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Antitrust:EU Commission sends supplementary Statement of Objections to Teva on suspected ‘pay-for-delay’ pharma agreement

The European Commission has sent a supplementary Statement of Objections to Teva Pharmaceutical Industries Ltd. (“Teva”) and Cephalon Inc. (“Cephalon”), now a subsidiary of Teva. This is a procedural step in the Commission’s ongoing investigation under the EU antitrust rules.

It follows the Commission’s Statement of Objections, in which the Commission had reached the preliminary conclusion that the patent settlement agreement between Cephalon and Teva concerning the sleeping disorder medicine modafinil may have delayed the entry of a cheaper generic medicine, in breach of Article 101(1) of the Treaty on the Functioning of the European Union (TFEU), thus causing substantial harm to EU patients and health service budgets through higher prices for modafinil.

In the worldwide agreement settling their patent litigation, Teva undertook not to sell its cheaper generic modafinil products in the European Economic Area and, in exchangereceived, according to the Commission’s preliminary assessment, from Cephalon a significant transfer of value through a series of cash payments and various other transactions.

The supplementary Statement of Objections complements and clarifies the Commission’s assessment underlying, in particular, the preliminary conclusion that the parties’ conduct constitutes a restriction of competition ‘by object’, also in view of recent judgments of the Court of Justice of the EU, and it does not prejudge the outcome of the investigation.

More information is available on the Commission’s competition website, in the public case register under the case number AT.39686.

https://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_code=1_39686

Arianna Podesta – Maria Tsoni –