On Thursday 30 April the CJEU handed down its decision in the SPC referral Royalty Pharma (C-650/17) (here[1]); its latest in a decade-long attempt to explain exactly what is meant by the requirement in Art. 3(a) of Regulation (EC) No 469/2009 (the “SPC Regulation”): “the product is protected by a basic patent in force”.

Factual Background

Royalty Pharma owns European Patent EP 1 084 705 B1 (EP ‘705) which claims the use of DPP-IV inhibitors for the treatment of diabetes. Royalty Pharma sought a SPC in Germany, designating EP ‘705 as the basic patent and sitagliptin, a DP-IV inhibitor used in the treatment of diabetes, as the product. However, although it falls within the scope of the claims of EP ‘705, sitagliptin is not itself claimed or disclosed within the patent, and was in fact developed subsequent to the filing of EP ‘705 by Merck & Co. Merck & Co has a subsequent patent to the specific compound sitagliptin, and an SPC based upon sitagliptin in conjunction with that patent. Merck & Co is a licensee of Royalty Pharma’s EP ‘705.

The DPMA (German Patent and Trade Mark Office) rejected Royalty Pharma’s application on the basis of non-compliance with Art. 3(a) on the basis EP ‘705 did not contain any specific disclosure of sitagliptin. Royalty Pharma appealed to the Bundespatentgericht (the Federal Patent Court), which agreed with the DPMA: it considered the active ingredient in question must be specifically identifiable as forming part of the subject matter covered by the claims of the basic patent.

Questions

The Bundespatentgericht acknowledged that its decision demonstrated that there was a deviation in the application of Art. 3(a) on a national level (noting a perceived contrast with the English interpretation and the application of “core inventive advance”[2]), and that companies required certainty on the equal application of the SPC Regulation throughout the European Union. Accordingly, the Bundespatentgericht referred the following three questions to the CJEU:

1.  Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation (EC) No 469/2009 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?
2.  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?
3. 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?

The referral was initially joined with a further reference from the English Court of Appeal in the Sandoz v Searle litigation (C-114/18), which related to whether a basic patent with a claim in the form of a Markush formula could be considered to cover a product for the purposes of Art. 3(a).   However, following the AG opinion in the joined references, the Sandoz reference was removed from the Register of the Court, and has since been detached from the Royalty Pharma case.

Teva (C-121/17)

Following the Royalty Pharma referral, but before the AG’s opinion was issued, the CJEU issued a decision in the Teva (C-121/17) referral (here).  Teva also relates to Art. 3(a) (though in the context of a combination product), and asked the broad question “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of Regulation No. 469/2009?” The CJEU held that:

[57] “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.”

The Bundespatentgericht elected to maintain the Royalty Pharma reference following the CJEU’s decision.

AG’s Opinion

Advocate General Hogan’s opinion in the combined Royalty Pharma / Sandoz case was issued in September 2019 (here). Briefly, AG Hogan considered that the relevant test for Art. 3(a) had been set by the CJEU in Teva, and that the test was “technologically neutral” and therefore applicable to all products irrespective of whether they have a single active ingredient, or a combination of active ingredients.

CJEU Decision

The decision is relatively short and, in supporting the substantive judgment on the questions referred, relies solely on the decision in Teva. In its preliminary remarks the Court confirms that following Teva the “core inventive advance” approach is not relevant for the interpretation of Art. 3(a). From the outset therefore the Court firmly sets out that Teva is the central case concerning the interpretation of Art 3(a) of the SPC Regulation.

Questions 1 and 2

The Court deals with questions 1 and 2 together, and the decision reinforces the primacy of the claims as interpreted in light of Art. 69 of the European Patent Convention for an Art 3.(a) assessment. It states that a functional claim is not precluded from covering a product, provided that the claims can be understood, in light of the description of the invention, to relate “implicitly but necessarily” to the product in question (see paragraph [36]). In contrast to AG Hogan’s Opinion, this assessment is to be undertaken by the skilled person at the priority date in light of their “general knowledge” as well as the “state of the art”.

Importantly, the CJEU also states that “[i]t follows that the granting of an SPC is in principle not ruled out even if the product that is the subject of the SPC cannot be taken individually as a specific embodiment from the teaching of the basic patent” [41]. A product which is not a specific embodiment is not excluded if the skilled person can nonetheless specifically identify it at the priority date on the basis of their general knowledge, the state of the art and the information in the patent.

Applying the Teva test to sitagliptin, the CJEU opined that sitagliptin falls within the scope of the invention and therefore meets the first stage of the test.  However, it indicated that whether the second stage is satisfied is a matter for the national courts, as it requires an assessment of whether the skilled person at the priority date “be able to directly and unambiguously derive from the patent specification – such as filed – to deduce that the product that is the subject of the SPC falls under the protection of this patent” [42].

In answering questions 1 and 2 the Court therefore concluded that Art 3(a) of the SPC Regulation must be interpreted as meaning “that a product is protected by a basic patent in force, within the meaning of this provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily relates to the invention protected by this patent, but without being individualised as a specific embodiment from the teaching of said patent, insofar as the product is specifically identifiable, in the light of all information disclosed by the same patent, by a person skilled in the art, on the basis of his general knowledge in the relevant area on the date of filing or priority of the basic patent and the state of the art on this same date”.

Question 3

The CJEU’s response to question 3 is more succinct, but no less interesting. Like AG Hogan, the Court noted that allowing post-filed data into an assessment of whether a product is covered by a patent for the purposes of granting a SPC could unduly benefit the patentee, and that rewarding research leading to a separate invention made after the patent filing undermined the fundamental purpose of the SPC regime.

The CJEU therefore held that a product which is developed after the priority date of the basic patent in question as the result of an “independent inventive step” cannot be considered to be protected by that basic patent for the purposes of Art. 3(a). This is irrespective of whether it falls within the scope of protection conferred by a functional definition. The person skilled in the art (who is notoriously uninventive) would not be able to see the inventive compound in the claims of the basic patent.

In summary therefore, the Court said “…a product is not protected by a basic patent in force within the meaning of that provision [i.e. Art 3(a)] where, although falling under the functional definition given in the claims of this patent, it was developed after the filing date of the application for the basic patent, after an independent inventive step”.

Given the importance of SPCs to the Life Sciences community, it already seems clear that there will be debate over the words “independent inventive step” (or “autonomous inventive step” as the phrase is translated into English from some of the languages of the decision).

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[1] At the time of writing an English translation has not yet been uploaded to Curia, and this article has been written based upon a translation from the German.
[2] The core inventive advance approach essentially considers whether the product (as defined by the SPC Regulation) embodies the main inventive concept of the basic patent.