The Supreme Court held that prosecution history estoppel has no legal basis in the Italian patent law system. The assessment of patent infringement must be carried out by taking into consideration the objective meaning of the patent as expressed in the claims, interpreted in light of the description and drawings, but without giving relevance to the subjective intent of the patent owner.
Moreover, the Supreme Court stressed that the differences between the contested product and the features provided by the patent claim do not exclude infringement by equivalence when:
The Court of Appeal held that in order for the invention to lack the novelty requirement as a result of prior disclosure, it is necessary that the invention is known, before the patent application is filed, by a potentially indefinite number of people who are able to understand the characteristic features of the invention and who are not obliged to keep it secret. In this case, the court confirmed that there was no prior disclosure since the machineswere not accessible to third parties and the people who inspected them were bound by confidentiality obligations.
The judges confirmed that the defendant committed contributory infringement of the claimant’s process patent having sold a machine intended to implement the claimed method to a Canadian customer. According to the Court of Appeal, there was contributory infringement since the defendant made profits in Italy by knowingly supplying means, indispensable for the implementation of the process protected by the patent, to another person who applied that process, despite the fact that the implementation of the process took place outside Italy.
The court then went on to reverse the first instance judgment (which had held that damages could only be calculated on the basis of a reasonable royalty and not on the other criteria, e.g. lost profits) since the patentee was bound by an exclusive agreement to supply the patented machine to a different North American customer and therefore could not have sold it to the infringer’s Canadian customer. The Court of Appeal, though recognising that the infringer’s sales had not caused the patentee any loss of profits, nevertheless ordered the infringer to disgorge the profits made from the sale of that specific machine.
The Court of Appeal upheld the first instance decision declaring the invalidity of the SPC for the medicinal product Truvada. It held that the combination of the active ingredients tenofovir disoproxil and emtricitabine was not protected by the basic patent in compliance with Article 3(a) of the SPC Regulation, as interpreted by the CJEU in the parallel Gilead case (C-121/17).
In particular, the court pointed out that emtricitabine was not mentioned in any way in the basic patent; the reference in the patent to the possible combination of compounds (including tenofovir) with other therapeutic ingredients could not reasonably be interpreted as an implicit reference to emtricitabine.
Also, the mere fact that at the priority date of the patent, in the light of prior art, the combination of tenofovir and emtricitabine was possible did not constitute a sufficient condition for determining that emtricitabine was or could be considered as “protected by the basic patent” according to Article 3(a) of the SPC Regulation.
The Court of Milan addressed for the first time in Italy the issue of infringement of second medical use patents.
Although the decision dealt mainly with the invalidity of the Italian designation of AstraZeneca’s patent for lack of inventive step, the judges also held that Teva’s medicinal product did not infringe. The patent related to the use of fulvestrant in the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and where such treatment had failed.
In particular, according to the court, Teva's product did not amount to direct or contributory infringement because it was not suitable to be used in accordance with the claimed use, neither from a regulatory point of view (since in the Summary of Product Characteristics and the Patient Information Leaflet did not refer to the specific claimed use) nor from a practical point of view (since AstraZeneca was not able to prove that such use was actually carried out in oncological practice in Italy).
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