Italian court confirms hefty fines on Novartis and Roche

By Gabriele Accardo

On 2 December 2014, Italy’s Tribunale Amministrativo Regionale del Lazio (“TAR Lazio”) handed down its ruling (only available in Italian) concerning the alleged anticompetitive agreement between Roche and Novartis in the market for ophthalmic drugs used to treat some serious vascular eyesight conditions, which, in its decision of 27 February 2014, the Italian Competition Authority (“ICA”) found to be in breach of article 101 of the Treaty on the Functioning of the European Union (“TFEU”), and imposed fines totaling Euro 92 million and Euro 90,5 million on Novartis and Roche respectively (see Newsletter 2/2014 p. 18 and Newsletter 1/2013, p. 11, for additional background).

It is recalled that, according to the ICA, Roche and Novartis aimed at excluding the ophthalmic use of Roche’s Avastin in order to advantage the sales in Italy of Lucentis, which is distributed by Novartis. In particular, the decision found that since 2011 the two companies colluded to create an artificial product differentiation by claiming the use of Avastin for ophthalmic purposes to be more dangerous than in reality, in order to influence the prescriptions of doctors and health services in favor of the more expensive Lucentis. The ICA had found that Roche and Novartis had put into effect a “pervasive and continuous” concerted practice via meetings and exchange of emails.

The TAR Lazio essentially upheld the ICA’s findings, notably as to the anticompetitive object of the contacts between the two competitors, based on documentary evidence, such as exchange of written communications as well as companies’ internal documents. However, interestingly the court made an important point as to the scope of the assessment in similar matters, ultimately discarding a significant share of arguments put forward by the parties.

In particular, the TAR Lazio held that the scope of the ICA’s investigation and therefore of the TAR Lazio’s jurisdiction exclusively focuses on the assessment of the allegedly anticompetitive agreement between competing companies concerning the marketing of Avastin and Lucentis. As a result, for the purposes of the decision, all the arguments put forward by the parties in relation to such medical and scientific aspects relating to the products (scientific analysis and safety) go beyond the scope of the ICA’s powers, i.e. safeguarding competition, and therefore the protection of patients as consumers of the products at issue.

Likewise, the TAR Lazio further held that pharmacovigilance requirements or even the legitimate contacts between Roche and Novartis, such those relating to the vertical relationship between the two groups owing to their licensing agreement, were also outside the scope of the assessment.

Based on such premise, which resulted in the TAR Lazio discarding the “scientific” arguments put forward by the parties in order to rule out the substitutability between Avastin and Lucentis, the TAR Lazio concluded that Avastin and Lucentis were indeed substitutable and therefore belonged to the same product market based on the wide-spread off-label use of Avastin to treat some serious vascular eyesight conditions (as an anti-VEGF, or anti vascular endothelial growth factor), the fact that even in Italy the NHS reimbursed certain drugs used off-label and that, with regards to safety, Avastin had been recognized internationally as the only anti-VEGF drug for ophthalmic use.

Clearly, the TAR Lazio’s approach, which is subject to appeal before the Council of State, questions one of the fundamental aspects of competition law assessment, in particular with regards to allegedly anticompetitive agreements, which is that the assessment has to be performed within the legal and economic context in which such agreements may occur. Arguably, the Council of State will tell whether, by discarding as not relevant all the considerations relating to the regulatory framework which is pervasive in the pharmaceutical sector, the ICA and the TAR Lazio may have ultimately gone too far in defining the scope of the relevant factors that have to be assessed in similar cases.