ITALY Law and Practice Contributed by: Daniela Ampollini, Luca Pellicciari, Elena Mannini and Andrea Beltrame, Trevisan & Cuonzo
the two main criteria to assess equivalence fol - lowed by Italian courts are as follows: • the obviousness test, according to which infringement by equivalence is found if the solution used to circumvent the literal word - ing of the claim when facing the need to solve the same technical problem would be obvious to the skilled person in light of the prior art and the common general knowledge; and • the Function-Way-Result (FWR) test (or triple test), according to which the element of the accused product that makes it different from the claimed product is equivalent, and therefore does not avoid infringement, if it performs the same function, in substantially the same way, and so as to obtain the same result, compared to the element recited by the claim. Italy does not have a prosecution history of estoppel, although discussions over statements rendered to the EPO examiner during prosecu - tion often arise in patent litigation to determine the scope of protection. Italian courts often view the patentee’s statements made during prose - cution as not necessarily relevant for defining the scope of protection. Recent case law of the Supreme Court confirmed this approach and stated that interpreting a patent strictly on the basis of the prosecution history would introduce an inadmissible purely voluntarist hermeneutical element. In addition, some courts have stated that any relevance of the file history may (at most) be limited to claim amendments neces - sary to differentiate the claims from the prior art and overcome objections of novelty or inventive step. In contrast, amendments intended to over - come formal objections, such as added matter, by concerning solely the literal formulation of the text of the claims (and, hence, the literal scope
of protection) cannot become relevant in order to exclude a potential equivalence assessment. 1.11 Clearing the Way There is no obligation to “clear the way” ahead of a new product launch, although taking appro - priate steps towards obtaining an assessment of invalidity or non-infringement can mitigate the risk of being reached by a PI. Institution of main revocation or non-infringement proceed - ings ahead of a new product launch is indeed standard practice for generics or biosimilars, at least in cases of patents at high risk of being enforced. 1.12 Experts In Italian patent litigation, either in preliminary or merits proceedings, the evaluation of the rel - evant technical issues relating to validity and infringement is always subject to consideration by a court-appointed independent expert (Court Appointed Expert, CAE). The CAE is generally chosen amongst relatively senior Italian patent attorneys with specific experience in the given technical field and asked to produce a writ - ten opinion untangling the technicalities of the case. Acting as a court adviser, the CAE must be impartial. Delivery of the CAE opinion is a stepwise pro - cess. First, the court will appoint the CAE by decree, who will be requested to appear at a specific hearing to give the formal oath and to hear the technical question under dispute that the CAE is called upon to solve. Then, a techni - cal discussion will take place before the CAE through the submission of written briefs and replies to be prepared by the parties through their own counsel and technical consultants. The parties thus feed their arguments (mostly in writing) and technical evidence to the CAE. All relevant documents can be submitted to the
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