Key Facts
- •Newron Pharmaceuticals SPA appealed the refusal of a supplementary protection certificate (SPC) by the Comptroller-General of Patents, Trade Marks and Designs.
- •The basic patent (EP 1 613 296 B) concerned the use of safinamide in combination with levodopa/PDI for treating Parkinson's disease.
- •The marketing authorisation (MA) relied upon was for safinamide alone (XADAGO), not the combination claimed in the patent.
- •The Hearing Officer found the MA did not cover the claimed combination for two reasons: the MA was for safinamide alone, and it did not sufficiently address the combination with both levodopa and a PDI.
Legal Principles
The term 'product' in the SPC Regulation refers strictly to the active ingredient or combination of active ingredients, not the therapeutic use.
SPC Regulation, Article 1(b); CJEU cases Pharmacia Italia, MIT, Yissum, Santen
The 'product' in an SPC application is the product identified in Article 1 of the MA, and how it is used does not form part of the product's identification.
Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat)
The SPC Regulation balances the interests of patentees and other stakeholders, meaning some meritorious inventions may not qualify for extended protection.
Abraxis Bioscience v Comptroller-General of Patents [2017] EWHC 2014; Santen, Case C-673/18
Outcomes
The appeal was dismissed.
The MA was for safinamide alone, not the combination claimed in the patent. The court found the Hearing Officer's analysis of the MA to be correct and consistent with established case law. The therapeutic use of the product cannot be imported into the definition of the product itself.