The Italian Court of Cassation rules on damages from patent infringement and the concept of ‘marketing’
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With judgment no. 20074/2025, the Supreme Court returned to the issue of compensation for damages in relation to patent infringement and, in particular, the distinction between the sale and marketing of the infringing product for the purposes of compensation for damages.
Boehringer Ingelheim Pharma GmbH & Co. KG (BI), owner of patent EP418716 (relating to a class of compounds including tiotropium bromide) and the related supplementary protection certificate UB2004P000849 (SPC), had brought proceedings before the Court of Milan against Sicor S.r.l. and Teva Pharmaceutical Industries Ltd for infringement of the Italian portion of the patent and SPC, seeking an injunction, withdrawal from the market, penalties and compensation for damages.
The Court had found that infringement had occurred in judgment no. 8273/2018 and, subsequently, in judgment no. 9417/2022, had awarded damages of over €12.5 million. This was calculated by applying BI's gross operating margin both to the quantities of counterfeit product actually sold by Sicor (4,123.29 g) and to those that Sicor had declared to have given as free samples or intended for internal use, e.g. for testing (9,814 g); in the absence of specific evidence to the contrary, the Court had considered the latter to be “marketed” as well.
However, on appeal by Sicor and Teva, the Milan Court of Appeal, in judgment no. 157/2024, reduced the compensable damages to approximately €3.7 million, considering that compensation should be limited to the quantities actually sold. This led to an appeal to the Court of Cassation by BI, which did not agree with this limitation.
In the decision in question, the Court of Cassation focuses on the interpretation of Article 66 of the Italian IP Code, according to which the rights conferred by the patent include the exclusive right to manufacture, use, market, sell and import the patented product.
In this context, according to the Court of Cassation, the Court of Appeal had erred in considering that only the sale of products for consideration was compensable: on the contrary, all activities of “marketing” or “use” of the counterfeit product that may infringe the patent monopoly are compensable, and therefore also the quantities placed on the market in forms other than sale, including the transfer of free samples. Hence, the ruling was overturned, and the case was referred back to the Milan Court of Appeal with a different composition, which is called upon to decide the case again on the basis of the principles expressed by the Court of Cassation.
The decision, incidentally, comes after the same Court of Cassation had already ruled in judgment 18372/2024 on another point of the dispute, namely the application of the so-called “Bolar exemption” contained in Article 68 of the Italian IP Code: “the exclusive right conferred by the patent does not extend, whatever the subject matter of the invention:... b) to studies and experiments aimed at obtaining, including in foreign countries, authorisation to place a medicinal product on the market and to the consequent practical requirements, including the preparation and use of the pharmacologically active raw materials strictly necessary for this purpose”.
On that previous occasion, the Court, rejecting the appeal by Sicor and Teva, had emphasised that the Bolar exemption also applies to companies producing the active ingredient of the patented drug not for themselves but for third-party generic manufacturers who are not equipped to produce it themselves but intend to enter the market when the patent expires. However, this interpretation presupposes: (i) that production is requested in advance by the generic manufacturer (and not proposed to the generic manufacturer by the manufacturer); and (ii) that the contract between the parties provides for the generic manufacturer's commitment to use the active ingredient only for the purpose of obtaining the marketing authorisation.
