Mylan v Gilead Sciences Finland and Others (CJEU, C-473/22, 2024)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Finnish Market Court (Markkinaoikeus), the Court of Justice held that Article 9(7) of Directive 2004/48 does not preclude a national regime of no-fault liability of the applicant for provisional measures, under which any damage caused by a measure later lifted must be compensated, provided that the court can adjust the amount of damages in the light of the circumstances of the case, including the defendant’s contribution to its own loss (operative part). The judgment clarifies Bayer Pharma (2019), which did not confine compensation to cases of fault on the applicant’s part (points 37 to 40). Patent and SPC holders seeking provisional measures in a Member State with such a regime therefore bear the risk even in the absence of fault.

Facts and procedure

On 3 December 2009 the Finnish patent office granted Gilead a supplementary protection certificate for the combination of tenofovir disoproxil and emtricitabine, used against HIV, based on European Patent EP 0 915 894 (point 13). In spring 2017 Mylan won two Finnish public tenders for a generic medicine; the basic patent expired on 25 July 2017 (points 14 and 15). On 15 September 2017 Gilead sued Mylan for infringement of the certificate and sought provisional measures; Mylan brought an action for invalidity on 30 November 2017 (point 16). The Markkinaoikeus granted the measures on 21 December 2017, backed by a penalty of EUR 500,000 (point 17). At Mylan’s request, the Korkein oikeus (Supreme Court) set them aside on 11 April 2019 (point 18). The Markkinaoikeus annulled the certificate on 25 September 2019, a ruling that became final on 13 November 2020 (point 19). Mylan claims EUR 2,367,854.99 under Chapter 7, section 11, of the Code of Judicial Procedure (point 20).

The applicable law

Article 9(7) of Directive 2004/48 requires that the court be able to order the applicant to provide appropriate compensation where provisional measures are revoked or lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no infringement or threat of infringement. Article 3 requires measures that are fair, proportionate, avoid barriers to legitimate trade and provide safeguards against abuse. The provision draws on Article 50(7) of the TRIPS Agreement (points 32 to 36). Finnish law requires a party that obtained a provisional measure unnecessarily to compensate the other party for the resulting damage (point 12).

Question

Is a national regime of no-fault liability of the applicant for provisional measures compatible with Article 9(7) of Directive 2004/48 and, if not, what regime does that provision require (point 26)?

Decision

Article 9(7) makes compensation subject to three conditions: the lifting of the measures or a later finding of no infringement, the existence of damage, and a causal link (points 29 and 30). Fault on the applicant’s part is not among them (point 31). The provision lays down a minimum standard and leaves Member States free to adopt fault-based or no-fault liability (points 32 to 36). Bayer Pharma requires only that the court be able to take account of all circumstances, including the conduct of the parties, whatever the regime (points 37 to 40). A no-fault regime fits the balance struck by the Directive: compensation is the counterpart of measures obtained quickly, without definitive proof of infringement, and the applicant bears that risk (points 44 to 48). Where the right is retroactively annulled, the defendant’s conduct was legitimate and compensating it creates no barrier to legitimate trade (point 49). Deterrence is preserved, as the court may take the defendant’s conduct into account and exclude damage it aggravated itself (point 50). Having answered the first question in the affirmative, the Court did not address the others (point 52).

Key points for practice

• Article 9(7) does not require proof of fault on the applicant’s part; it sets three conditions: lifting of the measures or no infringement, damage, causation (points 29 to 31).
• Member States remain free to choose fault-based or no-fault liability (points 32 to 36).
• Whatever the regime, the court must be able to adjust compensation to the conduct of the parties (points 37 to 40 and 50).
• Practical point: before seeking provisional measures on a vulnerable patent or SPC, the holder should quantify its damages exposure under the applicable national law, since later invalidation of the right may be enough to trigger liability (points 44 to 49).

Provisions applied

Directive 2004/48/EC (enforcement of intellectual property rights)

Arts 3 and 9(3) and (7); recital 22

Other provisions

TRIPS Agreement, Arts 1(1) and 50(7)

National law

Code of Judicial Procedure (oikeudenkäymiskaari), Chapter 7, section 11 (Finland)

Case law cited

Bayer Pharma (C-688/17); Koch Media (C-559/20); Phoenix Contact (C-44/21); Diageo Brands (C-681/13)

Related decisions

• Bayer Pharma v Richter Gedeon and Exeltis, CJEU, 12 September 2019, whose scope the Court clarified (points 37 to 40).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, French version), consulted on 11 October 2026. Only the official text is authoritative.