Merck Serono S.A. v The Comptroller-General of Patents, Designs, and Trade Marks

Hearing dates: 11 December 2024

Approved Judgment

This judgment was handed down remotely at 10.30am on 28/1/2025 by circulation to the parties or their representatives by e-mail and by release to the National Archives.

This appeal relates to the application by the appellant Merck for a supplementary protection certificate (SPC) for a pharmaceutical called cladribine. The application relies on a basic patent EP 1 827 461 which relates to the use of cladribine for treating multiple sclerosis, and a 2017 marketing authorisation for the medicinal product MAVENCLAD which contains cladribine as an active ingredient and is indicated for the treatment of highly active relapsing remitting multiple sclerosis. The problem is that the application has been held not to meet the requirements of the relevant provisions because of the existence of an earlier marketing authorisation for a medicinal product containing cladribine as an active ingredient, contrary to article 3(d) of the relevant Regulation ((EC) No. 469/2009). In fact there were two earlier marketing authorisations, one for a medicinal product called LEUSTAT issued in 1995 and another for a medicinal product called LETAK issued in 2004. Each of these authorisations are for a medicinal product containing cladribine as an active ingredient for the treatment of hairy cell leukaemia.

This is therefore another case raising the question of the relationship between patents for second medical uses of pharmaceutical products and the SPC regime, and the position of the CJEU judgment in Neurim Pharmaceuticals v Comptroller C-130/11 [2012] RPC 23.

A recent summary of the development of the CJEU cases on this topic was set out in February 2024 in Newron Pharmaceuticals v The Comptroller [2024] EWCA 1471 (Lewison, Moylan and Birss LJJ) at [19] – [22] of my judgment. I will come to the detail below, but briefly the position is as follows. By 2012 the effect of a series of CJEU decisions was that no certificate would be granted in a situation like the present one because the intended use of a product was irrelevant. That line of cases started with Pharmacia Italia SpA C-31/03 [2004] ECR I-10001 and included C-202/05 Yissum Research and Development Company of the Hebrew University of Jerusalem v. Comptroller-General of Patents [2007] ECR I-2839. Then in 2012 in Neurim, the CJEU changed tack and held that the law would permit a certificate in these circumstances, taking the intended use into account. Essentially the CJEU's reasoning was that this outcome was in accordance with the objectives of the Regulation and so the CJEU was applying what the Advocate-General in that case called a schematic-teleological interpretation. However in 2020 in Santen C-673/18 the Grand Chamber of the CJEU overruled Neurim, holding that this teleological approach was wrong and that the correct interpretation of the Regulation was such that no certificate would be granted in a case like the present one. Finally in 2024 this court in Newron applied Santen to the case before it, dismissing the appeal.

The present application was filed in 2018, before Brexit and also before Santen. The matter came to be decided by the Comptroller's Hearing Officer, Deputy Director Mary Taylor at a hearing in March 2023. In her decision ( BL O/0484/23) of 26 May 2023 the Hearing Officer refused the application, essentially because she decided to follow Santen. A distinct issue before the Hearing Officer, and on appeal to the Patents Court (Michael Tappin KC sitting as a Deputy Judge of the High Court) was whether, at the time the development of MAVENCLAD took place, Merck had a legitimate expectation that it would be entitled to a certificate based on Neurim prior to it being overruled in Santen. That case failed before the Hearing Officer, the appeal was dismissed by Mr Tappin and no appeal to this court was sought on that ground.

The appeal to this court is based on a single ground. Merck contends that Santen is wrongly decided and that the Court of Appeal should depart from it. As well as the question of departure itself, there is a prior question whether it is open to this court to depart from Santen at all given Newron.

Merck's case on departure is that the teleological approach of Neurim is the right approach and that when this is taken, the result would be the grant of a certificate. It is not in dispute that if Neurim represents the law then Merck would be entitled to a certificate, and so the focus in this case is on departure from Santen. In summary Merck's case in favour of departing from Santen is as follows:

i) There is a lack of cogency and consistency in CJEU case law in relation to Article 3(d).

ii) The teleological reasoning of the CJEU in Neurim was careful and correct and should be followed, otherwise the SPC Regulation “will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose” [this is a quote from Jacob LJ in Neurim]. This teleological approach is supported by later judicial consideration, including in the UK, and by the position adopted by the UK Government in the Abraxis reference.

iii) The CJEU's reasoning in Santen is regressive, overly literal, restrictive and conveys no practical benefit to the UK IPO or the public at large.

Before dealing with these aspects of the argument on departure, it is convenient to deal with the prior question first.

Could this court depart from Santen?

Santen and the CJEU cases prior to it are what was called “retained EU case law” in s6(7) of the European Union (Withdrawal) Act 2018 as enacted and are now called “assimilated EU case law” as a result of the amendments made to the 2018 Act by the Retained EU Law (Revocation and Reform) Act 2023. As Arnold LJ explained in Industrial Cleaning Equipment (Southampton) Ltd v Intelligent Cleaning Equipment Holdings Co Ltd [2023] EWCA Civ 1451 at [80], that means it continues to form part of domestic law after Brexit and continues to bind lower courts.

Under the terms of s6(5) of the 2018 Act the Supreme Court has power to depart from a CJEU judgment like Santen, but only on the same basis as that court would depart from one of its own precedents, or one of the House of Lords, in accordance with the Practice Statement (Judicial Precedent) [1966] 1 WLR 1234. A similar power was extended to the Court of Appeal by a statutory instrument made under the powers in s6(5A) of the 2018 Act. By s6(4)(ba) of the 2018 Act a relevant court defined in such a statutory instrument is not bound by any assimilated EU case law so far as provided for in that statutory instrument.

The statutory instrument is the European Union (Withdrawal) Act 2018 (Relevant Court) (Retained EU Case Law) Regulations ( SI 2020/1525). In its terms the Court of Appeal is a “relevant court” by paragraph 3(b). The position of relevant courts is provided for in paragraphs 4 and 5, as follows:

4(1) A relevant court is not bound by any retained EU case law except as provided in paragraph 2.

(2) A relevant court is bound by retained EU case law so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court.

5. In deciding whether to depart from any retained EU case law by virtue of section 6(4)(ba) of the 2018 Act and these Regulations, a relevant court must apply the same test as the Supreme Court would apply in deciding whether to depart from the case law of the Supreme Court.

The effect of these provisions is as follows. The principles to be applied by the Court of Appeal in deciding whether to depart from any retained EU case law are the same as those to be applied by the Supreme Court, in other words the 1966 Practice Statement. However that power is only available to the Court of Appeal if it is not bound by the retained EU case law, as provided for in paragraph 4. The Court of Appeal is only bound by retained EU case law if the circumstances in paragraph 4(2) apply, otherwise it is not bound (paragraph 4(1)). Paragraph 4(2) applies so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court. Post-transition case law is defined in paragraph 2 of the statutory instrument as being “any principles laid down by, and any decisions of, a court or tribunal in the United Kingdom, as they have effect on or after IP completion day”.

So for paragraph 4(2) to apply, there must be a decision of a court which modifies or applies that retained EU case law and that decision must itself be binding on the Court of Appeal. Therefore, for example, a prior decision of the High Court applying the retained EU case law would not prevent the Court of Appeal from exercising the power to depart. However if the relevant prior decision was a judgment of the Court of Appeal it would follow that since, subject to Young v Bristol Aeroplane [1944] KB 718 CA, the ratio decidendi of that prior decision would be binding on the subsequent Court of Appeal, then the power to depart would not be available to that subsequent Court of Appeal as long as the modification or application of the retained EU case law was part...