On 1 February 2019, Setterwalls reported on successfully representing Sandoz in a dispute regarding a supplementary protection certificate (SPC) for medicinal products at the Patent and Market Court of Appeal (PMÖD) (here). In a new preliminary ruling, case number C-650/17 (Royalty Pharma), the Court of Justice of the European Union (ECJ) has confirmed the principles for interpretation of Article 3(a) of the Supplementary Protection Certificate Regulation which formed the basis for PMÖD’s decision from 2019.
Background – PMÖD applied the test from Teva vs Gilead in the Darunavir Case
A medicinal product is often the result of lengthy and costly research. Promotion of pharmaceutical research within the EU requires favourable and balanced regulations which stimulate such research. Against this background, a European regulation was introduced for supplementary protection certificates for medicinal products to extend the protection period by up to five years. One of the requirements established in Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation) for an SPC to be granted is that the product (i.e. the active substance) must be protected by a basic patent in force (Article 3(a)). The said article has been the subject of interpretation by the ECJ on a number of occasions, most recently 30 April this year, when the Court passed judgement on Royalty Pharma, and previously in July 2018 in case C-121/17 (Teva vs Gilead).
PMÖD applied the interpretation principles from Teva vs Gilead in case no. PMÖ 12172- 18 in relation to the SPC certificate for the active substance darunavir (the Darunavir Case). PMÖD concluded that the SPC for darunavir is likely to be invalid, as darunavir is not protected by a basic patent in force, meaning that it was granted in violation of Article 3(a) of the SPC Regulation. The Royalty Pharma judgement confirms that PMÖD was correct to apply the test set out in Teva vs Gilead in the Darunavir Case, and brought welcome clarity in some remaining detail queries regarding what it means for a product to be protected by a basic patent in force.
The test in Teva vs Gilead
In accordance with previous practice from the ECJ, the scope of protection for a basic patent in force is determined by Article 69 in the European Patent Convention (EPC) along with the protocol on the interpretation of that provision. The SPC must not only regard a product that is covered by the scope of protection of the basic patent, but the product must also either be explicitly mentioned or necessarily and specifically referred to in the patent claims. Teva vs Gilead specified that if a product is not specifically mentioned, then in order for a product to be considered to be protected by a basic patent in accordance with Article 3(a) of the SPC Regulation, the following is required:
- that the skilled person must necessarily consider the product to fall under the invention covered by that patent, and
- that the product specifically could have been identified by a skilled person in light of all the information disclosed by that patent and in light of the skilled person’s common general knowledge at the priority date.
Two cumulative conditions must therefore be met in the event that the product is not specifically mentioned in the patent claims.
Clarification from Royalty Pharma
Teva vs Gilead referred to a combination product with two active substances. One remaining question following Teva vs Gilead was whether the test (i.e. the two cumulative conditions) in Teva vs Gilead has general applicability and is also applicable in relation to products with one active ingredient. Through Royalty Pharma it is now clear that the test has general applicability and PMÖD was therefore correct to apply the test in relation to darunavir in the Darunavir Case.
Another remaining question following Teva vs Gilead was whether the term ‘the core inventive advance’ is relevant for the interpretation of Article 3(a) of the SPC Regulation. There have been difference of opinion amongst EU Member States on this matter. The ECJ’s very clear response is that the term ‘the core inventive advance’ is not relevant for the interpretation of Article 3(a). It is thus clear that there is no room for any type of inventive step assessment, in relation to Article 3(a) of the SPC Regulation. The scope of protection of the SPC shall be limited to the technical properties of the invention that is protected by the basic patent, determined through the application of Article 69 in the EPC and the protocol on its interpretation.
Through Royalty Pharma, the ECJ has also clarified that the scope of protection of the basic patent shall be determined at the priority date. If the result of research occurring after the priority date could be taken into account, an SPC would enable the patent holder to obtain protection for these results, even if they were not known at the priority date. The Court emphasises that the aim of the SPC is not to expand the scope of protection for the basic patent to include more than the invention covered by the patent. On the contrary, this would go against the purpose of the SPC Regulation. It is therefore not possible to obtain an SPC for a product which has been developed through independent inventive work conducted after the priority date of the basic patent. In other words, if a patent has been granted after the priority date of the basic patent for a product which is indeed covered by a functional definition in the basic patent, an SPC cannot be granted for this product, as it has been developed through independent inventive step.
At present there are no further pending requests for preliminary rulings regarding the interpretation of Article 3(a) of the SPC Regulation. The requirement that a product must be protected by a basic patent in force may, at least for now, be considered to be clear.