The AG sticks close to the CJEU's test for Article 3(a) SPC Regulation
In joined cases C‑650/17 (Royalty Pharma) and C‑114/18 (Sandoz), Advocate General Hogan's opinion reiterates a number of times that the correct approach to determining whether a "product is protected by a basic patent in force" for the purpose of Article 3(a) of the SPC Regulation No 469/2009 (SPC Regulation) is to be determined according to the test set out by the CJEU in Teva v Gilead (C‑121/17):
"Article 3(a) of [SPC Regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is 'protected by a basic patent in force' within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."
This, the Advocate General (AG) notes, "lays down a definitive test for the interpretation of Article 3(a) … which must be applied by national courts in concrete cases." In his view, the Teva ruling in large part supersedes earlier rulings on Article 3(a) and he stresses that his intention is not to depart in any manner whatsoever from it.
However, neither C‑650/17 or C‑114/18 concern products containing several active ingredients of the kind that Teva addresses. Instead, C‑650/17 concerns functional definition claims in a basic patent relating to the treatment of diabetes mellitus by administration of dipeptidyl peptidase IV (DP IV) inhibitors. While it discloses a number of specific DP IV inhibitors, the patent also refers to the fact that other, unspecified, DP IV inhibitors may be used.
One such inhibitor not specified individually by the patent is sitagliptin. By contrast, in Case C‑114/18 the claimants challenged the validity of an SPC for "Darunavir or the pharmaceutically acceptable salt, ester or prodrug thereof". Marketed as 'Prezista', the product is a protease inhibitor used as an anti-retroviral medication to treat HIV. The basic patent in force on which the SPC relies claims a Markush formula of immense breadth. While this covers darunavir generically, the compound is not specified or identified in any of the claims of the patent, by name or structure, or anywhere in the specification.
The AG states, however, that it is clear from the very language utilised by the Court in Teva that the above test applies both to products consisting of a single active ingredient and products composed of several active ingredients.
The test therefore applies equally to the Markush claims and the functionally defined claims of the present case. The AG also emphasises that the two part test in Teva must be applied from the point of view of a person skilled in the art, and on the basis of the prior art, at the filing date or priority date of the basic patent.
Where practitioners reading the opinion will be more puzzled, is the AG's test for whether a product necessarily fall under the invention covered by the patent. He says this is satisfied if:
"…the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent."
It is hoped the CJEU may throw some light on what this means. Regarding the meaning of "specifically identifiable" in the second part of the Teva test, the AG states that this requires:
"…that is be established that a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question."
This seemingly requires only that the product is known somewhere, anywhere, in the prior art.
As always with AG opinions, it now remains to be seen if the CJEU will follow the AG's reasoning or take a different approach. (Paul England, Senior Professional Support Lawyer)
The AG's Opinion
Decision date: 11 September 2019
Court: CJEU
Judge: Advocate General Hogan
Stay of proceedings in the English Patents Court
It has been a while since there was an application to stay English patent proceedings pending parallel proceedings in the EPO. David Stone (Deputy High Court Judge) has decided the most recent such case in Coloplast v Salts Healthcare Limited [2019] EWHC 1979 (Pat).
Previously, the Court of Appeal had set out guidance on whether a case should be stayed (which decision is at the discretion of the Patents Court) in IPCom GmbH & Co KG v HTC Europe Co Limited and Ors [2013] EWCA Civ 1496. The judge applies the guidance to the facts of this case as follows:
- The refusal of a stay will not irrevocably deprive Salts of a benefit of the concurrent jurisdiction of the EPO and this court – Coloplast has offered to undertake to repay any monetary compensation it receives if the patent is subsequently revoked.
- There is some commercial certainty that would be achieved at a considerably earlier date in the case of these proceedings. While the parties may not have absolute certainty (or certainty outside the United Kingdom), until the EPO proceedings are finally resolved, it is preferable to obtain certainty at least in the United Kingdom, one of the largest markets for Coloplast and the largest market for Salts, sooner rather than later.
- The resolution of these proceedings may, by deciding some important issues (including, for example, infringement), promote settlement.
- Given the length of time that it will take for each set of proceedings, these proceedings are likely to be concluded first. Certainly, if these proceedings are stayed and the EPO does not revoke the patent, there will be a considerable delay which causes significant prejudice to Coloplast. Rather, early determination of these proceedings will achieve some certainty for the parties: denying a stay will not cause irrevocable harm to Salts.
- In this case, there is some public interest in dispelling the uncertainty.
- While there is a risk of wasted costs if no stay is granted and the EPO eventually revokes the Patent, this is outweighed by commercial factors associated with early resolution, as will "normally" be the case.
On this basis, the judge displaces the normal, default position by refusing to grant the stay. (Paul England, Senior Professional Support Lawyer)
The decision
Decision date: 31 July 2019
Court: England & Wales Patents Court
Judge: Deputy High Court Judge David Stone
Glycosylated antibodies patent anticipated and lacking technical contribution
Takeda v Roche [2019] EWHC 1991 concerns an action to revoke Roche's EP 2 007 809 titled "glycosylated antibodies". There was a counterclaim of infringement in respect of Takeda's Entyvio product, a formulation of the antibody vedolizumab, approved for ulcerative colitis and Crohn's disease.
The patent was held invalid for lack of novelty, lack of technical contribution (AgrEvo obviousness) and lack of clarity (insufficiency), but would otherwise have been infringed.
The case contains a nice legal issue concerning anticipation: we know that to anticipate by prior use, it must be possible for the person skilled in the art (without undue burden) to analyse the prior used composition sufficiently in order to be able to reproduce it for themselves.
Does this mean, as Roche argued in the context of a prior art document, that every feature of the embodiment disclosed in the prior art must be reproducible? Or are only those features that are claimed by the patent under attack? The answer is the latter, unless the unreproducible unclaimed features of the prior art make it impossible to reproduce at all.
There is also a discussion of ambiguity insufficiency (not to be confused with lack of clarity, which is not an insufficiency objection): in this case, the skilled person reading the patent would think they could use a nano-bore or a micro-bore LCMS system with QTOF to evaluate the glycans in an antibody sample.
But, depending on which machine they use, the result could either fall inside the claim or outside it. Whichever result the skilled person gets, they would not know that if they used the other machine they would get a different answer. They would not know for certain whether the sample falls within the claim or not. This is an example of ambiguity and renders the patent insufficient. (Paul England, Senior Professional Support Lawyer)
The decision
Decision date: 17 July 2019
Court: England & Wales Patents Court
Judge: Mr Justice Birss
