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EC to investigate Novartis and J&J in antitrust probe

Claims companies agreed to delay entry of generic painkiller

Novartis Johnson Johnson

Johnson & Johnson and Novartis are the latest pharma companies to face a European Commission investigation into anticompetitive practices, this time for allegedly delaying the entry of a generic painkiller.

The EC is looking into claims that the Dutch subsidiaries of J&J and Novartis' Sandoz unit forged an agreement to keep generic fentanyl off the market after the expiration of patent protection on J&J's branded product.

The 'statement of objections' issued by the Commission marks the first action in the investigation, which is expected to take months to resolve.

According to the complaint, Janssen-Cilag paid Sandoz not to launch a generic competitor to its fentanyl patch product – through a deal presented as a co-promotion agreement – thereby “depriving users of fentanyl in the Netherlands from access to a cheaper painkiller”.

It is alleged that Sandoz received monthly payments for abstaining from launching its generic between July 2005 and December 2006.

So-called 'pay-for-delay' deals have been in the EC's sights for years, and a formal investigation across the pharma industry got underway in 2008 after unannounced inspections at a number of companies.

Antitrust charges have also been laid against Servier and four generic companies in a case involving the French drugmaker's Coversyl/Aceon (perindopril) cardiovascular product and against Lundbeck and eight generics firms for holding back cheaper versions of blockbuster antidepressant Cipramil (citalopram).

Other companies in the spotlight in recent years include Cephalon (now Teva) with its narcolepsy drug Provigil (modafinil), although a case involving AstraZeneca and Nycomed was dropped last year.

Meanwhile, in the US the Federal Trade Commission also stepped up its scrutiny of deals between brand and generic pharma companies, filing court petitions to have pay-for-delay deals declared illegal and raising federal scrutiny of inter-company licensing deals. 

1st February 2013

From: Regulatory



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