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 - 1 November 2024 - is below:

UK

Patent Court opines on secondary evidence.

On 25 October 2024, the Patents Court handed down its judgment in Pfizer v Uniqure Biopharma B.V [2024] EWHC 2672 (Pat), finding that EP(UK) 3 581 650 (EP 650) was valid and infringed. Uniqure Biopharma B.V is the patent proprietor of EP 650 and Pfizer alleged that the EP 650 lacks inventive step over a single piece of prior art (PCT Application WO 99/0496) and is insufficient. EP 650 is exclusively licensed to CSL Behring LLC. Uniqure Biopharma B.V and CSL Behring LLC alleged that Pfizer infringes EP 650. EP 650 protects the use and method of production of a Factor IX polypeptide mutant. The mutant has a 8-9 fold increase in activity over wild-type FIX.  The advantage of this  is that a smaller amount of the mutant is needed to enable an effective therapeutic effect, reducing the risk of a damaging immune response. Pfizer argued that the invention in EP 650 lies in the Padua variant of FIX protein called R338L-FIX and that this protein was identified in the prior art as one of the preferred embodiments.

The parties’ submissions raised issues concerning whether, in relation to the assessment of obviousness, there could be focus on the expectation of success. They considered the relationship between (i) whether the invention was obvious to try with a reasonable expectation of success, (ii) motivation and (iii) technical prejudice.  Further they raised arguments on the weight to be given to secondary evidence. Judge Hacon concluded that, in relation to obviousness, it was important to consider whether the claimed invention would have been perceived by the skilled team at the priority date as being obvious to try with a reasonable expectation of success. He considered that motive is not a key factor at play as, if there is a reasonable expectation of success, there would have been sufficient motive.

The Judge concluded that (i) the activity of R338L-FIX was stated in the prior art, (ii) the skilled person would have known that it was possible to make recombinant DNA encoding R338L-FIX and to test the FIX protein expressed by the gene for clotting activity. Further, he noted that something was obvious to try if there was a reasonable expectation of success. The Court held that it was not obvious to try using a gene encoding R338L-FIX for gene therapy in the treatment of haemophilia B with any reasonable expectation of success. He considered that success in this case meant that the clotting activity of R338L-FIX was at a level sufficient to make DNA encoding it suitable for the treatment of haemophilia B. He also concluded that the identification of R338-FIXL in the prior art as a preferred embodiment would have been perceived as a patent attorney’s work product and would not have made any impression on the skilled person. Therefore, EP 650 was valid and infringed.

UPC

Hague Local Division partially grants r.190 RoP order to produce evidence (UPC_CFI_327/2024). 

On 14 October 2024, the Hague Local Division granted Winnow's request for Orbisk to provide evidence, ordering Orbisk to provide specific technical documents related to features of the Orbi System that allegedly infringes Winnow's patent (EP 3 198 245 B1, “A system and Method for Monitoring Food Waste”).

The r. 190 RoP request had been filed by Winnow at the outset of the claim. A previous order from the Hague Local Division had rejected Orbisk’s request to extend the term to respond to the r. 190 RoP request to align with its statement of defence (three months after the service of the claim). The Court agreed with Winnow that the r. 190 RoP request must be handled with speed, as it was necessary for any information obtained to be used in its reply to Orbisk’s statement of defence, particularly as the Court would require further time to actually decide on the r. 190 RoP request and, if granted, for confidentiality issues to be addressed. This is in line with the front-loaded nature of the UPC.

In the most recent order, the Court summarised the requirements that must be satisfied for granting requests to produce evidence. These were:

• the requesting party must have presented evidence “reasonably available” to it in support of its claims (including entitlement to the patent and infringement);
• the evidence to which access is requested must be “specified” and lie in control of the other party;
• the other party’s confidential information must be protected; and
• based on the general rules of Art. 41(3) and 42 UPCA, as well as Art. 33 of the Enforcement Directive, any order to produce evidence must satisfy the requirements of proportionality, equity, and fairness.

In this case, the Court considered that a prima facie case of infringement exists based on Winnow’s claim as filed and that a presumption of validity also exists, as the patent was examined and granted by the EPO.

In relation to infringement, the Court noted that Winnow could not be expected to be entirely conclusive in its argumentation and evidence on infringement without the requested evidence, as the requested evidence was pertinent to the infringement of certain claim features, and so necessary for the claim.

The Court also considered that Winnow had supported its claim with publicly available evidence, and that it was credible that the requested evidence lies in the control of Orbisk.

Regarding validity, at this stage of proceedings it was considered inappropriate for the Court to assess validity in depth (as this is a matter for the main proceedings) unless there was a clear cut case of invalidity, which was not the case here.

The Court only partially granted the request in that a subset of documents from the original request were ordered to be produced. However, the decision left open the possibility for Winnow to submit a further r. 190 RoP request if, having reviewed the ordered evidence, it can show that it still reasonably needs more evidence for the infringement claim.

This is an important decision in that it highlights the usefulness of r. 190 RoP requests where publicly available evidence as to infringement has been exhausted. That is, of course, not an unusual circumstance in the field of computer implemented inventions, where evidence for infringement from publicly available sources is limited and the internal operation of devices or software cannot be reverse engineered. Had the request been refused outright it would have suggested that the only appropriate approach for claimants to take to obtain the necessary evidence would have been to request a saisie or “order to preserve evidence”, under Art. 60 UPCA) before filing the action which would clearly be more onerous and arguably expensive for both parties.

UPC

Hamburg Local Division considers confidentiality in documents submitted in previous proceedings.

On 24 October 2024, the Hamburg Local Division granted an order restricting access to confidential documents in 10x Genomics v President and Fellows of Harvard College and Vizgen, Inc (UPC_CFI_22/2023). The document concerned was a licence agreement entered into by the claimant and the claimant’s application was to restrict access such that it was available only to the defendants’ outside attorneys. The licence had originally been disclosed in US proceedings between the parties and was subject to a protective order. Vizgen sought permission to share the document with one named individual within its organisation.

Protection of confidential documents is provided for under Art. 58 of the UPCA and r. 262A RoP. Furthermore, the Local Division of the Hague has held (in UPC_CFI_239/2023, App. 589842/2023) that the parties can agree on restricted confidentiality clubs in proceedings before the UPC. The claimant argued that such agreement had been entered into, since the parties had agreed before the court in the US that the licence would be open for use in the UPC proceedings on the condition that it would be subject to the same protections as in the US proceedings.

The Judge-Rapporteur, Sabine Klepsch, granted the claimant’s application. They noted that the court does not have to be satisfied that the document does indeed contain trade secrets, there need only be evidence that the existence of a trade secret is predominantly probable. The Judge-Rapporteur also found that the parties had agreed to enter into the restricted confidentiality regime and that this was not undermined by Vizgen’s argument that its application for access to the licence concerned had been filed prior to that agreement. The Judge-Rapporteur also did not consider that the confidentiality of the agreement should be overruled by Vizgen’s “equality of arms” arguments, which were that an individual within the claimant had access to its licence agreement and disclosure of the claimant’s licence should be on the same terms. The Court did not consider that restricting the disclosure of the licence agreement lead to any undue prejudice to Vizgen.

SWEDEN

Swedish Parliament passes a new Patent Act entering into force 1 January 2025.

On 16 October 2024, the Swedish parliament passed a new Patent Act, which will come into force on 1 January 2025. The new Patent Act will be divided into stand-alone chapters instead of consecutively numbered sections and will include definitions to key terminology e.g. novelty and inventive step. There are also substantive updates to the Patent Act.

The use of biological materials for developing plant varieties and some computer programme uses are exempt under the new Patent Act. The test for indirect infringement has also been amended such that the alleged infringer using the means essential for the invention must “know or ought to have known” that the means being used is intended to carrying out the invention. The previous wording of the Patent Act states that the alleged infringer “know or in light of the circumstances it is evident".

Further, under the new Patent Act, products manufactured legally in another jurisdiction but offered for sale in Sweden (or imported and stored) can now be subject to recall, destruction, change or detention if the product is protected by a Swedish patent.