SPC combination products - Teva v Gilead Sciences

Products containing a combination of active ingredients have proved particularly difficult to assess in this regard, and the issue is now the subject of a further referral to the CJEU in Teva UK Limited & others v Gilead Sciences Inc.

The proceedings

The claimants challenged the validity of Gilead's SPC covering TRUVADA®, which is a combination product consisting of two active ingredients, (i) tenofovir disoproxil (TD) and (ii) emtricitabine.

Claims 1 and 2 of the basic patent relied on for the SPC ('the patent') relate to compounds of formulae (1a) and (1) (which encompass TD). Notably, claim 27 relates to the basic compound together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.

In its judgment, the court considered that the inventive advance of the patent is the disclosure of the new compounds of formulae (1a) and (1), including TD. Given this invention, claim 27 is not considered to reflect any further inventive advance. Emtricitabine is not mentioned or referred to in the patent.

The question to be answered by the court was therefore whether TRUVADA® (the combination product of TD and emtricitabine) was "protected" by the patent.

Referrals to the CJEU

In his judgment, Mr Justice Arnold reviewed previous referrals to the CJEU on this question and the subsequent guidance provided. By way of example, he noted that the CJEU has previously commented that, in addition to the product falling within the scope of at least one claim of the basic patent, the claims of the patent must relate "implicitly but necessarily and specifically, to the active ingredient in question" and that the "active ingredient must constitute the subject-matter of the invention covered by that patent" .

Arnold J therefore concluded that when determining whether a product is "protected" by a basic patent: "It is clear that it is not sufficient that dealings in the product would infringe a claim applying the Infringing Act Rules. It is also clear that it is necessary that the product falls within at least one claim of the basic patent applying the Extent of Protection Rules. But it is not clear whether that is sufficient. It appears from the case law of the CJEU that it is not sufficient, and that more is required; but it is not clear what more is required".

Thus, with respect to the present proceedings, Arnold J appeared to suggest that a determination that the combination of TD and emtricitabine falls within the scope of claim 27 is not sufficient for it to be "protected" by the patent. However, he is of the view that it is not clear what possible further requirements must be met.

The following single question has therefore been referred once again to the CJEU:

What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?

As for previous referrals Arnold J has made to the CJEU on this matter, he has also proposed an answer that he considers will provide the clarification required. To this end, Arnold J has suggested that to be "protected" by a basic patent the combination of active ingredients, as distinct from one of them, "must embody the inventive advance of the basic patent".

It remains to be seen if the CJEU will provide a definitive answer on how to determine whether a product is "protected" by a basic patent, in particular when considering combination products, and whether it will follow the answer suggested by Arnold J. We will continue to keep you up to date with further developments in this regard.

Case details at a glance

Court: High Court of Justice Chancery Division Patent CourtParties: Teva UK Limited & Others (claimants) and Gilead Sciences Inc (defendant)
Citation: [2017] EWHC 13 (Pat)
Date: 13 January 2017
Full decision: http://dycip.com/tevaewhc13