On February 17 2012 Barcelona Commercial Court No 5 issued a judgment upholding a counterclaim brought by Actavis Spain SA and declared the invalidity of Pfizer Inc's Patent EP1957452 (EP'452). The judgment also dismissed in its entirety the infringement action brought by Pfizer against Actavis and other defendants.
In May 2010, after Actavis and other companies had launched various generic drugs of atorvastatin magnesium onto the market, Pfizer sued them for alleged infringement of the EP'452 patent, which covers a certain polymorph of atorvastatin magnesium, and for unfair competition.
According to Pfizer, the defendants' atorvastatin magnesium generic drugs infringed its patent because they contained the crystalline form of atorvastatin magnesium, which was protected by the patent.
Pfizer also argued that the marketing of the defendants' generic drugs resulted in acts of unfair competition, affirming that their advanced launch before the expiry of the atorvastatin calcium patent (EP409281) had given them a competitive advantage in the atorvastatin market.
According to Pfizer, by launching their products, the defendants had also erected a barrier to market entry for Pfizer that damaged its business strategy, which consisted of being the first to launch its own atorvastatin generic drug a little before the expiry of the atorvastatin calcium patent.
Actavis opposed the action, affirming that its generic drug did not infringe the EP'452 patent as it contained a crystalline form of atorvastatin magnesium which was different from that protected by the patent. Actavis also filed a counterclaim seeking revocation of the patent due to lack of novelty and lack of inventive step.
In its judgment of February 17 2012 Barcelona Commercial Court No 5 upheld Actavis's allegation of lack of inventive step and revoked the EP'452 patent. In summary, the decision concluded that starting from atorvastatin magnesium as disclosed in the prior art and, based on his or her common general knowledge, it would have been obvious to a person skilled in the art to look for different crystalline forms of atorvastatin magnesium, which would have led him or her to the specific polymorph claimed in EP'452.
Therefore, the court declared the invalidity of the patent and dismissed Pfizer's infringement actions, sentencing Pfizer to pay Actavis's court costs.
Pfizer has not appealed the judgment; thus, the decision has become final.
For further information on this topic please contact Sara Pelaz at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]).