Teva UK Ltd v Chiesi Farmaceutici SpA

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeMr Justice Birss
Judgment Date02 June 2020
Neutral Citation[2020] EWHC 1311 (Pat)
Docket NumberCase No: HP-2019-000041
Date02 June 2020

[2020] EWHC 1311 (Pat)





Royal Courts of Justice, Rolls Building

Fetter Lane, London, EC4A 1NL


Mr Justice Birss

Case No: HP-2019-000041

Teva UK Limited
Chiesi Farmaceutici SpA

Thomas Mitcheson QC, Daniel Piccinin and Stuart Baran (instructed by Pinsent Masons LLP) for the Claimant

Charlotte May QC, Sarah Ford QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Defendant

Hearing date: 18th May 2020

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

Mr Justice Birss Mr Justice Birss

In this action the claimant (Teva) seeks to revoke three patents held by the defendant (Chiesi). The patents are EP (UK) 2 146 704, EP (UK) 3 034 073, and EP (UK) 2 010 190. The claims essentially relate to a combination of beclomethasone and formoterol in an inhaler (DPI or MDI). The claims of 704 and 073 relate to the use of this product in rescue treatment for acute episodes of asthma attacks, when needed, as a complement to the maintenance treatment of asthma with the same medicament. The claims of 190 relate to the combination with certain excipients in an MDI, essentially for use for the prevention or treatment of severe broncho-pulmonary disease (either asthma or COPD).


The defendant has a product called FOSTAIR. Its name outside the UK is FOSTER. The product is protected by these patents amongst others. These patents are due to expire in 2027/28. Data exclusivity for the defendant's product expired in 2012.


The action commenced in October 2019. In its Defence and Counterclaim served in December 2019 the defendant counterclaimed for infringement of all three patents on a quia timet basis, on the footing that the claimant threatens and intends to infringe. The case is listed for trial in October 2020, to be heard at the same time as a parallel claim between Lupin Healthcare (UK) Ltd and Chiesi.


The defendant pressed the claimant for disclosure or a product description in relation to its product alleged to infringe. The claimant's response was to apply to strike out the infringement claim. The strike out is brought primarily on the ground that the pleaded case has no real prospect of success. The claimant contends there is no evidence it threatens or intends to commit an infringing act and that no sufficient support for that allegation is pleaded in the Particulars of Infringement. Therefore the infringement claim should be struck out. This is the first major issue I have to decide.


The claimant has an alternative ground for the strike out – based on abuse of process; and the claimant also submits that even if the infringement claim should not be struck out, it should be stayed, for reasons relating to competition law.


Also relevant is that the claimant has offered an undertaking to give the defendant 14 days' notice of any launch of a product. The precise period of 14 days is negotiable to a limited pragmatic extent. However the claimant is not by that pragmatic approach contemplating a significantly longer period such as 2 months' notice. The 14 days' notice is only meant to be sufficient time to allow the defendant, if advised, to bring an urgent claim for an interim injunction.


The claimant also submits that competition law plays a part in the analysis, particularly as a result of the recent judgment of the CJEU in the Paroxetine litigation (Case C-307/18 Generics (UK) and ors (Paroxetine) ECLI:EU:C:2020:52; January 2020). The point relates to the information which the claimant says the defendant says the claimant must disclose to the defendant if the infringement claim goes ahead. It is submitted that this disclosure, even if ordered by the court, would amount to a concerted practice contrary under Art 101(1) TFEU (and the equivalent provisions of the Competition Act). There may be a defence of necessity under the ancillary restraint doctrine (the doctrine is described in Sainsbury's v Mastercard [2018] EWCA Civ 1536at paragraph 58), but that would not justify disclosure now, only later. The competition law point is the other major issue I have to decide. For this purpose there is no difference between the position under Art 101 TFEU and the Competition Act.


The defendant contends that the infringement claim has a real prospect of success and should not be struck out. The defendant also denies that competition law has any bearing on the issues to be decided. A stay is also resisted. The defendant has also applied for disclosure relating to infringement. It is common ground that if the infringement claim is to go to trial along with validity in October, then some form of disclosure should be given. There may be issues of detail but they can be resolved if necessary when this judgment is handed down.


I propose to address the strike out in its own terms first. Then, if necessary I will consider the competition law submissions.


The evidence consists of witness statements from the solicitors acting for the parties. One thing is worth making clear at this stage. An important aspect of the way the claimant has put its case so far is that it has taken care to make no statement either way about its intentions. Occasionally in argument one might think that counsel was making a submission about what the claimant actually intended but that was not what was meant and nothing said at the hearing was a statement on the claimant's behalf about its intentions.


Arguments about the basis for quia timet infringement actions come up from time to time in patent cases. The legal test is whether the relevant party threatens and intends to commit the act alleged to infringe. It is also important to have in mind that this is an application to strike out. That means that the question is not whether the pleaded material proves that the claimant threatens and/or intends to infringe, but only whether, based on the material pleaded, there is a real prospect of success of establishing that at trial.


I had to grapple with how the legal test is applied in MSD v Teva (efavirenz) both at the interim stage (a strike out and interim injunction) at [2012] EWHC 627 (Pat) and at trial [2013] EWHC 1958 (Pat). That involved a review of the authorities. I applied that summary of the law from the trial judgment in MSD v Teva at the trial in Actavis v ICOS (tadalafil) [2016] EWHC 1955 (Pat) (that case went on appeal but not on this point). The summary of the law in Actavis v ICOS was followed by Arnold J in Generics (UK) v Sandoz (G-CSF) [2017] EWHC 2276 (Pat).


It is sufficient to start by setting out the conclusion reached at paragraph 56 of MSD v Teva (trial):

“The principle I derive from these authorities is that the question the court is asking in every case is whether, viewed in all the relevant circumstances, there was a sufficiently strong probability that an injunction would be required to prevent the harm to the claimant to justify bringing the proceedings. …”


Counsel for the claimant made various submissions which appeared to seek to qualify or add to this in various ways, emphasising statements in other cases about whether there was a risk of grave irreparable harm or an imminent threat. I do not accept that those qualifications should be added to the statement of the legal principle, at least as it applies in a patent case. Many of the statements derive from cases in the law of nuisance, in which the circumstances relating to the grant or refusal of final injunctions is different. The cases often deal with factors relating to interim injunctions and final injunctions at the same time, but that is not the issue before me.


Counsel for the claimant also argued that there was or should be a legal principle in patent cases that a quia timet action cannot proceed with no relevant marketing authorisation pleaded. It is a prerequisite. Counsel for the defendant did not agree. The claimant's case on that is primarily based on some things I said in Actavis v ICOS but is also said to follow from a consideration of the authorities in other jurisdictions. I will deal with Actavis v ICOS first. The two passages relied on are at paragraphs 353 and 356 of that judgment.


At paragraph 353 of Actavis v ICOS I said:

“353. Viewed objectively today, the UK market for tadalafil is large and valuable. It is obvious that a generic company would wish to sell tadalafil once the SPC has expired. Actavis and Mylan have applied for and are obtaining marketing authorisations for their generic tadalafil products. That is an expensive and time consuming process. Viewed objectively, it only makes sense if they are planning to sell tadalafil sometime. The 181 patent (and, I will assume, 092) are potential obstacles. Bringing proceedings to revoke them is not proof of an intention to sell but it also supports the inference based primarily on the marketing authorisation.”


And at paragraph 356 of Actavis v ICOS I said:

“356. The flaw in the logic of the question posed by Actavis and Mylan is that the inference on which this quia timet infringement action is based does not derive solely or even predominantly from the fact they have sought to clear the way by applying to revoke patents. It derives from the marketing authorisation process. Furthermore, while there is a cost and trouble associated with product and process descriptions, that only arises because there...

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