Since its in-depth inquiry into the pharmaceutical industry in 2008-2009, the European Commission (the “Commission”) has monitored patent settlement agreements. In its 2014 report published on 2 December 2015, the Commission revealed the results of its analysis of 76 patent settlement agreements between originators and generics  (a number “far below” the figures of previous years), concluding that “the number of settlements that might attract competition law scrutiny remains at a low level”.  In fact, 88% of the settlements analysed fell into categories that the Commission considered prima facie do not require competition law scrutiny (para. 51).

The Commission classifies the settlements in two groups: those that do not restrict the generic company’s ability to market its own product (“A-type” settlements) and those that limit the generic company’s ability to enter the market (“B-type” settlements). B-type settlements are classified as either (i) agreements that do not contain a “value transfer” (“B-type.I” settlements) and (ii) agreements that do contain a “value transfer” (“B-type.II” settlements).  In the report the Commission reiterates that “this is not to suggest that [B-type.II settlements] would always be incompatible with EU competition law. This needs to be assessed on the basis of the circumstances of each individual case” (para. 17).

In the final section of the report, the Commission notes that pharmaceutical companies continue to conclude settlement agreements, despite its on-going scrutiny of B.II type settlements. The General Court’s pending judgments in Lundbeck and Servier may have an impact on this in the future.

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Photo of Miranda Cole Miranda Cole

Miranda Cole is a partner based in the firm’s Brussels office.  She practices competition and communications law and policy, and has more than 15 years of experience in the field.  Ms. Cole’s competition law expertise encompasses merger control, actions under Articles 101 and…

Miranda Cole is a partner based in the firm’s Brussels office.  She practices competition and communications law and policy, and has more than 15 years of experience in the field.  Ms. Cole’s competition law expertise encompasses merger control, actions under Articles 101 and 102 TFEU, advisory work and actions before the European courts in Luxembourg.

She has particular expertise in advising companies active in the technology and communications sectors in complex and strategic regulatory and policy matters, with particular expertise regarding the impact of evolving regulatory frameworks on new technologies and services.  In the communications sector she has extensive experience advising in connection with all aspects of European and international regulation, policy and competition law, and counselling in connection with the impact of regulation on transactions.