“Review of Key Pharmaceutical Patent Cases in France in 2023”

In 2023, the French patent courts were particularly busy with significant pharmaceutical cases, particularly those involving Supplementary Protection Certificates (SPCs). The French Supreme Court issued landmark decisions on the interpretation of the European SPC regulation, with the most notable judgments resulting from disputes between the Dana Farber Cancer Institute and Ono Pharmaceutical against the French Patent and Trademark Office (INPI).

The Supreme Court in Paris (Cour de Cassation) has paved the way for future SPC rulings by applying the CJEU’s Royalty Pharma decision. The disputes at the centre of these decisions revolved around patents for monoclonal antibodies, for which the INPI rejected applications for SPCs on the grounds that they did not meet the requirements of Regulation 469/2009.

The Supreme Court reviewed these decisions in light of the CJEU judgement in the Royalty Pharma case against the German Patent and Trademark Office (DPMA). The most recent decision in the dispute between Dana Farber Cancer Institute and the INPI stands out, as the Court of Appeal had already overturned the decision of the INPI, a rare occurrence in previous disputes between SPC applicants and the INPI.

The Supreme Court dismissed the INPI’s appeal in January 2024, applying the criteria laid down by the CJEU. According to the judges, EP 424 did indeed protect the human monoclonal antibody avelumab. The court also rejected the INPI’s request to refer questions to the CJEU concerning the allowability of SPCs in the circumstances presented.

The Supreme Court confirmed the case law that it had first set out in its judgment on Ono Pharmaceutical in the dispute over nivolumab and pembrolizumab in February 2023. The INPI had rejected both applications, a decision that was upheld in the appeal. However, the highest-instance court then overturned this Court of Appeal decision from 2021, applying the ruling of the CJEU in Royalty Pharma for the first time.

In contrast, patent disputes relating to mobile communications or digital technology patents played a lesser role, with the market paying most attention to the Court of Appeal decision in Assia vs. Nokia and Orange over DSL technology.

At the start of 2024, the curtain came down on the final act of the patent dispute between Philips, TCL and ETSI. While the original dispute between the Dutch patent holder and the Chinese mobile phone manufacturer has long since settled, standardisation body ETSI is left with the costs of the proceedings following the latest ruling by the Court of Appeal.

This week, the market is eagerly awaiting the oral hearing at the Paris Court of Appeal in the dispute between Intellectual Ventures and numerous mobile phone providers. This is one of the largest telecommunications disputes in the country.

In other high-profile SPC disputes, the focus was on the question of whether an office can grant an SPC for a combination of active ingredients, if an SPC already exists for one of the individual active ingredients in the combination. This question is at the crux of several disputes, some of which are still pending at the CJEU.

In the pan-European battle between Bristol-Myers Squibb and Teva, France takes a different course. Blood thinner Eliquis is one of Bristol-Myers Squibb’s most important blockbuster products. For two years, a dispute has raged throughout Europe over the market entry of generic products containing the active ingredient apixaban.

In the high-profile pan-European dispute over fingolimod, whether a preliminary injunction can be obtained for a patent that the EPO has not officially granted is the main question. In France, after the first instance decision, the Court of Appeal also rejected Novartis’ application in the dispute against Biogaran.

Eli Lilly has battled with various generic manufacturers over pemetrexed for years. After French courts awarded the pharma company damages in some cases, the Judicial Court Paris rejected similar claims of the innovator against Viatris. The patent in suit, Eli Lilly’s EP 1 313 508, forms the basis of the blockbuster chemotherapy drug Alimta. It expired in mid-2021. However, litigation over damages is still ongoing.

In conclusion, 2023 was a year of significant patent disputes in the French courts, particularly in the pharmaceutical sector. The landmark decisions issued by the French Supreme Court have set the stage for future rulings on SPCs and have the potential to significantly impact the pharmaceutical industry.