Newron Combination Lock – UK Patents Court Restricts Combination SPCs
Summary
The decision in Newron provides a useful review of the SPC Regulation Article 3 and the debate over the meaning of ‘product’ in pharmaceutical marketing authorisations. The UK Patents Court has restricted the use of supplementary protection certificates (‘SPCs’) for combination products in Newron v Comptroller-General of Patents,[1] where the SPC-applicant challenged the Comptroller-General’s refusal to grant an SPC for a patent related to Parkinson’s Disease treatment, arguing that the marketing authorisation for the medicinal product XADAGO should be considered as an authorisation for the combination of three active ingredients. The Respondent maintained that the marketing authorisation was for the active ingredient safinamide alone, not the combination. The judge dismissed the appeal, upholding the Hearing Officer’s decision that the marketing authorisation was for safinamide alone and not for the combination.
Background
This case concerns an appeal by Newron from the decision of the Deputy Director acting for the Comptroller, dated 1 December 2022, which refused Newron’s application for an SPC on the grounds that it did not meet the requirements of Article 3(b) of Regulation (EC) No. 469/2009 (the ‘SPC Regulation’). The basic patent (EP 1 613 296 B) relates to a combination of three active ingredients (safinamide, levodopa, and a Peripheral Decarboxylase Inhibitor (‘PDI’)) for use in treating Parkinson’s Disease. The basic patent expires on 7 April 2024. Newron challenged the Hearing Officer’s reasons for finding that the marketing authorisation for the medicinal product XADAGO, which was relied upon in support of the SPC application, was not an authorisation for this combination. He said that the marketing authorisation was for the active ingredient safinamide alone, and not for a combination of safinamide, levodopa, and a PDI. He also said that the marketing authorisation was not in relation to safinamide in combination with both levodopa and a PDI. Newron attacked both reasonings in its appeal.
Parties’ submissions
The Appellant, Newron, argued that the marketing authorisation for the medicinal product XADAGO should be considered as an authorisation for the combination of safinamide, levodopa, and a PDI for use in treating Parkinson’s Disease. The SPC application was filed in 2015, while the UK was still part of the European Union. It was common ground that the Judge should apply the law as it was at that time.
Article 3 of the SPC Regulations is as follows:
‘Article 3 Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate.’
In support, Newron relied on the Opinion of the Advocate-General in Medeva v Comptroller-General of Patents,[2] suggesting that the term ‘product’ might have a different meaning as between the different limbs of Article 3.[3] Different national courts have taken different approaches when it comes to the interpretation of the term ‘product’ and whether it has to be the same for each limb of Article 3 (see for example our article on the case of Merck v Clonmel here [link: https://www.vennershipley.com/insights-events/combo-breaker-combination-products-and-the-spc-regulation/]). In the Appellant’s submissions, the term ‘product’ in Article 3(b) could be considered more broadly than elsewhere in the SPC Regulation, and could include the combination of the three active ingredients. However, the judge rejected this submission, stating the phrase should have the same meaning throughout the SPC Regulation. The Hearing Office had relied on the UK precedent of Yeda v Comptroller-General of Patents,[4] which states that ‘how a medicinal product is used does not form part of the identification of the product itself.’[5] Newron attacked Yeda as being a decision ‘reached hastily’ and potentially ‘wrongly decided on the facts.’[6]
Counsel for the Comptroller-General rejected this argument and referred to the line of European case law with which Yeda was consistent, which Arnold J. (as he then was) set out in Abraxis Bioscience v Comptroller-General of Patents.[7] Arnold J. found that it was ‘important that the SPC Regulation should provide a simple and predictable system which could be operated by national patent offices in a uniform manner,’[8] and therefore SPCs should not be granted for new formulations of old ingredients, even if that this might deprive meritorious inventions of extended protection. This is supported by paragraph 16 of the Explanatory Memorandum which led to the SPC Regulation, and recital 10 of the SPC Regulation itself.
Decision and Reasons for Judgement
The judge dismissed the appeal, upholding the Hearing Officer’s decision that the marketing authorisation for the medicinal product XADAGO was for the active ingredient safinamide alone, and not for a combination of safinamide, levodopa, and a PDI. The Hearing Officer was deemed to have correctly applied the SPC Regulation.
The judge emphasised that the SPC system should be simple and predictable, and that the product authorised by a marketing authorisation should be the product identified in article 1 of that marketing authorisation. Marketing authorisations under Regulation (EC) No 726/2004 generally set out specifics of what has been authorised in article 1, and then in articles 2 and 3, they reference any conditions for the authorisation and any requirements for the labelling and packaging of the product. In this case, article 1 of the marketing authorisation was specific to ‘Xadago-safinamide,’ Xadago being the name of the medicinal product. No other product was identified, and there was no mention of any combination of safinamide with anything.[9]
The judge noted that the Appellant’s central submission, that it had done valuable research and must be entitled to an SPC unless there was a good reason why not, was not the correct approach.[10] Rather, following Abraxis, the judge stated that the SPC Regulation is a balance of competing interests, and some meritorious inventions do not qualify for extended protection. The judge also rejected the Appellant’s argument that safinamide would ‘always’ be used in combination with levodopa/PDI. He found that even if that was correct (of which he had doubts), that would not be sufficient to go against the established case law, which does not allow ‘therapeutic use’ to be imported into the definition of product for Article 3(b)[11] (see Yeda above).
Commentary
This decision is unhelpful to those looking to obtain SPCs based on a combination of marketing authorisations, and limits the possibilities for obtaining combination SPCs in the UK overall. This decision means that only marketing authorisations specifying all the active ingredients in a fixed combination would be sufficient to support an application for a UK SPC for that combination.
[1] Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs [2023] EWHC 1471 (Ch) (16 June 2023)
[2] Medeva v Comptroller-General of Patents, Case C-322/10, [2012] RPC 25,
[3] Above n. 1 at 11.
[4] Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat)
[5] Ibid. at 26.
[6] Above n. 1 at 13.
[7] Abraxis Bioscience v Comptroller-General of Patents [2017] EWHC 2014
[8] Above n. 1 at 22.
[9] Above n. 1 at 32.
[10] Above n. 1 at 42.
[11] Above n. 1 at 44.
