© Virginia Mayo/Associated PressNeelie Kroes, competition commissioner, said she would not hesitate to open antitrust cases.
One common tactic, said Neelie Kroes, the European competition commissioner, was for drug companies to amass patents to protect active ingredients in the medicines - in one case, 1,300 patents for a single drug. Another tactic, she said, was for pharmaceutical companies to sue the makers of generic drugs for ostensible patent violations, which tended to delay the availability of the lower-cost products for years.
Ms. Kroes made her comments Friday while presenting the preliminary findings of a broad investigation into accusations of anticompetitive practices in the drug sector. She also turned her sights on the generics companies, which she said had received $200 million from pharmaceutical companies over seven years in exchange for holding their products off the market.
Patients and health care systems in Europe would have saved at least 3 billion euros, or $3.8 billion, from 2000 to 2007 - or shaved 5 percent off the medical bills - if companies had let generics into the market sooner, she said.
She did not identify the companies and did not say legal action was imminent. But she did say that European officials "will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached."
The report "is likely to lead to enforcement action to test whether individual companies' strategies infringe competition law," said Stephen Rose, competition partner at the law firm Eversheds.
The pharmaceutical industry is facing the losses of patents on many of its blockbuster products in coming years as well as new challenges in the United States, where President-elect Barack Obama could give the government's Medicare program the power to directly negotiate with pharmaceutical companies - a change that the Bush administration has resisted - though the impact on prices will depend on the authority Congress grants.
Ms. Kroes began the investigation in January with a series of raids on major drug companies, including GlaxoSmithKline, Pfizer and Sanofi-Aventis, on suspicion that they and other companies were slowing the availability of generics and new medicines. The European Commission aims to speed generics to market and raise the number of new medications available.
On Friday, European officials published documents retrieved from those raids. They did not identify the authors, but the documents appeared to come from brand-name pharmaceutical companies.
"I suppose we have all had conversations around 'how we can block generic manufacturers,' " one document stated. "Don't play games in patenting new salt forms too late, the generics manufacturers are starting earlier and earlier," the document stated, apparently referring to pharmaceutical ingredients.
Another document said, "We identify options to obtain or acquire patents for the sole purpose of limiting the freedom of operation of our competitors."
Major drug makers criticized officials for publishing the statements.
The officials "used selective quotations to seek to mischaracterize the industry as anticompetitive," said the European Federation of Pharmaceutical Industries and Associations, an industry trade group.
"Those quotes simply show how innovators have rightly sought to protect their inventions and illustrate the highly competitive nature of innovation in this sector, which is entirely to the benefit of society," the statement from the trade group said. "They are not evidence of competition law infringements as the report itself recognizes - it states expressly it reaches no such conclusion."
Generics makers in Europe said they welcomed the report, saying it reflected the barriers patients face in buying less expensive drugs. They aim to ease the process of placing generics on the market when patents expire, and to raise the hurdles for pharmaceutical companies to sue them for suspected patent violations.
Yet European investigators have also turned their focus to generic companies, finding they have accepted payments from brand-name drug makers as part of patent litigation, perhaps in exchange for delaying generic medicines.
In the United States, the Federal Trade Commission has said these so-called reverse payments violate antitrust law by dividing up the market.
On Friday, generics makers maintained that the practice was less widespread in Europe. Ms. Kroes had identified such payments worth 200 million euros, representing more than 10 percent of settlements of patent litigation involving generics companies from 2000 to 2007.
Generics makers said the value of settlements in Europe uncovered by Ms. Kroes represented a relatively small sum compared with the size of settlements in the United States.
They said problems could be fixed by changing laws and rules that govern the way medicines are marketed.
Over all, the pharmaceutical market in Europe is worth 214 billion euros a year ($276 billion), or 430 euros ($555) for each European resident, according to the European Commission, the executive arm of the European Union.
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