A more “fit for purpose” SPC Regulation?

Apart from the various comments posted at the foot of yesterday's blog item on Case C-130/11 Neurim Pharmaceuticals,  The SPC Blog has also received the following observations from Andrew Hutchinson (Associate Solicitor, Simmons & Simmons LLP)

A more “fit for purpose” SPC Regulation?

The CJEU’s judgment has allowed Neurim to obtain an SPC and so in that sense has followed the Court of Appeal (England and Wales) and the Opinion of Advocate General (AG) Trstenjak of 3 May 2012. However, while the CJEU has allowed Neurim’s application to proceed, as is now a common theme in SPC decisions, it seems to have struggled to formulate a legal test that can be applied generally and simply to all cases.

The CJEU has not applied the same test or gone into the detailed reasoning of the AG’s Opinion, which suggested that an earlier authorisation should be ignored if it did not fall within the scope of the protection of the later basic patent. This test required the assessment of the scope of protection of the basic patent in question and a determination of whether any earlier authorisations fell within it. The clear water between Neurim’s patent and the earlier authorisation was not in dispute. However, the CJEU may have been reluctant to apply this test given that finer distinctions may arise and an assessment of the scope of protection of a basic patent could overburden the SPC-granting authorities. The CJEU may have also been concerned about causing conflicts with its own earlier decisions, in particular Pharmacia (case C-31/03) and Yissum (case C-202/05), which the High Court for England and Wales had already assessed and considered, acte clair, to preclude Neurim’s SPC.

While the CJEU has held that the mere existence of an earlier authorisation can no longer be said to be automatically relevant to (and perhaps preclude) a later SPC application for the same product, the CJEU has provided hardly any test at all. As a result, it is not completely clear how similar to Neurim a subsequent case will need to be to benefit from this decision. In this sense, the decision provides for a specific exception to the stricter, literal interpretation of Articles 3(d) and 13(1), as opposed to applying a wider, more general teleological interpretation.

The requirements for benefiting from Neurim are split into two parts, which are closely connected: (1) is your SPC application for an old product with a “different application" and (2) do you have a “new patent” for that different application as your basic patent (paras 25-27). The central question is therefore: what is covered by "a different application"? A second medical use appears to qualify. There is no mention of the need for there to be a different species (as was the case in Neurim) but, as this is not addressed, it may be argued that this is a further limitation. This also leaves open the issues of any non-active components, new formulations, inventive excipients, etc.

Overall, some will seek to limit the scope of this decision while others will seek to extend it, so the circumstances of the case in question will be paramount. Another common theme in SPC decision continues: more referrals are likely.  It remains to be seen whether, as Jacob LJ commented when referring Neurim to the CJEU, cannot yet be ascertained whether allowing Neurim’s SPC will create a more “fit for purpose” SPC Regulation. It may only be a small step in that direction.