European Union regulators accused drugmakers of costing consumers in 17 countries as much as $3.8 billion by using patent lawsuits and other alleged anti-competitive tactics to keep cheaper generic medicines off the market.

An investigation of several major drugmakers - including Pfizer, Glaxo and Sanofi Aventis - showed they blocked or stalled generics from entering the market to prevent losing revenue on their more profitable drugs, according to the European Commission. Regulators say pharma filed disputes, lawsuits and multiple patent applications for the same drug. In one case, 1,300 applications were involved.

Patent litigation lasted on average three years, and generic drugmaker won some 60 percent of the cases, but brand-name drugmakers also struck deals that limited how generics could be sold - and made payments of more than $250 million to their generic rivals as part of the arrangements (here is the EU preliminary report, an executive summary and various fact sheets - here, here, here and here.

The EU says the average delay for generics to go on sale was seven months. Regulators based the lost billions on a sample of meds that faced the loss of exclusivity from 2000 to 2007 in 17 countries. The savings could have been realized if generics had been approved for sale without delay. Only 28 new types of drugs were launched from 2000 to 2004, fewer than the 40 that launched from 1995 to 1999.

“These preliminary results show that market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed, at significant cost to healthcare systems, consumers and taxpayers,” EU Competition Commissioner Neelie Kroes, says in a statement (pictured left)

“We now have a solid view of what is happening and why: the next step is to discuss our findings with the stakeholders and to draw the necessary conclusions. It is still early days, but the Commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached.”

The EU has not yet charged any drugmaker formally, but regulators raided the offices of several drugmakers in different EU states earlier this week (you can read more background here).

The probe began in January and raids also involved AstraZeneca, Merck, Johnson & Johnson, Wyeth, Sandoz, Teva Pharmaceutical, Servier and Slovenia’s Krka. The inquiry was triggered, in part, by a 2005 case against AstraZeneca, which was fined for filing misleading info to patent offices to delay generics of an ulcer drug.