On 9 July 2020, the CJEU followed the Advocate General’s recommendation in Santen (see Is Neurim fit for purpose? Santen AGO on SPCs for second medical use suggests not), effectively abandoning Neurim and returning to a literal and narrow interpretation of the SPC Regulation.
The consequence appears to be that second medical use patents will no longer benefit from SPC protection. Whilst this provides the certainty sought by some, many will be disappointed. The policy reasons behind Neurim remain valid today, and will not be addressed by the SPC system.
Prior to Neurim, a narrow and literal interpretation of the SPC Regulation was adopted. It was not possible to obtain SPC protection for an active ingredient which was already the subject of an MA, based on a second MA for a new use or different formulation of that active ingredient.
The Neurim decision opened the door for obtaining SPCs for second medical use patents. Neurim acknowledged that the development of secondary medical uses for known substances is a significant part of pharmaceutical research, and a fundamental objective of the SPC Regulation is to ensure sufficient protection to encourage such research. In the referral of the UK case to the CJEU, Jacob LJ went as far as to say that, if second medical use patents could not get the benefit of an SPC, the SPC Regulation would “not be fit for purpose”. The CJEU agreed and adopted a broad interpretation of the Regulation.
Since Neurim, there has been a lack of clarity as to the extent of its application. A summary of the CJEU referrals leading up to Santen is at Is Neurim fit for purpose? Santen AGO on SPCs for second medical use suggests not.
The recent Santen decision follows the primary conclusion of the AG that, in light of the numerous inconsistencies in this area, and in line with a strict interpretation of the SPC Regulation, SPCs should no longer be available for second medical use patents, where the active ingredient has been the subject of an earlier MA.
In particular, the judgment makes it clear that for the propose of obtaining SPC protection:
- a product is defined by reference to its active ingredient(s), and not its therapeutic application;
- the first MA of a product is the first MA for the active ingredient, even if it is for a different therapeutic application of that active ingredient; and
- when defining the first MA of a product, there is no need to take into account the limits of the protection of the basic patent.
Whilst this provides the sought after certainty, it also effectively overrules the decision in Neurim and, for many, will be seen as a step backwards.
The SPC system aims to provide sufficient protection to encourage the development of medicinal products in Europe. The development of secondary medical uses for known substances is a significant part of pharmaceutical research, particularly with the increased use of AI and big data. Without the ability to obtain SPC protection for these secondary uses, does the SPC system achieve its aim?