European Commission closes investigation into alleged abuse by Boehringer Ingelheim

On 6 July 2011 the European Commission issued a press release announcing that it decided to close its investigation into Boehringer Ingelheim’s alleged misuse of the patent system, in relation to combinations of three broad categories of active substances in the area of chronic obstructive pulmonary disease (“COPD”) drugs, in breach of Article 102 of the Treaty on the Functioning of the European Union.  The Commission launched an antitrust investigation in 2007 amid allegations by Spanish pharmaceutical company Almirall that Boehringer had acted to keep competitors out of the market where it is the market leader with its blockbuster drug Spiriva (see Newsletter 4/2009 p.6 for background information).

In particular, Almirall had raised concerns that Boehringer’s patent applications relating to combinations of active substances (one of which was discovered by Almirall) for new treatments of CODP were not only without merit but would also have the potential of blocking or considerably delaying market entry of Almirall’s innovative combination medicines along with the active substance discovered by Almirall (so called mono-product).  While Boehringer did obtain a European patent for one of the combination products, the UK High Court of Justice revoked the UK patent in 2009. The European Patent Office followed suit and later revoked the patent granted (decision subsequently appealed by Boehringer). Boehringer had also filed so called divisional patent applications that were based on the main patent application.

Following discussions with the European Commission in 2010, Boehringer and Almirall agreed to a mutually acceptable solution to their dispute in which:

  • the applications allegedly blocking entry will be removed in Europe;
  • a license will be granted in two countries outside Europe; and
  • pending litigation between the parties will be ended.

Almirall will therefore be able to launch its combination medicines after obtaining marketing authorization from the competent bodies.

The Commission deemed the settlement between the parties the most efficient way to ensure that consumers will be able to benefit from Almirall’s product. Consequently, the case will be closed without imposing any fine on Boehringer.  This result differs significantly from a recent case in which the Commission fined the pharmaceutical company AstraZeneca Euro 60 million – the fine was later reduced by the EU General Court to Euro 52.5 million, and further appeal is pending before the European Court of Justice – for misusing both the patent system and the procedures for marketing pharmaceuticals (see Newsletter 5/2010 p. 7 and Newsletter 4/2010, p. 6 for background information on this and other related cases). [Gabriele Accardo]