In three rulings handed down on 1st February 2023, the Cour de cassation (the French highest civil court) applied, for the first time, the teachings of the CJEU in Royalty Pharma Collection Trust v. Deutsches Patent- und Markenamt case (C-650/17) on 30 April 2020 on Article 3 (a) of the SPC EU Regulation.
In the decision, the CJEU ruled that Article 3(a) must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of that provision, if:
- it corresponds to a general functional definition used by one of the claims of the basic patent;
- and it necessarily comes within the scope of the invention covered by that patent;
- but it is not otherwise indicated in individualised form as a specific embodiment of the method of that patent;
provided that it is specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.
The CJEU also ruled that article 3(a) must be interpreted as meaning that a product is not protected by a basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition given in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step.
The cases brought before the Cour de cassation opposed the General Director of the French Patent Office (INPI) to (i) Ono Pharmaceutical co. Ltd and Mr X, in relation to their SPC applications on pembrolizumab (docket No. 21-13.663) and on nivolumab (docket No. 21-13.664), and (ii) Wyeth LLC and The General Hospital Corporation, with respect to their SPC application on osimertinib (docket No. 21-17.773).
In the pembrolizumab and nivolumab cases, the Cour de cassation quashed the judgments of the Paris Court of Appeal which had upheld the decisions of the General Director of the French Patent Office to deny the grant of the SPC applications. In particular, the Court held that the Court of Appeal had not ascertained, first, whether the methods for manufacturing anti-PD-1 monoclonal antibodies were well known to the person skilled in the art at the relevant date and whether the basic patent described how to screen the relevant anti-PD-1 antibodies so as to identify those that fulfil the function of the invention (i.e. inhibition of PD-1) and, second, whether the person skilled in the art could accordingly achieve through routine operations all the antibodies fulfilling the function covered by the patent.
Before the decisions of the Cour de cassation, the Court of appeal of Paris, in a case relating to another anti-PD-L1/anti-PD-1 antibody, avelumab (Dana Farber Cancer Institut, 25 May 2022, docket No. 21/08514), had changed its position in considering that, as long as the basic patent described screening methods for identifying anti-PD-L1/anti-PD-1 antibodies, avelumab was specifically identifiable by a person skilled in the art in light of the information disclosed by that patent, without independent inventive step. It is now up to the Court of appeal of Paris on remand to decide whether this should also be the case for the patents relating to pembrolizumab and nivolumab.
With respect to the case on Osimertinib, an EGFR inhibitor, the Cour de cassation dismissed the appeal lodged against the Paris Court of Appeal’s judgment which had upheld the General Director of the French Patent Office’s denial of the grant of the SPC application on osimertinib. The Supreme Court notably confirmed the reasoning of the Court of Appeal according to which, even if osimertinib corresponds to the general functional definition given by the basic patent, it could not be protected by SPC as it was unknown to the person skilled in the art at the relevant date and could not be deduced directly and unambiguously from the basic patent. Osimertinib was therefore considered not specifically identifiable by the person skilled in the art based on their common general knowledge in the relevant field and on the state of the art at the filing or priority date of the patent.
The three judgments are available:
- General Director of the French Patent Office (INPI) vs. Ono Pharmaceutical co. Ltd and Mr X, docket No. 21-13.663 (pembrolizumab case) in FR and EN;
- General Director of the French Patent Office (INPI) vs. Ono Pharmaceutical co. Ltd and Mr X, docket No. 21-13.664 (nivolumab case) in FR and EN;
- General Director of the French Patent Office (INPI) vs. Wyeth LLC and The General Hospital Corporation, docket No. 21-17.773 (osimertinib case) in FR and EN.