The European Commission has closed an antitrust investigation of Boehringer Ingelheim which had been accused of effectively blocking market entry to potential competition to its chronic obstructive pulmonary disease blockbuster Spiriva.

Allegations had been made by Spain's Almirall that the German drugmaker had filed for unmeritous patents 2003 regarding new treatments of COPD. 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 the disease with a new active substance that had been discovered by Almirall, aclidinium bromide.

Almirall had complained that Boehringer's patent applications would have the potential of "blocking or considerably delaying" the market entry of its medicines that would compete with Spiriva (tiotropium), which is partnered with Pfizer and had world wide turnover of close to 3 billion euros last year.

Then, in autumn 2010, the Commission asked Boehringer and Almirall "to find a mutually acceptable solution to their dispute, within the limits of EU antitrust rules". As such, the former has agreed to remove the alleged blocking positions, which 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, Joaquin Almunia, said that "this positive outcome means that it will now be easier to introduce new innovative medicines for the treatment of certain lung diseases". He added that "this is good news for patients suffering from COPD".

'Problematic' pharma patent settlements decrease

Meantime, the Commission has published the results of its second patent settlement monitoring exercise concerning the pharmaceutical sector which  shows a continuing decline of 'pay-for-delay' settlements.

The report identified 89 patent settlement agreements between originator and generic companies in 2010, compared with 207 during the eight-and-a-half years covered by the sector inquiry concluded in July 2009. It also compares with 93 agreements during the 18 months covered in the first monitoring exercise.

However, the number of settlements that limit generic entry against payment from the originator to the generic company - decreased significantly more in importance and number. Such settlements accounted for 45 out of 207, while in the first monitoring period the figure dropped to nine out of 93 of the settlements. In 2010, only three out of 89 of the settlements "fell into the category that might attract scrutiny".

Commissioner Almunia said: "I note with satisfaction that the number of patent settlements potentially problematic under EU antitrust law continues to decrease without calling into account companies' legitimate right to settle disputes amicably". He added that the Commission "will remain vigilant that companies' behaviour respect antitrust law and do not delay entry of cheaper pharmaceuticals".

The monitoring exercise will be repeated in 2012.