This country-specific Q&A provides an overview of the legal framework and key issues surrounding patent litigation law in Italy.
This Q&A is part of the global guide to Patent Litigation.
For a full list of jurisdictional Q&As visit http://www.inhouselawyer.co.uk/index.php/practice-areas/patent-litigation/
What is the forum for the conduct of patent litigation?
Commercial chambers instituted in 23 among the main court districts retain exclusive jurisdiction for intellectual property cases, including patent infringement and invalidity/revocation actions.
Commercial judges are selected among senior members of the judiciary system. While Italian judges have a legal, non-technical background, our commercial judges are specifically skilled in patent matters, although their level of experience in the field may vary depending on the court seized.
The court having territorial jurisdiction to hear a patent infringement action is the court of the domicile of the defendant or, alternatively, of the place where the alleged infringement is taking place. Patentees may avail of the latter criterion to forum shop to their courts of choice.
What is the typical timeline and form of first instance patent litigation proceedings?
Patent litigation can originate from a claim of infringement, a claim of non-infringement (resulting into declaratory proceedings) or a claim of invalidity (resulting into revocation proceedings).
Infringement and declaratory claims can be pursued either in the form of ordinary merits proceedings or in the form of urgent proceedings aimed at the grant of preliminary relief.
Invalidity claims are in principle pursued by means of ordinary proceedings, although the majority of the case law allows motions for preliminary declaratory relief based on invalidity arguments only.
There is no “bifurcation” between infringement and invalidity/revocation proceedings. Courts seized with ordinary patent infringement proceedings are always competent to hear a counterclaim of patent invalidity/revocation. Counterclaiming patent revocation in response to ordinary infringement proceedings is in fact standard practice for alleged infringers. Invalidity is also regularly used as a defence in preliminary proceedings.
The timeline of proceedings varies depending on the court seized. Taking the courts of Milan, Turin and Rome (arguably the main courts for patent litigation) as a reference, the average timeline of ordinary infringement and revocation proceedings can be identified in 2 to 3 years, whereas that of preliminary proceedings can be identified in 4 to 6 months.
Can interim and final decisions in patent cases be appealed?
First instance decisions handed down in ordinary proceedings can always be appealed before the territorially competent Court of Appeal. Appeal court judgments can be further appealed (on point of law only) before the Court of Cassation, which sits in Rome.
The deadline to appeal before the Court of Appeal and the Court of Cassation is 6 months from publication of the judgment subject to appeal, although a shorter deadline of 30 days can be triggered by formally serving the judgment on the parties.
First instance decisions handed in interim (PI) proceedings can always be appealed before a Panel of three judges from the same Commercial Chamber, within 15 days from publication.
Which acts constitute direct patent infringement?
Under Article 66 Italian IP Code, every act that involves putting the patented invention into effect and earning a profit or commercial advantage out of it.
A good way of paraphrasing this rather aseptic, catch-all provision is looking at direct infringement as typically consisting of manufacturing, importing, exporting, marketing and selling or offering for sale the allegedly infringing goods or services, as well as of any other activity susceptible of securing market shares to the infringer, including advertising and promotion activities.
Do the concepts of indirect patent infringement or contributory infringement exist? If, so what are the elements of such forms of infringement?
Italian case law has since long developed the concept of indirect or “contributory” infringement. A finding of contributory infringement is subject to two conditions. One, the supply of means that are essential to put the patented invention into effect. Two, the contributory infringer is aware, or should be aware using normal diligence, that those means are intended to be used for purposes of putting the invention into effect.
The contributory infringement doctrine was made the object of statutory provisions in 2016, as part of the alignment of the Italian law system with the laws that ratified the Unified Patent Court Agreement.
The newly introduced provisions (Art. 66 Italian IP Code, paragraphs 2 bis, ter and quater) provide further guidance for the application of the contributory infringement doctrine. In particular:
- the supply of necessary means amounts to contributory infringement if intended for putting the invention into effect “in a country where the invention enjoys patent protection”. While this provision is still awaiting guidance from the case law, its literal meaning is that contributory infringement applies irrespective of whether the downstream direct infringement takes place or is intended to take place in Italy or in another country, as long as it is a country where the invention enjoys patent protection
- the supply of means necessary to put the invention into effect does not amount to contributory infringement if the supplied means are staple commercial products, unless the supplying party has actively induced the supplied person or entity to carry out infringing conducts
- the supply of means necessary for putting the invention into effect amounts to contributory infringement even when directed to persons or entities shielded by a patent exemption (such as the experimental exemption or Bolar exemption).
How is the scope of protection of patent claims construed?
Art. 52(1) of the Italian IP Code provides that the scope of protection is determined by the patent claims, interpreted in light of the description and the drawings. As provided in subsequent paragraph 52(2), patent claims need to be interpreted so as ensure both the patentee’s right to a fair protection and, on the other hand, legal certainty for third parties.
Our statutory provisions are therefore perfectly aligned with the principles condensed in Article 69 of the European Patent Convention (EPC) and the related Protocol of Interpretation.
The material application of the above statutory provisions has resulted into our courts introducing a ‘doctrine of equivalents’, which was itself made the object of a statutory provision in 2010, namely Art. 52(3) which states that in determining the scope of protection, account must be taken of features that might be equivalent to the claimed features.
Our doctrine of equivalents has witnessed the adoption of several tests. The test most likely to be applied by Italian courts today is the renowned “triple test”, according to which an element is equivalent to the claimed features if it performs the same function, in the same way so as to obtain the same result. That being stated, the assessment of whether a patent is or is not infringed by equivalents is fact-sensitive and to a large extent affected by the specificities of the case.
Italy does not have a prosecution history estoppel, although discussions over statements rendered to the EPO examiner during prosecution often arise in patent litigation. Italian courts have a trend of considering the patentee’s statements during prosecution irrelevant for purposes of determining the scope of protection, the main argument being that those statements are released in an administrative (not jurisdictional) venue and for purposes of curing a potential grant impediment/invalidity, which is a matter separate from infringement. Nevertheless, the issue is still fairly controversial.
What are the key defences to patent infringement?
Non-infringement, invalidity and the patent exemptions set forth in Article 68 Italian IP Code, the most important being the experimental use exemption and the Bolar exemption.
The experimental use exemption shields “activities carried out in a private, non-commercial environment and for non-commercial purposes, or of an experimental nature”. The prevailing interpretation is that this exemption typically shields only those research and development activities aimed at achieving innovations overcoming or winning over the patented product or process i.e. at achieving new inventions.
Our Bolar exemption instead covers studies and experiments directed at obtaining a Marketing Authorization for a medicinal product (generics as well as originators) and the consequent practical requirements, including the preparation and use of the patented active substance in the amounts that are strictly necessary for the MA registration procedure.
While Bolar litigation is hardly frequent, a seminal judgment issued in 2018 by the Milan Court clarified the boundaries of the Bolar exemption and in particular the conditions that must exist for the latter to be invoked by mere API manufacturers, thus bringing clarity over the issues that had been left open in the unresolved Astellas v. Polpharma litigation.
What are the key grounds of patent invalidity?
The grounds of invalidity under which a patent may be revoked reflect the patent grant requirements set forth in the EPC. Italian courts focus mainly on the issues of novelty and inventive step, whereas formal requirements such as added matter and sufficiency are more likely to be kept in the background.
How is prior art considered in the context of an invalidity action?
The relevant prior art is identified and interpreted differently depending on which is being considered between novelty and inventive step.
The prior art relevant to the assessment of novelty is the ‘state of the art’ as defined in Art. 46 Italian IP Code, namely everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing or before the date of priority (if priority is claimed) and Italian or European patent applications filed before the filing or priority date, even when not yet published by said date.
Combination of prior art references is not allowed when assessing novelty. In principle, lack of novelty is found only in presence of a prior art reference that discloses alone each and any of the claimed features. References or notions of common general knowledge may be used to interpret certain parts of the disclosure.
The prior art relevant to the assessment of inventive step is the ‘state of the art’ as defined in Art. 46 Italian IP Code, minus patent applications that, while filed before the filing or priority date, were not yet published by said date.
A criterion that should further narrow the prior art relevant to the assessment of inventive step is the technical field or background of the relevant person skilled in the art. For example, as opposed to a patent directed at the formulation of a known active pharmaceutical ingredient, the relevant prior art should not include all documents discussing the active at hand, but only documents pertaining to the formulation of such active or similar actives. Some of our courts are however more generous than this argument would allow and tend to be over-inclusive when selecting the relevant prior art.
In the framework of inventive step, prior art is considered in light of the renowned problem-solution approach applied by the EPO.
Can a patentee seek to amend a patent that is in the midst of patent litigation?
A patent in the midst of litigation can be amended either by means of an application to amend filed directly at the Italian Patent and Trademarks Office (PTO) or, if the litigation includes a claim of invalidity/revocation, directly in court.
Our system does not contemplate the filing of auxiliary requests. No matter whether it is filed before the PTO or in court, an application to amend is a one-off withdrawal of the broader scope of protection defined by the previous claim set.
Is some form of patent term extension available?
The only form of patent term extension available are Supplementary Protection Certificates for medicinal products and for plant protection products.
Old national legislation governing the grant of certificates for medicinal products has since long been repealed. As of today, the rules governing the grant, duration and the protection ensuing from supplementary protection certificates are those set forth in EU Regulation 469/2009 (for medicinal products) and EU Regulation 1610/96 (for plant protection products).
A thick body of national case law revolving around the grant or validity requirements of SPCs for medicinal products has formed over the years, fostered by the continuous stream of referrals decided by the Court of Justice of the European Union (CJEU) ever since the ‘90s.
As of today, the most controversial requirement is arguably Art. 3 (a) of the SPC Regulation and in particular the interpretation of the actual meaning of the wording “protected by the basic patent” following the Medeva (C-322/10), Actavis (443/12) and Eli Lilly (493/12) CJEU judgments.
Recent case law from the Milan court has also engaged with the interpretation of the meaning of the expression “active ingredient” as used in the SPC Regulation, and eventually applied the principles set forth on the subject in the Forsgren (631/13) referral.
Some controversy has also arisen as to whether the SPC Regulation allows the grant of a certificate to a patent holder that is not, at the same time, the holder of the relevant Marketing Authorization. While we have knowledge of this ground being used in court proceedings (as part of broader invalidity claims encompassing other reasons for invalidity), Italian courts have yet to pronounce on the issue.
How are technical matters considered in patent litigation proceedings?
Italian judges have no technical background and are always assisted by a Court-Appointed Expert. CAEs (normally senior patent attorneys registered with the court) are appointed in both merits and interim (PI) proceedings and asked to produce a written opinion untangling the technicalities of the case and providing their view on whether the patent is valid and infringed.
Delivery of the CAE opinion is a stepwise process. The parties feed their arguments (mostly in writing) and technical evidence to the CAE before the latter produces a preliminary opinion. The parties review said opinion and provide their own comments (once again, mostly in writing). Further to this, the CAE produces a final, non-binding opinion which serves as a “primer” or guidance for the judge to adjudicate the case.
Parties are allowed to appoint their own experts and avail of their support when submitting their arguments and evidence to the CAE. However, these experts do not act as “expert witnesses”. They are professionals (mostly patent attorneys skilled in the relevant technical field) who work alongside and cooperate with lawyers when preparing arguments for the CAE.
Is some form of discovery/disclosure and/or court-mandated evidence seizure/protection (e.g. saisie-contrefaçon) available, either before the commencement of or during patent litigation proceedings?
Our system contemplates a saisie-type measure, which is generally referred to as “search order”. Search orders assist patentees (and holders of other IPRs) in situations where evidence of the infringement is particularly difficult/impossible to get. Typically, this is the case when the infringing product is not on the market or cannot be retrieved from the market, or when the patent to be enforced is directed to a process that is being used within the infringer’s premises and does not show up in the final product.
The grant of a search order is subject to the patentee demonstrating a substantial likelihood that the patent is being infringed (prima facie case) and the impossibility to get hold of the full evidence of the infringing conduct if not by accessing the premises of the alleged infringer.
Once issued, the search order (which is normally granted ex parte) empowers the Court Bailiff to forcefully access the infringer’s premises and “search” the evidence of the infringement within those premises. Parties are authorized to attend the search operations via their lawyers and consultants. Parties may also be authorized to attend in person or via their representatives. Depending on the circumstances and at the petitioner’s request, the search order may also carry an order to seize allegedly infringing goods found during the operations.
Subject to validation of the search operations (to this end, an inter partes hearing needs to take place before the Judge shortly after the search operations) the evidence collected can thereafter be used by the patentee for purposes of instituting infringement proceedings. These must be instituted within the mandatory deadlines of 30 calendar days or 21 working days from validation of the search operations, whichever accounts for the longest period. Failure to comply with this deadline will extinguish the search and invalidate all the collected evidence.
Our proceedings have no “discovery”, neither in the US nor in the UK manner of speaking. Judges nevertheless retain the power to order the disclosure of certain documents, at the parties’ request and depending on the circumstances. The typical situation is the issue of orders to disclose all accounting and financial information, when a case of infringement/validity has been met and for purposes of determining a damage award.
Are there procedures available which would assist a patentee to determine infringement of a process patent?
Procedurally speaking, patentees holding patent rights on a process can file for the grant of a search order, as already discussed above.
Our system does not contemplate the possibility for the judge to order the alleged infringer to disclose a description of its process. On point of law, however, Art. 67 Italian IP Code provides for the reversal of the burden of proof in favour of holders of process patents if the product obtained through the patented process is new or, alternatively, if the patentee can demonstrate to have gone through reasonable efforts to determine the process used by the infringer, without success.
The meaning of the word “new” as used in Art. 67 is controversial. We have old (but still valid) case law to the sense that for purposes of Art. 67, “new” should be intended as commercially new or innovative, whereas some scholars have suggested that “new” should be intended as tantamount to “novel” i.e. novel over prior art. The prevailing argument should be the former, although our system could use a little more guidance from the case law on this issue.
Are there established mechanisms to protect confidential information required to be disclosed/exchanged in the course of patent litigation (e.g. confidentiality clubs)?
Briefs and documents filed by the parties, witness testimony, minutes and hearing protocols cannot be accessed by third parties. According to our rules of civil procedure, all third parties have access to is the judgment/decision and its content, once the latter is published.
While the above already ensures a certain degree of protection of confidential information exchanged or referred to by the parties during the proceedings, cases where the need to shield confidential information exists as opposed to the other parties of the proceedings, or cases that the judge cannot decide but by making reference to such confidential information in the text of the judgment call for additional protection.
The institution of “confidentiality clubs” and the adoption of measures suitable to conceal or redact the text of the judgment/decision in the parts referring to the confidential information are common practices in our courts.
These practices are now the subject of statutory provisions, adopted as part of the implementation of EU Directive 2016/943 (Trade Secrets Directive).
Along with a general provision requiring judges to take all appropriate measures and steps for the protection of confidential information, those statutory provisions specifically contemplate the judge’s power to restrict access to all documents on file to certain persons only, and order that the decisions/judgments be redacted in those parts that the judge will specifically identify as containing or referring to confidential information of the parties.
Unlike in other jurisdictions, the above measures are not adopted by virtue of a formal agreement entered into between the parties, but imposed by the judge by means of an order/decree.
According to a literal interpretation of the above mentioned statutory provisions, the above measures should available only in proceedings concerning the breach or violation or infringement of confidential information/trade secrets. Nevertheless, there seems to be no reason why the same measures should not apply to patent infringement proceedings by analogy, in the extent to which reference to trade secrets is relevant to establish patent infringement.
Is there a system of post-grant opposition proceedings? If so, how does this system interact with the patent litigation system?
The Italian patent system does not contemplate opposition proceedings, nor post-grant procedures of any other sort.
That being stated, with Italy being part to the European Patent Convention our system is obviously affected by the post-grant opposition system of the European Patent Office.
There is a reasonable degree of interaction between EPO opposition proceedings and our court proceedings. This is particularly true for PI proceedings. A patent that has “survived” the review of the Opposition Division or the Boards of Appeal is generally perceived as a strong patent and, thus, more likely to meet the prima facie case of validity which is required for the grant of preliminary relief.
We have no rules making it mandatory for judges to stay proceedings in view of pending EPO opposition procedures. Judges nevertheless have a discretionary power to stay ordinary proceedings if the EPO opposition procedure carries sufficient uncertainty that the patent will still exist at the end of the opposition and/or sufficient uncertainty over the claim set that will actually survive the opposition and the related scope of protection.
The above discretionary power is exerted on a case-by-case basis. Our experience is that some courts are more inclined to grant a stay, whereas other courts are definitely more reluctant.
To what extent are decisions from other fora/jurisdictions relevant or influential, and if so, are there any particularly influential fora/jurisdictions?
While our courts remain fairly independent in the face of foreign judgments, they are inclined to consider and potentially draw guidance from decisions issued in parallel litigation abroad. UK, Germany and the Netherlands are perceived as the most important jurisdictions for patent matters.
How does a court determine whether it has jurisdiction to hear a patent action?
The court having territorial jurisdiction to hear a patent infringement action is the court of the domicile of the defendant or, alternatively, of the place where the alleged infringement is taking place. Patentees may avail of the latter criterion to forum shop to their courts of choice.
The court seized with patent infringement proceedings is always competent to also hear a revocation action filed by way of counterclaim, in response to the infringement action.
Revocation actions can also be filed in the form of main proceedings i.e. not in response/by way of counterclaim to an infringement action. When filed in the form of main proceedings, revocation actions are subject to the exclusive jurisdiction of the court of the place that the patentee elected as its domicile in the patent application (in the case of a national patent) or upon validation (in the case of a national EP designation). The patent domicile is normally coincident with the offices of the patent attorney instructed to apply for/validate the patent.
What are the options for alternative dispute resolution (ADR) in patent cases? Are they commonly used? Are there any mandatory ADR provisions in patent cases?
Arbitration proceedings are possible in theory, although some debate has been going on as to whether patent validity can be devolved to arbitrators. This debate has little relevance in practice. As far as Italy is concerned, arbitration proceedings are far from common in patent matters.
What are the key procedural steps that must be satisfied before a patent action can be commenced? Are there any limitation periods for commencing an action?
Under Italian law, patents do not need to have received formal grant before they can be enforced. They can be enforced already at their stage of application, provided that no judgment in ordinary proceedings can be pronounced before formal grant. PIs can instead be granted based on patent applications only.
A special procedural requirement applies to the enforcement of (the Italian designation of) European patents or patent applications. These need to be validated by means of formally filing the Italian translation of the patent with the PTO before they can be enforced. For European patent applications, enforcement requires the filing of a translation of the patent claims only.
There are no statutes of limitation for commencing a patent infringement action, although a statute of limitation period does apply in respect of damages and return of profits.
The statute of limitation for patent infringement damages is the same as normally applicable to damages connected to tort liability i.e. 5 years.
There is some controversy as to whether the same statute of limitation applies to the return of infringer’s profits, which patentee can claim alternatively to damages. Recent case law has stated that the return of profits remedy does not belong to the tort liability system and is therefore subject to the ‘general’, longer statute of limitation, namely 10 years.
Which parties have standing to bring a patent infringement action? Under which circumstances will a patent licensee have standing to bring an action?
Exclusive licensees have standing to bring a patent infringement action. Their standing concurs with the standing of the patentee.
Non-exclusive licensees have standing to file for patent infringement, however only as co-plaintiffs joining in alongside the patentee and/or the exclusive licensee.
Who has standing to bring an invalidity action against a patent? Is any particular connection to the patentee or patent required?
Like all civil actions, a revocation action must be assisted by an interest into bringing legal proceedings. The ‘test’ applied to patent revocation/invalidity actions is however rather generous. The practical result is that virtually anyone can apply for patent revocation.
Are interim injunctions available in patent litigation proceedings?
Yes. Preliminary injunctions (PIs) are normally granted inter partes. Ex parte PIs are possible but as far as patent matters are concerned, they are granted only in cases of exceptional urgency.
PIs are granted subject to (i) a prima facie case of validity and infringement and (ii) the risk of an irreparable harm for the patentee in the absence of an injunction.
Since our judges do not have a technical background, assessing prima facie validity and infringement will normally require the appointment of a Court Appointed Expert to provide a non-binding opinion untangling the technicalities of the case and providing the CAEs’ view on the case, see point 12 above. As opposed to ordinary proceedings, the CAE’s assessment in PI proceedings is necessarily condensed in time given the urgent nature of the proceedings.
As regards irreparable harm, the patentee must prove that without a PI it will suffer an irreparable harm, namely a harm that would be impossible to restore by means of mere economic compensation at the end of full blown merits proceedings. Generally speaking, irreparable harm arguments revolve around the market share erosion that the patentee will suffer should the infringer be allowed to carry on with the infringing conduct throughout the normal course of ordinary proceedings.
There is no fixed rule or statute of limitation period for the filing of a PI motion, but patentees need to react promptly. A delay in seeking relief of a few months already might impair the urgency of the case and, thus, the chances of getting a PI.
A further criterion that courts may take into account in deciding whether to grant or dismiss a PI is balance of convenience i.e. which party is most likely to suffer the most serious consequences, the patentee (in case the PI is dismissed and the patent is subsequently found valid and infringed in merits proceedings) or the alleged infringer (if the PI is granted and the patent is subsequently revoked/found not to be infringed). This requirement is not provided for in statutory provisions. However, it can be taken into account as part of the judge’s discretion/equitable assessment.
The typical timeline for the grant of a PI would be 3-4 days (when granted ex parte) and 4-6 months (when granted inter partes).
Our system does not contemplate cross-undertakings. The judge might order the petitioner to post a bond to cover for potential liabilities in case the PI is lifted, but this provision is basically never applied in practice. The reason for this is that, unlike in other European jurisdictions, there is no automatic liability for the petitioner in case the PI is granted and subsequently lifted following a finding of invalidity/non-infringement. Liability for the petitioner is found only if it can be demonstrated that the latter has taken legal action out of due diligence. As far as we are aware, findings of liabilities were reached only in exceptional cases of negligence and bad faith.
What final remedies, both monetary and non-monetary, are available for patent infringement? Of these, which are most commonly sought and which are typically ordered?
The final remedies available to patentees are:
- • permanent injunctive relief
- • astreinte or penalty due for each act in breach of the injunction/delay in conforming to injunction
- • damages/lost profits
- • return of profits (alternative to damages/lost profits)
- • destruction of infringing goods or assignation of infringing goods to patentee
- • order of withdrawal/recall from market
- • publication of the judgment on relevant newspapers/magazines.
Injunctive relief, damages, return of profits and recall of the infringing products from the market are the remedies most typically sought and granted in patent litigation. Injunctive relief is normally assisted by an astreinte order. Destruction or, alternative, assignation of infringing goods might apply depending on the circumstances.
Publication of the judgment on relevant newspapers/magazines is traditionally regarded as a tool that compensates for the harm that the infringement might have caused to the holder of intellectual property rights might in terms of reputation. As such, it is most commonly granted in trademarks and copyright cases, and less frequently in patent cases.
On what basis are damages for patent infringement calculated? Is it possible to obtain additional or exemplary damages?
Damages are calculated in the form of the patentee’s lost profits, namely the profits that the patentee would have earned on the sales of the infringer had the infringement not taken place.
For purposes of seeking lost profits, the patentee must provide evidence of its cost structure. The “lost profit” is normally calculated on the basis of the profit margin obtained by deducting variable costs from the revenues earned on the infringing sale. This is also referred to as the “contribution margin”.
Whatever the patentee’s contribution margin, the patentee’s lost profits are never lower than the reasonable royalty that the infringer would have had to pay had it taken a license on the patent. The reasonable royalty awarded in patent infringement proceedings is normally “punitive” i.e. it adds up a few percentage points with respect to market standard royalty rates.
An alternative, concurrent criterion is the return of infringer’s profits. In particular, the patentee can request that the court orders the infringer to return all the profits it scored on the infringing sales/activities. Infringer’s profits are not cumulative to damages. They can be awarded either as an alternative to lost profits/reasonably royalty or to the extent in which they exceed lost profits/reasonably royalties.
The determination of the patentee’s lost profits and/or reasonable royalty and the infringer’s profits is normally demanded to a Court Accounting Expert, in the framework of damage proceedings that are normally separate/taken up after the issue of a first instance judgment on the merits of the case.
Our system does not contemplate the award of exemplary/punitive damages.
How readily are final injunctions granted in patent litigation proceedings?
Provided that the patentee has applied for injunctive relief upon filing its action, the grant of injunctive relief is generally perceived as consequential to a finding of infringement. That being said, the proportionality principle which judges are required to take into account when applying injunctions and corrective measures (which follows from Directive 2004/48) may be invoked to at least calibrate the effects of the injunction and ensure that they are commensurate to the infringing conduct and, importantly, to public interests.
Are there provisions for obtaining declaratory relief, and if so, what are the legal and procedural requirements for obtaining such relief?
The threshold for the filing of declaratory proceedings is lower i.e. more generous than other jurisdictions. Declaratory relief is subject to the general requirement of an interest in bringing legal proceedings, which claimants can satisfy by making a reasonable case that there is a possibility that they might be facing infringement proceedings. Unlike other jurisdictions, declaratory relief does not require that the patentee has actually threatened infringement proceedings.
As noted above, declaratory proceedings are available in the form of both ordinary and preliminary proceedings. Preliminary declaratory relief is subject to the additional requirement of urgency.
In preliminary declaratory proceedings, urgency is normally substantiated by referring to market reasons calling for a quick assessment of non-infringement, such as the need for the alleged infringer to protect the upcoming market launch of its product/services from patent infringement initiatives. The urgency required to obtain preliminary declaratory relief would generally not exist in situations where the alleged infringer has already launched its product on the market.
What are the costs typically incurred by each party to patent litigation proceedings at first instance? What are the typical costs of an appeal at each appellate level?
A party seeking to engage in patent litigation before Italian courts should consider attorney’s fees for no less than Eur 100K for the first instance, although figures can more than triplicate depending on the complexity and value of the technology at stake. Court fees are negligible, in the range of a few hundred euros.
The costs of appeal proceedings are generally lower as these normally do not imply a repetition of the complex technical assessments, but only a review of those already occurred during the first instance.
Can the successful party to a patent litigation action recover its costs?
Italian courts have a history of awarding attorney’s fees based on tariffs set forth by the Ministry of Justice, which are lower than market standard attorney’s fees.
Recent legislative amendments providing for an increased discretionary power for our judges in awarding attorney’s fees have led to a marked improvement of our legal cost awards, although these are still a fraction of the costs that a party is likely to bear for its attorneys.
What are the biggest patent litigation growth areas in your jurisdiction in terms of industry sector?
Akin to what happened with the introduction of generics in the early 2000s, the coming of biotechnologies and the consequent market success of biological medicinal products and their biosimilars resulted into a boost of pharmaceutical litigation in recent times and it seems there is still room for growth in this field. Electronics and FRAND related litigation is also expected to grow, partly as a result of the SEP industry’s global trend of shifting towards new industry sectors (i.e. automotive and IoTs) as well as of the approach Italian courts are adopting following the CJEU case law in Huawei (C-170/13), which seems to be less stringent on SEP holders than in other EU jurisdictions.
What do you predict will be the most contentious patent litigation issues in your jurisdiction over the next twelve months?
Second medical use patents are becoming increasingly important for the pharmaceutical industry. The need to ensure that, once available on the market, the generic or biosimilar is not used in an infringing manner calls for new, practical solutions from the case law and is going to be a hot topic in the upcoming months.
Which aspects of patent litigation, either substantive or procedural, are most in need of reform in your jurisdiction?
The institution of specialized IP courts over 15 years ago and the consequent improvements that our jurisdiction has been achieving ever since in terms of timeline of proceedings and quality of the judgments have made of Italy a go-to jurisdiction for patent litigation matters in Europe.
A few, distinguishing aspects of our procedural system make Italy particularly attractive for patent strategies, such as the possibility of enforcing patent applications and to obtain PI relief before patent grant, or the approach our courts take to the remedy of infringer’s profits, which is basically automatic following a finding of infringement and, according to recent case law, subject to a 10-year statute of limitation.
The biggest room for improvement lies with the way in which our judges tackle on the technical issues underlying the case. While our judges have no technical background and therefore need to rely greatly on the opinion received by the Court Appointed Expert, they are not directly involved in the process leading up to the CAE opinion. The CAE is left to deal with the parties and dispose of their arguments when writing his opinion. Being directly involved in said process, for instance by introducing the feature of proper “expert witnesses” akin to what happens in the UK and by allocating more room to oral discussions, would allow judges to better grasp on the technical background of the case and result in more efficient, balanced judgments.
What are the biggest challenges and opportunities confronting the international patent system?
The European patent community has been holding its breath for the Unified Patent Court system to eventually happen, and Italian patent practitioners make no exception.
While the uncertainties deriving from Brexit and the complaint pending before the German Federal Constitutional Court seem to have spoiled UPC excitement across Europe, the UPC still represents the biggest challenge ahead for the international patent system.