The opinion of Advocate General Hogan was delivered today in cases C-650/17 (Royalty Pharma) and C-114/18 (Sandoz). The opinion is available here.
These cases concern the interpretation of Article 3(a) of the SPC Regulation, which requires the product which is the subject of the SPC to be “protected by a basic patent”. Ever since the CJEU’s ruling in Medeva (C-322/10) there has been confusion as to how compliance with this seemingly simple provision should be assessed. Further referrals on this point have provided a degree of clarification, although some uncertainty remains. For example, C-121/17 (Teva) gave some explanation as to how Article 3(a) should be applied to combination products, although it stopped short of providing explicit answers to several other important points.
Teva does not specifically address how Article 3(a) should be applied to products which are a single active ingredient. Teva also does not specify whether falling within the scope of a “Markush” formula or a functional definition is enough to comply with Article 3(a) for single active ingredient products. “Markush” formulae are commonly used in patents relating to small molecule inventions, as they allow applicants to claim protection for a class of compounds in a concise way. “Functional definitions” allow active substances to be defined with reference to their properties, such as their mechanism of action (e.g. “a compound which inhibits enzyme XYZ”), as opposed to purely their chemical structure. The CJEU has been called upon to rule whether SPCs are available when a single active ingredient product either falls within the scope of a Markush formula (C-114/18) or within the scope of a functional definition (C-650/17).
A significant step was taken today with the publication of a legal opinion by Advocate General Hogan. An Advocate General is usually asked by the CJEU’s judges to prepare an advisory opinion about the legal issues at stake before those judges reach a decision.
The Advocate General is of the opinion that Article 3(a) does not preclude the grant of an SPC when an active ingredient falls within the scope of either a Markush formula or a functional definition, provided that the active ingredient also satisfies the two-step test established in Teva for combination products. That is, 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:
(i) the active ingredient must necessarily, in light of the description and drawings of that patent, fall under the invention covered by that patent, and
(ii) the active ingredient must be specifically identifiable, in light of all the information disclosed by that patent.
With regard to point (i), the Advocate General opined that “an SPC may not be granted in respect of a product if, 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 claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent”.
On point (ii), he took the view that, for Article 3(a) to be complied with, it must be the case 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 Advocate General also discussed the issue of whether a consideration of the basic patent’s “core inventive advance” was relevant to the assessment of Article 3(a). The concept of “core inventive advance” arose in earlier case law, for example concerning the application of Article 3(c) of the SPC Regulation. However, the Advocate General was of the opinion that this concept “does not apply and is of no relevance” to Article 3(a).
The Advocate General’s opinion is not binding on the CJEU and so it remains to be seen whether the opinion will be followed. Any confirmation that SPCs are not precluded for active ingredients falling within Markush claims or functional definitions will be welcomed by innovators. That said, practical application of the test laid out in Teva by the national patent offices and courts may generate further questions in this area.