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

The French Court of Appeal has implemented the CJEU's decision on supplementary protection certificates for the first time. As a result, the French Patent Office (INPI) must now grant SPC applications for HIV treatment filed by Janssen Pharmaceutica.

 

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.

 

 

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.

 

 

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.