Strict liability in preliminary injunction proceedings: Advocate General opinion

In a case that is being closely watched, Advocate General Szpunar recently issued an opinion on whether the strict liability regime for losses caused by preliminary injunctions (PI), based on intellectual property (IP) rights that are subsequently found invalid, is consistent with the Directive on the enforcement of IP rights (2004/48/EC). (C‑473/22, Mylan v Gilead, 21 September 2023.)


The opinion concerns a case originating from the Market Court of Finland. Mylan requested Gilead to pay approx. 2.3M€ as damages for losses caused by a PI sought by Gilead against Mylan, based on a supplementary protection certificate that was subsequently found invalid.

Mylan argued that the PI had been sought unnecessarily which would expose Gilead to strict liability under well-established Finnish case law. This provides that a person who obtains a PI is strictly liable for compensation if the IP right on which the PI was granted is subsequently found invalid.

Gilead argued that such a liability regime was contrary to the Enforcement Directive following the CJEU’s earlier ruling in Bayer Pharma (C‑688/17, 12 September 2019). The CJEU ruled in this case that the mere fact of repealing the PI should not allow national courts to automatically and in any event order the PI applicant to compensate the defendant for any loss suffered.

Opinion of Advocate General Szpunar

The Market Court referred the case to CJEU asking if the strict liability regime of Finnish law was compliant with the Enforcement Directive.

The AG first explained the approach taken by the CJEU in Bayer Pharma, as well as the characteristics of strict liability regimes in most countries. He stated that the automatic nature of strict liability regimes, that are independent of the circumstances of the case and based only on the status of the person concerned, is precisely what is precluded by Article 9(7) of the Enforcement Directive which states:

Where the provisional measures are revoked or where they lapse due to any act or…

Full article available on PatentHub

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