On May 28 2015 the Barcelona Commercial Court No 1 dismissed a preliminary injunction motion in a patent case regarding fenofibrate (SECALIP).
Swiss company Abbott Products Operations AG applied for a preliminary injunction against Spanish company Kern Pharma SL for alleged infringement of European patents EP1275387 and EP2050445.
Kern Pharma had obtained marketing authorisation for its generic drug Fenofibrato Kern Pharma 145 milligram (mg) in October 2014 and planned its launch for June 2015. The active ingredient fenofibrate contained in Kern Pharma's product is nanonised.
Abbott is the registered exclusive licensee of EP1275387 and EP2050445, the holder of which is French company Fournier.
EP1275387 claims a method of preparing a granule that comprises spraying "a suspension of fenofibrate in micronized form having a size of less than 20 µm [microns]" onto an inert support.
Abbott argued that this feature of the patent claim would cover any suspension of fenofibrate with a particle size below 20 µm and therefore would cover even nanonised fenofibrate.
According to Kern Pharma, its fenofibrate 145 mg product did not infringe EP1275387 because its active ingredient was in nanonised form and not "in micronised form", as required by the patent claim.
EP2050445 claims all and any fenofibrate composition with a certain dissolution profile. Opposition proceedings against this patent are pending at the Opposition Division of the European Patent Office.
Regarding EP2050445, Kern Pharma argued for its invalidity due to lack of novelty, insufficiency and lack of inventive step. The hearing took place from March 2 to 4 2015.
The court upheld Kern Pharma's allegations and dismissed Abbott's preliminary injunction application, as it found that there would be no infringement of EP1275387, whereas there were strong indications of the invalidity of EP2050445.
As regards EP1275387, the court reviewed the expert evidence submitted by the parties regarding the meaning and interpretation of the words "in micronized form" in the patent claims, as well as the general knowledge available at the priority date of the patent (1997). In this regard, it concluded that a person skilled in the art would have understood "in micronized form" to mean with a particle size of at least 1 micron, therefore excluding nanonised fenofibrate. Thus, Kern Pharma's product would fall outside the scope of EP1275387.
Regarding EP2050445, the court considered that it was appropriate to make a provisional assessment of its validity, as it was challenged by the defendant. In this regard, it first examined the lack of novelty allegation raised by Kern Pharma and upheld it. Based on the experimental evidence on file, the court accepted that there was enough evidence to prove that Fournier's prior art fenofibrate product Lipanthyl 200 already exhibited the dissolution profile claimed in EP2050445, which would therefore seem to lack novelty.
For further information on this topic please contact Ignacio Pontijas at Grau & Angulo by telephone (+34 91 353 36 77) or email ([email protected]). The Grau & Angulo website can be accessed at www.gba-ip.com.
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