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CJEU – Opinion AG in Mylan v. Gilead / SPC

28 Sep 2023

Opinion of Advocate General Szpunar delivered on 21 September 2023, Request for a preliminary ruling from the markkinaoikeus (Market Court, Finland), Mylan AB v. Gilead Sciences Finland Oy, Gilead Biopharmaceutics Ireland UC, and Gilead Sciences Inc., Case C‑473/22, ECLI:EU:C:2023:699

Placing on the market of products infringing SPC rights – Provisional measures ordered on the basis of an SPC – Subsequent annulment of the SPC and revocation of the measures – Consequences – Right to appropriate compensation for losses caused by the provisional measures – Liability of the applicant for the provisional measures for losses caused by them – National legislation providing for strict liability


1. Where the protection conferred on the holder of an intellectual property right, such as a patent or a right derived therefrom, expires or where that right is considered legally vulnerable and likely to be declared invalid, the holder’s competitors may be tempted to place on the market products infringing that right without waiting for it to lapse. By placing their products on the market prematurely, they obtain a competitive advantage which allows them to gain market share before other more scrupulous competitors arrive. This is common practice, particularly in the pharmaceutical market, where manufacturers of generic medicines do not always wait until the protection of the originator product has ceased to be effective before placing their own product on the market, in the hope that that protection will expire quickly.

2. Such a practice is referred to as ‘launch at risk’. The perpetrator faces the risk of opposition from the holder in the form of measures seeking to protect the intellectual property right in question. This could consist, inter alia, in a provisional measure ordered by a court to stop the infringement with immediate effect. In this situation, the holder’s competitor bears the risk of making a financial loss, since it might not see a return on its investment.

3. However, in the event that, after the provisional measure has been adopted, the intellectual property right to be protected by that measure is declared invalid, or if it is found that there was no infringement of that right, the question arises of the right of the person whose economic activity has thus been unduly hindered to claim compensation for losses from the holder of the intellectual property right who applied for the provisional measure.

4. Although the provision of EU law – itself derived from international law – requiring Member States to provide for such a right of redress in their national legal systems is tersely and generically worded, the Court of Justice, in its judgment in Bayer Pharma, (2) gave it a more precise meaning, further framing the Member States’ margin of discretion.

5. In the present case, it is necessary to analyse, in the light of the guidance provided in that judgment, the liability regime adopted in Finnish law. This is similar to the regimes in force in the national law of several other Member States – that is to say, a strict liability regime.



80. In the light of all of the foregoing considerations, I propose that the Court of Justice should answer the questions for a preliminary ruling referred by the markkinaoikeus (Market Court, Finland), as follows:

(1) Article 9(7) of Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights

must be interpreted as precluding national legislation providing, in the situations referred to in that provision, for a liability regime for the applicant for provisional measures that does not allow the court hearing an action for compensation of the loss caused by those provisional measures to take into account – in addition to the premisses of that liability set out in that provision – other relevant circumstances of the case in order to assess whether or not to order such compensation.

(2) The court hearing an action for compensation for losses under Article 9(7) of Directive 2004/48 must take into account, in order to assess whether or not to order such compensation – in addition to the premisses of that liability set out in that provision – other relevant circumstances of the case, both before and after the application for the provisional measures at issue, which allow it to assess the justified nature of that application in the light of the risk of irreparable harm caused to the applicant in the absence of such measures.

The entire opinion can be read here.