French court rules that clinical trials can constitute patent infringement

Insulet has once again been successful against Medtrum at the Judicial Court of Paris, which found an Insulet patent for an insulin delivery system for diabetes patients valid and infringed by its rival. In a unique turn of events, however, the court based its finding on Medtrum's use of the infringing product during its clinical trial phase.

The Judicial Court of Paris has found in favour of Insulet in a case on the merits regardingEP 1 874 390, ruling that Medtrum’s A6 and A7+ TouchCare devices infringe the valid patent.

But, in a move not before seen in the French courts, the judges found that it was Medtrum’s clinical trials for its A7+ TouchCare device which constituted infringement. The company has also based its reimbursement file, meaning the price it could assign to each product, on said clinical trial.

While, in patent proceedings, the Paris court has always considered importation and online sales infringing acts, in this instance Insulet triumphed without the infringing devices even going to market. Usually in such cases, the infringement finding is handed down only once the products are commercially available.

Insulet and Medtrum in the market

Both companies produce devices which automatically dispense insulin into a patient with diabetes without the need for regular injections. As the population grows, and with more people diagnosed with diabetes, the devices are increasingly sought after in the market.

Insulet is a US-based medical device manufacturer which primarily produces Insulin pumps. Medtrum is involved in the management of diabetes. For example, the Chinese company produces medical devices to help control the disease, and creates tools to support healthcare professionals. It is also engaged in research regarding the development of an artificial pancreas.

Parallel proceedings are ongoing in Germany. In August 2020, the Regional Court Düsseldorf found that Medtrum infringed EP 390 (case ID: 4c O 20/19). Medtrum did not appeal. However, in March 2024 the Federal Court of Justice will hear the nullity case.

Turning on the trial

In its pleadings, Insulet had contended that rival Medtrum’s A6 and A7+ devices infringe EP 390. Medtrum disputed the validity of a previous saisie-contrefaçon and what it described as the ‘potentially abusive nature of proceedings’, while Insulet argued on the basis of unfair competition and for damages.

Thus, in October 2023, the Judicial Court of Paris found in favour of Insulet. It declared the previous saisie-contrafaçon legitimate and rejected Medtrum’s request for damages for abusive proceedings and abusive seizures of counterfeit goods. However, the court also rejected Insulet’s request for destruction of A6 and A7+ TouchCare devices and patch tanks in France.

But the real crux of the case turned on Medtrum’s use of its infringing devices for clinical trials. The company used its A7+ TouchCare devices to conduct trials, whereby it compared its products with Insulet’s rival Omnipod devices. This was the first tubeless, insulin-delivery system available on the market.

Medtrum used the results in a regulatory dossier, which the French health authorities required to obtain pricing and reimbursement approval for the company’s new Nano A8 version. It had developed the Nano A8 following a preliminary injunction against its A6 and A7+ devices.

PI up first

Insulet first initiated the case concerning EP 390 in France in 2020, ordering a saisie-contrefaçon at the Medtrum representative’s home in France. It then filed an infringement lawsuit over the patent, which covers a ‘fluid delivery device’.

The Judicial Court of Paris ordered a preliminary injunction in March 2021 against Medtrum’s A6 and A7+ TouchCare products. Insulet did not request the clinical trials be stopped, in order to avoid disrupting medical services to patients.

In May 2023, a Paris Court of Appeal decision then confirmed the first-instance PI. As a result, Medtrum never commercialised the A6 and A7+ products, which it had used in the clinical trials, instead developing its product into the updated Nano A8 version.

A Supreme Court action is pending, although the PI expired upon commencement of the first-instance merits hearing.

In July 2023, in parallel proceedings, the Judicial Court of Paris ordered subsidiaries Medtrum GmbH and Medtrum B.V. to recall all Nano TouchCare models sold in France (case ID: 352J-W-B7H-CZUVZ). This was on the basis of alleged infringement of Insulet patentEP 2 438 957.The case remains pending on the merits.

In the same month, the Higher Regional Court Düsseldorf declared that the A7+ infringes EP 957 B1 (I-2 U 79/22).