Historical Archive

Delaying the arrival of generics: this is how pharmaceutical companies do it


 ·        16 May 2014 La Presse.it

Treviso, May 16th (LaPresse) - The problem of 'reverse payment', the mechanism for protecting branded drugs by pharmaceutical companies that hold patents, which pay generic drug manufacturers to stay out of the market or delay access, in Europe it is much less developed than the United States.

"The first time the European Commission dealt with it was in 2009", explained the lawyer Claudio Tesauro during his speech at the 9th edition of the conference 'Antitrust between national law and European Union law' in Treviso . "The Commission – he continued – has dealt with the potential anti-competitive scope of settlement agreements in a special section of the new guidelines, identifying three hypotheses: compensation for restriction, the case of cross licenses and non-challenge clauses".

Among the recent cases dealt with by the Commission, there is that of Lundbeck.

The decision arrived in June 2013. "Lundbeck held the exclusive patent on the antidepressant drug Citopram which expired in 2002 – explained Tesauro – and in view of the expiry of the patent, four genericists were preparing to enter the market.

Lundbeck, however, agreed with them, obtaining the commitment not to market their drugs in exchange for sums of money, purchases of drugs to destroy them and distribution agreements". The Commission fined Lundbeck 93.8 million to generics for 52.2 million.

Another case of reverse payment is that of Johnson & Johnson, on which the Commission ruled in December 2013. "J&J held the patent on the painkiller Fentanyl, which expired in 2005 – explained Tesauro – and in the meantime a genericist was preparing to enter the market with an economic version

Articoli correlati

Back to top button
Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco