France: French Competition Authority Imposes Fine Of € 40.6 Million On Pharmaceutical Company Sanofi-Aventis For Abusive Limitation Of Generic Entry

On 14 May 2013, the French Competition Authority (FCA) imposed a fine of € 40.6 million on the pharmaceutical company Sanofi-Aventis, which is a subsidiary of the Sanofi group, for having abused its dominant position on the market for the active ingredient clopidogrel by conducting a communication campaign denigrating the generic medicine produced by its competitors, thereby limiting their ability to enter the market.

Sanofi-Aventis is the manufacturer of the world's fourth best-selling medicine, Plavix, which is used to prevent relapses of serious cardiovascular diseases.

On 2 November 2009, the French manufacturer of generic medicines Teva Santé lodged a complaint to the FCA against Sanofi-Aventis for an alleged abuse of a dominant position. In its complaint, Teva Santé claimed that though the patent protecting the active ingredient in Plavix in Europe expired in 2008, Sanofi-Aventis filed complementary patents in order to extend its initial protection, and implemented a commercial strategy to promote its own generic version of Plavix while denigrating the generic medicinal products of Teva Santé and other generics producers.

In its decision, the FCA first concluded that the active ingredient clopidogrel, used to produce the medicine Plavix and its generics, constituted a distinct product market. The FCA next concluded that Sanofi-Aventis was dominant on this market due to its 60% market share, which is five times the market share of its closest competitor, and also due to the fact that it has been commercialising Plavix since 1999. The FCA then found that Sanofi-Aventis had abused its dominant position by implementing a global and structured communication strategy with the aim of influencing doctors and pharmacists to stop the generic substitution process. This strategy consisted, for example, of convincing doctors to insert the indication "non-substitutable" in their prescription of Plavix to patients, and of encouraging pharmacists to substitute Plavix by Sanofi-Aventis's own generic medicine.

According to the FCA, the communication campaign of Sanofi-Aventis shed doubts on the efficiency and safety of the products of generic competitors. In addition, the campaign was implemented from September 2009 to January 2010, namely right at the time of the first wave of generic market entry in France. As a result of this strategy, the generic medicine marketed by Sanofi-Aventis had an atypically high market share as compared to other generic medicines, and the effective penetration rate of the generic medicines (priced 55% cheaper than Plavix) was much lower than expected. The FCA therefore concluded that Sanofi-Aventis' practices infringed Article 102 TFEU and imposed a fine of € 40.6 million on the company.

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