High Court Upholds Santen Ruling on SPC Applications in Merck Serono SA Case

Citation: [2023] EWHC 3240 (Ch)
Judgment on

Introduction

The High Court of Justice in the case of Merck Serono SA v The Comptroller-General of Patents, Designs and Trade Marks [2023] EWHC 3240 (Ch) decided upon the applicability of the Court of Justice’s ruling in Case C-673/18 Santen with respect to the grant of a Supplementary Protection Certificate (SPC) by the UK Intellectual Property Office (UKIPO). This case hinged upon the interpretation of Article 3(d) of the Regulation (EC) 469/2009 and its ex tunc (retroactive) application following a reinterpretation by the Court.

Key Facts

Merck Serono SA (Merck) applied for an SPC based on a patent concerning “cladribine” for the treatment of multiple sclerosis, and the case revolved around whether the marketing authorisation (MA) Merck used as the basis for the SPC was the first authorisation to place the product on the market as a medicinal product, as required by Article 3(d) of the Regulation. Previous authorisations existed for the same active ingredient for different therapeutic uses. The UKIPO, aligned with the Court of Justice’s ruling in Santen, rejected the application, indicating that the previous MAs precluded the grant of an SPC for a new therapeutic application of the same active ingredient.

Merck contended that their application was filed with a legitimate expectation of being granted an SPC based on the then-prevailing interpretation of the law as dictated by the Court of Justice in Neurim, which had been effectively reversed by the subsequent Santen ruling.

Several legal principles are at play in this case, central among them:

  1. Supplementary Protection Certificates (SPCs): A form of intellectual property right that extends the protection of patented pharmaceutical products beyond the term of the patent to compensate for the time taken to obtain marketing authorisation.

  2. Interpretation of the Regulation (EC) 469/2009: Article 3(d) requires that the SPC application’s MA must be the first authorisation to place the product on the market as a medicinal product.

  3. Ex tunc vs. Ex nunc: The Court of Justice’s judgments are generally applied ex tunc, giving them retroactive application unless explicitly stated otherwise.

  4. Legitimate Expectations: Recognised by the courts (including the Court of Justice) but typically applied to the actions and representations of administrative authorities, not shifts in case law.

  5. Judicial Precedent: While higher courts in the UK can alter precedent (and hence the interpretation of the law), lower courts cannot evade the application of a higher court’s decision.

Outcomes

The Deputy Judge, Michael Tappin KC, concluded that the Santen judgment applies ex tunc, given the Court of Justice’s absence of any temporal limitation in its ruling and its traditionally retroactive application of judgments. Hence, the Santen ruling invalidated SPCs based on the earlier Neurim interpretation and affected all SPCs granted or pending under that premise.

The Deputy Judge also rejected Merck’s claim of legitimate expectation, asserting that such a principle could not override the substantive provisions of the Regulation in consideration of a higher court ruling.

Conclusion

The High Court’s decision reaffirmed the fundamental principle of the retrospective effect of Court of Justice judgments and emphasised the narrow circumstances under which an exception to the principle of legal certainty may be invoked. The rejection of Merck’s appeal underscores the adherence of the UK courts to the principle that shifts in case law interpretations, especially substantive law, are applied ex tunc, leaving little room for deviation based on legitimate expectations. This maintains the uniform and coherent application of EU-derived law in the UK post-Brexit, up to the cut-off date, within the prescribed field of intellectual property rights concerning SPCs for pharmaceuticals.