MSD can appeal SPC ruling due to 'wrongly decided' case

Judge says UK courts should depart from a European precedent following Brexit | MSD counsel says appeal had been granted due to courts' “flip-flopping” on the precedent(s) set by the landmark cases Neurim and Santen.

Merck (known as MSD outside of the US) can appeal a decision relating to its application for a secondary medical use supplementary protection certificate (SPC), after a judge found that an earlier landmark case may have been “wrongly decided”.

Michael Tappin KC, a deputy judge at the High Court of England and Wales, granted the pharma company permission on February 8 to appeal a December ruling by the England and Wales High Court in favour of the UK Intellectual Property Office (UKIPO).

In doing so, Tappin found fault with an earlier ruling in C-673/18 Santen, that had been cited in the winning arguments put forward by the UKIPO.

He further suggested that Santen—delivered by the Court of Justice for the European Union (CJEU) three years ago in an SPC case—could be potentially cast aside by the UK courts.

Commenting on LinkedIn, Daniel Selmi, a barrister from New Square Chambers who represents MSD, welcomed the decision and predicted an exciting year “for anyone with even a passing interest in SPCs and patents”.

Selmi added that the appeal had been granted because of “the flip-flopping from the UK courts on the precedent(s) set by the landmark cases Neurim and Santen”.

Two opposing precedents

The issue at the heart of this case can be traced back to the 2012 ruling in Case C‑130/11 Neurim. According to this decision, obtaining a new marketing authorisation (MA) for a different medical use of an existing product could fulfil the first authorisation requirement for a SPC.

MSD’s dispute with the EUIPO followed six years later when the pharma company applied for an SPC for the active ingredient Cladribine, which is used in multiple sclerosis treatment drug Mavenclad.

The patent for Cladribine was granted to MSD in 2012 and is set to expire in December 2025.

However, in 2020, the Santen decision delivered by the Court of Justice for the European Union (CJEU) overturned Neurim. In that case, pharma company Santen had sought an SPC for a new medical use of ciclosporin—but was rejected because the European court held that ciclosporin had a prior MA for a different use.

As a result, the UKIPO examiner told MSD in September that its application was rejected on the grounds set by Santen. However, MSD and the examiner continued to correspond, which led to a hearing before the UKIPO hearing officer in March 2023.

The hearing office found that earlier MAs for medicinal products containing cladribine for treating hairy cell leukaemia already existed and, according to Santen, the application must be rejected.

MSD countered that the Neurim judgment should be applied—as this was case law when their application was filed in 2018—and that the Santen judgment should not be considered.

A real prospect of overturning Santen

However, the hearing officer concluded that the CJEU intended Santen to apply retroactively to all applications, regardless of when they were made.

MSD also argued that in Santen, the application was based on a patent for a different dosage form of a known active ingredient, whereas the new therapeutic use cited in its application is “entirely novel”.

But in later proceedings, the High Court went on to defer to the EUIPO’s citation of Santen.

Following its setback at the High Court in late 2023, MSD approached Judge Tappin who subsequently granted MSD the right to appeal last week.

In his permission form, he wrote that the UK courts should depart from Santen following Brexit and under the terms set by the European Union (Withdrawal) Act 2018.

“The Court of Justice had previously taken the contrary position in Neurim, and in my judgment there is a real (as opposed to fanciful) prospect that the Court of Appeal will decide to depart from Santen and adopt the position in Neurim,” added Tappin.

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