England and Wales High Court (Chancery Division) Decisions

IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT

		The Rolls Building, 7 Rolls Buildings, London EC4A 1NL
		29th December 2016

Mr Justice Henry Carr :

1. The Defendant ("AbbVie") is the proprietor of a number of patents relating to the antibody adalimumab, sold under the trade mark Humira. Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$12.5 billion. Adalimumab is a fully human antibody that binds and neutralises the activity of TNFa. The basic patent for adalimumab (EP 0,929,578) and its associated UK SPC (GB/04/002) will expire on 15 October 2018.
2. Humira has been approved for the treatment in adults of rheumatoid arthritis, psoriatic arthritis and psoriasis. The basic dosage regimes for those indications, as set out in the Summary of Product Characteristics, specify or include the administration of 40 mg adalimumab every other week as a single dose via subcutaneous injection ("40 mg sc eow"). AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime in the treatment of various indications.
3. The Claimants in these various proceedings (respectively "FKB" and "SB/Biogen") each intend to market a biosimilar adalimumab product in Europe, including the United Kingdom, after expiry of the basic adalimumab patent and its associated SPCs, if they can clear the way of secondary patents before then. They seek declarations that their products were obvious and/or anticipated at the priority date. If such declarations are granted, then the Claimants will have a so-called "Gillette defence" to complaints of acts committed in the United Kingdom, on the basis that if there is infringement of any of the patents in suit, then these patents must be invalid.
4. This judgment concerns an application by AbbVie for summary judgment, or alternatively to strike out these proceedings as an abuse of process, and applications by FKB and SB/Biogen to amend their Particulars of Claim in the light of recent events.
5. This is the latest in a series of applications by AbbVie, the effect of which, if successful, would be to avoid a trial in the United Kingdom. In particular, Claim No HP-2015-000053 ("FKB1") (which concerns EP UK 2,940,044 ("the 044 patent") and EP UK 1,944,322 ("the 322 patent") was issued on 29 October 2015. AbbVie applied to strike out parts of that claim. I dismissed that application by a judgment dated 1 March 2016 ("the FKB1 judgment"). On 24 March 2016 SB/Biogen issued Claim No HP-2016-000016 ("S/B") in respect of the same patents as are in issue in FKB1. On 9 May 2016 FKB issued Claim No HP-2016-000025 ("FKB2") (which concerns EP UK 1,737, 491 ("the 491 patent")). AbbVie applied to set aside service of, or alternatively to strike out, FKB2. Arnold J dismissed that application by a judgment dated 8 September 2016 ("the FKB2 judgment"). Appeals by AbbVie from the FKB1 and FKB2 judgments were heard on 28 and 29 November, and judgment was reserved.
6. The trial of the FKB1 and S/B claims is due to commence imminently, on 16 January. Evidence of fact was served by the Claimants on 17 October 2016; technical expert evidence was exchanged on 8 November 2016; legal expert evidence relating to priority issues was exchanged on 25 November 2016 and reply evidence should have been exchanged by the date of this judgment. FKB2 is due to be tried in June 2017.
7. On 15 November 2016, AbbVie informed FKB and SB/Biogen, in solicitors' correspondence, that it had de-designated the UK from the 044 patent. It also informed the EPO that it no longer approved the text of the 322 patent. Both of these patents are in issue in FKB1 and S/B. Further, the letter indicated that AbbVie was prepared to submit to revocation in the United Kingdom of the 491 patent. AbbVie also offered undertakings, the effect of which, it claimed, was that it would not obtain any patent protection in the United Kingdom that would be infringed by the Claimants' biosimilar products as a result of their use of the dosage regimens for the indications specified in the declarations sought. It agreed to pay the costs of the proceedings and provided draft consent orders.
8. This offer was not acceptable to the Claimants, who invited AbbVie to submit to judgment, which would obviously end the proceedings. AbbVie refused to do this and continues to resist the grant of any declarations by the Court. Application notices, giving the juridical basis of the application (strike out or summary judgment) were served by AbbVie on 30 November 2016. Since the hearing in the Court of Appeal, when AbbVie gave certain undertakings to the Court, the scope of those undertakings has been expanded to take account of objections by the Claimants. The undertakings are now in their fourth draft.
9. In short, AbbVie's position on this application is that there is now no real prospect of a court finding that the declarations sought serve a useful purpose, and that the continuation of these proceedings would be an abuse of process, and a disproportionate waste of court resources.
10. FKB and SB/Biogen's position is that AbbVie is not prepared to offer the relief sought, or even an acknowledgement in terms of the declarations, because it would be a clear indication throughout Europe that the biosimilar products have been cleared in the United Kingdom. AbbVie resists such clarity because it has threatened to pursue proceedings for infringement throughout the world. The Claimants argue that AbbVie refuses the declarations precisely because they will serve a useful purpose, by influencing courts throughout Europe, removing any confusion in the marketplace, promoting settlement and preventing interference with the Claimants' supply chains between Europe and the United Kingdom. The Claimants say that if AbbVie continues to resist the declarations, then FKB1 should go to trial in January, as there remains a substantive issue between the parties as to the Claimants' entitlement to the relief sought.
11. Furthermore, the Claimants submit that the latest move by AbbVie cannot be viewed in isolation. It is part of a long course of conduct, whereby AbbVie has dragged out proceedings for as long as possible whilst threatening to sue for infringement, and then has abandoned its patent rights at the last moment, whilst filing further divisionals with very similar claims. This strategy is designed to encourage market uncertainty, whilst shielding AbbVie's patents from the risk of a finding of invalidity. In support of this submission they rely on conduct by AbbVie in the EPO, which is summarised below.

AbbVie's conduct in the EPO

12. In the FKB1 judgment, I summarised the facts relied on by FKB at the time. The Particulars of Claim in its original form sought to revoke two granted patents, namely EP (UK) 1 406 656 ("the 656 patent") and the 322 patent.
13. The 656 patent claimed the use of adalimumab in the treatment of rheumatoid arthritis by the 40 mg sc eow dosage regime. The application for the 656 patent was filed on 5 June 2002. It was not granted by the EPO until eleven years later, on 9 June 2013. During the nine month opposition period following grant, fifteen oppositions were submitted. AbbVie eventually filed its observations in response to the oppositions, together with no less than nineteen statements of fact and expert reports, on 22 December 2014. On 24 April 2015 AbbVie requested the grant of a divisional from the 656 patent ("the Fourth Divisional Application"), having previously requested the grant of three other divisionals. Between August and October 2015 various opponents submitted replies to the observations filed on behalf of AbbVie. However, on 4 November 2015, six days after the Claim Form was issued in FKB1, AbbVie wrote to the EPO stating that it no longer approved the text of the granted 656 patent. Accordingly, the EPO revoked the 656 patent on 16 November 2015. The Fourth Divisional Application, which claimed essentially the same subject matter as the 656 patent, was published on 4 November 2015.
14. FKB applied to plead these facts by amendment to its Particulars of Claim. It alleged that AbbVie intended to delay the entry of competing Humira biosimilar products by prolonging commercial uncertainty. FKB claimed that the purpose of abandoning the 656 patent was to avoid adjudication on its patentability by the UK court and the Opposition Division, whilst seeking to ensure that the subject matter of the alleged invention of the 656 patent was maintained by the Fourth Divisional Application. The object, according to FKB, was to prevent FKB from clearing the way in respect of its FKB327 biosimilar after expiration of the SPC for the basic adalimumab patent.
15. AbbVie disputed that there was any connection between its decision to abandon the 656 patent and the commencement of the UK proceedings by FKB. I held that there was a good arguable case that the allegations which were sought to be added by amendment were correct, for the reasons advanced by FKB. Arnold J reached a similar conclusion in the FKB2 judgment, when he found at [28] that:

"In my judgment these points are sufficient to show that FKB has a real prospect of establishing that AbbVie Bermuda's purpose in filing the amendments to EPA491, requesting a further rule 71(3) communication and reserving the right to pursue the deleted subject matter by way of one or more further divisional applications was to shield some or all of the subject matter of EPA491 from timely scrutiny by this Court, or at least prolong the uncertainty as to whether such subject matter founds a valid patent."

16. FKB and SB/Biogen now seek to rely on further facts in support of this aspect of their case. The fourth divisional Application was granted on 16 November 2016 as the 044 patent. According to FKB, at the hearing before me which resulted in the FKB1 judgment, AbbVie indicated that it was seeking to expedite the grant of the 044 patent. In fact, it sought to delay the grant as long as possible. On 16 March 2016, the EPO issued a rule 71(3) notice of its intention to grant the application. AbbVie did not seek to expedite the grant. On the contrary, it waited three months, and on 17 June 2016 disapproved the text and requested some minor typographical amendments. AbbVie also requested that the EPO should issue a further rule 71(3) notice, thereby triggering a further four-month pre-grant period in which AbbVie could consider whether or not to accept grant. AbbVie could have waived this request for further notice. At AbbVie's request, the EPO issued a further rule 71(3) notice, on 27 July 2016, of its intention to grant the fourth divisional Application. AbbVie could have approved that text at any time, but it chose to wait until the full four months had expired.
17. From the beginning of October 2016, the parties were proceeding on the basis that the 044 patent would be granted in time for the FKB1 trial, and AbbVie confirmed this in correspondence. Accordingly, FKB and SB/Biogen produced pleadings to address the 044 patent. The pleadings also addressed the 322 patent, which was to be considered at the FKB1 trial. Both parties served extensive expert evidence on 8 November 2016, each side relying on three expert reports, addressing the issues raised by the 044 and 322 patents and the Arrow declarations.
18. However, on 15 November 2016, and without any explanation, AbbVie de-designated the UK from the 044 patent, and disapproved the text of the 322 patent, leading to its revocation. Furthermore, AbbVie indicated that it would be willing to submit the 491 patent to revocation in respect of the UK.
19. As explained in Dr Gilbert's third witness statement at [29] – [31], FKB's advisors discovered that, on the last day possible before grant of the 044 patent, AbbVie had applied for a fifth divisional, which was not mentioned in its solicitor's letter of 15 November 2016. The form of the claims of the fifth divisional are known to AbbVie, but not to the Claimants, as it has not been published.
20. The Claimants contend that all this is consistent with AbbVie's well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents, and then throwing in the towel just before its patents are scrutinised by the court, whilst covering the same subject matter with further divisionals. I consider that there is at least a good arguable case that the judge at trial will accept this contention. Furthermore, these recent events cast doubt upon AbbVie's claim that its conduct in respect of the 656 patent had no connection with the UK proceedings. If there is a trial, this can be explored in cross-examination.
21. AbbVie's answer is that none of this matters. Since it is submitting to revocation of all EP (UK) patents concerning dosage regimen and formulation, and giving undertakings in respect of future applications, there can be no useful purpose to the continuance of these proceedings. I will evaluate this submission when considering whether there is a real prospect that the trial judge will exercise his or her discretion to grant the declarations sought in the forthcoming trials.

AbbVie's statements concerning its Humira patent portfolio

22. At [59] of the FKB1 judgment I noted that FKB had produced in evidence a transcript of statements by AbbVie's Chief Executive Officer, Mr Gonzalez, where he expressed AbbVie's intention to seek injunctive relief to prevent "at-risk" launches of products which are biosimilar to Humira. Since March 2015 Mr Gonzalez has made similar statements, which the Claimants seek to plead by amendment. It is unnecessary to set out all of the statements, and two examples will serve, from conference calls made by Mr Gonzalez to investors during 2016:

"Back in October, we outlined in detail the extensive portfolio of IP that we have for HUMIRA and our confidence in that IP and it goes beyond any one single patent. And I can tell you that we remain confident in that IP portfolio and we've made it very clear that we intend to vigorously defend all of our IP against anyone that potentially infringes it."

" … I think we have a strategy that we have developed that we will put in place at the point at which we see biosimilar competition in any market around the world. We will obviously implement that strategy outside the US potentially earlier, in an earlier timeframe."

The law in relation to declarations

23. As in the FKB1 judgment, I shall follow the general principles set out by Kitchin J in the Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat): [2007] FSR 39 ("Arrow"). He cited the following authorities:

i) Messier-Doughty v Sabena [2001] 1 All ER 275 where Lord Woolf MR explained at [41] that the approach to the grant of declarations is pragmatic, and a matter of discretion rather than jurisdiction. He stated that the use of negative declarations should be rejected where it would serve no useful purpose. Negative declarations are unusual and caution should be exercised when extending the circumstances in which they are granted. On the other hand, where a negative declaration would help to ensure that the aims of justice are achieved "the courts should not be reluctant to grant such declarations. They can and do assist in achieving justice."

ii) Financial Services Authority v Rourke [2002] CP Rep 14 where Neuberger J stated that the power to make declarations was unfettered, and that the court had to consider whether, in all the circumstances, it was appropriate to make such an order. He held that when considering whether to grant a declaration, the court should take into account "justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose and whether there are any other special reasons why or why not the court should grant the declaration."

iii) The judgments of Pumfrey J and the Court of Appeal in Nokia Corp v Interdigital Technology Corp [2006] EWHC 802 (Pat); [2006] EWHC Civ 1618; [2007] FSR 23. Nokia sought declarations of non-essentiality in respect of certain Interdigital mobile phone patents. In upholding the decision of Pumfrey J that there was jurisdiction to grant such declarations, Jacob LJ said at [20] that:

"I do not say that anyone could apply for declarations of the kind sought by Nokia. There would have to be real commercial reasons for the person seeking the declaration to have standing to do so. An interest in making 3G telephones which must therefore comply with the standard is clearly sufficient."

Summary judgment

24. I shall apply the well-known approach to summary judgment on this application as set out by Lewison LJ in Easyair Ltd v Opal Telecom Ltd [2009] EWHC 339 at [15].

Abuse of process

25. Mr Tappin QC, for AbbVie, contends that it is well established that the bringing or continuation of an action where "the game is not worth the candle" can be an abuse of process and so can be struck out under CPR Part 3.4. In particular, he relies upon the judgment of Lord Phillips MR in Dow Jones v Jameel [2005] EWCA Civ 75 ("Jameel"). Jameel was a defamation case in which the principles to be applied to disproportionate litigation were considered. Lord Phillips said:

"54 … An abuse of process is of concern not merely to the parties but to the court. It is no longer the role of the court simply to provide a level playing field and to referee whatever game the parties choose to play upon it. The court is concerned to ensure that judicial and court resources are appropriately and proportionately used in accordance with the requirements of justice …

…

69 if the claimant succeeds in this action and is awarded a small amount of damages, it can perhaps be said that he would have achieved vindication for the damage done to his reputation in this country, but both the damage and the vindication will be minimal. The cost of this exercise will have been out of all proportion to what has been achieved. The game will not merely not have been worth the candle, it will not have been worth the wick.

70 … It would be an abuse of process to continue to commit the resources of the English court, including substantial judge and possibly jury time to an action where so little now seems to be at stake."

26. I was referred to a number of other cases in which the proportionality principle has been applied, but it is not necessary to refer to them, as they apply the principles set out above to their own facts. I fully accept that there will be claims which can achieve so little that the resources required by a trial will be disproportionate to what is at stake. In such cases it is necessary to consider not only the cost to the parties but also the unnecessary utilisation of court resources, to the disadvantage of other litigants.

Application to the facts of this case

Would the declarations sought serve a useful purpose?

27. This is the principal area of dispute between the parties. AbbVie contends that there are now no extant patents in the UK and that fact, together with its undertakings, mean that there is no risk that patent protection in the United Kingdom will be infringed by the Claimants' products as a result of their use in accordance with the dosage regimens in issue. Therefore, the Claimants have cleared the way of patent protection in the United Kingdom, and so have achieved the utility and commercial purpose of the Arrow declarations.
28. Furthermore, AbbVie relies upon [43] of the FKB1 judgment where I said:

"the existence of the divisional applications gives rise to the need and justification for seeking declaratory relief. AbbVie could withdraw the "GB" designations of the divisional applications or acknowledge that it can have no claim under them in this country in respect of a product having the specified characteristics of FKB's product. If it did so then the commercial purpose of the declarations sought would fall away"

29. AbbVie submits that it has taken this course and therefore there is no commercial purpose in pursuing the case to trial. AbbVie contends that it is not the function of the UK Patents Court to act as an advisory body for other courts around Europe, which would be a disproportionate use of court resources. It points out that Arrow declarations must be limited to the United Kingdom as a matter of comity and respect for decision-making in other jurisdictions, and because of Articles 24 and 27 of the recast Brussels Regulation 1215/2012. It asserts that if this litigation is allowed to proceed, then a party who had never had patent protection in the UK could come to the Patents Court to seek an Arrow declaration, because of its potential utility in influencing other courts around Europe.
30. AbbVie submits that in the circumstances there is no real prospect of the Court granting the declarations, because there is no real prospect of it concluding that they would serve a useful purpose. Alternatively, it submits that the claims are an abuse of process, in that any possible utility is out of all proportion to the cost of the forthcoming trials. It submits that the expenditure of judicial and court resources on the resolution of the dispute cannot be justified. It would be an abuse to use the resources of the UK court to resolve a dispute that, according to AbbVie has no connection with the UK, to obtain relief to influence other jurisdictions.
31. Before considering the Claimants' submissions in answer, I should observe that I do attach weight to AbbVie's submissions, which are relevant to the balance that I must draw when considering whether there is a real prospect that the judge at trial will grant the declarations. However, I do have some reservations.
32. First, if, as AbbVie submits, the declarations have no useful purpose, and the steps that they have taken have the same effect in clearing the way, it is very difficult to see why it refuses to submit to judgment, or alternatively to give an acknowledgement in the same form as the declarations. In the absence of any explanation in evidence, there is a strong inference that AbbVie recognises that the declarations are more damaging to its strategy in relation to its Humira patent portfolio, than the rather complex set of undertakings and abandonment of UK patent protection that it proposes.
33. Secondly, I accept that an Arrow declaration provides a Gillette defence to allegations of infringement in the United Kingdom, and any such declaration must be limited to the United Kingdom. However, depending on the facts of the case, the grant of such a declaration may serve a number of useful purposes, in circumstances where the defendant resists such relief, and the claimant regards any offers of settlement as unsatisfactory.
34. Thirdly, Mr Tappin QC is entitled to rely upon passages in the FKB1 judgment concerning the effect of de-designation of UK patent protection and appropriate acknowledgements. However, those statements were made based on the pleadings and evidence that were before the Court at the time. I am now faced with an application to amend the Particulars of Claim, supported by evidence, which relies on additional facts in support of additional claims of the utility of the declarations. The Claimants are entitled to have this application considered on the basis of those pleadings and evidence, since AbbVie has radically shifted its position since the FKB1 judgment.
35. Fourthly, I do not accept that if the declarations are granted in the present case, a party who had never had UK patent protection could seek similar declarations. The facts of the present case are very different, since AbbVie abandoned its UK patent protection shortly before trial, and has a long record of similar conduct. The exercise of discretion in each case will depend upon a multifactorial assessment of all relevant circumstances, and postulating different facts does not advance the argument.
36. I now turn to the submissions of Mr Andrew Waugh QC on behalf of FKB, which were supported by Dr Justin Turner QC on behalf of SB/Biogen.
37. First, the Claimants point to the basic dispute to which I have already referred. AbbVie will not submit to judgment or provide an acknowledgement in terms of the declarations. This must be because there is a useful purpose to the Claimants in obtaining declaratory relief, which AbbVie seeks to avoid. In spite of a challenge in evidence by the Claimants for AbbVie to explain its conduct, it has chosen to remain silent in its evidence as to why it changed course so shortly before the FKB1 trial.
38. In my judgment, there is force in this submission. The judge at trial may well conclude that AbbVie has consistently adopted a policy of publicly expressing its confidence in its Humira patent portfolio, and its intention to enforce it against competition from biosimilars, whilst at the same time shielding patents within the portfolio from scrutiny by the court. The trial judge may take the view that when patent protection is abandoned by AbbVie, another sub- divisional is applied for, thereby perpetuating commercial uncertainty.
39. In my view, there is a real prospect that the judge at trial may consider that the grant of the declarations would serve a useful purpose, namely, to make it more difficult for AbbVie to continue this strategy, and thereby to create commercial uncertainty which will impede the launch of the Claimants' competing biosimilars. It may be considered that AbbVie is "willing to wound and yet afraid to strike" and that the time has come to put its professed confidence in its ability to prevent biosimilar competition to the test.
40. Secondly, the Claimants submit that the declarations, and a judgment by the UK court, if the declarations continue to be resisted, will be influential in other European Courts and tribunals, and will make it more difficult for AbbVie to obtain preliminary injunctions, particularly in jurisdictions where validity cannot be challenged whilst patents are under opposition in the EPO. In this regard, it relies on the judgment of Arnold J in TNS v Nielsen [2009] EWHC 1160 (Pat):

"In my judgment, those authorities demonstrate that it is perfectly legitimate for the claimant to seek to obtain a judgment of this Court on the validity of the patent in suit in the hope that it will lead to a settlement of the dispute between the parties throughout Europe. Nor, in my judgment, would it be in any way illegitimate for the claimant, absent such a settlement being achieved, to seek to rely upon the judgment of the English court in proceedings before the courts of other contracting states or the European Patent Office. It is commonplace for parties litigating on the same European patent in a number of contracting states to put before the courts of one contracting state decisions arrived at in one or more other contracting states."

41. The Claimants emphasise what has been referred to as the "spin-off value" of such judgments in patent cases by reference to the statement of Jacob LJ in Grimme Landmaschinenfabrik GmbH & Co KG v Scott (t/a Scotts Potato Machinery [2010] EWCA (Civ) 1110 at [80]:

"Broadly speaking we think the principle in our courts – and indeed that in the courts of other member states – should be to try to follow the reasoning of an important decision in another country. Only if the court of one state is convinced that the reasoning of the court in another member state is erroneous should it depart from a point that has been authoritatively decided there. Increasingly that has become the practice in a number of countries, particularly in the important patent countries of France, Germany, Holland and England and Wales. Nowadays we refer to each other's decisions with a frequency which would have been hardly imaginable even years ago. And we do try to be consistent where possible."

42. 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, if that were the only 'useful purpose' relied on, I doubt whether the continuation of this litigation would be proportionate. 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. The argument that the resources of the UK courts should not be used merely to assist in cases in other parts of Europe would hold considerable sway. However, it is not the only useful purpose relied on, and it is one relevant factor which the trial judge may weigh in the balance when considering whether to grant declaratory relief.
43. Thirdly, the Claimants submit that the declarations have a useful purpose in protecting their supply chain to the United Kingdom as well as in other parts of Europe. In particular, Dr Gilbert explains in her fourth statement at [7] – [9] that certain components which are necessary for SB/Biogen's product to be marketed in the UK (e.g. vials) are to be sourced in parts of Europe. The grant of the declaration will achieve commercial certainty, and prevent suppliers from declining to provide the necessary components to FKB. Similarly, Mr Inman in his eleventh statement at [2.8a] refers to the need to counter the chilling effect that AbbVie's conduct is having on the Claimants' ability to deal with third parties, such as distributors, around Europe.
44. I think there is force in this submission. It is important to remember that Mr Gonzalez's threats of worldwide litigation are intended to have, and are likely to have had, a chilling effect on competition from biosimilars, including on third-party suppliers. That is likely to impede the Claimants' ability to market successfully their products in the United Kingdom. There is a real prospect that the judge at trial may consider that the grant of declarations, in these circumstances, will serve a useful purpose.
45. Fourthly, the Claimants contend that a useful purpose of the declarations is to provide clarity, including in the United Kingdom. They point out that AbbVie's undertakings are complicated. As a result of alleged omissions identified by the Claimants, these undertakings are now in their fourth draft. The Claimants submit that the lack of clarity gives rise to a continuing risk of divisionals which apply to the United Kingdom, and which are not covered by the undertakings. They also submit that the declarations provide clarity for third parties and apply directly to the claimant's products. Such clarity is necessary, given AbbVie's conduct to date, and is not provided by AbbVie's proposal.
46. In my judgment, there is force in this submission. There is a real prospect that the judge at trial will consider that there is a need for clarity, which is provided by the declarations, and not provided by AbbVie's undertakings. The United Kingdom market for Humira is in excess of £400 million per annum. The Claimants are entitled to be sceptical that AbbVie has chosen to abandon all future patent protection for this market. AbbVie is aware, and the Claimants are not aware, of the existence and scope of "submarine divisionals" that may be used in the future to impede the marketing in the UK of biosimilars. There is a real prospect that the judge at trial will consider that this, together with the need for clarity when dealing with third parties, is a useful purpose for the grant of the declarations.
47. Fifthly, the Claimants submit that the grant of the declarations will promote a settlement on a European or even a worldwide basis, in that it changes the parties' negotiating positions. AbbVie would need to take account of the fact that the Court has declared that it cannot prevent the marketing of the Claimants' products in spite of AbbVie's public statements to the contrary, which have extended to Europe in general.
48. In my view, there is some weight to this point. The circumstances of this case are most unusual, given AbbVie's strategy which I have outlined above. In those circumstances there is a real prospect that the judge at trial will consider that the promotion of settlement, in combination with the other factors relied on by the Claimants provides a useful purpose for granting the declarations.

Justice to the Claimants

49. The Claimants contend that it is just that they should have a judicial determination of the issue in order to achieve the useful purposes set out above. They further submit that it is just that such determination should be achieved within a reasonable timeframe. They point out that yet again AbbVie has abandoned its patent protection after a great deal of evidence has been served, and at a very late stage in the proceedings. They submit that it will be just to grant the declaration to minimise the risk of repetition of this conduct, which is designed to shield AbbVie's patent portfolio from scrutiny.
50. I have concluded that there is a real prospect that the judge at trial will consider that the grant of the declarations will achieve one or more useful purposes. In those circumstances, it is difficult to see why it would not be just to the Claimants to grant such declarations, if they are otherwise justified at trial.

Justice to the Defendant

51. AbbVie repeats its submission that it has given the Claimants what they wanted and what Arrow declarations are designed to achieve – freedom to operate in the UK after October 2018. In the circumstances it contends that it would be contrary to the aims of justice and of court resources to continue to expend substantial time and effort on the matter.
52. I will consider the question of court resources when dealing with the issue of abuse of process. However, if the judge at trial considers that there is a useful purpose in granting the declarations, and that they are otherwise justified, it seems most unlikely that he or she will consider that it is unjust to AbbVie that they should be granted.

Special reasons for or against the grant of the declarations

53. I consider that there is a real prospect, when faced with the most unusual facts of this case, that the judge at trial will consider that 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.

Conclusion

54. I consider that there is a real prospect that the judge at trial will exercise his or her discretion to grant the declarations sought, in the unusual circumstances of this case. Therefore, I dismiss AbbVie's application for summary judgment.

Abuse of process

55. I have carefully considered whether it is a proportionate use of resources of the UK court to allow these trials to proceed, in the light of AbbVie's abandonment of UK patent protection and its undertakings. I have concluded that the continuance of these claims is a proportionate use of such resources, and is certainly not unfair to AbbVie. This is a case where a great deal is at stake. The size of the UK market is huge. There is a real prospect that the court will consider that the grant of the declarations will serve a useful purpose, and that this is the reason why AbbVie continues to resist them. In the circumstances, it is not an abuse of process by the Claimants to continue to seek the relief which AbbVie refuses to offer. This is not a case where it can be said that the game is not worth the candle. On the contrary, it is worth a great many candles.

Conclusion

56. I shall dismiss AbbVie's application for summary judgment, and its application to strike out these proceedings as an abuse of process, and I shall allow the amendments to the Particulars of Claim in the form currently pursued by the Claimants.