More particularly, the Court affirmed the FCA’s conclusion that Janssen infringed competition law by, on the one hand, disparaging competing fentanyl specialties towards health professionals, emphasizing the risks associated with a switch from Durogesic© to a generic version and, on the other hand, intervening in the French Health Authority’s (“ANSM”, formerly AFSSAPS) process to oppose the listing of Ratiopharm’s specialty as a generic drug of Durogesic©. The Court, however, granted Janssen a small decrease in fine (from €25 million to €21 million ) considering that its actions did not aim at challenging Ratiopharm’s marketing authorization but only the listing in France of its fentanyl specialty as a generic version of Durogesic©.
While the Court followed in the footsteps of precedents with respect to Janssen’s conduct vis-a-vis healthcare professionals, the confirmation that communications between a pharmaceutical firm holding a dominant position on the market and health authorities can lead to an abuse is a first and shows that the ambit of competition law is, in fact, limitless. It thus remains to be seen whether the French Supreme Court, where the case is now pending, will take a similar view or choose a different path.
A judgment in line with precedents on disparagement practices
In line with the approach followed in previous cases concerning the pharmaceutical sector (Plavix© and Subutex©), the Court confirmed that an originator company commits an abuse of dominance when it engages in a campaign against generic drugs, questioning their bioequivalence, effectiveness and safety.
According to the Court, Janssen had slightly modified the language of an ANSM’s statement recognizing the risk, during the treatment, of switching between fentanyl specialties (either between an originator and a generic or between two generics) by only emphasizing the risk associated with the substitution of Durogesic® for a generic version, allegedly leading professionals to believe that prescribing a generic instead of the originator drug could be dangerous and was thus not recommended.
Communications with health authorities: beware of a possible abuse
The Court’s judgment was mostly expected on this second aspect, relating to Janssen’s alleged conduct vis-a-vis the French Health regulator. In a nutshell, Janssen took the initiative to send several letters to the ANSM which initially led it to refuse, in July 2008, to consider Ratiopharm’s fentanyl specialty as a generic version of Durogesic©. However, after informing Ratiopharm of this decision and following a reevaluation of the case in September 2008 at the request of the latter, the ANSM ultimately changed its mind in November 2008 but, in order to take into account the risks put forward by Janssen, decided in parallel to issue a warning regarding the switch between fentanyl specialties, especially for certain categories of patients (such as children or the elderly).
In its appeal, Janssen criticized the FCA for having considered that it had jurisdiction to review and interpret the communications between a pharmaceutical firm and its sectorial regulator. According to Janssen, in doing so, the FCA interfered with the ANSM’s prerogatives that it derives from the law, thereby committing an abuse of power. In addition, Janssen argued that its interactions with the ANSM could not qualify as an economic activity and should therefore fall outside the scope of competition law.
The Court rejected Janssen’s arguments. Upholding the FCA’s approach, the Court not only concluded that Janssen’s intervention before the ANSM was part of a strategy to maintain its dominant position on the market and was therefore subject to competition law, but also validated, out of principle, FCA’s ability to assess the merits of a pharmaceutical firm’s intervention and communications vis-à-vis health regulators. The Court, however, opined that the FCA could do so only to the extent that its review remains limited to an analysis of the legal and factual context in which the conduct took place.
And precisely, in this case, the finding of an abuse by the FCA did not rely on any analysis of scientific communications between Janssen and the ANSM but was motivated by the FCA’s determination that Janssen had unduly raised a legal debate before the ANSM regarding the generic status of Ratiopharm’s drug while such debate was closed since the European Commission, following an arbitration procedure in the context of the mutual recognition procedure, had enjoined the ANSM to deliver a marketing authorization to Ratiopharm’s drug. Therefore, according to the Court, the FCA “did not exceed its powers when preliminary determining the legal and factual framework in which Janssen’s intervention before the ANSM took place” and was right not to “[consider] itself bound by the legal analysis followed in the case by the ANSM’s director or the ANSM itself” insofar as, despite not being in agreement with the ANSM, the FCA did not call into question the legality of the ANSM’s decision. In addition, the Court noted that the ANSM does not have an exclusive jurisdiction to interpret the laws relating to medicines for human use.
It stems from the above that any communication between an originator company and health authorities in the context of generic or biosimilar entry can now, depending on the circumstances, potentially lead to an abuse, if the FCA concludes that such communication forms part of a strategy aiming at delaying or eliminating competition. More particularly, the Court’s judgement seems to confirm that a distinction should now be made between objective communications on scientific or public health issues, supported by solid evidence, which according to the FCA would continue to escape its jurisdiction, and other types of communications, which may therefore be reviewed by the latter. The question however remains how to distinguish between the two categories when, in practice, even an intervention with a legitimate objective, supported by scientific evidence, may have a hidden commercial side to it that the FCA may be tempted to review.
Key points and takeaways for the future
- This case is a reminder that originator companies should be extremely careful in all their communications (including the drafting of internal documents) on generics or biosimilars, both before, upon and after market entry. In practice, the use of any “buzz word” around generic or biosilimar entry may be suspicious and any communication that does not accurately reflect the reality may be interpreted negatively by the FCA and easily lead, depending on the circumstances, to the finding of an abuse.
- The judgment confirms the growing importance of the FCA’s powers which, with the blessing of the Court, can now intervene beyond pure competition law issues, irrespective of the fact that it may not have the required knowledge and expertise to appropriately appreciate the validity of scientific and regulatory arguments put forward by pharmaceutical companies before health authorities.
- However, it does not mean that pharmaceutical companies holding a dominant position cannot continue to legitimately defend their own interest – be it commercial or other – as long as it can be demonstrated with supporting evidence, that they compete on the merits.