European Commission - Press release
Antitrust: Commission welcomes improved market entry for lung disease treatments
Brussels, 6 July 2011 - The European Commission has closed an antitrust investigation into allegations by Spanish pharmaceutical company Almirall that the German pharmaceutical company Boehringer Ingelheim had filed for unmeritous patents regarding new treatments of chronic obstructive pulmonary disease (COPD). The Commission investigation concerned the alleged misuse of the patent system in order to exclude potential competition in the area of COPD, in breach of EU antitrust rules. As Boehringer agreed to remove the alleged blocking positions, this lifts the obstacles to the launch of Almirall's products and the Commission no longer needs to pursue the case.
Commission Vice President in charge of competition policy Joaquín Almunia said: "This positive outcome means that it will now be easier to introduce new innovative medicines for the treatment of certain lung diseases. This is good news for patients suffering from COPD, a respiratory disease often caused by smoking."
The Commission's investigation concerned Boehringer's alleged misuse of the patent system in relation to combinations of three broad categories of active substances treating COPD with a new active substance that had been discovered by Almirall. Almirall had raised concerns that Boehringer's patent applications would have the potential of blocking or considerably delaying the market entry of Almirall's competing medicines. In autumn 2010 the Commission suggested to Boehringer and Almirall to find a mutually acceptable solution to their dispute, within the limits of EU antitrust rules.
The settlement agreement that the parties have now concluded addresses the Commission's concerns. In particular the alleged blocking positions will be removed for Europe, a licence will be granted for 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 authorisation from the competent bodies. The Commission concluded that a settlement between the parties is the most efficient and speedy way to ensure that consumers will be able to benefit from Almirall's product and has closed the case.
Separately, the Commission today publishes the results of its second patent settlement monitoring exercise for compliance with EU antitrust rules (see IP/11/840). This exercise bears no connection to the above mentioned case.
Boehringer is the market leader in the treatment of COPD, with its blockbuster drug Spiriva achieving a world wide turnover close to €3 billion in 2010. In 2003, Boehringer filed patent applications for new treatments of CODP. These applications related to combinations of three broad categories of active substances treating COPD with a new active substance that had been discovered by Almirall. Almirall objected to these filings, alleging that the patents were unmeritous, but once granted could nonetheless block or considerably delay the market entry of its own innovative combination medicines. The patent applications allegedly also had a negative impact on Almirall's efforts to bring to market the product based on the active substance discovered by Almirall (so called mono-product).
Boehringer initially succeeded in obtaining a European patent for one of the combination products. However in 2009 the UK High Court of Justice revoked Boehringer's UK patent for the combination product because of obviousness (lack of inventive step) and insufficiency. In March 2010 the patent was also revoked by the European Patent Office (EPO). Boehringer appealed this decision to the next EPO instance, which would have kept the contested patent in force until the appeal had been decided. Some years ago Boehringer had also filed so called divisional patent applications that were based on the main patent application, which were dormant, but could have been reactivated and thus prolong the patent dispute even after the EPO annulled the contested patent.
When the Commission was informed of the matter it started an investigation and initiated formal proceedings on 22 February 2007. Following the conclusion of the competition inquiry into the Pharmaceutical Sector (see IP/09/1098) the investigation was relaunched. Its main focus was to establish whether Boehringer had filed patent applications and had obtained patents by providing misleading information to the EPO.