Newron Pharmaceuticals SpA v The Comptroller-General of Patents, Trade Marks and Designs

For supplementary protection certificates, “the product” has the same meaning throughout the SPC Regulation: the active ingredient or combination of active ingredients identified by Article 1(b). Therapeutic use does not become part of the product merely because an ingredient is used as add-on therapy or is clinically effective alongside other medicines.

The marketing authorisation must identify the same product as the basic patent. References to other medicines may explain use without making them part of the authorised product. A meritorious invention does not qualify where the statutory conditions are unmet.

Newron appealed from a UK Intellectual Property Office decision dated 1 December 2022 refusing its application for a supplementary protection certificate under Article 3(b) of the SPC Regulation.

The basic patent claimed safinamide in combination with levodopa and a peripheral decarboxylase inhibitor for treating Parkinson’s disease. The application relied on a marketing authorisation for Xadago, identified as safinamide. The issues were whether that authorisation was for the patented combination and whether it related to safinamide combined with both levodopa and a peripheral decarboxylase inhibitor.

1. Appeal dismissed. The marketing authorisation did not authorise the same product as the basic patent.
2. Article 1(b) gives “the product” a single meaning throughout the SPC Regulation. It means the active ingredient or combination of active ingredients. Therapeutic application does not form part of the product’s identification. This was consistent with Pharmacia Italia, MIT, Yissum, Santen and Yeda.
3. The Xadago authorisation identified the medicinal product as Xadago-safinamide. Its terms, summary of product characteristics, annexes and packaging pointed to safinamide alone. References to levodopa explained use but did not identify a combination product.
4. The value of the research and the asserted necessity of levodopa/PDI could not alter the statutory analysis. The SPC Regulation balances competing interests and does not guarantee extended protection for every meritorious invention.
5. Separately, references to a peripheral decarboxylase inhibitor were too few, embedded and equivocal to show that the authorisation was for the combination. They established only a possible use of safinamide as part of that combination.
6. The fresh evidence application was refused. The evidence could have been adduced below and was largely irrelevant. The admitted clinical-development guideline did not assist and could not change the applicable law.

• High Court (Intellectual Property List): appeal from the UK Intellectual Property Office decision of 1 December 2022. Appeal dismissed.