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 - 10 November 2023 - is below:
Court rules on confidentiality of disclosure materials after trial
On 8 November 2023, Michael Tappin KC (sitting as a Deputy Judge of the High Court) handed down a decision regarding confidentiality in two samples of particles that had previously been given by way of disclosure in the proceedings. Decision here.
Following trial, an order pursuant to CPR 31.22 was made which did not include certain CT Scans Files derived from the particles as it was questionable whether they had been relied on at trial and therefore placed in the public domain. As readers may be aware, CPR 31.22(1) provides that a party to whom a document has been disclosed in English proceedings may use the document only for the purpose of the proceedings in which it is disclosed, except where – (a) the document has been read to or by the court, or referred to, at a hearing which has been held in public; (b) the court gives permission; or (c) the party who disclosed the document and the person to whom the document belongs (if different) agree.
In this case, the Claimant Saint-Gobain (SG) became aware that 3M had in its possession particles which were said to have been produced by Mr Rowenhorst of 3M in the 1990s in accordance with the teaching of the Rowenhorst prior art cited in the merits proceedings. SG sought discovery of those particles through the §1782 procedure in the United States but 3M agreed to provide two samples of the particles (“the Rowenhorst particles”). It did so on the basis that they would be treated as if they were disclosure documents and so subject to the provisions of CPR 31.22 and that they, and any data or images derived from analysis of the particles, would only be provided to certain classes of individuals involved in these proceedings. SG agreed to treat the Rowenhorst particles as disclosure documents and to treat the particles, data and images deriving from them, as confidential on a pro tem basis, but reserved the right to argue that they were not in fact confidential. SG arranged for a company called OR3D to produce computed tomography (CT) scans of particles from each of the two samples. The product of that process was the CT Scan Files. These are digital files which allow 3D representations of the particles to be viewed using special software. Using those files it is also possible to take measurements of the particles in question. It is also possible to use the files to generate 2D images of the particles from any angle.
At trial, 2D images derived from the CT Scan Files, rather than the CT Scan Files themselves, were included in the exhibits to an expert report, and the annex to a Notice of Experiments contained more detail derived from the CT Scan Files relating to two of the Rowenhorst particles. These documents were protected by a pro tem confidentiality order. Shortly before trial, the parties each produced scaled-up 3D printed models of certain of the particles, based on the CT Scan Files, and agreed that those models could be used at trial. Measurements of one of those particles were also introduced at trial by SG without objection from 3M. In addition, SG provided the Judge at trial with a USB stick containing the CT Scan Files. No pro tem confidentiality order was made over the CT Scan Files on the USB stick.
Following the trial, SG took the view that it was under no restrictions on the use of the CT Scan Files themselves. It therefore provided them to its external US lawyers and to its European patent attorneys. Images and measurements derived from the CT Scan Files were filed at the EPO in opposition proceedings against 3M’s patents. 3M disagreed on the basis that the CT Scan Files were not part of the court file or evidence and had not been referred to in open court, having only been included on the USB stick handed to the judge during the trial. SG therefore issued an application seeking declarations that the CT Scan Files were read by the Court or were referred to at trial within the meaning of CPR 31.22(1)(a), that SG’s use of the CT Scan Files in the EPO opposition proceedings would not contravene CPR 31.22(1), and that SG would be free to use the CT Scan Files in any other proceedings. 3M responded with an application seeking an order pursuant to CPR 31.22(2) prohibiting SG from using the CT Scan Files for purposes other than the UK proceedings, whether in the EPO opposition proceedings or otherwise.
In its submission, SG relied on eight instances where the CT Scan Files were referred to but not viewed during the trial. 3M’s submission was that nonetheless, the CT Scan Files were not “referred to” at trial within the meaning of CPR 31.22(1)(a). The Judge concluded that CPR 31.22(1)(a) would apply because the CT Scan Files were “referred to” at the trial. It was therefore not necessary to decide whether the CT Scan Files were also “read by” the court or the Judge.
The Judge then went on to consider whether it would be appropriate to make an Order under CPR 31.22(2) which states that “The court may make an order restricting or prohibiting the use of a document which has been disclosed, even where the document has been read to or by the court, or referred to, at a hearing which has been held in public.” SG submitted that this Order could only be made at the actual hearing where the document was referred to. The Judge saw no merit in that argument. 3M responded that SG’s use of information from the CT Scan Files in the EPO proceedings had caused (and will continue to cause) 3M expense in filing submissions in response to address submissions made by SG. 3M also sought to argue that it had made clear that its principal response to any submission made by SG based on information in the CT Scan Files had been (and would be) that there was no evidence that the Rowenhorst particles were the inevitable result of practising the Rowenhorst prior art. The Judge concluded that the Court should not make an order under CPR 31.22 (2) to prevent SG continuing to use the CT Scan Files in other proceedings. The CT Scan Files had been available to SG to use free of any restrictions for 19 months and therefore it was not appropriate to make such an Order now. The Judge did require SG to provide an undertaking to give 3M 21 days’ notice of any intention to use the CT Scan Files for any purpose other than legal proceedings.
The case therefore illustrates the risk that internal documents disclosed in UK proceedings, where disclosure is available and routinely ordered, can be subsequently exported to proceedings in other jurisdictions, and likewise the opportunities that are available to the receiving party.
Supreme Court holds that patent holder is not liable to a health insurer for enforcing a later invalidated patent
On 3 November 2023, the Supreme Court of the Netherlands handed down its judgment upholding the Court of Appeal decision to overturn the District Court of the Hague’s decision to grant health insurer Menzis Zorgverzekeraar NV (Menzis) damages against AstraZeneca AB (AstraZeneca) for enforcing a patent which was later invalidated against a generic company.
The dispute concerns the enforcement of Astra Zeneca’s patent, EP 0 907 364 (EP 364), which was revoked by the Court of Appeal in 2014 for lack of inventive step. Prior to this, and following a finding of validity from the first instance District Court in 2012, AstraZeneca asserted EP 364 against various generic companies. Upon the patent being subsequently held invalid, Menzis argued that AstraZeneca had acted wrongly or been unjustly enriched by asserting EP 364 against generics and causing unnecessarily high prices to be paid by Menzis. In overturning the District Court decision, the Court of Appeal held that there was no unlawful act or unjust enrichment.
In its judgment, the Supreme Court noted that the fact that AstraZeneca had not acted unlawfully did not automatically imply that the enrichment alleged by Menzis was justified. However, the Court of Appeal was correct in finding that AstraZeneca had not been unjustly enriched on the facts, and the finding did not show an error of law. Menzis argued that AstraZeneca knew, or should have realised, that a serious, non-negligible chance existed that its patent would not stand up in opposition or invalidity proceedings and that this was the standard for assessing whether AstraZeneca acted unlawfully. Menzis considered that the Court of Appeal raised too high a threshold for assuming culpability by assuming that the holder of an EP patent with effect in various European countries, including the Netherlands, could in principle rely on a validity judgment of the Dutch court at first instance on the Dutch part of the patent. The Supreme Court disagreed, holding that the Court of Appeal did not raise too high a threshold for assuming culpability. The Court of Appeal took the relevant circumstances into consideration in connection with one another, not basing its judgment solely on one circumstance, and as such was entitled to rule that AstraZeneca could in principle rely on a validity judgment of the Dutch court on the merits, also in light of the fact that several courts abroad had reached a similar judgment at the time. The Supreme Court declined to comment on the remainder of the complaints of the plea, considering that these did not raise questions of importance to the unity or development of the law.
The Supreme Court dismissed the appeal, maintaining the high threshold applied by the Court of Appeal for liability of the patentee in these circumstances, and ordered Menzis to pay the costs of the proceedings.
JURI committee publishes draft reports on the planned new SPC Regulations
On 13 October, the European Parliament’s Committee on Legal Affairs (JURI) published a draft report on each of the four planned new SPC Regulations outlining a number of modifications to the initial proposals of the European Commission; these proposals include those for a unitary SPC for medicinal products and a unitary SPC for plant protection products. (The draft reports can be found here, here, here and here.) A few noteworthy proposed amendments are discussed below.
The JURI committee (the Committee) has proposed clarification of the initial proposal allowing the grant of multiple SPCs for the same product only on condition that they are filed by different patent holders who are “not economically linked”. According to the Committee, “economically linked” should be interpreted as meaning where “different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder”. This definition effectively excludes licence agreements between independent entities.
The Committee has also made further proposals that the decisions on oppositions by the EUIPO relating to unitary SPCs shall include a “detailed reasoning”, as well as that oppositions should also be available against positive examination opinions relating to applications for paediatric extensions of unitary SPCs. In addition, the Committee has proposed that where more than one opposition has been filed, they should be dealt with jointly and a single decision should be provided.
Deliberations of these draft reports are well underway and a revised version is envisaged to be adopted by the European Parliament as early as February 2024.