Fresenius Kabi Swissbiosim GmbH & Ors v Millennium Pharmaceuticals, Inc [2026] EWHC 1994 (Pat)

[2026] EWHC 1994 (Pat)Case Nos: HP-2026-000010, 000011, 000019 & 000028
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (CHD)
PATENTS COURT
Venue Royal Courts of Justice, Rolls Building, Fetter Lane, London, EC4A 1NLDate 31 July 2026
Before
THE HON MR JUSTICE MELLOR
Between
fresenius kabi SWISSBIOSIM GMBH (2) FRESENIUS KABI LIMITED ADVANZ PHARMA SERVICES (UK) LIMITED ACCORD HEALTHCARE LIMITED SAMSUNG BIOEPIS UK LIMITED-and-MILLENNIUM PHARMACEUTICALS, INC.Claimants in HP-2026-000010 Claimant in HP-2026-000011 Claimant in HP-2026-000019 Claimant in HP-2026-000028 Defendant in HP-2026-000010, 000011, 0000019 & 000028
Mr Michael Conway (instructed by Winston Taylor International LLP) for Fresenius ClaimantsMs Charlotte May KC and Mr Thomas Lunt (instructed by Pinsent Masons LLP) for AdvanzMr Iain Purvis KC (instructed by Powell Gilbert LLP) for AccordMr William Duncan (instructed by Simmons & Simmons LLP) for Samsung BioepisMr Andrew Waugh KC and Mr Richard Darby (instructed by Allen Overy Sherman Sterling LLP) for Millennium, the Defendant in each action)Hearing Hearing date: 24 July 2026
Approved JudgmentThis judgment was handed down remotely at 10.00am on 31 July 2026 by circulation to the parties or their representatives by e-mail and by release to the National Archives..............................THE HON MR JUSTICE MELLOR
[1]On 24 July 2026, I heard the joint CMCs in the four actions set out in the heading. With some encouragement from me, a number of issues were resolved during the hearing. This judgment is primarily concerned with a particular issue arising in the action between Advanz and Millennium which concerns the terms on which the confidential details of Advanz’s proposed biosimilar products are to be disclosed. Most of the confidentiality regime was agreed but the outstanding issue related to the scope of a prosecution bar. This judgment contains my reasons for my imposition of an extended prosecution bar at the hearing (explained further below).

Background

[2]The common theme is that in all four actions, the claimant seeks to revoke various patents belonging to Millennium, the Defendant in each action, part of the Takeda group, and/or to secure declarations of non-infringement and/or Arrow relief. All the patents relate to Millennium’s anti-α4β7 antibody, vedolizumab, which is marketed under the trade name Entyvio®, said to be Takeda’s most important product. In argument, Millennium and Takeda were used interchangeably to refer to the Defendant and I have done the same in this Judgment so, the terms Millennium and Takeda are synonymous.[3]Each of the claimants wish to clear the way for the UK launch of their own biosimilar vedolizumab product, the details of which are confidential. Thus, to the extent that infringement or non-infringement is in issue, either directly or via an Arrow declaration, there are likely to be issues particular to each claimant depending on their respective product and formulation.[4]Vedolizumab is a monoclonal antibody which binds α4β7 integrin, a molecule preferentially expressed on gut homing T helper lymphocytes that migrate to the gastrointestinal tract. Vedolizumab blocks α4β7 integrin from binding to its receptor (“MAdCAM-1”), which is expressed on gut endothelial cells, thereby reducing gut inflammation by blocking T-lymphocytes from entering the gut. Accordingly, “Entyvio®” is a biological therapy indicated for treating adults with moderately to severely active ulcerative colitis (“MS-UC”), moderately to severely active Crohn’s disease (“MS-CD”) and moderately to severely active chronic pouchitis.[5]The original patents protecting vedolizumab in the treatment of Crohn’s disease and ulcerative colitis stem from filings claiming priority to a US provisional application filed as early as 15 August 1996. That protection has now expired.[6]These actions are concerned with so-called ‘follow on’ patents. The four patents are: i) EP (UK) 3 329 965 B1(“EP 965”) ii) EP (UK) 3 311 834 B1 (“EP 834”) iii) EP (UK) 2 704 798 B1 (“EP 798”) iv) EP (UK) 4 403 579 B1 (“EP 579”)[7]There are also two patent applications involved, which, because of their status are the subject of Arrow declarations: i) EP 4 378 484 A1 (“EPA 484”), this being a divisional from the same family as EP 965. ii) EP 4 438 625 A1 (“EPA 625”), this being a divisional from the same family as EP 834.[8]EP 965 and EPA 484 claim a regimen for intravenous (“IV”) administration of vedolizumab comprising 300 mg IV at weeks 0, 2 and 6, followed by fourth and subsequent doses of 300 mg every 4 or every 8 weeks after the 3rd dose.[9]EP 834 and EPA 625 claim a regimen for subcutaneous (“SC”) administration of vedolizumab comprising an induction phase and a maintenance phase, the former comprising 300 mg IV at weeks 0 and 2, and the latter comprising 108 mg SC every two weeks.[10]EP 798 claims a formulation comprising 300 mg of vedolizumab reconstituted from a lyophilised formulation.[11]EP 579 claims stable liquid formulations of an anti-α4β7 antibody. Claim 8 specifies the use of such formulation in SC administration.[12]Accordingly, the patents and applications broadly fall into two camps i) EP 965, EP 834, EPA 484 and EPA 625 all concern dosing regimens in respect of vedolizumab and were referred to as the “Dosing Patents”. ii) EP 798 and EP 579 concern formulations for vedolizumab and were referred to as the “Formulation Patents”.[13]All these patents and applications share a filing date of 2 May 2012 and an earliest priority date of 2 May 2011.[14]The first action was commenced by Fresenius (HP-2026-000010, served on 24 February 2026), swiftly followed by the second action commenced by Advanz (HP-2026-000011 served on 27 February 2026).[15]On 8 April 2026, the trial in those two actions was fixed to float in a 5 day window commencing on 6 April 2027 with a 15 day estimate.[16]On 19 May 2026, the third action was commenced by Accord (HP-2026-000019).[17]The parties to those first two actions agreed that they should be case managed and heard together.[18]The fourth action was commenced by Samsung Bioepis (HP-2026-000028 on 15 July 2026), and Samsung applied to join the trial already listed. It does not make sense to have Samsung’s claim tried separately and, having resolved certain disputes, I directed that Samsung should join the existing trial.[19]The disputes just mentioned largely stemmed from Millennium’s concerns about losing the existing trial date due to(i) Samsung joining, having relied on a further piece of prior art not yet cited by the first three claimants,(ii) the array of different pleadings of invalidity and the lack of full alignment of those pleas and(iii) the risk of the claimants having multiple counsel teams.[20]Millennium argued that certain conditions should be imposed now on the cases which the claimants are allowed to run, specifically, that: i) The claimants should be required to align their Grounds of Invalidity in all material respects with that of Fresenius’ claim and provide a single consolidated validity pleading. ii) Takeda should then serve its amended Defences to all Claimants in response to the consolidated Grounds of Invalidity and in response to any claims for declarations of non-infringement which have been pleaded by the Claimants. iii) The Claimants should jointly instruct leading counsel.[21]Millennium’s overriding concern appeared to me to avoid at all costs losing the existing trial date, and their conditions were designed to minimise the risk of that happening. However, there are reasons why I considered it was not necessary for me to take as cautious an approach as that for which Millennium argued.[22]In the very helpful skeleton arguments I received for this application, various detailed comparisons of the respective validity attacks were set out.[23]It is unnecessary to detail those comparisons. It suffices to note that there is a good deal of alignment already but it is by no means complete.[24]Now that the constitution of this action and the general shape of the trial is apparent, it is to be expected that there will be further rationalisation of the invalidity attacks which will have to be dealt with at trial.[25]In that regard: i) to differing extents, these actions are still at an early stage. Some of the claimants may have only recently become aware of all the prior art now pleaded. ii) each of the claimants propose an order that they use their best endeavours to align each of their respective Particulars of Claim and Grounds of Invalidity by 10 September 2026. iii) the use of best endeavours is an onerous obligation. Furthermore, the offer of this provision in the draft Order indicates that the claimants expect to make significant progress in this alignment endeavour, but that they need more time to accomplish this. iv) further rationalisation is to be expected bearing in mind that there must be overlap between the various pieces of prior art currently pleaded. v) all these claimants have experienced representation and they know that running multiple citations in support of obviousness does not inspire confidence that the patent is indeed obvious. vi) there are already indications of significant cooperation between the claimants: their skeleton arguments for this application were aligned to avoid overlap, and the claimants have already agreed to use their best endeavours to share a single set of experts.[26]So, in my view, it makes sense to allow the claimants some further time to decide on which are their best pieces of art from the current pool. If my expectations turn out to be wrong and these best endeavours do not achieve near total alignment of the validity cases and expert evidence on the claimants’ side, then Takeda have the option to return to Court. At that point, the Court is likely to expect each claimant who remains non-aligned to have good reasons for insisting on their position.[27]For these reasons I indicated that I would accept the claimants’ offer to use best endeavours and I declined to impose any more stringent conditions on the validity cases, at least at the moment.[28]So far as Takeda’s third proposal was concerned (sharing leading counsel), I have almost no visibility at the moment of the arguments which may emerge over infringement. Takeda are being cautious here too, reserving their position as to the scope of expert evidence. In these circumstances, one of the claimants may regard the arguments over infringement as sufficiently important to warrant instructing leading counsel. Accordingly, I did not consider it appropriate to pre-emptively limit their options. As ever, if costs are expended unnecessarily, they may not be recovered and/or a proportion may be ordered to be paid by the other side.[29]Before turning to the main reason for this Judgment, I will mention briefly another issue debated at the CMC which concerned a point pleaded by Fresenius in their Grounds of Invalidity and some disclosure offered by Millennium which they said proved the point was a bad one. Since Fresenius had not seen the disclosure yet and it was not in evidence, I declined to strike out the paragraph in the pleading or to make any order for costs. If necessary those matters can be raised again on a later occasion.

The Advanz Confidentiality Issue

[30]This issue concerns the imposition of a prosecution bar. Mr Waugh KC for Takeda acknowledged that prosecution bars had been agreed between parties in the past, but he questioned whether the Court should exercise the power to impose a prosecution bar.[31]The relevant background to this issue is as follows.[32]Advanz wishes to market two vedolizumab formulations in the UK: one intravenous and one subcutaneous (together, the “Advanz Formulations”).[33]Advanz wishes to disclose the Advanz Formulations to Millennium/Takeda, at least so that Millennium can engage with its request for a declaration of non-infringement. Advanz and Millennium have been negotiating the terms of a confidentiality club for this information, and there remained a single issue between them.[34]They have agreed: i) That Takeda may have UK lawyers and two in-house personnel in the confidentiality club. ii) That the two in-house individuals should be prohibited from involvement in claim drafting prior to grant of a patent.[35]The issue is whether those two in-house individuals should also be prohibited from being involved in claim amendments or auxiliary requests in foreign proceedings or the EPO for granted patents (Advanz’s position) or whether no such bar should be imposed (Takeda’s position).[36]Advanz took the view that Millennium were not taking a position of principle that a post-grant prosecution bar is inappropriate. To the contrary, Advanz contended that Takeda accepted there is a risk of inadvertent use of confidential information disclosed for the purpose of these proceedings only. Instead, Takeda’s resistance stems from a practical problem arising out of Millennium’s preferred choice of in-house representatives.[37]Millennium / Takeda wish to elect as their in-house representatives a certain Ms Selli and a Ms Cole who are in-house individuals at Takeda. Ms Selli is Takeda’s Lead Counsel, IP Litigation. Ms Cole is Takeda’s Head of IP Litigation.[38]Ms Selli and Ms Cole are intimately involved in prosecution and litigation of patents in other jurisdictions and the EPO. Specifically, “Ms Cole has overall responsibility and oversight of all patent litigation matters at Takeda, including the present Entyvio® patent litigations” (Noor 1 [57]) while “Ms Selli is responsible for the day-to-day handling of all matters relating to national and EPO proceedings concerning the Entyvio® patent portfolio” (Noor 1 [58]).[39]Accordingly, so Ms May KC submitted on behalf of Advanz, these two individuals are on Takeda’s global stage for prosecuting and enforcing its patents to vedolizumab. According to the evidence, they are the only two individuals at Takeda who have this global oversight and involvement. Advanz is concerned about the risk of inadvertent misuse of its confidential information precisely because of the roles these two individuals have and the difficulties they will face in putting Advanz’s confidential information out of their minds when they decide upon amendments in other jurisdictions.[40]Furthermore, Advanz submitted that Millennium / Takeda have not put forward any evidence that any other representatives would be unable to receive the confidential information and submit to the prosecution bar, and yet still provide adequate instructions in these UK proceedings. From an organisation with 50,000 employees (Weekes 1 [7]), Ms May submitted it would be surprising if no one else could be found. I must return to consider the evidence below.

Applicable principles

[41]There was no dispute on the case law, but as usual the two protagonists chose to emphasise different points.[42]The starting point is the analysis of Floyd LJ in OnePlus v Mitsubishi [2021] FSR 13; [2020] EWCA Civ 1562. Both sides referred to his synthesis of principles which are generally applicable to the handling of confidential information in litigation at [39]. Those ten points are familiar but it is nonetheless useful to remind myself of them specifically: ’39. Drawing all this together, I would identify the following non-exhaustive list of points of importance from the authorities:(i) In managing the disclosure of highly confidential information in intellectual property litigation, the court must balance the interests of the receiving party in having the fullest possible access to relevant documents against the interests of the disclosing party, or third parties, in the preservation of their confidential commercial and technical information: Warner-Lambert [1975] R.P .C. 354 at p.356; Roussel [1990] R.P .C. 45 at p.49.(ii) An arrangement under which an officer or employee of the receiving party gains no access at all to documents of importance at trial will be exceptionally rare, if indeed it can happen at all: Warner-Lambert [1975] R.P .C. 354 at p.360; Al-Rawi [2011] UKSC 34 at [64].(iii) There is no universal form of order suitable for use in every case, or even at every stage of the same case: Warner-Lambert [1975] R.P .C. 354 at p.358; Al-Rawi [2011] UKSC 34 at [64]; IPCom 1 at [31(ii)].(iv) The court must be alert to the fact that restricting disclosure to external eyes only at any stage is exceptional: Roussel [1990] R.P .C. 45, p.49; Infederation at [42].(v) If an external eyes only tier is created for initial disclosure, the court should remember that the onus remains on the disclosing party throughout to justify that designation for the documents so designated: TQ Delta [2018] EWHC 1515 (Ch) at [21] and [23];(vi) Different types of information may require different degrees of protection, according to their value and potential for misuse. The protection to be afforded to a secret process may be greater than the protection to be afforded to commercial licences where the potential for misuse is less obvious: compare Warner-Lambert [1975] R.P .C. 354 and IPCom 1; see IPCom 2 at [47].(vii) Difficulties of policing misuse are also relevant: Warner-Lambert [1975] R.P .C. 354 at p.360; Roussel [1990] R.P .C. 45 at pp.51–52.(viii) The extent to which a party may be expected to contribute to the case based on a document is relevant: Warner-Lambert [1975] R.P .C. 354 at p.360.(ix) The role which the documents will play in the action is also a material consideration: Roussel [1990] R.P.C. 45 at p.49; IPCom 1 at [31(ii)];(x) The structure and organisation of the receiving party is a factor which feeds into the way the confidential information has to be handled: IPCom 1 at [33].’[43]Ms May for Advanz also relied on the Court of Appeal’s decision in InterDigital v OnePlus [2023] EWCA Civ 166. In that case, at first instance I had settled the terms of a confidentiality club to apply to third-party licences, and the club provided for an EEO (External Eyes Only) tier and a highly confidential tier. The highly confidential tier required in-house personnel at OnePlus not to be involved in licensing negotiations for a period of 2 years, and the dispute was whether that undertaking should be in wide or narrow form. The wide form contended for by InterDigital applied to any SEP licensing. The narrow form contended for by OnePlus was that it should be limited only to licensing discussions with the particular counterparty to the particular InterDigital licence contract in question. I decided in favour of the wide form, at that stage of the action.[44]Upholding my decision, Birss LJ said at [28]-[29]:
“28. There are two key factors about the circumstances which support the order in the wide form. The first is the stage in the proceedings. The authorities make clear that a staged approach is appropriate (see Mitsubishi paragraph 27). Imposing a wider form of order at an early stage is plainly sensible as a more cautious approach, as the judge recognised. In general it is more straightforward to relax confidentiality restrictions over the course of proceedings, as and when appropriate, than it would be to try to impose tighter restrictions after starting with a more liberal regime. 29. The second factor is the structure and organisation of the receiving party and the evidence about it. As the judge explained in paragraph 27, at that time there was very little evidence available. InterDigital’s evidence about why the particular restriction was justified was quite thin, but OnePlus’s evidence in reply was even thinner. OnePlus had only identified one individual it wanted to put forward in the regime but there was no convincing evidence about what difficulties might be caused by the wide restriction and no information about the number of lawyers or other staff in the relevant parts of the overall organisation, even though it was clear from InterDigital’s evidence that as a whole the defendants’ organisation is a substantial one. As Mitsubishi paragraph 28(x) [sc.39(x)] notes, this matters. For example in IPCom v HTC [2013] EWHC 52 (Pat) one of the factors taken into account in striking the balance in that case and permitting disclosure to a particular named individual was the very small size of the IPCom organisation (see paragraphs 31-32). There was in effect no-one else who could usefully see it. Whereas in the present case, a wide restriction applied to certain individuals within OnePlus might well, as a result of the size of the organisation, be of no real inconvenience at all. OnePlus may well have staff who could give instructions in the action without a prohibition on their being involved in future licensing negotiations amounting to a significant or any difficulty. Such licensing may be handled by others anyway or at least could be handled by others for the relevant period. Another option particularly for a large organisation could be to put in place what is now called an information barrier or ethical wall, between the litigation and licensing teams.”
[45]On this basis, Ms May stressed that the decision is only whether to require a post-grant prosecution bar at this stage, whilst Advanz’s information remains confidential – this being a reference to the fact that at some point next year, certain details of Advanz’s formulation will be published by the FDA.[46]Focussing more particularly on the issue in question, the citation of authority began to verge on persuasion by way of factual analogy. Mr Waugh relied on some observations made by Meade J. in in General Electric v Siemens Gamesa Renewable Energy[2022] EWHC 490 (Pat), at [18]-[19] that prosecution bars are not a common approach in the UK and the Court should be careful not to accede to requests for such restrictions in relatively generic cases:
“18. That is not a common approach in the United Kingdom at the moment. No doubt there are cases where prosecution bars have been agreed between parties. Indeed, Dr. Baran referred me to one that he was aware of. I do not get much out of that either. For all I know, in that case, it was easy to agree a prosecution bar because the party sought to be restricted by it just did not object. I do not know. 19. In any case, I do not think that a prosecution bar is, in any sense, a normal step to take in the UK, and I do not think it is the default position, certainly, and because the situation before me is a relatively generic one, as I have said already, I would be concerned that if I acceded to that part of GE’s submission in particular, it would be a step on the road to making prosecution bars more common or even very common in the UK, and that would require a good deal of thought before it should happen.”
[47]Mr Waugh also drew my attention to a point on the facts in General Electric where Meade J, applying the factors identified in Oneplus, refused to include a prosecution bar in the confidentiality order, inter alia because such an approach “would require a significant, and possibly entirely impractical, rearrangement of [the receiving party’s] business which is not justified by the level of confidentiality that has been suggested.” (at [28]). Mr Waugh suggested that, in the present case, this is a factor which likewise strongly militates against Advanz’s proposed extended prosecution bar.[48]For her part, Ms May reminded me of three cases, the first being Roussel Uclaf v Imperial Chemical Industries (No.2)[1990] RPC 45 (CA), a decision which underpins propositions (i) and (vii) of Floyd LJ’s summary in Oneplus, albeit that Floyd LJ relied on the summary of the principles in the Judgment of Aldous J. at p49. In Roussel, ICI resisted giving its process description to in-house members of Roussel. One reason was the risk that the information may be deployed in ongoing French litigation, where disclosure could not be obtained by order of the French court. Aldous J held that ICI’s process description should be disclosed to a single individual at Roussel provided that the individual should thereafter not be involved in the French litigation.[49]The Court of Appeal upheld Aldous J.’s decision on the basis there was no ground for them to interfere. Ms May relied on another passage in the judgment of Aldous J. at p51 lines 4-14, where he discussed the practical problems which can arise:
‘The defendants also say that disclosure to the plaintiffs would result in the plaintiffs using that information, whether consciously or subconsciously, in the corresponding proceedings in France. In that country there is no discovery and the plaintiffs case is based on deduction from analysis of "Karate" and the statements of the defendants. They submit that, if disclosure were made to anybody concerned with the French litigation, it would be putting him in a similar position to that in which "the confidentiality club" find themselves. In discussions he would have to show equal interest in matters which were not directed to the proper issues, as to those which were. This is, to my mind, a valid objection to general restricted disclosure and, therefore, before any disclosure is ordered precautions will be needed to ensure that the person to whom the documents are shown is removed from the French proceedings.’
[50]Ms May’s second case was Merck Sharp & Dohme Ltd v GlaxoSmithKline Biologicals SA [2018] EWHC 3425 (Ch) where Henry Carr J determined whether the receivers of the confidential information (being MSD’s PPD) should be restrained from using that information in connection with the drafting or amending of any patent applications or patents for the purposes of the UK proceedings. In that case, the restriction contended for would prevent the receiving party from using the PPD to prepare claim amendments in the UK proceedings.[51]The judge recorded at [32] that GSK agreed to be subject to a confidentiality agreement that mirrors the provisions of CPR 31.22(1), and he refused the restriction that would affect claim amendments in the UK proceedings at [40]:
“I have reached the firm view that GSK should not be restrained in any way from the use to which it puts this information in the UK proceedings beyond that which is provided for by our rules.”
[52]Ms May contended that decision aligned with Advanz’s position, where they accept the information may be used in these proceedings, but not abroad.[53]Ms May’s third reference was to IPCom GmbH & Ors v HTC Corp [2013] EWHC 52 (Pat) at [31(i)], which underpins proposition (i) in Oneplus. She submitted that in striking a balance between the competing interests of the parties, the court should not facilitate the granting of a competitive advantage to one and inflict a competitive disadvantage to the other unless justice requires it to take that course.[54]As I said, there was no dispute over the case law I have summarised and I applied these principles as necessary. Application to the Facts The issue

Application to the Facts

[55]A prosecution bar has already been agreed by Takeda which relates to Fresenius and Accord. Takeda stress that the agreed prosecution bar already has a wide breadth: it applies to “any patent office actions prior to patent grant or in reissue applications after grant at the United States Patent and Trademark Office, any participation in or actual contribution to drafting, amending, modifying or advising regarding the drafting, amending or modifying of patent claims or participation in domestic and/or foreign patent office correspondences or fee payments” with respect to vedolizumab.[56]As Mr Waugh submitted, this means that the individuals at Millennium who see the Fresenius and Accord confidential information cannot have any input into the prosecution of any Millennium patents relating in any way to vedolizumab (which would include patents unrelated to dosing or formulation) up to grant (including re-issues in the case of the US), including formulating claims for divisionals or amending existing applications.[57]Advanz, however, say this is insufficient. Advanz takes the position that Takeda’s in-house team can only see Advanz’s formulations if they agree to a prosecution bar which extends to all granted patents relating to vedolizumab. This is the extended prosecution bar sought by Advanz.[58]Advanz make no allegation of deliberate misuse and the issue revolves around the risk of subconscious use (Floyd LJ’s proposition (vi)) but also, more specifically, the difficulty of putting the information out of mind when taking decisions to which the information is relevant (cf Roussel). Although each side emphasised points under various of Floyd LJ’s propositions, it is unnecessary to set out all these submissions, but I emphasise that I had them well in mind at the hearing and when preparing these reasons. In the remainder of this judgment I concentrate on those central points in order to determine whether they justify the extended prosecution bar sought by Advanz.[59]I will add one point however. Mr Waugh placed some emphasis on the fact that Fresenius and Accord did not seek the extended prosecution bar sought by Advanz. I do not know whether the die is already cast for Fresenius and Accord, so it is too late for them to change matters, but I doubt it is for Samsung. Equally, since none of the formulations have been revealed to me or discussed in evidence, I have no idea whether there are special features of one or more of the formulations which stand them apart from the others. In short, if I was otherwise satisfied that Advanz required the protection of the extended prosecution bar, the fact that the other claimants did not seek the same protection did not seem to me to be a factor against the grant of that relief to Advanz.

The nature of the information

[60]At this stage I must proceed on the basis that the Advanz Formulations are confidential – Advanz characterised them as a trade secret. The evidence indicates that certain information may become available via US regulatory filings in the next 12 months, but that is unlikely to happen before the trial of this action takes place. Naturally, Advanz accept that to the extent that Advanz’s confidential formulation information can be obtained legitimately from public sources, confidentiality protection (including any prosecution bar) will fall away.[61]Millennium accepted that the Advanz formulations are confidential, and characterised the information in question as relating to the dose/concentration of the protein, the list of excipients used, and the amounts of those excipients in their IV and SC formulations and the pH of the formulations.

The time period

[62]In her evidence, Ms Weekes for Advanz accepted that certain details of the excipients and their concentrations in the Advanz formulations will become public in the US once FDA marketing authorisations are granted, and agreed that it usually takes the FDA approximately 12 months to approve such applications. On that basis, the prosecution bar would not be indefinite and the confidentiality of the formulations accepted by the FDA in June 2026 would cease around Q2 2027 (i.e. around the date of the trial).[63]Millennium argued that this time period is the critical period in national and EPO proceedings requiring important decisions on amendment ‘with respect to multiple patents under opposition or attack across multiple jurisdictions including the EPO, the UK, the Netherlands and France’: Noor 2, [10].

Millennium’s arguments

[64]I have summarised Advanz’s position above. Here I summarise the arguments made by Mr Waugh for Millennium.[65]Millennium’s argument in summary was that such a restriction would be unduly restrictive, unnecessary and manifestly disproportionate because of: i) the nature of the information sought to be protected and the relatively short time period during which Advanz’s formulations will remain confidential; ii) the protections already in place from the agreed prosecution bar; and iii) the fact that it would cause severe prejudice to Millennium, as it would make it impossible for the relevant in-house team to carry out fundamental aspects of their role which are of crucial importance to Millennium’s business and cannot feasibly be outsourced to others. Indeed, Millennium’s solicitor in her evidence stated that if the Court decided to extend the prosecution bar in the way proposed by Advanz - Millennium will be unable to agree to such terms and therefore will not have access to Advanz’s formulations.[66]Millennium argued that many of the concerns identified by Ms Weekes do not apply to Millennium and do not justify the extension of the prosecution bar: i) First, her point that the formulations would be highly valuable to those developing other biosimilars does not apply to Millennium. I accept Millennium’s argument so far as it goes, but it does not address the risk of Millennium securing post-grant patent protection which might cover Advanz’s formulation(s). ii) Second, Millennium argued that the risk that Advanz’s formulations could be used inadvertently by Millennium in relation to filing divisionals and amending existing applications is already practically eliminated by the agreed prosecution bar wording.[67]As to the specific concern (also referred to at Weekes 1, [20]) of inadvertent use of confidential information in relation to the amendment of granted patents, Millennium argued that this risk is extremely low, for two main reasons: i) First, the Millennium in-house representatives are highly qualified and experienced lawyers who are extremely familiar with dealing with confidential information subject to stringent confidentiality obligations and also fully understand the obligation not to use confidential information for any purpose other than the UK proceedings (Noor 1 [56]). Ms Selli and Ms Cole understand the requirements of CPR 31.22 and can comply by continuing to participate in post-grant amendment discussions whilst ensuring that they do not use confidential formulation information from the UK proceedings (Noor 2 [15]). This is what is expected of experienced UK solicitors handling confidential information and Ms Selli and Ms Cole are not any less capable of doing the same given their professional experience and responsibilities (Noor 2 [14]). As such the risk of either of those individuals inadvertently using the confidential information is low. ii) Second, Mr Waugh placed heavy reliance on the two guardrails which apply to any post-grant amendment: they must neither add matter nor extend protection, and submitted that the opportunity for inadvertent misuse of confidential information is severely curtailed as a result. Ms Weekes cited as an example Takeda’s Auxiliary Requests 8 and 22 in the EP 965 EPO Opposition as examples of broad claims being narrowed to include formulation details. In response, Ms Noor explained that those auxiliary requests were filed defensively in response to six oppositions attacking the validity of EP 965 and were fallback positions to preserve patent validity and were not attempts to capture any specific competing products. In relation to that last phrase I observe that an amendment may have more than one consequence, but I acknowledge the point that in an EPO Opposition amendments have to be occasioned by a ground of opposition.[68]Overall, Mr Waugh invited me to find as follows: i) The Oneplus factors do not support, and indeed positively point away from the Court requiring the extended prosecution bar to be included in the confidentiality terms; ii) The negative case management impacts of such an order being made are additional powerful reasons not to make it; iii) Advanz has not identified anything peculiar to this case which takes it out of the norm; and iv) The Court should be loath to order the extended prosecution bar for precisely the reason identified by Meade J in General Electric set out above.

Advanz’s arguments in more detail

[69]For her part, Ms May submitted that the risk of subconscious misuse of the confidential information was serious, absent the proposed prosecution bar. She maintained that the risk is particularly acute owing to Millennium / Takeda’s current choice of proposed in-house representatives. Absent a prosecution bar, they propose to elect the only two individuals in Takeda who have ongoing and primary involvement in all aspects of the prosecution and enforcement of the Entyvio® portfolio globally, including drafting, considering or giving instructions in relation to claim amendments or auxiliary requests in all foreign proceedings and the EPO.[70]Ms May submitted that Ms Noor’s evidence is littered with examples that emphasise the trans-jurisdictional co-ordination in which Ms Selli and Ms Cole are involved. She pointed to these passages: i) “Both of these individuals hold responsibilities within Takeda that extend beyond these UK proceedings” (Noor 1 [56]); ii) “Ms Selli is responsible for the day-to-day handling of all matters relating to national and EPO proceedings concerning the Entyvio® patent portfolio. She …is involved in all aspects of case strategy including positions on infringement and claim amendments to be filed in national and EPO proceedings.” (Noor 1 [58]); iii) “Ms Selli is closely involved on a day-to-day basis in coordination with external counsel, with strategic input from Ms Cole on the approach to be adopted” (Noor 1 [60]); iv) In relation to Ms Selli and Ms Cole, it is said that “no other individuals at Takeda are responsible for and provide instructions to local counsel in national litigation proceedings nor EPO counsel for EPO Oppositions related to Entyvio®” (Noor 1 [62]); v) “Ms Cole and Ms Selli are the only individuals at Takeda responsible for both defending the validity of, and enforcement of, the Entyvio® patent portfolio” (Noor 1 [62]); vi) “the impact [of Ms Selli and Ms Cole entering the prosecution bar] would be felt globally” (Noor 1 [67]); vii) Specifically, it is said that Ms Selli was primarily involved with calls on which 43 auxiliary requests for EP 965 were prepared (Noor 1 [59]).[71]Accordingly, Ms May submitted that if Ms Cole and Ms Selli are nominated to receive the Advanz confidential information, on Millennium’s proposed confidentiality regime they would still be able to have input in relation to granted patents in other jurisdictions. In practical terms, that would mean any of the foreign equivalents of EP 965, EP 834, EP 798 and EP 579 and, additionally, any patents that subsequently grant in these families. Ms May pointed to Ms Weekes’ evidence where, in her exhibit CW-3, she produced the INPADOC read-outs of the relevant patent families. The EP 798 Family comprises 116 patents or patent applications and the EP 579 Family comprises 113 patents or patent applications.[72]Further, Ms May drew attention to what she called an oddity of the prosecution state: that both the EP 798 Family and the EP 579 Family contain information in their original PCT specifications relating to methods of administration, formulation and dosage regimens both by way of common disclosures and disclosures which overlap (Weekes 1 [13]). The original specifications of these patents are sufficiently broadly drafted that claims of granted patents might feasibly be amended to incorporate details of the Advanz formulations which are not limitations of the claims of EP 798 and/or EP 579 in their present forms (Weekes 1 [39]). Further, there are enough patents/applications that potentially three could be amended in an attempt to catch each of the Accord, Fresenius and Advanz formulations separately (Weekes 1 [39]).[73]As already indicated, Advanz did not suggest that Ms Selli or Ms Cole would deliberately breach any confidence. Their point, however, was that the nature of the information is such that it is extremely difficult, if not impossible, to put it out of one’s mind when deciding what post-grant amendments to make. That is exacerbated by the size of Millennium’s patent portfolio concerning vedolizumab, and so the frequency with which these decisions may arise.[74]Indeed, Ms May submitted that Millennium recognises the risk of inadvertent misuse of the confidential information, since it proposes to restrict the two Takeda Nominated Persons from being involved in pre-grant claim drafting. Mr Waugh submitted that their agreement to the limited prosecution bar did not support the argument here but Ms May submitted that the same risk also arises in relation to granted patents. See Weekes 1 [40] and Weekes 2 [10-18].[75]Ms May invited me to consider an example based on the thought process set out by Aldous J. in Roussel (quoted above at [‎49]):
“In discussions [the in-house individual] would have to show equal interest in matters which were not directed to the proper issues, as to those which were.”
Here, she submitted, it would be extremely difficult for an in-house individual to be involved in the preparation of claim language in foreign proceedings or the EPO while (on the one hand) having a keen eye on arguments concerning validity but (on the other hand) remove from their mind information concerning Advanz’s product and be entirely agnostic as to claim amendments from this perspective.[76]The specific example Ms May proposed concerned the claim for EP 579 which requires “at least about 60 mg/ml to about 180 mg/ml” of vedolizumab. If a claim amendment were proposed which narrowed that range, and narrowed in a way to exclude one or both of the Advanz Formulations, Ms Selli and Ms Cole would be alive to the fact. The mind simply cannot avoid the realisation.[77]But how then would they behave? They could not say “The amendment does not matter” – since that is untrue. But even the statement “I cannot comment on that” is problematic: it would convey that opining on the difference would involve using the confidential information and would thereby indicate that the claim amendment would make a difference.[78]Ms May concluded her example by submitting that Ms Noor’s evidence does not explain how, as a practical matter, Ms Selli and Ms Cole would avoid breaching confidence in such scenarios. Accordingly, she submitted that the only way in which it can be protected is the prosecution bar proposed by Advanz.[79]Finally, Ms May met head on the point made by Millennium that, since “it is not possible to extend the scope of protection”, the risk of inadvertent use of the information is “eliminated” (Noor 1 [50]). Ms May submitted the point was wrong, for the reasons set out at Weekes 2 [12-18] i.e. there may be a perceived sweet spot in a claim amendment: broad enough to capture the Advanz Formulations but narrow enough to avoid an invalidity attack. That sweet spot could only be identified using the confidential information. Accordingly, so Ms May submitted, the risk is very much live.

The key parts of the evidence

[80]Not surprisingly, this issue was ventilated in correspondence and continued to be debated in rounds of witness statements: Weekes 1 (10 July 2026), Noor 1 (17 July 2026, Weekes 2 (21 July 2026), Noor 2 (22 July 2026). In her submissions, Ms May invited me to pay careful attention both to what is said in the evidence and to what is not said.[81]It suffices to refer to relevant paragraphs in Ms Noor’s evidence. First, Noor 1, [62]:
‘Ms Weekes asserts at paragraph 43 of Weekes 1 that given the size and sophistication of Takeda, it seems highly unlikely that Ms Selli and Ms Cole are the only individuals who are capable of deciding on the post-grant amendments in other jurisdictions. However, it is the case that no other individuals at Takeda are responsible for and provide instructions to local counsel in national litigation proceedings nor EPO counsel for EPO Oppositions related to Entyvio®. Takeda is a large organisation and there are patent attorneys involved in the prosecution of patents relevant to the Entyvio® product to grant, but that is a distinct team that does not have responsibility for the defence of, and enforcement of, the granted Entyvio® patents in the context of national litigation or oppositions. This organisational structure means that Ms Cole and Ms Selli are the only individuals at Takeda responsible for both defending the validity of, and enforcement of, the Entyvio® patent portfolio.’
[82]The issue continued to be debated in Weekes 2, to which Ms Noor responded in Noor 2, [17] in particular, which I need not set out. It suffices to note that the text I underlined in the quote from Noor 1, [62] above was repeated word for word in Noor 2 [17], which did not take the matter any further forward.[83]As already indicated, both of Ms Noor’s witness statements were preceded by discussion of this issue in correspondence. I was referred in particular to the letter dated 10 July 2026 from Millennium’s solicitors. This letter makes the arguments presented in Ms Noor’s evidence. There is, however, one sentence (underlined below) in the letter which we do not find repeated in Ms Noor’s evidence, despite the fact that she had two opportunities to do so. It suffices to quote this paragraph from the letter:
‘You have stated that our client is a large, multi-national pharmaceutical company with a significant IP portfolio presumably supported by a patent prosecution team with multiple personnel. However, there are no individuals other than Ms Selli and Ms Cole at our client’s organisation that are in a position to instruct us on the issue of infringement. Ms Cole and Ms Selli are the only individuals at our client’s organisation responsible for both defending the validity of, and enforcement of, the Entyvio® patent portfolio nationally and at the EPO. As we have explained, Ms Selli is responsible for the day-to-day handling of matters relating to national and EPO proceedings, and Ms Cole has overall responsibility and oversight, including on important strategic discussions.’
[84]Bearing in mind how all the other points made in this paragraph and in the letter feature in Ms Noor’s evidence, it is striking that the sentence I have underlined does not. This cannot have been an accident. I infer that the reason this point was not made in Ms Noor’s evidence was because it could not be made under a statement of truth.[85]This serves to confirm my instinct that in an organisation of the size and sophistication of Takeda, there are personnel, other than Ms Selli and Ms Cole, who are well qualified to instruct the external lawyers on any issues which arise out of the infringement case. On all the evidence, I so find.

Analysis

[86]It seemed to me that Millennium’s arguments were built on a foundation which did not exist. In essence, Millennium’s argument was very simple: there is no one else other than Ms Selli and Ms Cole who can adequately provide input to the lawyers on matters arising out of the infringement issues on the Advanz Formulations.[87]However, this foundation was not established in Millennium’s evidence. In fact, in all the circumstances, the evidence as a whole establishes the exact opposite – see above.[88]The point which Millennium seemed to me to have studiously ignored was this. Takeda is a huge organisation with very significant resources and some 50,000 employees in total. Takeda is engaged in a battle with the generic companies and their biosimilars, in which it is plain that Takeda is straining every sinew to perpetuate patent protection relating to vedolizumab, and if possible, to obtain protection which can be asserted against the biosimilars and/or their formulations.[89]I accept entirely that, in this litigation, Takeda’s lawyers and experts will need to take instructions from personnel in Takeda and are likely to need technical assistance from their client as well on the issues which may arise on infringement, whether it is direct infringement or by equivalents. I also bear in mind that the subject matter of the Dosing Patents and the Formulation Patents is not complex.[90]The application of the legal tests are for the lawyers, whether external or internal. However, Takeda’s evidence was completely silent on whether there are personnel in the organisation other than Ms Cole and Ms Selli who can advise on technical matters which may arise on or from the infringement arguments and/or a possible repercussive effect on the validity arguments. In the absence of evidence saying clearly there are no such personnel, I considered it remained open to me to draw an inference that there are such personnel, particularly in view of the size of the organisation and the importance of vedolizumab to Takeda.[91]It is clear that the extended prosecution bar in issue would apply to a large number of patents (either in opposition or under ‘attack’ post-grant) which are in the ‘critical period’ where amendments may need to be formulated.[92]In all the circumstances, and taking due account of all the arguments made to me, I concluded that(a) there remains a non-negligible risk of the subconscious use of confidential information owing to the intimate involvement that Ms Cole and Ms Selli have in foreign proceedings and at the EPO and(b) that the prosecution bar sought by Advanz will, in fact, benefit Ms Cole and Ms Selli since with that bar in place, they will not find themselves in very difficult situations where they struggle to keep information about Advanz’s formulations out of mind, when that information may be brought to front of mind by consideration of proposed amendments.[93]On the other side of the coin: i) I reject the suggestion that Takeda will suffer any material prejudice (severe or otherwise) if the extended prosecution bar were to be imposed. It does not necessitate a significant rearrangement of Takeda’s business, nor do I consider the necessary arrangements to be at all impractical (cf General Electric, above). ii) There is no restriction (as in MSD v GSK) on Takeda’s ability to propose amendments in these proceedings. I realise that, once such amendments have been proposed, they are public (subject to any further Order) and may be copied across to other proceedings, whether at the EPO or in other jurisdictions. Once public, I realise that the extended prosecution bar may be legitimately circumvented, but until then, it seems to me to retain a real purpose. iii) The situation in this case is far from being ‘generic’: indeed if one wished to design a situation in which the relevant personnel would have to struggle with Roussel-type difficulties, this would be a strong candidate. iv) In the same vein, I reject the suggestion (see [‎65.iii) above]) that ‘Millennium will be unable to agree to such terms, and therefore will not have access to Advanz’s formulations’. I do not accept that Millennium are forced to take that course.[94]Instead, if I conclude (as I have done) the extended prosecution bar should be imposed, it seems to me that Takeda face a different choice. If, as is likely, they wish Ms Selli and Ms Cole to continue in their central roles, then Takeda have to accept that those two individuals cannot have access to the Advanz formulations whilst they remain confidential. So their choice is to nominate other suitably qualified personnel to provide instructions on the infringement issues.[95]Furthermore, in the light of my analysis above, culminating in [‎85] above, I have my doubts as to whether Takeda will follow through with the threat outlined by Mr Waugh in his submissions. He submitted:
‘23 We say possible two effects on the case management 24 proceedings: (a) either Advanz's DNI request will have to be 25 adjourned to be determined after the main trial of this action 1 – once their formulations have become public, or (b) if the 2 information becomes public before trial, it may be possible 3 for the parties to, at that stage, see if they can make 4 progress on the DNI issue in time for the resolution of any 5 dispute to be addressed at trial. Both are unattractive, 6 which is why we say in the first instance it would be best not 7 to require the extended prosecution bar.’
[96]Once again, these submissions ignore (apparently deliberately) the fact that there are or are likely to be personnel at Takeda other than Ms Selli and Ms Cole who are well able to give instructions on the issue of infringement. In these circumstances, although I cannot bind any Judge (including myself) who may hear any application by Takeda that Advanz’s DNI should be adjourned and separated from the trial, I suspect that, for such an application to be successful, clear and compelling evidence would be required to establish the point made in the sentence I highlighted above in the letter of 10 July 2026.

Postscript

[97]As I was completing the draft of this Judgment, the solicitors for Advanz wrote to make a pragmatic suggestion to avoid any threat to the trial in the event that Millennium obtained permission to appeal on this issue and pursued such an appeal. In summary, the suggestion was that Takeda should nominate two persons (other than Ms Selli and Ms Cole) to the confidentiality club now and, in the event that Millennium’s appeal succeeded, they could then add Ms Cole and Ms Selli to the confidentiality club. Although I have not seen a response from Millennium to that suggestion, it seems eminently practical to me.