Paris Court of Appeal Overturns the French Patent Office decision to refuse the grant of Two SPC Applications Filed by Janssen Pharmaceutica on the basis of Article 3(a) of the SPC regulation
By Marie-Ange Pozzo di Borgo and Emilia Grenier, Associates at Gide Loyrette Nouel.
In two rulings issued on 16 May 2025, the Paris Court of Appeal annulled decisions by the French Patent Office (INPI) refusing to grant supplementary protection certificates (SPCs) to Janssen Pharmaceutica NV. These are interesting decisions as they relate to combinations of active ingredients and are the first decisions implementing the recent Teva v. MSD CJEU decision in France.
The SPC applications concerned the following combinations of active ingredients:
- First SPC: tenofovir alafenamide fumarate, emtricitabine, rilpivirine hydrochloride ;
- Second SPC: tenofovir alafenamide fumarate, rilpivirine hydrochloride.
Seized with appeals brought by Janssen, the Court sided with the company’s arguments, holding that the claimed combinations met the requirements of Article 3(a) of Regulation (EC) No 469/2009 concerning SPCs.
The Court found that the combinations necessarily fell under the invention covered by the basic patent. In doing so, it applied the principles established by the Eli Lilly, Royalty Pharma, and Teva rulings, and for the first time in this context, those from the Teva and MSD ruling of 19 December 2024 by the CJEU (joined cases C-119/22 and C-149/22).
The Court began by reaffirming that the assessment must first determine whether the combination subject to the SPC is a feature required for the solution of the technical problem disclosed by the basic patent.
Following Janssen’s reasoning, the Court concluded that the basic patent explicitly disclosed that the claimed combination produces a synergistic effect on HIV replication that differs from the sum of the effects of each active ingredient taken separately – notably allowing the reduction of the dose of the anti-HIV drug and its side effects.
This enhanced effect directly addresses one of the technical problems identified in the patent – namely, to provide a pharmaceutical composition with improved therapeutic properties for treating HIV.
Contrary to the assertions of the INPI, the Court found that the patent’s description did in fact emphasize that combining rilpivirine hydrochloride with one or more additional antiretroviral agents results in an enhanced therapeutic effect due to synergistic action against HIV replication. This analysis, however, had not been undertaken by the INPI in its decision to reject the applications.
Importantly, the Court held that the absence of specific experimental examples of the combination in the patent does not preclude the combination from being considered as forming part of the invention.
The Court also recalled that each active ingredient must be “specifically identifiable” in the basic patent. Specifically, addressing concerns over tenofovir being mentioned only within a broader list of compounds, the Court clarified that this does not preclude its identification. What matters is whether, based on the common general knowledge of the skilled person, the active ingredient is implicitly but unambiguously disclosed in the claims.
In this case, the Court found that the documents submitted by Janssen reflected the common general knowledge of the skilled person and demonstrated that tenofovir was part of the class of nucleotide reverse transcriptase inhibitors, which the patent expressly identified as agents that could be combined with rilpivirine.
From a procedural standpoint, the Court reaffirmed that, in appeals against INPI decisions, its review is confined to the evidence and arguments that were submitted during the administrative phase. As such, parties are precluded from introducing new documents that were not subject to adversarial debate before the INPI. Applying this principle, the Court excluded several documents filed by the INPI on appeal, as they had not been part of the original administrative proceedings.
Finally, the Court rejected the INPI Director’s argument that granting the SPCs would run counter to the purpose of Regulation No 469/2009 by fostering “evergreening” and prolonging market exclusivity. The Court held that such policy-based reasoning was irrelevant where the application satisfies the substantive criteria of Article 3(a). Moreover, the Court noted that this argument had not been included in the INPI’s initial decisions and therefore could not be relied upon ex post to justify the rejections and that the INPI was not free to change its arguments to try to save its decision in appeal.
These annulment decisions mark a significant development in French case law on SPCs involving combinations of active ingredients. They reflect a shift in the case law of the Paris Court of Appeal, offering renewed guidance for pharmaceutical innovators.
[The Authors of this article acted as counsel in the underlying case, and the article reflects their personal interpretation of the proceedings and outcome.]
Paris Court of Appeal Overturns the French Patent Office decision to refuse the grant of Two SPC Applications Filed by Janssen Pharmaceutica on the basis of Article 3(a) of the SPC regulation
By Marie-Ange Pozzo di Borgo and Emilia Grenier, Associates at Gide Loyrette Nouel.
