Bayer Pharma v Richter Gedeon and Exeltis (CJEU, C-688/17, 2019)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Budapest-Capital Regional Court (Fővárosi Törvényszék), the Court of Justice held that « appropriate compensation » in Article 9(7) of Directive 2004/48 is an autonomous concept of EU law (points 40 to 49), and that the provision does not preclude national rules excluding compensation for harm which the injured party failed to avoid by acting as could generally be expected of it, even where the patent on which provisional measures were based is later annulled (operative part). The national court must nevertheless be able to take account of all objective circumstances, including the conduct of the parties, to ascertain whether the applicant abused the measures (point 70). The judgment bears directly on the damages exposure attached to provisional measures in pharmaceutical patent cases.

Facts and procedure

Bayer Pharma filed on 8 August 2000 a patent application for a pharmaceutical product containing a contraceptive active ingredient, granted on 4 October 2010. Richter had begun marketing its products in November 2009 and August 2010, before grant, and Exeltis in October 2010. After a first request had been refused, the referring court on 11 July 2011 prohibited the marketing of those products against security; the orders, effective on 8 August 2011, were set aside on appeal for procedural defects, and new measures were refused as disproportionate. The patent was annulled in its entirety by the Hungarian Intellectual Property Office on 13 September 2012 and then by the referring court on 9 September 2014, a decision upheld on appeal on 20 September 2016; the infringement action was dismissed on 30 June 2017. Richter and Exeltis claimed compensation for the harm caused by the provisional measures (points 15 to 33).

The applicable law

Article 9(7) of Directive 2004/48 requires Member States to empower courts to order the applicant to provide the defendant with 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 (points 36 to 39). Article 3 requires safeguards against abuse of the measures (points 66 to 68). Under Hungarian law, a person causing unlawful harm is exempt if it shows that it acted as could generally be expected, and the injured party must likewise act to avoid or reduce the harm, with no recovery for harm resulting from a failure to do so (sections 339 and 340 of the 1959 Civil Code).

Question

Does Article 9(7) of Directive 2004/48, in particular the concept of « appropriate compensation », preclude national rules allowing the court to refuse compensation to a defendant that marketed its products despite the patent application or patent, where the patent is later annulled (point 34)?

Decision

« Appropriate compensation » must be given an autonomous and uniform interpretation in the light of the Directive’s harmonising aim (points 40 to 49). It is for the court to assess, in the circumstances of the case, whether compensation is justified; meeting the conditions in Article 9(7) does not automatically require all harm to be compensated (points 50 to 52). Whether a request for provisional measures was unjustified depends first on whether there was a risk of irreparable harm to the right holder (points 61 and 62). Marketing products despite a patent application or a patent may, prima facie, be an objective indication of that risk (point 63). The revocation of the measures is not, in itself, decisive evidence that the request was unjustified (point 64), since the contrary view could deter right holders from using such measures (point 65). The national court must nonetheless check that the applicant did not abuse the measures, taking due account of all objective circumstances, including the conduct of the parties (points 69 and 70).

Key points for practice

• Subsequent annulment of the patent does not automatically give rise to compensation for harm caused by provisional measures (points 52 and 64).
• The conduct of a defendant who launches despite a patent or published application may lead to compensation being refused for harm it failed to avoid (points 63 and 71).
• Review of abuse by the applicant remains, on the basis of all objective circumstances (points 69 and 70).
• Practical point: a generic company launching before validity is resolved bears a risk of its own, assessed under national liability law within the limits set by the Court (operative part).

Provisions applied

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

Arts 3 and 9(7); recital 22

Other provisions

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

National law

Law XXXIII of 1995 on patents, s 18; Code of Civil Procedure (Law III of 1952), s 156; Civil Code (Law IV of 1959), ss 339 and 340 (Hungary)

Case law cited

Padawan (C-467/08); Koppers Denmark (C-49/17)

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.