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||Neutral Citation Number:  EWCA Civ 1496
||Case No: A3 2018 0499
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH OURT OF JUSTICE
BUSINESS & PROPERTY COURTS OF ENGLAND AND WALES
HHJ Hacon (sitting as a High Court Judge)
 EWHC 375 (Pat)
||Royal Courts of Justice
Strand, London, WC2A 2LL
B e f o r e :
LORD JUSTICE FLOYD
MR JUSTICE BIRSS
|| (1) GLAXO GROUP LIMITED
(2) GLAXO OPERATIONS UK LIMITED (t/a GLAXO WELLCOME OPERATIONS)
(3) GLAXOSMITHKLINE TRADING SERVICES
||- and -
Justin Turner QC and Geoffrey Pritchard (instructed by Gowling WLG UK LLP) for the Appellants
Andrew Lykiardopoulos QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Respondent
Hearing date: 12 June 2018
HTML VERSION OF JUDGMENT APPROVED
Crown Copyright ©
Lord Justice Floyd:
- Following the initiation of revocation proceedings by the appellants (GSK), the respondent (Vectura) counterclaimed for infringement of five patents relating to the delivery of drugs by inhalation. GSK, who market such products for the treatment of chronic obstructive pulmonary disease and asthma under the brand name Ellipta, say that their products do not infringe and/or that the patents are invalid. The action is proceeding to a trial on all these issues in November of this year. In the meantime a dispute has arisen as to whether GSK can claim in addition a declaration that their Ellipta products were old or obvious at a particular date. Such a declaration, which has become known as an Arrow declaration after Arrow Generics Limited v Merck & Co Limited  EWHC 1900 (Pat), would, it is said, provide protection against allegations of infringement by Vectura of as yet ungranted patents. The judge (HHJ Hacon sitting as a High Court judge) struck out the claim for the Arrow declaration on the grounds that there was no prospect of the court granting it on the facts of this case as they presently appeared, or as they might emerge at the trial. GSK appeals, arguing that the judge should have let the claim go to trial, to be decided alongside the other issues.
The assumed facts
- As this is an application to strike out, or for summary judgment, I can take the assumed facts largely from GSK's pleading. Since the hearing before the judge, GSK have put forward draft re-amended particulars of claim which they contend fully reflect the facts and arguments as they were put before the judge. Mr Lykiardopoulos QC, who appeared for Vectura with Ms Anna Edwards-Stuart, took no objection to GSK's reliance on the draft re-amended particulars of claim for the purposes of the appeal. I will refer to this document as "the PC".
- Pursuant to an agreement made on about 5 August 2010 ("the 2010 Agreement"), and until some time in 2016, GSK were licensed by Vectura under a patent application referred to as "Staniforth" (and patents arising therefrom). The 2010 Agreement also identified an additional class of patents (the "Non-Assert Patents") under which GSK were granted a further licence to take effect from 31 July 2016, but from which further licence they had the right to exclude any of the Non-Assert Patents.
- GSK launched their Ellipta products in the UK in January 2014. Paragraph 2 of the PC alleges that the "Claimants' Products" are dry powder inhalation products containing the active ingredient vilanterol trifenatate blended with lactose and magnesium stearate and/or the active ingredient umeclidinium bromide blended with lactose and magnesium stearate. Paragraph 3 of the PC alleges that the Claimants' Products are manufactured by processes ("the Claimants' Processes") in which (i) lactose monohydrate and magnesium stearate are first blended together to produce a lactose/magnesium stearate "Pre Blend", (ii) micronized active ingredient combined with a portion of Pre-Blend is then sieved to de-lump the active ingredient, and (iii) the remaining Pre-Blend is added and the whole batch further blended to produce a homogenous blend.
- Paragraph 4 of the PC explains why GSK say that the making of the Claimants' Products according to the Claimants' Processes does not infringe any of the five patents in suit ("the Patents"). The last of the Patents was added to the proceedings upon its grant, at the suggestion of Vectura. The Patents are a sub-set of the Non-Assert Patents identified in the 2010 Agreement. Paragraph 5 states that, if and so far as the Claimants' Processes or the Claimants' Products fall within a claim of any of the Patents, then the Patent in question is invalid on the grounds set out in the accompanying Grounds of Invalidity.
- Paragraph 8 of the PC says that GSK are entitled to a declaration that (i) the Claimants' Processes and (ii) the Claimants' Products insofar as they are the direct product of the Claimants' Processes (and save for the active ingredients therein) were obvious for the reasons set of in the Grounds of Invalidity. In addition to identifying the prior art relied on (at paragraph 1), the Grounds of Invalidity assert (at paragraph 2) that:
"The Claimants' Processes … and the Claimants' Products … were obvious at and after 30 November 2000 to a person having regard to the state of art which comprised the matter set out under paragraph 1 …"
- The PC set out the history of the subsequent exchanges between the parties in paragraph 14:
"14. Following launch of the Ellipta products:
(a) in an email dated 21 January 2014, [Vectura] indicated its belief that "a number of [the Non-Assert Patents] cover the [GSK] products, or have the potential to do so".
(b) In an email dated 23 July 2014, [GSK] informed [Vectura] that they had "reviewed the Non-Assert Patents and at the present time we do not foresee the need to take the option of a licence post 2016. However, we will continually monitor the situation and will make our final decision at the appropriate time point."
(c) In an email dated 08 February 2016, [GSK] informed [Vectura] that "we've continued to monitor the Non-Assert Patents and can now confirm that we do not wish to take a licence under any of the patent families."
(d) In an email dated 09 February 2016, [Vectura] informed [GSK] that, on the basis of Single Particle Aerosol Mass Spectrometry (SPAMS) analyses of the Claimants' products, "these products are at least within the scope of US 8303991, EP 1337240 [i.e. '240 one of the patents in suit] and equivalent Vectura claims."
(e) On 08 April 2016 [Vectura] provided copies of the SPAMS analytical reports to [GSK].
(f) In an e-mail dated 09 May 2016 [GSK] confirmed it had reviewed the reports, and that it did not use the processes of the '240 patent. [GSK] reiterated that "we do not wish to take a licence under any of the Non-Assert Patents".
(g) In an e-mail dated 02 July 2016, [Vectura] reiterated its belief that US patent US 8,303,991 (in family VL0108 which family includes the Patents) "continue to be relevant to the products in question".
(h) In the same e-mail [Vectura] said, "In addition, there are a number of continuation and divisional applications pending in various territories from the Non-Assert patent families, including continuations from the '991 patent family that Vectura expect to grant shortly."
(i) On 27 July 2016 [Vectura] filed a "Complaint for Patent Infringement" in the United States District Court for the District of Delaware (C.A. No. 16-638-RGA) against [GSK] (the "US Action"), in which [Vectura] alleged [GSK's] Products infringed US patent US 8,303,991.
(j) On 12 August 2016 [Vectura] filed a "First Amended Complaint for Patent Infringement" in which an additional US Non-Assert Patent, US 8,435,567, was added to the US Action, which [Vectura] alleged [GSK's] Products also infringe.
(k) On 7 June 2017 [Vectura] notified [GSK's] US counsel that it intended to amend its pleadings in the US Action to include further allegations that [GSK's] Products infringe an additional US Non-Assert Patent US 8,956,661.
(l) On 23 June 2017 [GSK] filed their Claim Form, Grounds of Invaldiity and this Particulars of Claim with the UK High Court. The Claim Form was deemed served on 27 June 2017.
(m) On 17 July 2017 [Vectura] wrote to [GSK] stating that '818 would be granted and come in to force in the UK on 2 August 2017 (having received approval for grant on 9 February 2017), that it considered '818 to be relevant to [GSK's] Processes and [GSK's] Products, and that it intended to amend '763 to bring the claims into line with the Main Request that was pending before the EPO. Consequently [Vectura] invited [GSK] to amend their claim."
- By January 2016 the patents licensed under the 2010 Agreement had expired. On 26 July 2016 GSK formally notified Vectura that all of the Non-Assert Patents were excluded from the licence. Paragraphs 16 to 20 of the PC (with some slight amendment to account for an obvious error in numbering) continue:
"16. By [GSK's] aforesaid letter dated 30 May 2017, [GSK] also applied to [Vectura] for an acknowledgement in writing that neither carrying out [GSK's] Processes nor [GSK's] Products would infringe the European Non-Assert Patents (in addition to the Patents) and to the extent that this was not acknowledged, requested details of which of the European Non-Assert patents were said to be infringed by [Vectura] and upon what basis.
17. [Vectura] did not provide the acknowledgment requested in the 30 May letter. Therefore by a letter dated 20 December 2017, [GSK] requested acknowledgment that [GSK's] Processes and [GSK's] Products di not, and would not in the future, infringe [Vectura's] patents. In particular [GSK] requested:
"Please would you now let us know if your client is willing to provide its assurance (in a form to be agreed, but we anticipate it will need to be by way of an undertaking to the Court), that it will not in the future assert against our clients, in respect of the Products and Processes in issue in these proceedings, any patent claims arising from as yet ungranted patents with a priority date on or after 30 November 2000"
17A. The acknowledgement was sought because [Vectura] was pursuing a strategy of filing multiple patent applications around a single technical concept – the technical concept being the mixing of magnesium stearate and active ingredient in a high-energy process. This concept was claimed using different language in different patent applications including: "composite active particles", "composite active particles in which the magnesium stearate is "fused" to surface of the active, "composite active particles" in which the magnesium stearate is "smeared" over the surface of the active, and "microparticles". The use of different language means that success against one patent claim using one form of language does not guarantee that a subsequent patent infringement action brought in respect of a later patent, relating to the same technical concept, can be struck out. It follows that [Vectura's] strategy is creating commercial uncertainty for [GSK].
17B. The uncertainty is made greater by the fact that during the prosecution of a patent application claims may be amended such that it is not possible to determine the form in which the claims will be on grant. Further the existence of a single patent application can give rise to further divisional applications any time up until grant.
17C. [Vectura], by a letter dated 11 January 2018, refused to give the acknowledgement which was sought. However, by a later letter, dated 14 February 2018, [Vectura] offered an undertaking but on materially more limited terms
"In the event that none of the claims of the Patents are held to be valid and infringed in a final decision in these proceedings, that cannot be appealed, Vectura undertake not to assert in the UK any patent applications from within the Non-Assert Patent families with a priority date on or after the 30 November 2000 which subsequently proceed to grant against the Processes described in [GSK's] Confidential PPD and Products identified as being made directly therefrom…"
17D. [Vectura's] undertaking is limited to the "Non-Assert Patent families". Non-Assert Patent families are those which were in existence and owned by the Vectura Parties (and/or their affiliates) on 5 August 2010. [Vectura] has refused to extend its undertaking to patent families with a later application date and has offered no explanation of the reason why it is not prepared to do this.
17E. The existence of later patent families which might be asserted against the aforesaid commercial products is real as [Vectura] is continuing to file and prosecute patent applications relating to the technical concept of mixing magnesium stearate and active ingredient in a high-energy process. For example on 28 March 2014 it applied for an international patent PCT/GB2014/051003 (subsequently published as EP 2 978 415 A, hereafter the '415 Application) with a claimed priority date of 28 March 2013. The '415 application concern[s] magnesium stearate and fluticasone propionate. Its current claim is:
"Use of a stearate in an inhalable formulation for improving dispensed dosing reproducibility of the inhalable formulation from an automated powder filling apparatus, wherein the inhalable formulation further comprises a pharmaceutically active material which is selected from either a long-acting muscarinic antagonist, a long-acting beta-adrenoceptor agonist and/or inhaled corticosteroid, wherein the pharmaceutically active material is selected from budesonide, formoterol fumarate, glycopyrronium bromide, indicaterol maleate, umeclidinium bromide, vilanterol trifenatate, tiotropium bromide, salmeterol xinafoate and fluticasone propionate."
17F. The specifying of [GSK] active ingredients in the claim, being umeclidium [sic] bromide and vilanterol trifenatate, shows that [Vectura] is pursuing a strategy of continuing to file potentially relevant patent applications after 5 August 2010 and deliberately targeting its patent claims inter alia to [GSK's] products. This strategy in combination with a refusal to provide an undertaking which applies to later filed patent applications creates commercial uncertainty means that the declaration sought will serve a useful purpose.
18. [GSK] wish to have commercial certainty that they can continue to manufacture and sell [GSK's] Products. However, [GSK] are not able to seek revocation of any of the ungranted patent applications.
19. Furthermore, it is not possible, prior to formal notification from the EPO, for [GSK] to know when any particular patent application (and/or any related divisional) will be granted or what final form of claims it will have. Further given the strategy adopted by [Vectura] of pursuing divisional applications [GSK] will be faced with additional uncertainty which has the potential to continue until the expiry of the last patent of the European Non-Assert Patents, that is to say in December 2029.
20. In the premises, it would serve a useful purpose if the Court were to grant a declaration that [GSK's] Processes and [GSK's] Products insofar as they are the direct products of [GSK's] Processes (and save for the active ingredient therein) would have been obvious as of 30 November 2000 or at any date thereafter. This would establish that no patent applications in the patent family containing the Patents, or any later patent family, could validly claim or cover any acts in relation to [GSK's] Processes or [GSK's] Products in the UK by [GSK], thereby establishing commercial certainty for [GSK]."
- Accordingly, GSK's prayer for relief includes the following heads: (i) a declaration of non-infringement in respect of the five Patents; (ii) declarations of invalidity and revocation of the five Patents; (iii) a declaration (the Arrow declaration) in the following form:
"(a) [GSK's] Processes, namely a process in which (i) lactose monohydrate and magnesium stearate are first blended together to produce a lactose/magnesium stearate pre-blend ("Pre-Blend"), (ii) micronized active ingredient combined with a portion of the Pre-Blend is then sieved to de-lump the active ingredient, and (ii) the remaining Pre-Blend is added and the whole batch further blended to produce an homogenous blend, was obvious as of 30 November 2000 or at any date thereafter, and
(b) [GSK's] Products insofar as they are the direct products of [GSK's] Processes (and save for the active ingredient therein, were obvious as of 30 November 2000 or at any date thereafter".
- The significance of the 30 November 2000 date is that it is the claimed priority date of the patents in suit, all of which are Non-Assert Patents. By that date the application for Staniforth had been published (on 8 August 1996). As summarised to us, GSK's case in support of the Arrow declaration is that its processes are no more than an obvious implementation of Staniforth.
- Vectura has counterclaimed that GSK's Processes and Products infringe each of the five Patents.
- On 4 December 2017 Vectura applied to strike out the claim for the Arrow declaration.
- The application came on for hearing before HHJ Hacon on 23 February 2018, and he allowed it by a judgment delivered orally on the same day. By his order he struck out paragraphs 8 to 20 of the Particulars of Claim in the form in which they stood at that date. Those particulars did not at that stage include paragraphs numbered 17A-F. He also struck out the prayer for relief relating to the Arrow declaration and paragraph 2 of the Grounds of Invalidity.
- The Arrow declaration is, in effect, a declaration that a party has a Gillette defence as of a particular date against attacks by later patents. The Gillette defence can be traced to the speech by Lord Moulton in Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. In a Gillette defence a defendant contends that the product he is selling was obvious at a particular date, and cannot accordingly fall within a valid claim of a later patent. Although such a defence is raised in circumstances where the defendant is sued on specific patents, there is no reason why a properly worded declaration that a product is obvious at a particular date cannot provide protection against any later patent. As pointed out in the Arrow case itself, however, in order to render the issues for the court properly justiciable, the characteristics of the product in respect of which the declaration is sought must be clearly defined (see per Kitchin J at , ).
- In Fujifilm Kyowa Kirin Biologics Co., Ltd. v AbbVie Biotechnology Limited and another  EWCA Civ 1 this court examined for the first time whether Arrow declarations were available in principle, or whether there existed fundamental obstacles to their grant. Thus it was contended on behalf of the patentee inter alia that:
i) an Arrow declaration was in effect a challenge to validity of a patent which could only be made once a patent was granted in the proceedings identified in section 74 of the Patents Act 1977;
ii) such declarations were in substance a collateral attack on proceedings within the EPO, which the English court would not permit;
iii) to allow declarations in the Arrow form would be to open the floodgates;
iv) if the Arrow declaration does 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;
v) the Arrow case itself had therefore been wrongly decided.
- The court dismissed all these objections to the grant of Arrow declarations. At paragraph 93 the court explained that the existence, following grant, of the statutory remedy for revocation (and, I would add, declarations of non-infringement) needed to be borne in mind. The course envisaged by the Patents Act is that parties should wait and see what patent is granted before resorting to Arrow declaratory relief. However the statute did not create a bar to the grant of relief "in appropriate cases." At paragraph 98, giving the judgment of the court which included Longmore and Kitchin LJJ , I said:
"We have said enough to explain why we do not consider that there is any issue of principle which prevents the granting of Arrow declarations in appropriate cases. Drawing the threads together:
i) A declaration that a product, process or use was old or obvious at a particular date does not necessarily offend against section 74 of the Act.
ii) Such a declaration may offend against the Act where it is a disguised attack on the validity of a granted patent.
iii) Such declarations do not offend against the scheme of the EPC or the Act simply because the declaration is sought against the background of pending divisional applications by the counter-party.
iv) On the other hand the existence of pending applications cannot itself be a sufficient justification for granting a declaration.
v) Whether such a declaration is justified depends on whether a sufficient case can be made for the exercise of the court's discretion in accordance with established principles."
- Since then, there have been two notable further judgments at first instance. Fujifilm v AbbVie has gone to trial together with a related case brought against AbbVie by Samsung Bioepis: see Fujifilm Kyowa Kirin Biologics Company Limited v AbbVie Biotechnology Limited and Samsung Bioepis and another v AbbVie Biotechnology Limited  EWHC 395 (Pat). Henry Carr J held that a particular dosage regimen for the claimants' products was obvious and granted Arrow declarations. AbbVie appealed to this court solely against the grant of Arrow relief, and not against Henry Carr J's technical findings that the products were obvious. The case settled after we had heard argument but before judgment was handed down.
- In addition, in Generics (U.K.) Limited and another v Yeda Research And Development Company Limited and another  EWHC 2629 (Pat) Arnold J found a patent invalid after a trial, but was also asked to grant an Arrow declaration in the light of two further pending divisionals. At paragraph 206 of his judgment he made a finding that the product in question was obvious. He declined to go further and grant a declaration to that effect because he considered it would serve no useful purpose beyond that finding. That finding could be relied on to obtain summary judgment in certain circumstances were later patents to emerge and be asserted against the claimants in respect of that dosage regime. At paragraph 211 he said:
"… the Claimants rely upon their need for commercial certainty. I am unclear, however, how an Arrow declaration would provide the Claimants [with] greater certainty than this judgment. If this judgment stands, but 962A and/or 172A proceed to grant, then any claim for infringement by the Defendants against the Claimant in respect of the 40 mg TIW regimen can be met by an application for summary judgment seeking revocation of the patent(s) relying upon issue estoppels arising out of this judgment. An Arrow declaration would not preclude the need for an application for summary judgment, albeit based on the declaration, in such circumstances."
The judgment of HHJ Hacon
- Whilst acknowledging in paragraph 11 that the grant of an Arrow declaration was governed by the same principles as those which would govern any negative declaration, the judge took from paragraph 98(iv) of the judgment in Fujifilm v AbbVie the proposition that it was necessary for "something more" than the existence of pending patent applications to be identified before the court could go on to exercise its discretion to grant relief (see paragraph 9). He appears to have accepted that GSK were able to point to Vectura's ability to continue to apply for and obtain relevant patent protection. He noted (in paragraph 34) that there were other matters on which GSK relied, in particular that Vectura had a history of splitting divisional applications out of existing patent applications and that Vectura was doing this many years after the priority date. However, he concluded that these were not sufficient reasons for a claim for an Arrow declaration to be allowed to proceed to trial (see paragraph 35).
- Mr Justin Turner QC, who appeared for GSK with Mr Geoffrey Pritchard, submitted that the judge had been wrong to regard paragraph 98(iv) of the judgment in Fujifilm v AbbVie as imposing a jurisdictional threshold to the grant of an Arrow declaration. The facts alleged by GSK were a sufficient basis for the grant of an Arrow declaration at trial. He contended that Vectura had pursued a strategy of filing multiple patent applications to create a thicket of patents in relation to the use of magnesium stearate for formulations for dry powder inhalers. This strategy had been pursued over many years, such that the most recent divisional application from the patent families with a priority date of 30 November 2000 was filed in July 2017, some 16 years after the first filings. He took us through the various ways in which Vectura had formulated and re-formulated the language of their claims based on what he submitted was essentially a single inventive concept. Vectura's undertaking was limited to the Non-Assert Patent families. The 415 patent application indicated that Vectura's strategy of seeking to reformulate its patent protection for magnesium stearate was continuing, and was not limited to the Non-Assert Patent families. Furthermore, in 415, Vectura had taken the trouble to specify the active ingredients in the GSK Products, and so it could be seen as an attempt, if when the application matured into a granted patent, to target GSK specifically. There was sufficient here to show that a declaration would provide GSK with valuable commercial certainty. If there was no risk of further applications maturing into patents which would be asserted against GSK's Ellipta products, then it was surprising that Vectura had not given a more extensive undertaking.
- Mr Turner also relied on the principle that, in a developing area of the law, the court should refrain from deciding controversial legal issues. If "something more" was necessary to be established before the discretion to grant Arrow relief could arise, then it was important to define what that "something more" was.
- Mr Lykiardopoulos supported the judge's understanding of the Fujifilm case. He submitted that the courts had made it clear that the grant of Arrow relief was to be restricted to unusual cases. A sufficient reason had to be found before the court would allow a party to bypass the course envisioned by the statute, of waiting to see what patent was granted. The fact that a party was already relying on a Gillette defence in the context of the substantive claims on the granted patents did not make it a sufficiently unusual case. None of the other matters relied upon by GSK (all of which had been properly noticed by the judge) amounted to a sufficient reason. The judge had been exercising a discretion in striking out the claim, and this court should (on well-known principles) be slow to interfere with it.
- Mr Lykiardopoulos submitted further, in support of a respondent's notice, that this was a case where the declaration sought could not be granted for essentially two reasons. Firstly, he submitted that the products and processes in respect of which the declaration was sought were not sufficiently well defined to be properly justiciable. It was not clear whether GSK were asking for a declaration only in relation to their Processes and Products at the level of detail in the body of the declaration, or whether it was intended that the declaration should extend to every aspect of the process described in the Product and Process Description ("PPD") annexed to the PC. Secondly, he submitted that the only identified application, the 415 application, included active ingredients in its claim (as currently drafted), and GSK had specifically excluded the obviousness or otherwise of their active ingredients from the terms of their declaration.
- In my judgment paragraphs 98(iv) and 98(v) of this court's judgment in Fujifilm v AbbVie need to be read together, taking into account what was said in paragraph 93. The statutory remedy of revocation (and I would add the declaration of non-infringement) are remedies which are available if a relevant patent exists. Thus "any person" may bring a revocation action by identifying a granted patent and without the need to show any particular commercial interest (see Patents Act 1977 section 72 and Cairnstores Ltd v Aktiebolaget Hässle  FSR 35). Similarly a person wishing to obtain a declaration of non-infringement needs to do no more than identify the patent and provide the statutory particulars of his proposed act (see section 71 of the Patents Act 1977). The person seeking revocation, or a declaration of non-infringement, does not need to justify the need for the relief any further. As Jacob LJ said in Nokia v Interdigital  EWCA Civ 1618;  FSR 23 at 17:
"S.71 requires no claim of right nor even any intention by the applicant for a declaration to make or do the acts, the subject matter of the declaration he seeks. Normally, of course, the applicant will at least have in mind the possibility of doing those acts but whether he does or not is irrelevant. The only question is whether the patent covers what is described in the full particulars called for by s.71(1)(a)".
- The jurisdiction to grant an Arrow declaration is by contrast discretionary. Identification of a relevant application is a necessary but not sufficient condition for an application for such relief. It is necessary to go further and examine whether it would serve a useful purpose. The point being made by paragraphs 98(iv) and 98(v) in Fujifilm is the contrast between a remedy which depends only on the existence of a patent (or application) and one whose availability turns on a critical examination of the purpose which its grant would serve.
- GSK's case for the grant of Arrow relief does not depend on the mere existence of further applications. They contend that resolution of the issues which arise in relation to the granted patents may not give them, in the circumstances of this case, the commercial certainty they require. Vectura has shown a propensity over many years to describe what is essentially a single inventive concept in a variety of ways. Vectura has the potential to continue to reformulate the inventive concept using applications which are still on file, even if GSK are successful in revoking each of the five Patents.
- An oddity of the judge's decision is that, by striking out paragraph 2 of the Grounds of Invalidity (see paragraph 6 above) he has prevented GSKfrom running a true Gillette defence even in relation to the Patents on which they are now sued. Thus, as drafted, the PC pleads in paragraph 5 that "… if and insofar as [GSK's Processes and Products] fall within a claim of one or any of the Patents, it is averred that the Patent in question is invalid for the reasons set out in the Grounds of Invalidity …". Whilst paragraph 1 of the Grounds of Invalidity is a conventional attack on the claims of the Patents based on the prior art, paragraph 2 asserts that GSK's Products were obvious. It is true, for the reasons this court gave in paragraph 56 of Fujifilm v AbbVie, that it is not the practice to decide conventional patent cases using only Lord Moulton's approach, but we pointed out that it could operate as a cross-check. In those circumstances it is difficult to see what reason there could be for preventing GSK from obtaining a finding that their product was obvious as an answer to the claims based on the Patents. Thus, for example, Arnold J did make such a finding in Generics v Yeda (supra) at . It follows that I consider that the judge was wrong to strike out the allegation contained in paragraph 2 of the Grounds of Invalidity in any event.
- I do not accept that the judge was exercising a discretion when striking the claim for Arrow relief from the action. The task which he was required to undertake was to determine whether the pleaded facts and arguments gave rise to a realistic claim for Arrow relief which should go to trial. The discretion to grant Arrow relief is that of the trial judge, not that of the judge hearing the strike out application. In approaching this task at the interim stage one should have in mind that it is the facts and circumstances at the date of the trial which will ultimately be determinative of whether the discretion should be exercised: see per Lord Collins in AK Investment CJSC v Kyrgyz Mobil Tel Ltd  UKPC] 7 at . For similar reasons I do not accept that it is sensible to ask, at this stage, whether the facts relied on are sufficiently "unusual" to justify Arrow relief. This would be a particularly difficult test to apply at this interim stage before any facts are found.
- To my mind, GSK's claim that an appropriately worded Arrow declaration should be granted on these facts is plainly sufficiently realistic at this stage to be allowed to proceed to trial. Subject to the points raised by the respondent's notice, I would allow GSK's appeal.
The respondent's notice
- There is no dispute that the declaration must be formulated with clarity. The facts ultimately declared by the court must be clear, otherwise the declaration will simply give rise to further dispute and defeat the purpose for which it is granted. The declaration must also be clear so that the court can know what technical issues it has to decide. The declaration must therefore identify the combination of features of the products and processes in question on which the assessment of obviousness is to take place.
- As presently pleaded, the declaration sought by GSK focuses on three features of the Process which are specifically picked out in the prayer for relief. These are (i) blending to produce the lactose/magnesium stearate Pre-Blend, (ii) sieving to de-lump combined micronized active ingredient and a portion of the Pre-Blend, and (iii) the whole batch further blended to produce a homogenous blend. I will call this "the general declaration". However the declaration is introduced with the words "the Claimants' Processes, namely…". As Mr Turner pointed out, paragraph 3 of the PC states that "Further details of the Claimants Processes are set out in [the PPD]". On this view, the claimed declaration would require the court to adjudicate on the novelty and obviousness of every feature of the Processes described in the PPD. As he opened the appeal to us, Mr Turner described the claimed declaration as being one sought in relation to the Processes as described in the PPD. That is because GSK claim that their Processes as so described are no more than an obvious implementation of the published application for Staniforth. Put in this way, the features picked out in the prayer for relief do not limit the scope of the court's necessary enquiry. I will call this "the PPD declaration".
- I do not accept that it is clear at this stage that either the general declaration or the PPD declaration is so unclear that it could not be granted. In each case GSK would have to establish that the relevant features were old or obvious at the level of generality at which they are pitched.
- A separate question is whether the PPD declaration would impose on the court an unmanageable task, because it would be necessary to look at every aspect of what is a complex process and decide whether each feature is old or obvious alone and in combination. Mr Lykiardoupoulos argued that this would be the case, but he did not take us through the PPD in any detail to show us why this would be so. I would accordingly reject this ground of the respondent's notice. I would add, however, that the PPD declaration will require further case management on the way to trial. That is a matter for the Patents Court judge, but it would seem sensible for GSK to serve a schedule identifying features of the PPD which they accept are not shown by Staniforth, with a short statement of why they contend that they would be obvious and for Vectura to indicate any positive case which they have of why any of those features are inventive.
- I am not persuaded either by Vectura's second argument on their respondent's notice. It is clear from Arrow and the subsequent cases that there is no requirement that the declaration should identify all the features of the product or process. The consequence of the exclusion of the active ingredient from the characteristics of the processes declared obvious is that it will limit the protection available to GSK by the granted declaration. I accept that this means that the declaration would not provide protection if 415 is granted with claims in the form in which they presently exist. Those claims are, however, not set in stone. Moreover 415 is pleaded as an example of the alleged propensity to reformulate the inventive concept. The main relevance of 415, as it seems to me, is to show that Vectura continues to seek ways of protecting the use of magnesium stearate in these processes and products, and to that extent it supports the pleaded claim for Arrow relief. Whether there is sufficient overall in the circumstances as they exist at trial is a matter for the trial judge.
- For the reasons given, I would allow the appeal.
Mr Justice Birss:
- I agree.
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