Is article 3 (a) of the Regulation (EC) 469/2009 disappearing into the mist, or is clarity round the corner?

The interpretation of article 3 (a) of the Regulation (EC) 469/2009 concerning the Supplementary Protection Certificates for medicinal products (the “SPC Regulation”), has been in the center of attention for courts (including the CJEU) and for SPC enthusiasts alike.  The recent AG Opinion in C- 650/17 (Royalty Pharma) and C-114/18 (Sandoz) has provided for more food for thought, for the details of the case and the summary of the AG Opinion see IPKat post here.

What has been particularly interesting during the past few years is the interpretation of one of the criteria for SPC eligibility in the EU, namely the requirement that the product is “protected by a basic patent in force”. And while national courts and the CJEU have experienced fierce litigation concerning this exact seemingly innocent phrase, clarity is not succeeded.

The only matter on which there appears to be consensus is that the CJEU has rejected the so called “infringement” test: this means that in order to satisfy the “protected by a basic patent in force requirement”, it is not sufficient for the product to simply fall within the scope of a claim of the basic patent.

During the past few years, landmark decisions concerning the interpretation of the SPC Regulation have introduced two different tests, namely that the product must be “specified” or “identified” in the claims of the basic patent (Medeva, C-322/10), and that the product must reflect “the core inventive advance” of the basic patent (Actavis v Sanofi, C-443/12).

In the ruling of 25 July 2018 (Case C-121/17 Teva v. Gilead), Teva, the CJEU ruled that the Medeva test was complied with if, at the filing date (or priority date) of the basic patent:

(a) 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

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

Nevertheless, Teva does not specify what “specifically identifiable” is and while it has indicated that the protection of the basic patent is restricted to “technical specifications of the invention”, it has not gone so far as to explain what that in fact means. One of the important questions in this regard is how much specific need the patent applicant be in order for the basic patent to cover the specific substance. Certain concerns were in fact expressed with regards to the effects this interpretation would have on early stage patents and how this in its turn would influence research (let alone strategic decisions) in the pharmaceutical sector. Another very interesting aspect that was raised in the aftermath of Teva was the fact that the CJEU proceeded gladly to the interpretation of EPC (European Patent Convention) provisions, confirming the rather extensive view the Court has on its competence.

When analyzing Teva and its effects on the interpretation of the SPC Regulation, one could not fail to wonder what that would mean, for for instance Markush formulas or other forms of “creative” claim drafting such as functional definitions.

Τhe Opinion of AG in the referrals C- 650/17 (Royalty Pharma) and C-114/18 (Sandoz) attempts to answer exactly this question, namely how the test provided by Teva will be best applied in these forms of claim drafting.

This Kat wonders, how deep is the SPC mist?

One could sum up the important points made in the AG Opinion regarding the application of Teva in the following :

      i.         The two-part test of Teva is applicable not only to combinations of active ingredients but also to single ingredients (not so surprisingly, but still).
     ii.         The two-part test of Teva is entirely different from the concept of the “core-inventive advance” (thus this specific concept should not be applied with regards to article 3 (a)...hmm...at last!).
   iii.         With regards to Markush formulas, there could be no general rules as to whether and how the two-part test is satisfied, the national courts should look into the specific case at hand (ok, it seems however that there is a general rule, the combination must be known at the priority date).
    iv.         “a person skilled in the art” and “ the prior art” are terms to be defined and interpreted by national courts (due to lack of EU harmonization). At the same time, interpreting the “prior art” concept” as “common general knowledge” would in fact be in conflict with Teva. 
     v.         The “must necessarily fall under the invention”, means that in order for this criterion to be satisfied, the corresponding product referred to in the claims of the patent must be required for the solution of the technical problem disclosed in the patent. (In other words, optional components to a patent will be excluded).
    vi.         “Specifically identifiable” means that a person skilled in the art must be able to derive the product on the basis of all the information contained in the patent and in the prior art (so if a specific combination of a Markush formula is not known at the priority date or disclosed in the patent, it could not be protected by an SPC)

Interesting points made, and what is also interesting is the fact that in the same way as in the Teva ruling, the AG seems keen on including article 69 of the EPC (and its interpretation) in its line of reasoning. An SPC Regulation, in lack of EU patent law harmonisation, is definitely not an optimal scenario.

The CJEU ruling in C- 650/17 (Royalty Pharma) and C-114/18 (Sandoz) is very much welcome, and we surely hope it leads us to clarity and not deeper in the mist of SPC interpretation.