In this article we consider three important supplementary protection certificate (SPC) cases before the Court of Justice of the European Union (CJEU): C-650/17, C-114/18 and C-239/19.
C-650/17 and C-114/18 – Advocate General points the specific way
The Advocate General’s (AG) opinion has issued on two cases before the CJEU regarding SPCs. While not binding on the full court, if followed it may make it more difficult for applicants to obtain SPCs based on certain basic patents in the EU.
Article 3(a) of the SPC Regulation requires that, to be entitled to an SPC, the product must be “protected” by a basic patent in force. However, since the CJEU issued its decision in Medeva (C-322/10) in 2011, there has been considerable uncertainty in Europe about precisely what is required for this criterion to be fulfilled, over and above the product simply falling within the claims of the patent.
In 2018, the CJEU provided a little more clarity on this issue in its decision in Teva (C-121/17). In that case, relating to a combination drug, the CJEU ruled that Article 3(a) was met if (1) the combination of actives necessarily, in the light of the description and drawings of that patent, fall under the invention covered by the patent, and (2) each of those active ingredients must be “specifically identifiable”, in the light of all the information disclosed by the patent.
However, what the CJEU meant by this two-part test was still unclear: in addition, it was uncertain whether the test applied to an authorized product which was a single active ingredient. In particular, did part (2) of the test mean that the authorized product must be specifically disclosed in the patent, or would it be sufficient that the product fall under a functional claim or Markush claim?
Both of these issues were at stake in the above joined cases, both of which related to SPCs for single actives. In both cases, it was common ground that the product covered by the SPC was not specifically disclosed in the patent, but was not developed until after the filing date of the patent. However, both parties agreed in each case that the product fell under the functional definition in the claim (C-650/17) or a Markush claim (C-114/18).
The AG confirmed that, in his view, the Teva test should apply both to combination medicinal products and those consisting of a single active. He also opined that Article 3(a) does not, in principle, prevent SPCs from being granted for actives based on basic patents having functional definitions or Markush claims, provided the Teva test is met.
However, the AG considered that part (1) of the Teva test was not met by a product if at the filing date of the basic patent, the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by the patent. Although the AG did not elaborate on what was meant by the claims being “not required” it appears that this is something different from the “core inventive advance” test adopted by previous case law, which the AG opined as “of no relevance” in assessing whether Article 3(a) is met.
Of greater concern is the AG’s consideration of part (2) of the Teva test. The AG opined this was not met if, 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 of the patent. The “remains unknown” test, if followed by the full court, may preclude an active ingredient from SPC protection if the basic patent does not specifically disclose that active, but it is only disclosed after the filing date. This would make it much more difficult for applicants to obtain SPCs on any patent which does not disclose the specific active ingredient.
We will report the full decision as soon as the CJEU issues it and advise in more detail on how it may affect SPC applicants.
C-239/19 – CJEU ducks issue of “third party” SPCs
In spring 2019, we reported that the UK Patents Court had referred a question to the CJEU regarding the grant of SPCs to a party which does not have the consent of the marketing authorisation (MA) holder – so-called “third party SPCs”, see https://dycip.com/thirdparty-spc.
Regrettably, the CJEU has ruled the referral inadmissible. The CJEU considered the question referred “hypothetical” and not necessary to decide upon the dispute in the referred case. The CJEU also considered the UK’s planned departure from the EU irrelevant in deciding whether to accept the referral.
This is a disappointing outcome for all in the pharmaceutical industry, as it will mean for now that the uncertainty will continue on whether “third party” SPCs are allowable. However, it is likely that the issue will be raised again in other cases where it is material to the outcome of the case, and that the CJEU will finally consider the issue in full.