In a ruling between Merck and a group of patients over thyroid medication, the Paris Court of Appeal has ruled that patients cannot sue pharmaceutical companies' patents for invalidity in France. According to the court, since patients are not competitors, they lack commercial interest.
21 February 2022 by Christina Schulze
In France, the courts do not permit just anyone to file suit against a patent. In a recent decision, the Paris Court of Appeal has ruled a plaintiff must be a competitor, or be able to prove a commercial interest. The dispute was already making waves in terms of information rights for patients.
It also stands in contrast to proceedings at the European Patent Office, or even in Germany, where strawman oppositions are common.
The important decision was the result of an emotional dispute between pharmaceutical company Merck, and a group of patients who said they could not tolerate a modified composition of one of the company’s thyroid medicines.
In order to keep the concentration of the active ingredient levothyroxine sodium more stable with less variance over the entire three-year shelf life of the tablets, Merck changed the composition of blockbuster drug Euthyrox. However, the company complied by replacing the excipient lactose with mannitol and citric acid.
But its active ingredient levothyroxine sodium remained unchanged. The company filed a patent application for the new composition, EP 2 885 005.
A large number of patients take the thyroid drug Euthyrox on a long-term basis. According to press reports, there are three million patients in France alone. In 2017, Merck launched the newly-formulated drug on the French market. As a result, several thousand patients unsuccessfully sued the company because they felt they had been poorly informed about the new formulation.
The patients claimed they could not tolerate the new version. In particular, they suffered side effects that often accompany hyperthyroidism.
Following this unsuccessful lawsuit, a group of more than 70 patients challenged the company’s patent EP 2 885 005. They belong to the patient association Alerte Thytoïde. Corsican lawyer Anne-Catherine Colin-Chauley is president of the association, and its representative in court.
IP lawyer Jérôme Tassi of law firm Agilit has also represented the patients since 2019. He started his career at Loyer & Abello and is known in the patent scene for his publications on seizures, known as saisie-contrefaçon.
From the outset, Merck has worked with a team led by Simmons & Simmons partners François Jonquères and Marina Cousté in the patent proceedings.
An appeal to the cour de cassation is possible.
For Alerte Thytoïde
Agilit (Paris): Jérôme Tassi
Simmons & Simmons (Paris): François Jonquères, Marina Cousté; associate: Mickaël Da Costa
Court of Appeal Paris (20/07061), Chambre 2
Brigitte Chokron (Présidente), Laurence Lehmann, Agnès Marcade (both Conseillère), Carole Trejaut (Greffière)