"The legal framework is not in dispute and can be stated succinctly here. The starting point isCPR 17.3 which confers on the Court a broad discretionary power to grant permission to amend. The case-law is replete with guidance as to how that discretionary power should be exercised in different contexts. I need cite only two cases which taken together provide a helpful list of factors to be borne in mind when considering an application such as this: CIP Properties (AIPT) Ltd v Galliford Try Infrastructure Ltd[2015] EWHC 1345 (TCC) and Quah Su-Ling v Goldman Sachs International[2015] EWHC 759 (Comm) . From those cases, I draw together the following points. a) In exercising the discretion underCPR 17.3 , the overriding objective is of central importance. Applications always involve the court striking a balance between injustice to the applicant if the amendment is refused, and injustice to the opposing party and other litigants in general, if the amendment is permitted. b) A strict view must be taken to non-compliance with the CPR and directions of the Court. The Court must take into account the fair and efficient distribution of resources, not just between the parties but amongst litigants as a group. It follows that parties can no longer expect indulgence if they fail to comply with their procedural obligations: those obligations serve the purpose of ensuring that litigation is conducted proportionately as between the parties and that the wider public interest of ensuring that other litigants can obtain justice efficiently and proportionately is satisfied. c) The timing of the application should be considered and weighed in the balance. An amendment can be regarded as 'very late' if permission to amend threatens the trial date, even if the application is made some months before the trial is due to start. Parties have a legitimate expectation that trial dates will be met and not adjourned without good reason. Where a very late application to amend is made the correct approach is not that the amendments ought, in general, to be allowed so that the real dispute between the parties can be adjudicated upon. A heavy burden lies on a party seeking a very late amendment to show the strength of the new case and why justice to him, his opponent and other court users requires him to be able to pursue it. The timing of the amendment, its history and an explanation for its lateness, is a matter for the amending party and is an important factor in the necessary balancing exercise: There must be a good reason for the delay. d) The prejudice to the resisting parties if the amendments are allowed will incorporate, at one end of the spectrum, the simple fact of being 'mucked around' to the disruption of and additional pressure on their lawyers in the run-up to trial and the duplication of cost and effort at the other. The risk to a trial date may mean that the lateness of the application to amend will of itself cause the balance to be loaded heavily against the grant of permission. If allowing the amendments would necessitate the adjournment of the trial, this may be an overwhelming reason to refuse the amendments. e) Prejudice to the amending party if the amendments are not allowed will, obviously, include its inability to advance its amended case, but that is just one factor to be considered. Moreover, if that prejudice has come about by the amending party's own conduct, then it is a much less important element of the balancing exercise." a) In exercising the discretion underCPR 17.3 , the overriding objective is of central importance. Applications always involve the court striking a balance between injustice to the applicant if the amendment is refused, and injustice to the opposing party and other litigants in general, if the amendment is permitted. b) A strict view must be taken to non-compliance with the CPR and directions of the Court. The Court must take into account the fair and efficient distribution of resources, not just between the parties but amongst litigants as a group. It follows that parties can no longer expect indulgence if they fail to comply with their procedural obligations: those obligations serve the purpose of ensuring that litigation is conducted proportionately as between the parties and that the wider public interest of ensuring that other litigants can obtain justice efficiently and proportionately is satisfied. c) The timing of the application should be considered and weighed in the balance. An amendment can be regarded as 'very late' if permission to amend threatens the trial date, even if the application is made some months before the trial is due to start. Parties have a legitimate expectation that trial dates will be met and not adjourned without good reason. Where a very late application to amend is made the correct approach is not that the amendments ought, in general, to be allowed so that the real dispute between the parties can be adjudicated upon. A heavy burden lies on a party seeking a very late amendment to show the strength of the new case and why justice to him, his opponent and other court users requires him to be able to pursue it. The timing of the amendment, its history and an explanation for its lateness, is a matter for the amending party and is an important factor in the necessary balancing exercise: There must be a good reason for the delay. d) The prejudice to the resisting parties if the amendments are allowed will incorporate, at one end of the spectrum, the simple fact of being 'mucked around' to the disruption of and additional pressure on their lawyers in the run-up to trial and the duplication of cost and effort at the other. The risk to a trial date may mean that the lateness of the application to amend will of itself cause the balance to be loaded heavily against the grant of permission. If allowing the amendments would necessitate the adjournment of the trial, this may be an overwhelming reason to refuse the amendments. e) Prejudice to the amending party if the amendments are not allowed will, obviously, include its inability to advance its amended case, but that is just one factor to be considered. Moreover, if that prejudice has come about by the amending party's own conduct, then it is a much less important element of the balancing exercise."
"18. First, the proposed amendment must be properly formulated in the sense of being comprehensible and setting out clearly the case which the other party is to meet. The proposed amendment must satisfy the requirements of the CPR in terms of the proper particularisation and pleading of any cause of action asserted in the amended pleading. This is particularly so in the case of a late amendment (see per Lloyd LJ in Swain-Mason v Mills & Reeve[2011] EWCA Civ 14 ,[2011] 1 WLR 2735 at [73]). It is not open to a party seeking to make a late amendment to say that any deficiencies in the proposed pleading can be remedied in due course by further particularisation. 19. The new case set out in the proposed pleading must have a real prospect of success (see the commentary in the White Book at 17.3.16 and Mrs. Justice Carr's summary of the position in Quah Su-Ling v Goldman Sachs[2015] EWHC 759 (Comm) at [36]). The approach to be taken is to consider those prospects in the same way as for summary judgment namely whether there is a real as opposed to a fanciful prospect of the claim or defence being raised succeeding. It would clearly be pointless to allow an amendment if the claim or defence being raised would be defeated by a summary judgment application. However, at the stage of considering a proposed amendment that test imposes a comparatively low burden and the question is whether it is clear that the new claim or defence has no prospect of success. The court is not to engage in a mini-trial when considering a summary judgment application and even less is it to do so when considering whether or not to permit an amendment. Mr. Bergin says that this requirement only applies when the amendment in question is raising a new claim or defence. He contended that it did not apply if the amendment was in reality further particularisation or amplification of an existing claim. Mr. Pipe did not concede this but in my judgement Mr. Bergin is right. The requirement that the claim or defence proposed by way of amendment has a real prospect of success arises from the need to avoid the futility of allowing a claim or defence to be made by way amendment which is liable to be struck out or to be defeated by a summary judgment application. The same consideration does not apply if the line of claim or defence is in the original pleading and will remain in issue even if the amendment is not allowed. In practice in this case the Defendant said that the proposed amendments made new allegations while the Claimants said that they were no more than a fuller particularisation of the existing claim. 20. If the amendment is very late in the sense of being an amendment which will cause the vacation of an existing trial date then other considerations come into play. In such cases particular regard is to be had to the strength or otherwise of the new case and there is a heavy burden on a party seeking to make such an amendment to show that justice requires him or her to be allowed to do so (see Swain-Mason v Mills & Reeve; Quah Su-Ling v Goldman Sachs; and Nesbit Law Group v Acasta Europe Insurance Company[2018] EWCA Civ 268 ). 21. In the context of the current case those principles mean that I am to consider each limb of the proposed amendment. I must consider the amended pleading in relation to the original Particulars of Claim and assess whether a new claim is being made or whether the amendment is in reality no more than fuller particularisation of the existing claim. I am to consider whether the amended pleading satisfies the requirements of the Rules and is adequately pleaded. Where a new claim is being made regard must be had to whether it is a claim with a real prospect of success. I must then consider whether the inclusion of the new material will necessitate the loss of the trial date and if it would whether the Claimants have satisfied the heavy burden of showing that justice requires that they should nonetheless be permitted to advance the amended claim. 22. Having applied that approach to the limbs of the amended pleading separately I must then stand back and consider the combined effect of such parts of the proposed pleading as pass that scrutiny to see if that combined effect leads to a different result."
"... CIP PropertiesvGallifordTry Infrastructure[2015] EWHC 1345 (TCC) where Coulson J (as he then was) described ... lateness as a relative concept but an amendment is always in principle late if it could have been advanced earlier. Therefore, the question of when an amendment might have been sought should not be eclipsed by the potential complexity or importance of the arguments advanced by the amendment."
"60. In Financial Services Authority v Rourke Neuberger J (as he then was) proposed the following, with which we respectfully agree: 'It seems to me that, when considering whether to grant a declaration or not, the court should take into account justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose whether there are any other special reasons why or why not the court should grant the declaration.'"
"(vi) To allow declarations in the Arrow form would be to open the floodgates, so that a claimant faced with patent problems in, say, Romania could come to the English court for a declaration that a product is obvious, because it would be useful for him in connection with his business there. If the Arrow declaration does not raise issues of validity, then it would be a way of undermining the system of allocation of jurisdiction under the recast Brussels Regulation in ways which the courts have striven to prevent: See e.g. Gesellschaft für Antriebstechnik MBH & Co KG v Lamellen und Kupplungsbau Beteilungs KGCase C-4/03 [2006] FSR 45 ("
"We are not persuaded that declarations in the Arrow form will open any floodgates. The Arrow decision is now of some age, and has not resulted in many such cases being brought. The circumstances in which such declarations will be justified, will, we would have thought, be uncommon. Mr Hobbs' example of a business problem in Romania would be unlikely to justify the grant of a declaration by the English court."
"Given that a discretionary power exists, it is for the Patents Court to develop the principles for its exercise in more detail. It will be apparent from the above, however, that we consider an important factor to be borne in mind in the exercise of the discretion is the existence of the statutory proceedings for revocation, which should be regarded as the normal vehicle for obtaining any desired findings of invalidity."
"374. I accept that the spin-off value of a judgment in a contracting state can be very valuable, and it is legitimate for parties to rely upon such judgments in other contracting states. However, it is important not to extend this principle too far. Statements as to the spin-off value of UK judgments have been made in the context of applications to stay pending resolution of EPO oppositions, or of applications to expedite trials. Those cases are very different from the present. It is also important to guard against forum shopping, where a declaration from the UK Court is sought in cases which have no connection with this jurisdiction. 375. This is illustrated by the judgment of the Court of Appeal in Dow Jones v Jameel[2005] EWCA Civ 75 . The on-line version of the Wall Street Journal had published an article linking the Claimant to the funding of al Qaeda. The Claimant brought libel proceedings in the United Kingdom even though very few United Kingdom residents had seen the article. One of his objects was to seek a judgment which would vindicate him in respect of the global publication. When considering the question of vindication, the Court of Appeal at [65] referred to the judgment of Lord Hoffman in the Berezovsky v Michaels[2001] 1 WLR 1004 : 'The plaintiffs are forum shoppers in the most literal sense. They have weighed up the advantages to them of the various jurisdictions that might be available and decided that England is the best place in which to vindicate their international reputations. They want English law, English judicial integrity and the international publicity which would attend success in an English libel action. ... My Lords, I would not deny that in some respects an English court would be admirably suitable for this purpose. But that does not mean that we should always put ourselves forward as the most appropriate forum in which any foreign publisher who has distributed copies in this country, or whose publications have been downloaded here from the Internet, can be required to answer the complaint of any public figure with an international reputation, however little the dispute has to do with England. In Airbus Industrie G.I.E. v Patel[1991] 1 AC 119 your Lordships' House declined the role of 'international policeman' in adjudicating upon jurisdictional disputes between foreign countries. Likewise in this case, the judge was in my view entitled to decide that the English court should not be an international libel tribunal for a dispute between foreigners which had no connection with this country.' 376. The Court of Appeal in Jameel concluded at [66]: 'So far as concerns the issue currently under consideration there is no conflict between the view of Lord Hoffmann and the view of the majority. This action falls to be considered as relating exclusively to an independent tort, or series of torts, in this country. It is thus not legitimate for the claimant to seek to justify the pursuit of these proceedings by praying in aid the effect that they may have in vindicating him in relation to the wide publication.' 377. This (amongst other authorities relied on by AbbVie) shows that, when considering whether to grant the declaration in the present case, I am concerned with whether it will serve a useful purpose in the United Kingdom. A declaration which is sought solely for the benefit of foreign courts will rarely be justified, as was emphasised by Floyd LJ in the FKB Appeal Judgment. '95 We are not persuaded that declarations in the Arrow form will open any floodgates. The Arrow decision is now of some age, and has not resulted in many such cases being brought. The circumstances in which such declarations will be justified, will, we would have thought, be uncommon. Mr Hobbs' example of a business problem in Romania would be unlikely to justify the grant of a declaration by the English court.'"
"386. I do not accept AbbVie's submissions, and I accept the Claimants' case on this issue, to the extent set out below. If, as AbbVie submits, the declarations have no useful purpose, and the steps that they have taken have the same effect in achieving commercial certainty, there is no coherent explanation as to why it refuses to submit to judgment, or alternatively to give an acknowledgement in the same form as the declarations. The suggestion that AbbVie resists the declarations because it does not accept that the relevant dosing regimens were anticipated or obvious does not withstand examination, and has not been put forward in evidence. If that were the case, AbbVie would not have abandoned its UK patent protection. Had it maintained that protection, and won the trial, it would have been able to stop the launch of the Claimants' biosimilars. 387. In my judgment, AbbVie would not have invested the considerable resources that this trial has required unless there was a good commercial reason to resist the declarations. In the absence of any alternative explanation in evidence, I believe that the declarations will be more damaging to AbbVie's strategy in relation to its Humira patent portfolio than the complex set of undertakings and abandonment of UK patent protection that it has chosen to provide. ... 394. I consider that the grant of a declaration would serve a useful purpose, for the following reasons. First, commercial certainty. Mr Inman and Dr Gilbert suggested in their evidence that the reason why AbbVie had abandoned its UK patents was to shield them from the scrutiny of the UK Courts. They claimed that AbbVie continued to resist the declarations precisely because they would serve a useful purpose, namely to provide the Claimants with adequate certainty as regards the intended launch of their biosimilar adalimumab products; see for example Gilbert (3) [33]. ... 397. I have also found that AbbVie has made threats that it will enforce its patents against biosimilar competition anywhere in the world. The declarations will serve a useful purpose of dispelling commercial uncertainty in the UK (and European) market, which those threats have created. ... 401. I also consider that the declaration would serve a useful purpose in protecting the Claimants' supply chain for the UK market. At [2.8(a) – (b)] of his eleventh Statement, Mr Inman expressed concern as to the 'chilling effect' in the market, in the absence of a declaration, in that manufacturers of products are likely to find it more difficult to enter into an agreement with a prospective EU marketing partner, when despite the UK being patent free, the rest of the EU remained subject to the threat of potential patent litigation. He explained that, as a practical matter, due to the international nature of the industry, most biosimilar manufacturers will be unable to confine their manufacture and supply chain to within the UK, so the UK market may not be able to be exploited without being at risk of AbbVie's patents in other jurisdictions.' ... 404. Dr Gilbert explained in her fourth statement at [7]–[9] that if AbbVie were to commence proceedings for infringement of those patents which it has de-designated for the UK in other European jurisdictions, then it is foreseeable that this will have an effect on the supply of SB/Biogen's biosimilar to the UK market. She stated that once manufactured or imported into the EU, a pharmaceutical product may be transferred to other countries for QA release in accordance with EMA requirements, and may be transferred elsewhere for filling into vials, packaging and labelling before being stored at a central distribution hub. An injunction obtained at any of these locations could disrupt the European supply chain, including supply to the UK market. Dr Gilbert has been informed that SB/Biogen's plans for launching SB5 in the UK will involve such a European supply chain. 405. This evidence goes beyond spin-off value to assist the Claimants' products to be launched in other jurisdictions. It explains how the grant of a declaration will make injunctive relief in other jurisdictions less likely, and why this will be of direct benefit to the UK market. ... 412. I accept that the spin-off value of a judgment in a contracting state can be very valuable, and it is legitimate for parties to rely upon such judgments in other contracting states. However, on reflection and having regard to the legal principles which I have set out above, I have not taken this into account other than to the extent that this issue may have an impact on the UK market (see Gilbert (4) [7]- [9])."
"I consider that, on the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie's conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie's threats to sue for infringement throughout the world."