Newron Pharmaceuticals SpA v The Comptroller General of Patents, Trademarks and Designs

For article 3(b) of Regulation (EC) No. 469/2009, the authorised product is the active ingredient, or combination of active ingredients, identified in the marketing authorisation as the medicinal product. The product has the same meaning throughout article 3.

Instructions in a summary of product characteristics about using that medicinal product with another medicine describe its therapeutic use. They do not, without more, make the other medicine an active ingredient in the authorised product. The statutory balance is fixed by the Regulation and does not permit a case-specific, purposive enlargement of the definition of product.

Newron sought a supplementary protection certificate for a patent claiming safinamide used with levodopa and a peripheral decarboxylase inhibitor to treat Parkinson's disease. Its marketing authorisation for Xadago identified safinamide as the active ingredient, but stated that it was indicated as add-on therapy to levodopa.

The Hearing Officer refused the application. The High Court dismissed Newron's appeal: [2023] EWHC 1471 (Ch). Newron appealed to the Court of Appeal, contending that the marketing authorisation authorised the three-ingredient combination and, alternatively, a combination including safinamide and levodopa. The central issue was whether references to add-on therapy formed part of the authorised product for article 3(b).

1. Appeal dismissed. Birss LJ, with whom Moylan and Lewison LJJ agreed, held that the marketing authorisation did not authorise the combination protected by the patent.

2. Under articles 1(b) and 3 of Regulation (EC) No. 469/2009, a product is the active ingredient or combination of active ingredients of the medicinal product. That meaning is constant throughout article 3. The authorities, culminating in Santen, establish that the therapeutic application or manner of use of a product is not part of its identity for this purpose.

3. The Court rejected an outcome-driven construction founded on the general objective of encouraging pharmaceutical research. The Regulation itself strikes the balance between research, public health and generic competition. Its operation is intended to be relatively simple and transparent for patent offices.

4. The Commission decision and the opening sections of the summary of product characteristics identified Xadago and safinamide alone. The indication that safinamide was to be used as add-on therapy to levodopa described how safinamide was to be used. It did not make levodopa, or a peripheral decarboxylase inhibitor, an active ingredient in the medicinal product authorised for marketing. Newron was authorised to market safinamide, not the claimed combination. There was therefore no matching marketing authorisation under article 3(b).

5. The proposed expert evidence was both procedurally inappropriate and unnecessary. The second ground did not arise once the first ground failed. Birss LJ made no concluded determination of it.

• Court of Appeal (Civil Division) Dismissed Newron's appeal and upheld the refusal of the supplementary protection certificate application: [2024] EWCA Civ 128.

• High Court of Justice, Intellectual Property List (ChD) Recorder Douglas Campbell KC dismissed Newron's appeal from the Hearing Officer and upheld the refusal: [2023] EWHC 1471 (Ch).

• Patent Office The Hearing Officer refused the application because the marketing authorisation was for safinamide alone, rather than the claimed combination.