Pharma Faces Anti-Competitive Probes In The EU

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investigate-21Several drugmakers were raided today by European Union regulators, who are probing anti-competitive behavior and later this week plan to publish a report on the pharmaceutical industry, The Financial Times reports.

Neelie Kroes, EU competition commissioner, will this week release interim findings from an investigation launched in January to examine practices by brand-name and generic drugmakers that she suggested could be slowing the launch of new patented and cheaper generic meds, the FT continues.

The 400-page report - a precursor to final findings to be released next spring - is being watched with nervousness for indications that it will spark investigations and calls for broader policy reform. “I’m absolutely certain that in the next few months the commission will launch two or three companyspecific cases,” an exec at one drugmaker, which was studied, tells the paper.

The inquiry began when commission officials earlier this year raided the offices of a dozen leading drugmakers in Europe and took away confidential info about intellectual property rights, litigation and settlements. These included AstraZeneca, Glaxo, Pfizer and Sanofi-Aventis (back story).

These and other drugmakers that were not initially raided were required to fill out questionnaires at short notice under threat of sanctions with follow-up queries issued earlier this month, the FT reports, adding that the industry has made “hefty” submissions to Brussels, arguing that drugmakers are keen to develop drugs but have been hindered by scientific challenges and regulatory burdens.

But generic drugmakers have complained brand-name rivals exploit and extend drug patent rules to delay the launch of cheaper generics, while rejecting suggestions of any exclusive deals with the innovators to cut out rivals.

Lawyers say the commission’s questions have focused on issues including patent settlement deals in which brand-name drugmakers pay generic drugmakers to settle litigation. A key concern appears to be whether such deals may involve associated agreements under which generic manufacturers consent to stay out of the market for particular drugs, according to the FT.

“I think they will be particularly concerned about policing and establishing some rules in the settlement of patent litigation,” Tony Woodgate, partner at the Simmons & Simmons law firm, tells the FT.

Another focus has been “vexatious” litigation, in which a company uses the courts to delay or frustrate an opponent, rather than seek dispute resolution. The interim report is also expected to touch on broader aspects of Europe’s patent litigation system, which both companies and lawyers acknowledge operates in a piecemeal fashion. “I’m sure they will use this as advocacy for patent reform,” one pharma advocate tells the FT.

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