Court of Appeal implements CJEU ruling in Janssen’s dispute with INPI

The INPI had previously rejected Janssen’s applications, citing Article 3(a) of the SPC regulation. Janssen sought SPCs to protect combinations of active ingredients used in HIV treatment.

The Paris Court of Appeal ruling is the first in France to implement the CJEU decision regarding MSD’s drugs Janumet and Inegy. In December, the Luxembourg judges ruled on whether an SPC can be granted for a combination of two active ingredients when one is already protected by an SPC. The CJEU determined that an existing SPC for one active ingredient need not prevent granting an SPC for the combination (case IDs: C-119/22 and C-149/22).

The Supreme Court in Paris had suspended the parallel French proceedings in MSD vs Teva pending the CJEU’s decision. To date, the case at the highest French court is still pending.

Synergistic effect

In 2016, Belgian Janssen Pharmaceutica, a subsidiary of US life sciences company Johnson & Johnson, submitted applications to the INPI for SPCs covering two combination products based on EP 1 632 232.

The first SPC covered tenofovir alafenamide fumarate, emtricitabine and rilpivirine hydrochloride. The second concerned tenofovir alafenamide fumarate and rilpivirine hydrochloride.

The SPC application refers to Gilead’s marketing authorisation for a pharmaceutical product called Odefsey. Gilead developed the drug, which combines emtricitabine, rilpivirine hydrochloride and tenofovir alafenamide fumarate, with Janssen’s parent company Johnson & Johnson. The drug treats adults and adolescents with HIV-1.

Janssen Pharmaceutica claims the pharmaceutical compositions have improved therapeutic properties. According to the company, the combination produces a synergistic effect on HIV replication that exceeds the sum of each active ingredient’s individual effects. This allows for reduced dosage of the anti-HIV drug and thus causes fewer side effects.

INPI refuses grant

In 2022, the INPI refused to grant the SPCs, claiming the product in the application was not protected by the basic patent EP 232. The patent office found that the product was neither the subject of the invention nor specifically mentioned in the basic patent, thus failing to comply with Article 3(a) of the SPC regulation. Janssen appealed the decision.

The Court of Appeal has now ruled that the combinations do fall under the invention covered by the basic patent. The panel, comprising presiding judge Véronique Renard, chamber president Marie Salord and judge Gilles Buffet, annulled the INPI Director General’s decision (case IDs: 22/19235 and 22/19239).

In doing so, the court applied principles established by the Eli Lilly, Royalty Pharma and Teva rulings, and for the first time in this context, those from the CJEU’s Teva vs MSD ruling of 19 December 2024.

Janssen banks on SPC experience

Gide Loyrette Nouel represented Janssen. The IP team of this traditional French full-service law firm has established a reputation for its expertise in SPCs. The team previously represented Ono Pharmaceutical in a dispute against the INPI over SPCs for cancer drug Opdivo. In the current case, partner Raphaëlle Dequiré-Portier led, with counsel Marie-Ange Pozzo di Borgo and associate Emilia Grenier assisting.

The team collaborated with patent attorneys from Regimbeau. The firm’s Nicolas Bouquin and Julie Toueg handled prosecution before the INPI. Kilburn & Strode coordinated the SPC filings and appeals around Europe on instructions from Liesbeth Vervoort of Janssen’s US based mother company Johnson & Johnson.

Luca de Maria of Pellerin De Maria Guerre worked on the case as an attorney specialising in Court of Appeal procedures. Gide regularly works with him, as in the Optivo case.

In-house counsel Virginie Landais represented the INPI.