Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWCA Civ 1496

“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 …” 7. 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.” (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.” 8. 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”

“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].” “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” “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…” “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.”

“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.”

“… 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.”