru deliberately concealed information in its ex-parte application.

The Paris Local Division heard the parties' arguments on 10 March 2025. First, on the absence of risk of destruction of evidence, Maguin argued that the arguments made by Tiru at the ex-parte hearing were insufficient to justify ex-parte proceedings under r. 197 RoP and, in any event, it was a well-established company which was required to keep technical documents about its incineration furnace in order to certify its regulatory compliance. The Court held that this obligation on Maguin did not preclude the possibility that documents could be partially modified or that the search could be made impossible on the day of seizure, noting that the "legal texts" on the ex-parte seizure procedure did not require proof of the certainty of loss or destruction of evidence, but merely an existence of a risk of loss of evidence (even partial). While the Court agreed with Maguin that the mere digital format of the data alone was insufficient to demonstrate the existence of a risk of destruction or loss, the parallel request against Valinea Energie could not be ignored. The allegedly infringing incineration furnace had not yet been commissioned and Tiru had argued that its imminent commissioning would have made the preservation of evidence (i.e. describing the interior of the furnace) at Valinea Energie's premises extremely difficult. The need for concurrent execution of the preservation measures to preserve the effectiveness of the measures justified the ex-parte measure against Maguin.

On the lack of urgency, Maguin argued that Tiru should have been aware of the YouTube video at the time it was posted in August 2024. However, the Court indicated that the low number of views (77) on the YouTube video pointed to it not being widely disseminated. Further, a period of two months between becoming aware of the YouTube video and Tiru filing its preservation of evidence application was a reasonable time-frame for the preparation of such an application. Maguin further argued that there was no urgency since the allegedly infringing incineration furnace was not on Maguin's premises and the preservation of evidence measures could therefore have been carried out at any time. Again, the Court pointed to the effectiveness of the measures ordered against both respondents being dependent on them being carried out simultaneously.

Finally, in support of its argument that Tiru concealed information from the Court during its ex-parte application, Maguin alleged that Tiru was aware that the original furnace at Valinea Energie's site, designed in 1987, anticipated the invention in the patent. However, the Court held that it did not have to decide the question of Tiru's actual knowledge on this point, since the patent holder could not be expected, at the stage of requesting preservation of evidence, to respond in advance to possible attacks on the validity of the patent. Furthermore, no opposition proceedings were pending before the EPO, nor were there any other courts seized of a dispute on the validity of the patent. Therefore, Tiru was found not to have breached Rule 192.3 RoP in submitting its ex-parte request.

Accordingly, Maguin's request for retraction of the preservation of evidence measures was rejected.
 

CHINA

National Medical Products Administration publishes draft measures on clinical trial data protection for public consultation.

On 19 March 2025, China's National Medical Products Administration (NMPA) introduced draft measures relating to clinical trial data protection. The draft "Implementing Measures for Pharmaceutical Trial Data Protection (for Trial Implementation)" and accompanying "Working Procedures for Drug Trial Data Protection" have been provided for public consultation, which closes 18 May 2025.

The new draft measures are significant as they are the latest step in China's journey to implement a system for clinical trial data protection. Regulations relating to such a system were first introduced in 2002, but providing detailed rules governing its operation has proved controversial and difficult to implement. During a previous attempt in 2018, the NMPA released draft "Implementing Measures for Pharmaceutical Trial Data Protection (Interim)" which provided for a maximum 12 year protection period. However, industry pushback meant that these plans were shelved. Now, under the new proposed regime, innovative drugs, improved new drugs, generic drugs and biologics may all benefit from various data protection periods up to a maximum of 6 years, depending on their categorisation and the relative timing of the domestic and overseas marketing authorisations.
 

EPO/UPC

Revised EPO examination and UP guidelines in force from 1 April 2025.

From 1 April 2025, the new Unitary Patent Guidelines (UP Guidelines) and amendments to the Guidelines for Examination in the European Patent Office (EPC Guidelines) entered into force.

The UP Guidelines (available here) provide procedural guidance on Unitary Patent proceedings before the EPO, namely the process of filing a request for unitary effect and registration of the unitary effect. The UP Guidelines subsume the preceding Unitary Patent Guide (which has now been discontinued) and will be updated annually to take account of legal developments regarding the Unitary Patent and EPO practice as these continue to evolve.

The new amendments to the EPC Guidelines take account of case law changes from the EPO boards of appeal, decisions of the President, and other legal or procedural changes. Modifications can be viewed in mark-up here. Gender-neutral expressions are now being used in all official languages e.g. "person skilled in the art" has been changed to "Fachperson" and "personne du métier" in the German and French versions, respectively. Other substantive changes include information on the new validation state (Lao People's Democratic Republic) and clarification on the definition of AI and machine learning and the handling of applications in these technical fields (G-II, 3.3.1).