Pharmaceutical Patent Strategies : The Competition between Originator and Generic Companies within the European Union

University essay from Högskolan i Jönköping/IHH, Rättsvetenskap

Abstract:

The pharmaceutical market is a billon euro industry and the competition on the market is highly intensive. Primarily there are two competitors on the market, partly the originators which provide the market with new drugs, and partly the generics which produce copies of the originators‟ drugs. The originators are able to be granted patent protection of the drug under the European patent system, provided that the drug fulfils the requirements for patentability. During the period of patent protection the generics are not able to produce copies of the drug, but once the duration of the patent has expired the generics are able start the production. Thus, in order to hinder the generics to make copies of the drug, the originators apply various patent strategies. This has been noted by the European Commission, which conducted a sector inquiry of the pharmaceutical market in 2009. The presentation of the competition within the market focused on the applied strategies by the originator and concluded that all measures will be taken to hinder restrictions on the competition.

In conjunction, the General Court judged in a recent case that the originator AstraZeneca constituted an infringement of the competition law when their strategies were applied. The complexity of determine whether a strategy is lawful or not, is due to the interface between the intellectual property law and the EC competition law. This implies that the strategy can be lawful under the IP law but unlawful under the competition law. The Court has established that any strategy, regardless of its legality under the IP law, constitutes an infringement of the competition law if it might restrict the competition. The Courts do not provide sufficient guidelines of the conditions that constitute the infringement. Consequently, the strategies‟ legality is at present time uncertain.

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