On 20 December 2017, the French competition authority, the Autorité de la Concurrence (ADLC) announced that it had fined Janssen-Cilag and its parent company Johnson & Johnson €25 million for having delayed the entry and subsequent development of generic alternatives to the drug Durogesic. The ADLC focused on two distinct types of behaviour: repeated attempts to persuade the French regulatory body, the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), which were characterised as frivolous and without merit; and a sustained marketing campaign by Janssen-Cilag aimed at undermining the efficacy of the generics before medical practitioners.

Background. Durogesic is a powerful opioid analgesic, marketed in France by Janssen-Cilag, a subsidiary of Johnson & Johnson. It is prescribed in cases of severe pain, including those suffering from cancer and is administered in the form of a skin patch.

Interventions with medical authorities. Following authorisation in Germany of its generic formulation, Ratiopharm sought to obtain mutual recognition across the European Union to enable distribution of its new medicine. The European Commission gave its approval in October 2007, requiring member states to comply within 30 days. However, Janssen-Cilag wrote on several occasions to AFSSAPS, requesting meetings and calling into question both the European Commission’s decision and its legal status in France. Seeking to argue that the generics were not identical to Durogesic, Janssen-Cilag went so far as to question the efficacy and quality of the generic medicine, despite its bioequivalence having already been established. Janssen-Cilag also raised potential public health concerns, questioning the impact that substitutions could cause to some patients. This campaign was successful in delaying entry as AFSSAPS initially refused to recognise the generic drug, with authorisation following only one year later in 2008.

Targeted marketing campaign. Following authorisation, Janssen-Cilag engaged in a marketing exercise which the ADLC found was aimed at casting aspersions on the efficacy and quality of the generic versions with doctors and pharmacists. Its sales representatives were told to emphasise that generic alternatives did not have the same composition, nor quantity of active ingredient fentanyl as its Durogesic patch. This involved Janssen-Cilag training a specialist team of 300 sales representatives known as “commandos” and sending out numerous newsletters direct to medical practitioners, supported by statements in the trade press. In particular, Janssen-Cilag distorted the warning messages that had been issued by AFSSAPS, providing an incomplete and essentially alarmist message. The campaign also resulted in screensavers installed on doctors’ computers giving a special warning, complete with warning triangles. The campaign was so successful that a very low flat-rate reimbursement price was imposed by the French public authorities, fixing the price of the generic and the originator at the same low level.

Impact. The ADLC considered these practices to be very serious, delaying the entry of the generic in France by several months, whereas the ‘smear’ campaign was successful in ensuring a low penetration rate of the generic alternatives even after their launch. The ADLC report that 12,800 pharmacies, accounting for just over half of all French pharmacies, were subject to direct discussions. Janssen-Cilag itself conducted a survey to evaluate the effects of its campaign which concluded that 83% of pharmacists had memorised the risks associated with switching between fentanyl products. In addition, 12,000 French doctors have the screensaver installed on their computers.

Comment. This is not the first time that the ADLC has fined pharmaceutical companies for defamatory practices, with both Sanofi-Aventis and Schering-Plough being fined in 2013 for similar activities (see here). The question of misleading statements about product safety has also recently been addressed at EU level in the context of anti-competitive agreements, with Advocate General Saugmandsgaard concluding that an agreement to present scientific information in a misleading or unbalanced fashion is likely to restrict competition by object (more details here – and watch this space for the CJEU ruling due in a couple of weeks).

Nor is it the first time that Janssen has got into hot water over the marketing of Fentanyl – the marketing of this drug in the Netherlands was central to the European Commission’s 2013 decision in which fines totalling €10.7M were issued (the parties did not appeal this finding).

However, whilst there can be little surprise in the ADLC seeking to sanction the behaviour of Janssen-Cilag in the post-launch phase (particularly given the misleading nature of the communications to medical practitioners), its success in delaying entry onto the market in the first place seems to be as much the fault of AFSSAPS as a consequence of Janssen-Cilag’s regulatory interventions. The case appears very different from the conduct sanctioned in AstraZeneca, where patent authorities had no reason to doubt the factual information provided. Although the ADLC refers in this case to ‘legally unjustified’ arguments being presented, it also makes clear that the European Commission’s approval was binding on the French authority, something which should have been clear to AFSSAPS.