French Supreme Court overturns SPC decisions in Ono cases

On 1 February 2023, the French Supreme Court overturned the decisions of the Paris Court of Appeal which confirmed the decisions of INPI refusing the registration of Supplementary Protection Certificates (SPCs), filed by Ono and Professor H., for nivolumab and pembrolizumab. In doing so, the Supreme Court clarified the method which must be adopted by the INPI and Courts to evaluate whether or not a product is protected by a basic patent, within the meaning of Article 3 a) of the Regulation (EC) No. 469/2009 (the SPC Regulation), when it is only functionally claimed in said patent.

On 15 December 2015, ONO Pharmaceutical & Professor H. filed an SPC application (No. 15C0088), based on the European patent 1 537 878 (hereafter EP’878), filed on 2 July 2003, and on a marketing authorisation (MA) No. EU/1/15/1014 for nivolumab, granted to the company Bristol-Myers Squibb Pharma EEIG on 19 June 2015. On the basis of the same patent, ONO Pharmaceutical & Professor H. filed a second SPC application (No. 16C0001) on 06 January 2016, based on the marketing authorisation (MA) No. EU/1/15/1024 for pembrolizumab, granted to Merck Sharp & Dohme on 17 July 2015.

Both SPCs applications have been rejected by INPI on 02 March 2018 by two decisions, which have been confirmed by the Paris Court of Appeal on 19 January 2021.

These two decisions have been overturned by the French Supreme Court on 1 February 2023.

The SPC applications cover nivolumab and pembrolizumab, two anti-PD-1 monoclonal antibodies efficient to treat cancers.

The basic patent in both cases claims “immunopotentiating compositions” and its claim 3 concerns an “anti-PD-1 antibody which inhibits the immunosuppressive signal of PD-1 for the use in cancer treatment”.

The mission of the Supreme Court here was to judge the validity of the criteria adopted by the Paris Court of Appeal to conclude that nivolumab and pembrolizumab, which are not expressly named nor structurally identified, but only functionally claimed in the basic patent, are not “protected by” the basic patent on which is based the SPCs applications, within the meaning of Article 3 a) of the SPC Regulation.

In its decisions, the Supreme Court recalled the principles already established by the CJEU in that regard.

Indeed, in such particular cases, the CJEU has already clarified, that the registration of a SPC is possible if “from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent” “the claims [of the basic patent] relates [to the product] necessarily and specifically” (CJEU, 25 July 2018, TEVA, C-121/17).

In its Royalty Pharma decision, the Court then ruled that such product must be “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” and that such criterion is not met if said product has been “developed after the filing date of the application for the basic patent, following an independent inventive step”(CJEU, 30 April 2020, Royalty Pharma, C-650/17).

The CJEU thus stressed the key role of the interpretation of the claims, which shall be done in the light of the information disclosed by the patent, to determine the extent of the protection conferred by the basic patent.

Therefore, if all the necessary information are disclosed in the basic patent to identify and develop the product functionally claimed and if the skilled person unquestionably mastered the technics to do so at the date of filing of the basic patent (or priority date), no independent inventive step is then necessary to develop it, from the basic patent, and such product should be considered as “specifically identifiable” and thus “protected by [the] basic patent”.

In the present cases, INPI and the Paris Court of Appeal both recognised that nivolumab and pembrolizumab were implicitly and necessarily covered by the basic patent insofar as it falls within the functional definition contained in the claims of the patent.

Nevertheless, the SPC protection was rejected notably on the basis of the registration of subsequent patents, several years after the filing date of the basic patent¹, covering the structure of the antibodies. The time required to file these patents would be, according to the appeal court, a strong indicator of the complexity of the research which must be carried out and of the necessity to demonstrate, on the basis of the EP’848, an “independent inventive step” to develop such antibodies.

The Supreme Court rightly sanctioned that reasoning and overturned the Court of Appeal decisions since it has failed to proceed with the two following analysis:

• “To research whether the methods to develop monoclonal antibodies were well known for the person skilled in the art at the time of filing of EP'878, and whether EP'878, in its description, described how to screen the relevant antibodies to identify those that perform the function of the invention, ie those that inhibit the "PD-1 immunosuppressive signal"”;

• “To research whether the person skilled in the art could, on reading the patent and using his general knowledge, obtain, by a routine operations, all the antibodies fulfilling the function covered by the patent, including nivolumab and pembrolizumab”.

Therefore, the information available in the basic patent (examples, etc.) as well as the general knowledge of the person skilled in the art must be carefully assessed by INPI and Courts, in light of the function of the invention, to determine whether or not the product is specifically identifiable by the skilled person in the art.

This ruling is perfectly in line with the above-mentioned CJEU case law, claiming the key role of the claims, which shall be read in light of the information disclosed in the patent and the general knowledge of the person skilled in the art, to determine whether a product is protected by a basic patent, within the meaning of Article 3 a) of the SPC Regulation.

Through these decisions, the Supreme Court has thus provided a welcome clarification on the method to be adopted by the INPI and Courts to analyse if a product, which is only functionally claimed by the basic patent, falls within the scope of protection of this patent, and has, in doing so, confirmed the method used for the very first time by the Paris Court of Appeal, in the Dana Farber case, in its decision of 25 May 2022, to annul the decision of INPI.

Indeed, the application of the last CJEU decisions by French Courts has attracted much attention as the method to be used by INPI, concerning these specific SPCs applications, was unclear. This clarification is thus very welcome as it puts an end to legal uncertainty.

¹ Three years for nivolumab and five years for pembrolizumab.