UK SPCs remain restricted by CJEU decisions under retained EU law

UK SPCs remain restricted by retained EU law

It's (almost exactly) 3 years since the CJEU decision in Santen, which overturned Neurim and seemed to bring the house crashing down on SPCs for second/further medical uses (see our article here).

A recent UK IPO decision has highlighted the apparent inability - even post Brexit - to escape the impact of Santen, finding that there is no way out even for pre-dating SPC applications.

This is not the first rejection, and many multiple SPC strategies that were hatched following the trail blazed by Neurim in 2012 seem to have been scrambled.

As Neurim was so firmly raised and referred to the CJEU by the UK Court of Appeal, this flagged one of the obvious post-Brexit questions for SPC law: could/would the UK stick with Neurim and diverge from Santen/CJEU? Even if there was a will, the latest UK IPO decision has not found a way.

In this article, we recap on Santen, address its significance in EU law, highlight some UK SPC rejections and consider the possibility of UK/EU divergence.

What Santen says

Most commentators describe most CJEU decisions as far from clear. However, Santen - a decision from the CJEU Grand Chamber in July 2020 - left little room for doubt in its finding that a marketing authorisation for the new therapeutic application of an existing drug cannot be the "first authorisation".

This bit into one of the four fundamental pillars of SPC validity set out in Article 3 of the SPC Regulation; specifically the fourth one, Article 3(d).

In practical terms, this restricts the ability to apply for an SPC based on an authorisation for a new indication (eg a Type II variation to an existing marketing authorisation). As a result, an SPC applicant, despite investment in development/clinical trials for a new indication, might have to rely on an earlier authorisation - eg for the original or first indication. This outcome typically precludes any further SPC at all. 

Santen's status in EU law

Santen is undoubtedly a seminal decision in EU SPC case law, overturning and reversing the previously (equally) seminal decision in Neurim.

The EU has recently proposed significant SPC reforms (see our overview here). While no changes are proposed to Article 3(d), there are a number of new recitals added with the implied aim of assisting with the interpretation of Article 3. In this respect, Santen is expressly cited in the explanatory memorandum as an example of the case law which the new recitals seek to encapsulate.

So Santen seems to be favoured and may become enshrined in the newly proposed SPC Regulations. Therefore, despite the seismic shock Neurim achieved in opening the door to multiple SPCs back in 2012, it seems set to be even harder, if not impossible, to re-open it.

Recent UK SPC application tries, but cannot escape Santen

Many predicted that the fallout from Santen would be significant. Some SPCs granted following Neurim (including Neurim's own SPC) may have been granted and made it to expiry. However, questions were raised in relation to SPCs that were later in time.

And SPCs may be examined slowly, as occurred in a recent rejection in the case of Merck Serono's SPC application for MAVENCLAD®¹. This application was made before the delivery of the Santen decision. To paraphrase, the applicant's case here was: had the SPC been examined quickly based on Neurim, it would have been granted, and so that position should be preserved as a matter of legitimate expectation. Indeed, the applicant is said to have obtained 18 SPCs across the EU, and so should not suffer in the UK due to examination delay.

However, the UK IPO rejected the application under Article 3(d) as MAVENCLAD® was an authorisation for the active substance (cladribine) for treating multiple sclerosis, whereas cladribine was earlier authorised for treating hairy cell leukaemia (as LEUSTAT® and LITAK® as far back as 1995 and 2004 respectively).

So the UK IPO decision held that Santen applied retrospectively ("ex tunc") and not just from its date ("ex nunc"). So this finding gave the applicant no escape by going back in time.

Other UK IPO rejections

As mentioned above, Merck Serono's SPC application was not the test case for a rejection based on Santen. There are many SPC applications on the UK register which, at least in part, have been rejected based on its reasoning.

Many of the rejected applications concern antibody therapies, which are a common area for multiple SPC strategies given the multiple therapeutic indications that may be achieved, developed over time and subject to second medical use patents.

We commented on multiple SPC strategies in a previous article - here - written while Santen was pending and noting its potential impact. Indeed, both of the pending SPC applications we noted therein have now been rejected in the UK - in Sept 2021 and June 2022.² More UK IPO rejections followed in 2022, again relating to antibodies as well as other therapies.³

Where things stand post Brexit

Santen was delivered during the implementation period, ie after exit day but before IP completion day. As the above decisions highlight, Santen therefore forms part of retained EU case law and is binding on the UK IPO (which has further held its effect to be retrospective).

Under the current framework, the Court of Appeal or the Supreme Court have the power to diverge from Santen (and any CJEU case law) in certain circumstances. Such divergence has been attempted since Brexit in other areas of law, with at least one noteworthy failure (in TuneIn Inc. v Warner⁴). However, there is no sign that any of these UK IPO SPC rejections have been appealed (which would likely go to the High Court subject to leap frogging to the Court of Appeal). If this is right, the wait continues for an SPC test case to come along that might try.

In the meantime, the UK has proposed reforms seeking to curtail or end all retained EU law by the end of 2023, which caused considerably clamour and uncertainty this year. Indeed, the original reform proposals have now been amended and diluted, in particular with respect to the prospect of 'sunsetting' swathes of legislation. As it stands, the Retained EU law (Revocation and Reform) Act 2023 recently achieved Royal Assent (in June 2023). This changed the test that the UK's higher courts must apply to decide whether to depart from retained EU case law, which any test case will have to surpass.

Furthermore, as already mentioned, while the UK continues to consider its potential post-Brexit divergence, the EU is proposing its own reforms, via far-reaching pharmaceutical reforms as well as SPC reforms. Pending the outcome of those proposals, the EU may diverge from the UK and so the UK will need to consider whether to stay the same, follow or pivot in response.

Overall, in the middle of this landscape sit pharmaceutical companies interested in the grant and/or revocation of SPCs in many different fact patterns and complex scenarios. As an area that has always suffered from disharmony, the multiple dimensions and current reforms continue to make SPCs a particularly challenging arena in which to achieve it.

¹ Decision B O/0484/23 dated 26 May 2023.
² The reasoning for the latter is now available online via the UK IPO register / IPSUM, which explains that its rejection was an Article 3(d) / Santen.
³ For example, BL O/711/22 rejecting an SPC for Gazyvaro® and BL O/242/22 rejecting an SPC for Simponi®, which was also cited in multiple decisions rejecting other SPC applications for the same antibody therapy, as well as SPC applications for another antibody therapy, Stelara®.
⁴ Permission to appeal to the Supreme Court was refused in 2022.