Supplementary protection certificates and basic patents
For supplementary protection certificates (SPCs) to be filed in the EU, they must be based on a basic patent. Lise Luciani discusses this condition in the context of a recent French ruling.
Supplementary protection certificates (SPCs) are special IP rights that extend the duration of a pharmaceutical or phytopharmaceutical patent in Europe. The right was introduced at the beginning of the 1990s to encourage research (especially pharmaceutical research) by ensuring return on the often substantial investments required to develop and launch new drugs to market.
Supplementary protection certificates: CJEU issuing criteria
In a recent case, the French Institut National de la Propriété Industrielle (INPI) received an application for an SPC to protect the product atezolizumab. Atezolizumab is a monoclonal antibody directed against the PD-L1 protein (Programmed death-ligand 1), which plays an important role in suppressing the growth of tumours.
The SPC application had been submitted on the basis of a European patent 'New B7-4 molecules and their uses', filed in 2000, the claims of which relate to anti-PD-L1 antibodies and their use in modulation of an immune response in a subject. Indeed, the patent is based on the discovery of an antigen and describes the protein B7-4 (PD-L1) as a protein involved in the proliferation of T-cells and the modulation of immune responses. If anti-PD-L1 claims are claimed generically, there are no concrete examples of antibodies being made.
To obtain an SPC, however, it is important to remember that the product covered by the SPC application must be protected by an enforceable patent in the member states of the European Union (EU). At first sight, this condition may seem simple, but it actually raises many questions in practice.
The problem interpreting this rule in this case lies in the fact that the antibody is defined functionally in this patent, that is to say solely by its specific binding with an antigen, and not by its structure.
Since this type of functional definition is often encountered in patents, the Court of Justice of the European Union (CJEU) has clarified various aspects of this rule in past decisions to allow the IP offices of the EU Member States to apply it effectively.
In particular, the Royalty Pharma judgement rendered in 2020 specifies that, to determine whether a product is protected by the basic patent, it is necessary to check, when this product is not explicitly mentioned in the claims, whether it is necessarily and specifically referred to in one of these claims. To this end, two cumulative conditions must be met:
1) The product must, for a person skilled in the art, and in the light of the description and the drawings of the basic patent, fall under the invention covered by that patent, and
2) A person skilled in the art must be able to identify this product specifically in light of all the elements disclosed by the patent, and on the basis of the state of the art at the filing or priority date.
In order to determine whether the second of these conditions is satisfied, the CJEU recommends determining whether the subject of the SPC is included within the limits of what a person skilled in the art is objectively able to, on the date of filing or priority, to deduce directly and unequivocally from the specification of the patent as filed, based on their general knowledge in the field in question and in the light of the state of the art at that date.
Supplementary protection certificates: The atezolizumab ruling
In the present case, the INPI rejected the SPC application, on the grounds that the product covered by the SPC application would not be protected by the basic patent. This decision was confirmed by the Paris Court of Appeal (Paris Court of Appeal, pole 5, 2nd ch., May 26, 2023, 21/17890), which considered that the active ingredient atezolizumab was not specifically targeted by the basic patent.
The Court of Appeal considered that, if atezolizumab does fall within the functional definition covered by the basic patent, it has not been demonstrated that the person skilled in the art was able, on the date of filing or priority, to identify atezolizumab, a humanised monoclonal anti-PD-L1 antibody, of the Fc-modified IgG1 type, produced in Chinese hamster ovary cells by recombinant DNA technology, specifically, in view teachings of the patent, and on the basis of the state of the art at that date.
Although the patent does mention generic protocols for manufacturing antibodies, it targets both chimeric antibodies and humanised antibodies, and does not teach the person skilled in the art the direction in which they must direct their research, whereas research work is necessary to arrive at humanised anti-PD-L1 monoclonal antibodies having a therapeutic effect, and that it has not been demonstrated that it is a matter of a simple routine operation for the person skilled in the art.
The Court of Appeal specifies that it cannot be usefully argued that the absence of an explicit description, in the basic patent, of these different steps, is explained by the fact that they are molecular biology methods which form part of the general knowledge of a person skilled in the art.
On the other hand, the European patent relating to the specific identification of atezolizumab, which was filed by a third party company more than nine years after the priority date of the basic patent invoked, and the corresponding American patent may constitute an indication of the complexity of the research to be carried out to achieve this humanised antibody and of the independent inventive activity at the end of which it was developed.
This decision shows therefore an example of application by the INPI and the Court of Appeal of the criteria defined by the CJEU for the issuance of supplementary protection certificates.
For questions about supplementary protection certificates, including how and when to file them, speak to your Novagraaf attorney or contact us below.
Lise Luciani is a French and European Patent Attorney based at Novagraaf in Marseille.