NEWS

Patients cannot sue for invalidation of drug patents in France

Release time:

2022-03-18 16:29

In a patent invalidation suit, who can file a patent invalidation suit? Can anyone file a patent invalidation suit? In a thyroid drug ruling in France, the pharmaceutical company Merck and a group of patients, the Paris appeals court ruled that patients could not file a patent invalidation against a pharmaceutical company because the patient was not a competitor and lacked so-called commercial interest.

Merck changed the composition of the thyroid drug Euthyrox in order to keep the concentration of the active ingredient levothyroxine sodium stable, with less variation over the three-year shelf life. They used mannitol and citric acid instead of the excipient lactose, while its active ingredient, levothyroxine sodium, remained unchanged. After changing the formula, Merck filed a new ingredient patent application.

Many patients take the thyroid drug Euthyrox for a long time. In 2017, Merck launched a newly formulated drug in France, but patients could not receive the new thyroid drug because of the side effects of hyperthyroidism. Thousands of patients unsuccessfully sued Merck because they knew little about the new formula.

The patient also failed to file a patent invalidation lawsuit. The French court does not allow anyone to sue over the patent, and the court believes that the plaintiff must be a competitor or can prove its commercial interest. This ruling is different from the patent invalidation procedure of the European Patent Office, and even in Germany, the "straw man" system in patent invalidation is quite common.

On the other hand, more than 70 patients tried to challenge the invalidity of Merck's patents in the name of the association after they were unable to successfully file a lawsuit. The conflict between pharmaceutical companies and patients continues.
 

Patent Invalidation Litigation, Merck, Levothyroxine Sodium