Pay for Delay schemes being investigated by EU

Sanofi, Teva and Novartis raided in antitrust probe

By Nikki Tait in Brussels and Andrew Jack and Jane Croft in London

Published: October 6 2009 20:19
Financial Times

Sanofi-Aventis, the Paris-based pharmaceutical group, Israel’s Teva, the world’s largest generic drugs producer, and Novartis of Switzerland have all been raided by European competition officials in a fresh probe into suspected antitrust breaches believed to have occurred in France.

The European Commission said “surprise inspections” began at a number of pharmaceutical companies because of concerns about “possible anti-competitive business practices and/or abuse of a dominant position”.

The commission did not elaborate further, but the move comes less than three months after it completed a detailed 18-month probe into practices in the drugs sector. This concluded that the launch of generic rival drugs was being delayed and costs to consumers inflated. At the time, the commission claimed the patent-holding companies used various means to extend the commercial life of their products and delay generic entry for as long as possible – including lengthy litigation, restrictive settlement agreements and the filing of large “patent clusters” for a single medicine.

Although lawyers questioned whether such practices were necessarily illegal, the competition watchdog promised increased scrutiny of individual companies alongside a continuing probe it began against Servier of France early last year.

Only last week, Neelie Kroes, EU competition commissioner, told European lawmakers: “We are now capitalising on our pharmaceutical inquiry with new cases . . . Please look out for further news in the coming months.”

Sanofi has in the past negotiated “authorised generic” deals with low-cost drug producers once its patented drugs came under threat, although most such deals have been in the US. In Europe, it has been expanding its presence in generics through subsidiaries Winthrop and Zentiva.

The raids coincided with a keenly awaited ruling from Europe’s top court, broadly favouring GlaxoSmithKline in a long-running battle with the commission over so-called “parallel trade” in pharmaceuticals in Europe.

The court said the commission would need to reconsider its objections to GSK’s plan to raise some prices to Spanish wholesalers, to prevent them taking advantage of Spain’s low-price environment and export the drugs elsewhere in the EU.

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U.S., EU getting tough on "pay-for-delay"
By Tracy at Fierce Pharma
Jul 7 2009 - 10:04am

Forces are aligning against "pay-for-delay" patent settlements. After years of pooh-poohing the Federal Trade Commission's fight against the deals, the U.S. Justice Department now has signed up for the cause. In an appellate court filing, Justice said that it's unlawful for branded drugmakers to pay generic firms to stand down from patent challenges--unless the drugmakers can justify the deal.

The filing came in response to a request from the U.S. Court of Appeals in New York, which is hearing a case involving Bayer's antibiotic treatment Cipro. Bayer paid $398 million to Barr Laboratories in 1997 to keep a generic version off the market. Though the Justice Department wouldn't speak to the specifics of this case, it said that this particular appeals court has been too lenient in allowing pay-for-delay deals to stand. It, and other courts, have tended to uphold the deals as long as they don't extend past the drug patent's expiration date.

Meanwhile, the European Union may crack down on such deals. Antitrust regulators there have been probing the patent settlements for some 18 months, and in a preliminary report accused pharma firms of costing consumers billions by not only engaging in pay-for-delay deals, but with other tactics as well. Apparently investigators now are focusing on a few drugmakers and may be preparing antitrust actions against them. The antitrust agency plans to release another report tomorrow.
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