CJEU (C-179/16, Hoffman-La Roche): infringement of pharmacovigilance obligations may give rise to EU competition law liability

On 23 January 2018, the European Court of Justice (“CJEU”) issued its preliminary ruling in the Hoffman-La Roche case, where it had the chance to address some major issues regarding competition law in the pharmaceutical sector. The request for a preliminary ruling had been referred by the Italian Consiglio di Stato in relation to a cartel case where the Italian Competition Authority had fined Roche and Novartis for a total amount of 180 million euros.

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The European Commission provides guidance on SEP licensing but leaves open issues

On November 29, the European Commission published its long-awaited “Communication setting out the EU approach to standard-essential patents” (SEPs). The stakeholders were expecting from the Commission in-depth guidance on the definition of fair, reasonable and non-discriminatory (FRAND) terms in the context of SEP licensing. However, the Commission did not address all the open issues, leaving room for continued legal uncertainty on the exact meaning of FRAND. Continue reading “The European Commission provides guidance on SEP licensing but leaves open issues”

AG Saugmandsgaard Øe provides guidance on the application of EU competition law in the pharmaceutical sector

**Update**: see here the comment on the final judgment of the CJEU.

On 21 September Advocate General Saugmandsgaard Øe provided his Opinion to the CJEU on some key issues regarding competition law in the pharmaceutical sector. The request for a preliminary ruling was referred by the Italian Supreme Administrative Court (“Consiglio di Stato”) in relation to a cartel case where the Italian Competition Authority (“ICA”) fined Roche and Novartis for a total amount of 180 million euros.

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Decompiling the rules on trade secrets, software and reverse engineering

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My last post concerned trade secret litigation (read it here), and since I am (at least momentarily) quite fascinated by the subject of trade secrets, I decided to do a follow-up post on another topical issue in this field. In trade secret law, two types of behavior are generally considered to be allowed: i. independent discovery and ii. reverse engineering. Especially the latter sparked discussion in the EU with the arrival of the new Trade Secrets Directive (2016/943) (“TSD”). Reverse engineering is allowed based on Art. 3 (1) (b) and recital 16 of the TSD. Recital 16 of the TSD stipulates that

“[…] Reverse engineering of a lawfully acquired product should be considered as a lawful means of acquiring information, except when otherwise contractually agreed. The freedom to enter into such contractual arrangements can, however, be limited by law.”

Let’s pause here for a moment and decompile this provision:

  • Main rule: If you lawfully acquire a product, you may reverse engineer it.
    • Exception: Reverse engineering is not allowed if it has been contractually agreed that such behavior is not permitted.
      • Exception to exception: However, the freedom to enter into such an agreement restricting the permissibility of reverse engineering may be restricted by law. This, in a sense, takes you back to the main rule in the first bullet point.

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