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CJEU – Mylan v. Gilead / referral C-473/22 / Enforcement Directive

30 Nov 2022

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

From the report of the Dutch Ministry of Foreign Affairs:

“On 03-12-2009, the National Patent and Registration Office issued the Supplementary Protection Certificate No. 266 in Finland on the basis of the European patent validated in Finland. Mylan AB tendered its drug “EMTRICITABINE/TENOFOVIR DISOPROXIL MYLAN 200 mg/245 mg, film-coated tablet” in spring 2017 in public tenders of two Finnish nursing districts and won these tenders for the named product. The period of validity of the aforementioned basic patent has expired on 25-07-2017.

“Gilead Sciences Finland brought an action before the Markkinaoikeus (Special Court for Commercial Law, Competition Law, Public Procurement and Private International Law, Finland) on 15-09-2017 against, among others, Mylan AB for infringement of Supplementary Protection Certificate No. 266. In the same context, Gilead filed a request for an interim measure against Mylan AB. Mylan AB opposed Gilead’s action for infringement and Gilead’s request for an interim measure, and for its part filed an action for the annulment of Supplementary Protection Certificate No. 266 with the Markkinaoikeus on 11/30/2017.


“According to Article 9(7) of the Enforcement Directive, the judicial authorities shall have the authority to order the applicant, upon request of the defendant, to provide the defendant appropriate compensation for any injury caused by provisional measures if these these are revoked or where they 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 of an intellectual property right.

“It follows from the case law of the CJEU that the concept of ‘appropriate compensation’ within the meaning of Article 9(7) of the Enforcement Directive must be regarded as an autonomous concept of EU law which must be given a uniform interpretation within the territory of the Union. Moreover, in its case law the CJEU has not only emphasized that this concept must be interpreted autonomously and uniformly, but also that the interpretation of this concept cannot fall within the competence of different Member States.

“In Finland, liability under Article 9(7) of the Enforcement Directive is considered strict liability. In light of the above, in connection with the judgment of the CJEU in Case C-688/17, there currently seems to be a real ambiguity and differing views on whether a strict liability based compensation scheme can be considered compatible with Article 9(1) 7 of the Enforcement Directive. Since the interpretation of the concept of ‘appropriate compensation’ must be regarded as a matter for the CJEU and not for the national court, the Markkinaoikeus considers that in the circumstances of the present case it is almost necessary to submit the current application for a preliminary ruling.”

Questions referred:

1. Is a compensation regime based on strict liability, such as that described above (paragraphs 16 to 18 of this request for a preliminary ruling) which is in force in Finland, to be regarded as compatible with Article 9(7) of the Enforcement Directive?
2. If the first question is answered in the negative, what then is the nature of the liability for compensation on which the liability [Or. 11] under Article 9(7) of the Enforcement Directive is based? Is that liability to be regarded as a form of liability based on fault, an abuse of rights, or some other ground?
3. In relation to the second question, what circumstances must be taken into account in assessing the existence of liability?
4. In particular, as regards the third question, must the assessment be made solely on the basis of the circumstances known at the time when the provisional measure was obtained, or is it permissible to take into account, for example, the fact that the intellectual property right on whose alleged infringement the provisional measure was based was subsequently, after that measure was obtained, found to be invalid ab initio and, if so, what significance is to be attached to that circumstance?

The entire report of the Dutch Ministry of Foreign Affairs (in Dutch) can be read here.
The CJEU case file (in various languages) can be accessed here.