In its 18 October judgment the French Cour de Cassation upheld the €40.6m fine imposed on Sanofi-Aventis (“Sanofi”) by the French Competition Authority (“FCA”) in May 2013 and affirmed the judgment of the Paris Court of Appeal. The FCA found that Sanofi abused its dominant position in violation of Art. 102 of the Treaty on the Functioning of the European Union (“TFEU”) and art. L.420-2 of the French Commercial Code by denigrating generic competitors of its drug Plavix on the French clopidogrel market.

In July 2008, Sanofi put in place a strategy intended to convince healthcare professionals of the differences between Plavix and soon to enter generic clopidogrel products. The strategy included representations that the generic drugs contained clopidogrel salts that differed from the Plavix salt and were not indicated to be used in combination therapy with aspirin for patients suffering from the Acute Coronary Syndrome (“ACS”).  Sanofi also encouraged doctors to indicate on their Plavix prescriptions that the drug was “not-substitutable” (except with Sanofi’s own generic Clopidogrel Winthrop). A large number of doctors did so.  In its communications, Sanofi stressed Plavix’s established efficacy and safety profile regarding the prevention of atherothrombotic events, which the newly entering third party generic drugs did not have.

The Court of Appeal upheld the FCA’s conclusion that Sanofi put in place a structured strategy aimed at denigrating competing generics, and that by going beyond merely stating objective differences between Plavix and the generic products it abused its dominant position. The FCA emphasised that only “significantly different properties” in terms of safety and efficacy could have justified the statements made by Sanofi.  To qualify as a generic the product need not contain the same salt provided that it has the same principle active ingredient and does not have a different safety and efficacy profile.  Nor must it be approved for all of the same indications.  The absence of the ACS indication for the competing generics reflected the fact that this indication continued to be protected by a complementary patent, not the different salts they contained.  Sanofi’s communications on why Plavix and the generic competitors were not substitutable were thus incomplete and misleading.

The Cour de Cassation found that Sanofi had abused its dominant position and foreclosed generic entry to the French clopidogrel market.  It concluded that Sanofi’s communications were cumulatively misleading and had a dissuasive effect.  Further, the court found that, as a result of the “non-substituable” reference that doctors were encouraged to include on Plavix prescriptions, the evolution of generic substitution was unusual (with Sanofi’s own generic systematically maintaining a market share by volume above 30%).

Finally, the Cour de Cassation rejected Sanofi’s claim that the fine imposed was unjustified and disproportionate.  It expressly affirmed the 50% uplift to the base used to calculate the fine, as a reflection of the economic strength of Sanofi-Aventis and the group to which it belonged.