On 19 December 2023, the Patents Court rejected an appeal by Merck Serono SA of a UKIPO decision, which had determined that it was not entitled to a Supplementary Protection Certificate (SPC) in respect of its product cladribine on the basis that the application did not satisfy the requirements of Article 3(d) of the SPC Regulation (EC) 469/2009 (which is assimilated law in the UK). The Patents Court dismissed Merck's appeal, agreeing with the UKIPO that its marketing authorisation (MA) for Mavenclad (its branded cladribine product, indicated for the treatment of highly active relapsing remitting multiple sclerosis), was not the first to put cladribine on the market, as there were two earlier MAs for medical products containing cladribine (for the treatment of hairy cell leukaemia).
The decision is particularly interesting as the Court considered the interpretation of Article 3(d) of the SPC Regulation (which requires that the MA relied on for an SPC is the first to place the medical product on the market) by the Court of Justice in two key cases: its 2012 Neurim decision (Case C-130/11) and its 2020 Santen decision (Case C-673/18), which overturned Neurim. As Merck made its SPC application in 2018, i.e. before the CJEU's Santen decision, the appeal had to consider whether CJEU decisions can be restricted in their temporal scope, i.e. should Santen apply "ex nunc" (from now on) or "ex tunc" (from the outset)?
The Court decided that Santen applied without any temporal restrictions. As a result, Merck's SPC application did not meet the requirements of Article 3(d) and its appeal was dismissed. It will be interesting to see if Merck will now seek the Court of Appeal's permission to appeal the decision further.
Article 3 of the SPC Regulation sets out the requirements for obtaining an SPC. At the date of the SPC application, the conditions will be satisfied if:
- the product is protected by a basic patent in force (Article 3(a));
- a valid authorisation to place the product on the market as a medicinal product has been granted (Article 3(b));
- the product has not already been the subject of a certificate (Article 3(c)); and
- the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product (Article 3(d)).
In both Neurim and Santen, the Court of Justice had considered the meaning of "the first authorisation to place the product on the market" in Article 3(d).
The Neurim decision was handed down on 19 July 2012; the CJEU's interpretation of Article 3(d) was therefore the relevant law as at the date of Merck's SPC application, 12 February 2018. In Neurim, the CJEU found that Neurim's application for an SPC in respect of melatonin, where it relied on its patent for use of melatonin to treat insomnia (brand name Circadin) and its MA for the same use, had met the first authorisation requirement. This was despite the fact that melatonin had been the subject of a prior MA for use of a veterinary implant to improve the reproductive performance of sheep (known as Regulin). The Court of Justice concluded that the SPC met the first authorisation requirement on the basis that the later MA was for a different medical use, and the earlier use was not covered by Neurim's patent. As Merck's SPC application for Mavenclad also relates to a second medical use (of cladribine), the construction of Article 3(d) of the SPC Regulation in Neurim is beneficial to Merck's SPC application, if Merck is able to rely on it.
However, in July 2020, the CJEU handed down its decision in Santen, which overturned Neurim. Santen had also applied for an SPC in relation to its basic patent and MA for a product (ciclosporin for treatment of keratitis) which was a new medical use of an active ingredient that had already been the subject of an MA for a different medical use (ciclosporin had been the subject of a previous MA for preventing organ/bone marrow graft rejections and other indications). In contrast to Neurim, the Court of Justice held in Santen that an MA for a new medical use of an active ingredient that had been the subject of an earlier MA could not be considered to be the first MA for the purpose of Article 3(d) and the limits of protection of the patent relied on were irrelevant for the purpose of defining the first MA. Merck acknowledged that it would not be entitled to an SPC if Article 3(d) of the SPC Regulation was to be construed in accordance with the CJEU decision in Santen.
Merck advanced three grounds of appeal.
It argued that Santen was wrongly decided, on the basis of observations made by the Court of Appeal when making the reference to the CJEU in Neurim (echoed in other cases). However, Merck recognised that the High Court has no power to depart from Santen; only a higher court (the Court of Appeal or Supreme Court) can do so and Merck, therefore, reserved this ground of appeal for a higher court.
Secondly, Merck argued that the facts of its application could be distinguished from Santen. However, the Patents Court disagreed; the interpretation of Article 3(d) of the SPC Regulation in Santen was expressed in general terms.
Merck's main ground of appeal was that the CJEU decision in Santen should have ex nunc effect (i.e., applying from the date of judgment onwards in 2020) rather than having ex tunc (retrospective) effect. In particular, it should be treated as such because of the expectations of those in the industry that had relied on the law as stated in Neurim. Merck argued that it had relied on an expectation that it would be granted an SPC on the basis of Neurim, when it decided to revive its development programme for Mavenclad, and the UKIPO should therefore give effect to this expectation and grant an SPC. Although Merck's evidence was limited, the Patents Court agreed to proceed on the basis that Merck's reliance on Neurim was crucial to its decision making.
However, the Court considered that only the Court of Justice could impose a temporal limitation on the effect of its judgments, with such limitations only applied in extreme circumstances. The Court of Justice had not specified that its decision in Santen should apply with ex nunc effect and it was not open to the Patents Court to apply such a restriction. The Court concluded that Merck’s expectation that it would be granted an SPC based on Neurim, and its reliance on that when developing Mavenclad, could not give rise to a right to be granted an SPC as Santen operated without any temporal limitation.
Ultimately, the Patents Court held that the UKIPO had been right to refuse the grant of Merck's SPC based on the interpretation of Article 3(d) of the SPC Regulation in Santen. It did not matter that the SPC application had been made prior to Santen, as that decision had ex tunc effect.