This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
Over the years, pharmaceutical companies have obtained Supplementary Protection Certificates (SPCs) for a different application of a known active ingredient, for which a marketing authorisation had already been granted. The path for this practice was paved by the 2012 landmark decision Neurim of the Court of Justice of the European Union (CJEU) (C-130/11). However, critical tendencies against this approach are increasing. Just recently, in the Santen-referral (C-673/18), Advocate General Giovanni Pitruzzella called on the CJEU to reverse its approach in the Neurim-decision.
Background
Article 3 of the SPC-Regulation 469/2009 sets out the conditions for obtaining an SPC. Inter alia, the SPC-applicant must have a valid authorisation to place the product on the market. However, said authorisation must be the first authorisation to place the product on the market as a medicinal product (Article 3 (d) of the SPC-Regulation). Therefore, an SPC cannot be granted if there had already been an earlier marketing authorisation for the same product. Under the Regulation, the term “product” refers to the active ingredient(s) of a medicinal product (Article 1 (b) of the SPC-Regulation).
After applying a rather strict approach at first, the CJEU changed the landscape with its decision in re Neurim. In said case, the CJEU ruled that an earlier marketing authorisation for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for a use in humans, provided that the SPC application is within the limits of the protection conferred by the basic patent.
The reactions to this decision were controversial. Practitioners particularly questioned the scope of the term “different application of the same product”, which had led to uncertainty. The bringing of further referrals was conceivable.
Thus, following a referral of the UK High Court of Justice, the CJEU had to decide the case Abraxis (C-443/17) in 2019. It concluded that a marketing authorisation concerning a new formulation of an old active ingredient cannot be the first authorisation, if said active ingredient has already been the subject of a marketing authorisation as an active ingredient.
While providing some clarity at first sight, it remains unclear whether and in which cases the Neurim exception is still applicable.
The Santen Referral and the Opinion of Advocate General Pitruzzella
Now, a further referral is before the CJEU, namely from the Paris Court of Appeal in the case Santen.
The Paris Court of Appeal asked two specific questions, seeking to clarify the open issues following Neurim. The first question relates to the interpretation of the term “different application”, i.e. whether this should be understood strictly or broadly. The second question concerns the wording “application falling within the scope of protection conferred by the basic patent” and whether this means that the scope of the basic patent must be the same than that of the marketing authorization, i.e. being limited to the new medical use indicated in the authorisation.
On January 24, 2020, Advocate General Pitruzzella handed down his detailed opinion. The opinion, which is currently not available in English, is basically divided in two sections:
Firstly, Pitruzzella appeals to the CJEU to reverse its decision in re Neurim and apply a strict interpretation of the SPC-Regulation. According to Pitruzella’s primary and preferred suggestion, a marketing authorisation for a different and new application of an old active ingredient cannot be regarded as the first authorisation. In this context he provides a very detailed and thorough analysis of the legal framework and the underlying rationale. Pitruzzella takes apart the Neurim decision and argues that the CJEU’s broad approach contradicts the wording of the Regulation as well as the case law of the CJEU regarding the interpretation of the term “product” (referring in detail to the decisions Pharmacia Italia (C-31/03) Massachusetts Institute of Technology (C-431/04) and Yissum (C-202/05)). He also refers to the Max Planck Study on SPCs and urges the Court to answer which type of research is encouraged by the SPC-Regulation. Notably, Pitruzzella’s preferred suggestion is in line with the suggestion that was already made by Advocate General Øe in the Abraxis case.
Secondly, Pitruzella sets out his auxiliary suggestion in case the CJEU does not follow his preferred approach.
As regards the first question of the Paris Court, the Advocate General stresses that the scope of Neurim cannot lie in the extremes. On the one hand, a “different application” should not be limited to situations where a human use follows a veterinarian use. On the other hand, a “different application” should not cover situations where a patent concerns only minor modifications to known applications (e.g. different formulations, dosages and/or methods of administration). Considering this, Pitruzzella suggests that SPCs can be granted for a different application of a known active ingredient (for which an authorisation had been granted) when it relates to a new therapeutic indication of the active ingredient OR relates to a use, in which the active ingredient exerts a new pharmacological, immunological or metabolic action of its own.
Pitruzzella then addresses the second question of the Paris Court. He clarifies that Neurim would not provide for an interpretation where the scope of protection of the basic patent must be limited to the new medical use corresponding to the indication of the marketing authorisation on which the SPC application is based. In any case, Pitruzzella stresses that the scope of an SPC may under no circumstances extend to the active ingredient as such or to other uses of that active ingredient, which would also follow from Neurim.
Perspective and Impact on Business
While this is “only” the opinion of an Advocate General, it is a striking request for clarity to the CJEU. As the discussions on Article 3 (d) of the SPC-Regulation have been revolving for some time, it is conceivable that the CJEU will address the issues eventually. The Abraxis-decision already seemed like a step towards a narrower interpretation. Still, the CJEU did not follow Advocate Genral Øe’s strict approach or provide any specific guidance for the “different application”-test of Neurim back then. We will closely monitor whether the CJEU will now deal with the more specific questions of the Paris Court of Appeal.
As always, it remains to be seen whether and to what extent the CJEU follows the Advocate General. In any case, the decision of the CJEU will impact the focus of future business strategy. Neurim was an encouragement for the pharmaceutical industry to continue their investments in research and development for new applications of known substances. Pitruzzella’s primary suggestion may dampen such efforts. So essentially it seems like the dispute can be boiled down to the basic “policy” question of whether only the development of new active ingredients should and will be rewarded with an SPC.
