Beclomethasone & Formoterol - UK

On Jun 02, 2020, UK high court denied Claimant, Teva’s contention of “strike out” the infringement claim.

Background:

Defendant, Chiesi holds three patents, EP (UK) 2146704, EP (UK) 3034073, and EP (UK) 2010190, which essentially relate to a combination of beclomethasone and formoterol in an inhaler (DPI or MDI) for acute episodes of asthma attacks or for severe broncho-pulmonary diseases. These patents are due to expire in 2027/28. The defendants’ product is FOSTAIR, which is covered by these patents. Claimant, Teva commenced revocation action in Oct. 2019 against these patents. In its Defence and Counterclaim, Chiesi served infringement 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.

Court’s analysis:

Court said that 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.

Court said that based on witness statements claimant has put its case so far is that it has taken care to make no statement either way about its intentions. Counsel for the claimant 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 (Actavis v ICOS). Court said that the present case arises in circumstances referred to as “clearing the way”, where generic rival is thinking of entering the market by clearing hurdles such as patents associated with brand product. Like bringing court proceedings such as an action for patent revocation and/or declarations of non-infringement well before the generic launch on the market. And in this case claimant has initiated revocation proceedings against the patents. The starting point for such a claim is usually the simple inference from the fact claimant has brought revocation proceedings, that the rival presumably intends to infringe by launching a product within the period before expiry of the patent. That is a perfectly sensible inference to draw. Court thus said that there is no legal principle of the kind advanced by the claimant that a quia timet action cannot even be advanced without a marketing authorisation being pleaded. It cannot be derived from Actavis v ICOS. Moreover court noted that in “Generics v Sandoz [2017] EWHC 2276 (Pat)” in which Arnold J gave permission to allow a quia timet infringement claim to be added by amendment, there was no marketing authorisation in place at the time the decision was made.

Court said that it is important to be clear about timing. To commence a quia timet action in the first place the patentee has to show it has at that initial stage a real prospect of establishing that at trial – which may be months or years in the future – there is a sufficiently strong probability that an injunction would be required to prevent harm to the claimant occurring after trial. The question is not concerned with whether the rival may about to launch the product at the start of the action. So the fact there is no marketing authorisation in place when the claim form is issued, or otherwise when action begins, is not relevant. It is the existence of a threat and intention to start selling product sometime within the lifetime of the patent which justifies a quia timet infringement action.

With respect to pleadings of infringement, defendant relied on four points: the issue of the revocation proceedings, the expiry dates of the patents, the issue of equivalent revocation proceedings in Ireland where the claimant has a manufacturing facility which supplies the UK, and an exchange of correspondence. Court said that in this case the earliest expiry date for the patents is in 2027. The inference from the fact that the claimant has issued proceedings to revoke the patents in 2019 is that the claimant intends to sell a product protected by the patent before 2027. But, the claimant will need to obtain a marketing authorisation first to launch the product. The absence of a marketing authorisation today does not mean that there is no real prospect at trial of establishing a threat and intention to infringe. The claimant may have obtained a marketing authorisation by then. If the claimant had wished to say that it did not intend to launch unless it succeeded in revoking the patent, then it had a clear opportunity to do so in the exchange of correspondence. It did not. It is a reasonable inference from the claimant’s response in the present circumstances that the claimant wishes to reserve for itself the ability to choose to launch at risk using a product protected by the patents even if the patent(s) are found valid. The offer of two weeks’ notice does not allow the question of infringement to be decided in advance of launch. Court held that the defendant’s pleaded case has a real prospect of success at trial and court thus denied claimant’s application of strike out the infringement claim.