EU puts drugmakers on notice over medicine patents

ByABC News
July 8, 2009, 2:38 PM

BRUSSELS -- The European Union warned Wednesday of a wave of antitrust investigations into major drugmakers, saying they are stalling cheaper generic versions of their own medicines once exclusive patents expire.

"Makers of original medicines are actively trying to delay the entry of generic medicines onto their markets," EU Competition Commissioner Neelie Kroes said. "The commission will now step up its antitrust enforcement" and monitor deals between major and generic drugmakers.

The EU also started an investigation into France's Les Laboratoires Servier for hindering the launch of generic versions of its heart disease drug perindopril.

Regulators said they suspect that Servier did deals with generic rivals Krka, Lupin, Matrix, Niche Generics and Teva to hold back cheaper versions.

Brian Ager of EFPIA, an industry group representing 44 drugmakers, said the EU report "claims erroneously that industry practices in some way contribute to slowing generic entry. There's nothing to substantiate these claims."

The group said regulators had also recognized that "complex and divergent regulatory barriers are the primary cause of market entry delay" because of the high costs of filing and defending separate national patents in the EU's 27 states.

The EU's antitrust division called for an EU-wide patent and litigation system and for national governments to speed up generic drug approvals. But it blamed drugmakers too for trying to discredit generics with misleading campaigns and misusing marketing authorizations to delay generic launches.

The EU says generic drugs are on average 40% cheaper than their branded rivals two years after they launch and play a key role in driving down health costs for Europe's aging and ailing population.

The European Commission said it would monitor deals between major pharmaceutical companies such as Pfizer, GlaxoSmithKline and Sanofi-Aventis and generic drugmakers because "every week and month of delay costs money to patients and taxpayers."