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In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents may be based in part on statutory law, the interpretation of which is generally established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement.

This is the seventh post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, our third post examined the law in Germany, our fourth post examined the law in Denmark, our fifth post examined the law in the United Kingdom, and out sixth post examined the law in France.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands,  Doctrine of Equivalents – Germany,  Doctrine of Equivalents – DenmarkDoctrine of Equivalents – United Kingdom and Doctrine of Equivalents – France.

Doctrine of Equivalents in Italy

Background

Italy has a population of about 60 million and, as one of the most industrialized countries in the European Union (EU) together with Germany, it is an attractive market for many industries such as pharmaceuticals and telecoms.  As a result, many foreign companies often litigate in Italy, especially when it comes to important patents on which those companies start multinational litigation in the major EU countries.  Thus, for many years now, Italy has had in place a system of specialized intellectual property (IP) courts that have exclusive jurisdiction on patent matters that are staffed with highly experienced judges.

In patent litigation, the Italian IP judges almost always appoint a court expert to advise whether the patent is valid and infringed. The court expert is generally an experienced patent attorney working in private practice, who is free of conflicts, and has a suitable technical background in the field of technology of the litigation.  The expert renders an opinion on the “gist” of the case rather than only on specific technical issues. Specifically, the expert’s opinion is based on briefs filed by the patent attorneys representing the parties, rather than by (non-patent) lawyers. The involvement of an expert, whose opinion is generally fully adopted by the IP judges, contributes to the high quality of the court decisions. Because of the reliance by the IP judges on the findings of the expert, many  times a party wishing to launch a product in Italy before the expiration date of a patent will start an invalidity and non-infringement action on the merits, so as to try and obtain a favorable expert report, as this may significantly decrease the chances of a preliminary injunction (PI) being granted if the launch takes place after the expert report is issued.

Moreover, Italian patent litigation is appealing for three additional reasons. First, there is no requirement for the patentee to start a litigation on the merits once a PI is granted (unlike in other EU countries where, if the patentee does not start the litigation on the merits, the PI is automatically lifted). Second, the patentee is not liable to pay damages to the alleged infringer if, for example, during the course of subsequent litigation on the merits, the PI is lifted. Third, any first instance decision can be appealed by the losing party, without having to first request a leave to appeal.

Although there is no discovery in Italy, a patentee who suspects ongoing infringement and  is unable to find publicly available evidence of the infringement, can request, in ex parte proceedings, the authorization to inspect the premises of an alleged infringer by surprise (e.g., unannounced) so as to collect relevant evidence prior to commencing litigation on the merits or filing a request for a PI. This type of inspection is particularly helpful, such as, for example, in the case of process patents or in connection with patents relating to devices that are used by an alleged infringer in the course of its manufacturing activity. Since the inspection is a fact-finding measure rather than a punitive measure, the threshold for obtaining the authorization to carry out such an inspection from an IP judge is rather low, and these authorizations are frequently granted. The patentee has one month to carry out the inspection and then start the action based on the evidence collected.

First instance proceedings on the merits generally last about 18 to about 24 months. First instance PI proceedings can last as take as little as about 2 weeks to about 1 month.

Direct Infringement

In Italy, direct infringement is governed by Art. 66 of the Italian IP Code (IPC), which recites as follows:

“1. The rights for a patent of invention consist of the exclusive faculty to implement the invention and to gain profit therefrom in the territory of the Italian State, within the limits and under the conditions set out by this Code.

2.  In particular, the patent confers the following exclusive rights on its owner:

a) if the subject matter of the patent is a product, the right to prohibit third parties, unless authorized by the owner, from manufacturing, using, placing on the market, selling or importing for such purposes the product in question;

b) if the subject matter of the patent is a process, the right to prohibit third parties, unless authorized by the owner, from applying the process, as well as from using, placing on the market, selling or importing for such purposes the product directly obtained by the process in question.

2-bis. The patent also confers the exclusive right on the owner to prohibit third parties, except with his or her consent, from supplying or from offering to supply, to persons other than the parties entitled to use the patented invention, a means relating to an essential element of that invention and necessary for its implementation in the territory of a state in which the invention is protected, if the third party is aware of the suitability and intended use of said means to implement the invention or is able to have that awareness based on  ordinary diligence.

2-ter. Paragraph 2-bis does not apply when the means are constituted by products that are currently on the market, unless the third party induces the party to whom the means are supplied to carry out the acts prohibited pursuant to paragraph 2.”

 Claim Construction

Art. 52 IPC contains the provisions forming the legal basis for claim construction in Italian patent litigation:

“1. The claims specifically indicate what the subject matter of the patent is intended to be.

2.  The limits of protection are determined by the claims; however, the description and the drawings serve the purpose of interpreting the claims

3.  The provision in paragraph 2 must be understood so as to simultaneously ensure fair protection to the owner and reasonable legal certainty to third parties.

3-bis. In order to determine the scope of protection conferred by the patent, due account shall be taken of any element which is equivalent to an element specified in the claims.”

 The protocol of interpretation of Art. 69 of the European Patent Convention (EPC), i.e., the article relating to the extent of protection conferred by a patent and whose wording mirrors that of Art. 52 IPC, is also often relied upon for construing the claims in Italian patent litigation. Specifically, Art. 1 of the protocol of interpretation states that:

“Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.”

 Thus, under Italian law, claim construction is partly a mixed question of law and fact and the claims are construed on the basis of the specification, as well as on the basis of the prosecution history (see below) and the prior art.

Prosecution History (Prosecution History Estoppel)

The effect of the prosecution history when assessing the scope of protection of a claim in Italian patent litigation is governed by Italian case law. The presently prevailing case law provides that while any statements contained in the prosecution history are not necessarily binding on the patentee, they nevertheless can carry a significant weight when interpreting the claims of the enforced patent.  For example, recently the IP court of Milan stated that “in infringement proceedings the features intentionally excluded by the patent owner during examination for the purpose of distinguishing his patent from the prior art cannot be considered to be technical equivalents of the claimed elements (this approach has been reiterated multiple times by the present court, in line with the US file history estoppel theory). So as to respect the requirement of certainty of the limits of the exclusive rights with respect to … third parties, the owner has the duty to specify his claims, where his statements made in examination have a preclusive relevance with respect to the scope of protection of the  monopoly.” (Court of Milan, decision published on June 1, 2018).

Italian Supreme Court’s Case Law Regarding the Doctrine of Equivalents

The leading Italian case that established the test to be used when determining infringement by equivalents is the Italian Supreme Court decision dated January 13, 2004. In this decision, the Italian Supreme Court established that “[i]n order to assess …. whether the accused embodiment can be considered to be equivalent to the patented one, so as to represent an infringement thereof, it is necessary to determine whether, in allowing to obtain the same final result, the accused embodiment is inventive, thereby providing a solution that is not obvious with respect to the patented one and is not a repetition of the patented one either: this is the case for the solution that goes beyond the knowledge of the average skilled person facing the same problem. In fact, only in this case it is possible to consider that the [accused] solution falls outside the protected solution.” This test was then repeatedly endorsed by the Italian Supreme Court in several decisions, including decisions issued in 2011, 2012, 2015 and 2016.

Essentially, the test to determine infringement by equivalents involves answering the following two questions:

  1. Does the allegedly infringing solution lead to the same final result as the patented solution?

If the answer is no, then there is no infringement by equivalents. If the answer is yes, proceed to question 2.

  1. Does the allegedly infringing solution represent an invention with respect to the patented solution?

If the answer is yes, then there is no infringement by equivalents.  If the answer is no, then there is infringement by equivalents – unless the allegedly infringing solution forms part of the state of the art, in which case it is excluded from the scope of protection of the patent.

Pemetrexed Decisions

The recent pemetrexed litigation, which caused quite a stir throughout Europe, also reached Italy. In this case, Eli Lilly’s European Patent No. 1313508 (the ‘508 patent) had been granted with a claim directed to the use of pemetrexed disodium (an antifolate) to inhibit tumor growth in combination with vitamin B12. The underlying application had claimed the use of antifolate rather than pemetrexed disodium. During examination at the EPO, Eli Lilly had first amended its claims to pemetrexed in view of certain prior art. The EPO objected to the amendment arguing that the application as filed did not disclose pemetrexed, but rather only a specific salt thereof, namely the disodium salt.  As a result, Eli Lilly limited its claims to pemetrexed disodium.

In Italy, Fresenius argued that its generic product, which contained pemetrexed ditromethamine, did not constitute an infringement by equivalents of the ‘508 patent.  Specifically, Fresenius argued that the ‘508 patent was limited to a specific pemetrexed salt and that the patent could not be interpreted broadly because it had been limited during examination so as to exclude any salts other than the disodium salt. In contrast, Eli Lilly argued that infringement by equivalents existed because the limitation of the claims to the specific disodium salt was only because of formal reasons and a skilled person would understand that the salt form of pemetrexed used was irrelevant for the purpose of achieving the result of the invention. Based on this argument, Eli Lilly requested a PI.

At first instance, the Milan IP court denied the PI request.  Specifically, the Court found that the scope of protection of the patent, even when interpreted so as to take any equivalents into consideration, had to be limited so the objective scope of the patent as amended during examination, regardless of the type of objection that had resulted in the amendment.

On appeal, the appeal court reversed the first instance findings and granted the PI. The appeal court reasoned that  “unlike the limitations resulting from objections based on the prior art, a limitation introduced so as to overcome an added matter objection cannot effectively influence the application of the doctrine of equivalents, given that such objection focuses on  formal aspects relating to the literal wording of the text of the amended claims compared to the original text of the patent application.” Thus, the appeal court drew a distinction between claim amendments made for purposes of distinguishing the invention from the prior art and claim amendments arising as a result of formal objections, holding that in the latter case the limitations introduced during examination could be interpreted broadly so as to take into consideration any equivalents thereof.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners.

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