Is Neurim fit for purpose? Santen AGO on SPCs for second medical use suggests not

The Neurim decision opened the door for obtaining SPCs for second medical use patents. Although welcomed by innovators, the judgment was controversial, appearing to contradict both the wording of the SPC Regulation and previous CJEU decisions (see case summary below).

If the Advocate General’s (AG'’s) recommendation in Santen is followed, second medical use patents will no longer be able to benefit from SPC protection. However, the rationale behind Neurim still applies today. The industry eagerly waits to see whether the CJEU will abandon Neurim, or will instead seek to set out clear guidance on its application.

Summary of CJEU referrals in this area:

In reaching its opinion in Santen, the AG reviewed the following cases:

The Neurim approach:

Development of secondary medical uses for known substances is a significant part of pharmaceutical research. Neurim acknowledged that 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 Regulations would “not be fit for purpose”. The CJEU agreed and adopted a broad interpretation of the Regulation.

The Advocate General approach:

The scope and application of Neurim has always been uncertain and it was hoped that Santen would provide clarity.

In Santen, the importance of incentivising innovation was acknowledged. However, this was weighed up against the need for a uniform, simple and transparent system, as well as the conflicting interests of the generics market and medicine pricing.

The primary conclusion of the AG is 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. Neurim cannot be read as an exception to this approach, and should therefore be abandoned.

However, the AG recognises that the policy reasons behind Neurim remain valid today and, based on these considerations, acknowledges that the CJEU may wish to confirm Neurim. If this is the case, he suggests that SPCs may be available for secondary medical uses where the MA that forms the basis of the application:

•  covers a new therapeutic indication, ie the treatment of a new disease; or
•  relates to a use that exerts a new pharmacological, immunological or metabolic action, ie is akin to a new product.

If this is followed, it would appear to overturn Yissum and (possibly) MIT and Abraxis.