Updates in European SPC law - and no more pending CJEU referrals

The Santen decision

A few months have passed since Santen (C-673/18). In that decision, the CJEU restricted SPCs in relation to new therapeutic uses of existing drugs (adding to a line of case law already restricting SPCs for medical devices and new formulations) - see our update here. More than a change of emphasis, the outcome appeared to reverse an earlier seminal CJEU case (Neurim). That outcome has now been endorsed by recent developments in the UK IPO, and further inferred by activity in the Swedish courts.

UK IPO updates its guidance

In the October update to its Manual of Patent Practice, the UK IPO included a new section setting out its view on Santen, including the statement: "Ultimately, Neurim has been overturned...". This leaves little doubt as to the UK IPO's view on the impact of Santen, including as a decision delivered while the CJEU's case law still applies in the UK. The full ramifications remain to be seen in terms of the consequences for pending or granted UK SPCs based on strategies designed to implement caselaw now overturned.

Swedish courts withdraw the Novartis referral

The only remaining referral to the CJEU on matters of SPC law after Santen has been withdrawn. An order by the CJEU dated 25 September, which appeared on the case record this week, confirms the same.

This case - Novartis (C-354-19) - was focussed on a different aspect of SPC law (whether a single owner could obtain multiple SPCs for the same drug). However, it was nonetheless a referral arising out of a multiple SPC strategy and the significance of the Santen decision was apparent (as we remarked in our earlier article here). So while there are no reasons included in the CJEU's order for dismissal, it may not be a coincidence that this follows the outcome in Santen. Novartis' relevant UK parallel applications for SPCs remain pending. As noted already above, it remains to be seen whether they and other pending SPCs will be impacted by the UK IPO's updated guidelines, as discussed above.

Comment

There was little doubt that Santen and the reversal of Neurim would have significant ramifications for the pharmaceutical industry. This is now succinctly illustrated by the UK IPO's revised guidance. Furthermore, as well as further restricting SPCs, the reversal has rendered moot a number of questions left lingering around multiple SPC strategies based on Neurim. This appears to be the fate of the Novartis referral. National IP offices in Europe and the UK will still have plenty to consider concerning the impact of recent events, as will SPC applicants and challengers.

Another outcome of these developments is that there are no pending referrals to the CJEU on matters of SPC law. SPC referrals have tended to go through peaks and troughs. However, the UK Courts have typically made significant contributions to the peaks, and so with the sun seemingly about to set on the UK's ability to refer questions to the CJEU, there may be a greater chance of a prolonged trough.