Roche and Novartis continue fight against Italian fine despite court setback
This article was originally published in SRA
Roche and Novartis say they will continue to fight against the fine imposed on them earlier this year for allegedly colluding to exclude Roche's Avastin from the ophthalmology market in favor of Novartis's much more expensive Lucentis, despite losing their first challenge in the Italian courts1,2.
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The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.
In the latest development in the long-running case pitting Novartis and Roche against the Italian competition authority over a fine imposed in 2014, the Court of Justice of the EU has confirmed that the firms’ arrangement over Avastin and Lucentis could constitute a serious restriction on competition if it involved the dissemination of misleading information. The case now goes back to the Italian court.
A recent opinion from an EU advocate general is another blow for Roche and Novartis in their fight against an Italian fine imposed on them as a result of their agreement on the use of Avastin and Lucentis in wet AMD. If the opinion is followed by the court, it could have competition law consequences in areas such as product licensing.