Article 3(a) just keeps on giving: AG Opinion in SPC referrals C-650/17 and C-114/18

The Advocate General (AG) has issued his opinion in SPC Referrals C-650/17 (Royalty Pharma) and C‑114/18 (Sandoz). Both referrals seek clarification over whether an SPC may be granted to a specific, individualised, embodiment of the product claimed by the basic patent.  The referrals particularly relate to the correct interpretation of Article 3(a) of the SPC Regulation (Regulation (EC) No. 469/2009). Article 3(a) states that an SPC shall be granted for a product “protected by a basic patent in force”. C-650/17 asks how Article 3(a) should be applied to functional claims, and C‑114/18 asks how Article 3(a) should be applied to claims specifying a Markush formula. In his opinion, the AG is clear that Article 3(a) should be interpreted for these types of claims according to the test provided in the CJEU decision C-121/17 (Teva).

Clarity still needed after Teva?

Teva related to Gilead's SPC for the HIV combination therapy, Truvada. The SPC was based on the European patent EP0915894 (for more on the patent disputes surrounding Truvada, see IPKat post here). The patent only mentioned one of the drugs in Truvada. The CJEU adopted a two-step test for establishing whether each of the active ingredients of a combination product covered by an SPC must be specifically mentioned in the basic patent. According to Teva, An active ingredient is covered by a basic patent according to Article 3(a) if, from the point of a view of a skilled person at the priority date of the patent:

(1)    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

(2)    each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

Following the CJEU ruling, the UK courts found that Truvada could not be said to embody the technical contribution of the patent, as the patent only related to one of the active ingredients of Truvada.

The referrals in C-650/17 and C‑114/18 occurred before the CJEU decision on the interpretation of Article 3(a) in Teva. However, the parties maintained their request for preliminary opinions in both referrals, maintaining that further clarification of Article 3(a) was needed. In particular, did the two-step test of Teva apply to situations other than a combination product?

Case Background of C-650/17 (Functional claims)

The referral in case C-650/17 originated from a dispute before the German Court related to Royalty Pharma’s SPC application for sitagliptin, based on European Patent EP 1084705. Sitagliptin is an inhibitor of the enzyme DPIV and is authorised for use in diabetics to lower blood glucose levels. The patent broadly claims an DPIV inhibitor for lowering blood glucose levels. The dependent claims refer to specific inhibitors. Sitagliptin is covered by the patent but is not individually disclosed.

A decision by the German courts rejecting Royalty Pharma’s SPC application for sitagliptin was appealed to the German Federal Patent Court (Bundespatentgericht). The Federal Patent Court was of the opinion that the SPC could not be granted. In particular, the court considered that sitagliptin was not “protected by a basic patent” pursuant to Article 3(a) because stigliptin was not individually disclosed in the patent. However, the German Federal Patent Court noted that their interpretation of Article 3(a) was different to that of the UK Courts. In order to provide clarification, the German Federal Patent Court therefore stayed proceedings, and referred the following questions to the CJEU:

Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation (EC) No 469/2009 1 only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment?

Is it not therefore sufficient for the requirements of Article 3(a) of Regulation (EC) No 469/2009 if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent?

Is a product not protected by a basic patent in force under Article 3(a) of Regulation (EC) No 469/2009 if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?

Case Background of C‑114/18 (Markush formula)

The referral in case C‑114/18 relates to how Article 3(a) should be applied to claims specifying a large number of compounds in the form of a Markush formula. The referral from the UK Court of Appeal related to an SPC granted to Searle for the anti-retroviral, Darunavir. Sandoz and Hexal brought revocation proceedings in the UK courts against the SPC. Darunavir is an inhibitor of the HIV reverse transcriptase and is covered by the European EP 0810 209. The patent claims compounds in the form of a Markush formula. The Markush formula enables a large class of compounds to be claimed without the necessity of writing out every single chemical entity. Sandoz and Hexal estimated that the number of compounds covered by claim 1 was somewhere between 7 x 10¹³⁵ and 1 x 10³⁷⁷. Darunavir was covered by the claim but not disclosed specifically.

The Court of Appeal referred the following question to the CJEU:

Where the sole active ingredient the subject of a [SPC issued under Regulation No 469/2009] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of [Regulation No 469/2009] that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?

Opinion of the Advocate General

The AG was of the opinion that the test established by the CJEU decision in Teva is applicable to situations other than combination therapies: “any distinction between a product consisting of a single active ingredient and a combination of active ingredients is not material for the purposes of this test and any suggested distinction between the two types of products would not be a meaningful one” (para. 49).

The AG was also of the opinion that the two-part test of Teva should be considered technologically neutral. The two-part test therefore also applies to functional claims and Markush formula claims. From this, the AG reasoned that Article 3(a) “does not preclude the grant of an SPC for an active ingredient which is covered by a functional definition or a Markush formula provided, however, that the two-part test set out in [Teva] is satisfied”.

The two-part test of Teva requires that the product must be 1) covered by claimed invention of basic patent and 2) be ‘specifically identifiable’ from the basic patent (to a skilled person at the priority date). The AG summarised the second requirement as requiring “that it 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 is not the case where, in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question”.

The AG therefore concluded:

The two-part test applies both to products consisting of a single active ingredient and products composed of several active ingredients;

The concept of the ‘core inventive advance’ of the patent does not apply and is of no relevance in the context of Article 3(a);

Article 3(a) does not preclude the grant of a SPC for an active ingredient which is covered by a functional definition or a Markush formula provided, however, that the two-part test set out in Teva is satisfied;

The two-part test 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;

The first part of the two-part test is not satisfied if the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent;

The second part of the two-part requires that it 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.

 The full text of the AG opinion can be read here.