As part of our Thought Leaders series, Mewburn Ellis Partner Sam Bailey considers whether a pause in SPC-related referrals could be permanent
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Supplementary Protection Certificates (SPCs) are incredibly valuable intellectual property rights (we explored just how valuable in a recent Special Report). Their high value derives from the fact that they provide up to five years of additional exclusivity for medicinal products that have successfully navigated the arduous road through clinical trials and achieved the goal of a marketing authorisation.
One result of the high value of SPCs and the fact that the applicants for these rights are typically large pharmaceutical companies with relatively deep pockets is that any uncertainty or grey area in the SPC law (and there are plenty of these) will be worth arguing over right up to the highest possible level. As SPCs are governed by European Regulation, that highest level is the Court of Justice of the European Union (CJEU).
Stream of referrals
This has led to the CJEU being kept busy for many years by a regular stream of referrals from national courts across the EU asking it to clarify matters of SPC law. Indeed, in the past 25 years, somewhere in the region of 60 SPC questions have been referred for a decision. However, with the issuing of its most recent decision in the Santen case (C-673/18) in July 2020, and the subsequent withdrawal in September 2020 of a Novartis referral from the Swedish courts, the CJEU has cleared the books, leaving no pending referrals on matters of SPC law.
So, are all the SPC questions answered or is this just a pause in proceedings?
“The recent UK withdrawal from the EU means the CJEU has lost one of the major referring jurisdictions on SPC matters”
The recent UK withdrawal from the EU means the CJEU has lost one of the major referring jurisdictions on SPC matters. In the past 25 years or so, more than 40% of the referrals relating to SPCs have come from the UK courts. UK judges have built up enviable specialist technical knowledge relating to SPC matters, and it will be interesting to see if other jurisdictions fill in where the UK has left off in referring SPC questions to the CJEU. It will also be fascinating to observe how UK case law on SPCs develops without the binding nature of future CJEU case law to take into account.
The latest CJEU Santen decision seemed to demonstrate an effort (deliberate or otherwise) to provide a clear position on a legal point that went beyond the standard CJEU approach of restricting the decision to the specific facts of the individual case. This clarity and more general applicability in the decision was broadly welcomed by practitioners and applicants alike – whether they agreed with the substance of the decision or not.
Fertile ground
Nonetheless, despite this admirable attempt to establish clarity and close off avenues of argument, and even in the absence of future referrals from the UK, there remain significant areas of SPC law that could prove fertile ground for discussion. For example, despite the relatively recent refusal of the CJEU to address whether an SPC can be based on a marketing authorisation held by someone other than the SPC applicant, I doubt we have seen the last of this question at the CJEU level. In addition, I expect that the development of next-generation therapeutics such as biologics and personalised medicines will pose further tests to the limits of the SPC law, which will very likely end up at the CJEU for clarification.
It looks clear then, that the role of the CJEU in SPC disputes is not diminished and the questions are not yet all answered. The CJEU is just enjoying a well-earned breather.
To learn more about SPCs, download a copy of our Pharma and Life Sciences Patent Extensions in Europe 2021 Special Report.
