Pharmaceutical companies invest substantial sums in developing known active ingredients for new therapeutic uses. Finding a new use for a drug with a known safety is of significant benefit to patients because it reduces development time, speeding up access to new medicines. The current SPC regime in Europe does not, however, incentivise this valuable research because SPC protection is not available for new medical uses of previously approved active ingredients. In an upcoming case, the UK Court of Appeal will have an opportunity to reconsider existing case law, and potentially reopen the door for additional SPC protection for new medical indications of previously approved drugs.

Background

European case law has flip-flopped on whether SPCs for new medical indications of previously approved drugs are allowed. Under Article 3(d) of the SPC Regulation, the marketing authorisation relied upon to support the SPC application must be the first for that product. Prior to 2012, this provision was generally interpreted to mean that an SPC could not be granted if the active ingredient in question had been previously authorised in the EU, even if the earlier authorisation related to a completely different medical use to the subsequent one.

However, the landscape changed dramatically with the CJEU’s judgment in Neurim (C-130/11) in 2012. In Neurim, the CJEU diverged from previous case law and opened the door to SPCs for old active ingredients approved for new medical indications,  thereby providing an incentive for companies to engage in the research of new uses of previously authorised actives (see our earlier briefing note).

This did not last for long, however, with the arrival of subsequent CJEU decisions such as Santen (C‑673/18), which essentially reversed the CJEU’s judgment in Neurim, and confirmed that the MA relied upon to support an SPC must be the first for that product, regardless of the therapeutic application. This closed the door again on SPCs for new medical indications of old active ingredients, with potentially adverse repercussions for innovators who had sought SPC protection for redeveloped actives during the Neurim era.

Merck’s SPC and Appeal

The UK Court of Appeal will soon have an opportunity to decide how SPCs for new medical indications should be handled in the UK when it considers an appeal by Merck Serono (“Merck”) against a recent judgment of the UK High Court, relating to an SPC for a new medical indication for cladribine (Mavenclad).

On 12th February 2018 (i.e., before Santen was handed down by the CJEU) Merck applied to the UKIPO for an SPC for the product “cladribine” based on a marketing authorisation (EU/1/17/1212) for the medicinal product “Mavenclad”, indicated for the treatment of highly active relapsing remitting multiple sclerosis. This SPC application was refused by the UKIPO following a hearing on 8th March 2023.

In its decision, the UKIPO took the view that Merck’s SPC application did not meet the requirements of Article 3(d) of the SPC Regulation, as interpreted by the CJEU in Santen, in light of the fact that there had been earlier marketing authorisations for medicinal products containing cladribine as active ingredient, namely “LEUSTAT” (PL 00242/0232 issued on 3rd February 1995) and “LITAK” (EU/1/04/275 issued on 14th April 2004). According to the UKIPO, following Santen it was not relevant that the earlier approved products were indicated for a different medical use, namely treatment of hairy cell leukaemia.

Merck appealed against the UKIPO’s decision on three grounds, none of which were successful.

First, Merck argued that Santen should not be applied retroactively to SPC applications filed following Neurim because of the legitimate expectations of pharmaceutical companies that their research into further medical uses of previously approved products would be rewarded with extended exclusivity from SPCs. Merck argued that this was particularly true in the present case because, prior to Neurim, research into Mavenclad was winding down and “without the impetus of Neurim it may well be that [Mavenclad] would never have reached the market”.

In its judgment, the High Court dismissed this ground of appeal on the basis that, in the absence of any clear indication to the contrary in the CJEU’s judgment itself, Santen applies ex tunc and that Merck’s expectations cannot give rise to a right to be granted an SPC.

Second, Merck argued that there were factual distinctions from Santen. Whereas in Santen the SPC application was based on a patent which included claims covering the previously approved use, and the new and previously approved uses were highly similar; in this case the new medical use, namely the treatment of multiple sclerosis (MS), was unrelated to the previously approved indications, and the claims of the patent upon which the SPC is based were specifically directed to treatment of MS.

However, the High Court disagreed with Merck and held that Santen is a ruling on the interpretation of Article 3(d) of the SPC Regulation, which applies in general terms and therefore, factual distinctions between Merck’s case and Santen do not detract from the UKIPO’s application of Santen.

Finally, Merck argued that the SPC Regulation must allow for SPCs in respect of second medical use inventions, i.e. Santen was wrongly decided.

With regard to this final ground of appeal, Merck acknowledged that the High Court has no power to hold that Santen was wrongly decided. Instead, only the UK Supreme Court or the UK Court of Appeal can decide to depart from Santen.

Having rejected all three of Merck’s grounds of appeal, the High Court confirmed that the UKIPO was right to refuse Merck’s SPC application.

The future…

We understand that the High Court has granted permission for Merck to appeal against its own judgment. We therefore expect that the Court of Appeal will soon be grappling with whether it should retain the status quo, or diverge from EU case law and allow SPCs for new medical indications once again. Currently, UK and EU SPC law remain closely aligned, and this case represents an opportunity for UK case law to diverge in a patentee-friendly direction.

It is possible that this appeal will be heard at the Court of Appeal by Arnold LJ who has previously commented, in relation to the CJEU’s decision in Neurim, that he considers the Explanatory Memorandum to the SPC Regulation to indicate that “SPCs should be available for new applications (i.e., new therapeutic uses) of old active ingredients” (Abraxis Bioscience LLC v The Comptroller-General of Patents [2017] EWHC 14 (Pat), paragraph 63). Will Arnold LJ maintain this point of view? If so, it seems quite possible that the Court of Appeal could exercise its powers to depart from CJEU case law and revive ‘Neurim’ SPCs in the UK once and for all. That would certainly be good news for innovators investing in research to find new medical indications for known active ingredients.