Life Sciences & Pharma IP Litigation 2024 Comparisons

The standing to bring patent infringement actions lies with the registered patent holder. Well-settled case law has since long established that exclusive licensees also have autonomous standing to bring patent infringement proceedings, conditional upon the latter proving its quality of exclusive licensee upon lodging the case with the court. This can be achieved by either submitting a copy of the exclusive licence agreement along with the initial statement of claim or, alternatively (and generally more preferably given the sensitiveness of data and information that can be contained in licence agreement), by registering a so-called confirmatory licence with the Italian Patent Office.

There is no statutory provision clarifying whether co-owners have autonomous legal standing to sue for infringement, ie, to bring a patent infringement action without other co-owners as co-plaintiffs, and the point is debated. More often than not, however, this debate is of little relevance in practice since whether a patent co-owner can or cannot autonomously take action will be regulated by the contractual agreements that have either led to the patented invention (R&D agreements) or that were entered into specifically to establish and govern co-ownership of the patents covering the invention. 

Revocation actions and declaratory actions of non-infringement can be brought by anyone who has an interest, and the threshold is normally quite low. A statement that the party filing for revocation or declaratory relief has an interest in doing business in the technical field relevant to the patent will normally suffice. A higher threshold normally applies to declaratory actions of non-infringement when filed in the form of preliminary proceedings in that an additional layer is required in relation to urgency of the action, ie, the petitioner needs to establish it would suffer an irreparable harm absent the requested preliminary declaratory relief.

Patent infringement actions in the life sciences industry would normally target the infringing MA holder and the related Italian affiliate distributor, along with any further party involved in the manufacturing and supply chain of the infringing generic or biosimilar product, as long as they are active on the Italian territory. Whilst technically infringers, it is rather unusual for healthcare providers and hospitals selling/prescribing the infringing generic or biosimilar products to be involved in patent infringement proceedings. Healthcare regulatory authorities (such as the Italian Medicines Agency) may be involved at a very early stage of the case as the target of pretrial proceedings aimed at collecting evidence, for instance in cases where demonstrating infringement requires accessing the related MA dossier or Drug Master File. The Italian Patent and Trademark Office is never made a party of patent infringement proceedings, although the latter needs to be formally notified of court actions concerning national patents or nationally validated EPs.

Preliminary injunctions are available subject to the requirements of prima facie case and urgency. The former requires a reasonable case that the patent is both valid and infringed and is normally dealt with by Italian courts via the appointment of a Court Technical Adviser (CTA). Whilst experienced in patent matters, judges of the IP courts have a purely legal background. A CTA is therefore normally appointed to tackle the technicalities that need to be untangled to assess validity and infringement. CTAs are selected amongst senior patent attorneys registered with the court. The urgency requirement is met whenever a reasonable case can be made that market launch of the infringing GX, biosimilar or medical device is imminent. Delay in seeking relief might be a factor that works against urgency. Balance of convenience can also be a factor, especially in relation to the interest of patients or other third parties who may be at risk of losing treatments or diagnostic tools if the infringing product or device is removed from the market.

Preliminary injunctions (PIs) can be granted ex parte, although only in very exceptional cases. Standard practice is for PIs to be issued inter partes. The timeline for an inter partes PI is no less than six months, depending on the court seized. Generally speaking, the trigger for a PI is any activity beyond market approval that can qualify as preparatory for market launch of the infringing product or device. Courts are normally strict when applying this threshold, although ways to work around/mitigate this threshold are available, such as sending notice/warning letters. A response that is either ambiguous or explicitly declines an undertaking not to launch the infringing product or device on the market might be used as a leverage to argue urgency at the PI hearing.

Once lodged with the competent court, the PI motion will be assigned to a single, designated instructing Judge of the IP Chamber who will handle the proceedings and eventually adjudicate the PI. Upon receiving the motion, the instructing judge will either (i) issue the PI ex parte (if a request has been made to this sense and if the conditions for an ex parte PI are met) and set up an inter partes PI hearing while assigning the defendant a deadline to submit their defence prior to the PI hearing or (ii) issue a decree setting up a PI hearing and assign the defendant a deadline to submit its defence. The defence would normally need to consider both validity and infringement and urgency/procedural defences, although only the latter are likely to trigger an immediate rejection, ie, a rejection for lack of urgency/other procedural requirements. Defences on the substance of the case, namely on validity and infringement, will normally need the benefit of a technical background in order to be adjudicated. Thus, if at the PI hearing the instructing judge were to agree that urgency and procedural requirements are all met/in place, the judge will normally appoint a CTA and charge said CTA with the task of providing a reasoned, non-binding opinion on whether the patent is valid and infringed. Appointment of a CTA would normally happen at a formal case conference one to two weeks after the first PI hearing.

Upon being formally appointed, the CTA will also receive indications as regards the timeline for delivery of the CTA opinion. The CTA will call for the parties to submit detailed, comprehensive technical submissions presenting their arguments (no less than two rounds) before issuing a preliminary opinion, which the parties will be asked to comment upon in writing. A final opinion taking account of those comments will then be issued by the CTA and then uploaded onto the court e-registry. Save for the delivery of the CTA final opinion (which is court-mandated), the calendar of these activities is defined by the CTA in agreement with the parties and on a case-by-case basis.

A final hearing for oral pleadings will take place within one to two weeks after delivery of the CTA opinion. The PI is adjudicated with an out-of-court order that the instructing judge issues after the final hearing (i.e. no decision is announced at the hearing). The order that either grants or denies the PI can be appealed within 15 days before a Panel of three different judges from the same IP chamber. The appeal will normally consist of a single hearing, preceded by the filing of a thorough, detailed defensive brief by the party bringing the appeal. PI appeals normally last for two to three months.

Further, and importantly, Italian PIs are “stable”, ie, there is generally no need to file subsequent main proceedings to stabilise the PI if the latter has been requested or granted without ancillary measures (such as saisie-type measures or seizures). The court might request that the petitioner posts a bond as a condition for granting the PI, although this provision is rarely applied.

Italian national courts do not allow protective letters.

Infringement and validity proceedings are not bifurcated, with the result that infringement can be counterclaimed in the course of pending invalidity proceedings and in turn invalidity can be challenged/counterclaimed in pending infringement proceedings.

The above does not prevent parties from filing two different proceedings, one claiming invalidity and one claiming infringement of the same patent. A landmark judgment issued by the Italian Supreme Court in 2016 has stated that infringement proceedings have to be stayed until a decision on the parallel, separate, validity proceedings is issued, thereby opening the door to bifurcation strategies, especially by defendants of an infringement action.

Invalidity and infringement proceedings can be filed while opposition proceedings are pending and there is no provision in Italian patent law requiring that said proceedings be stayed due to the existence of opposition proceedings pending before a patent office. Italian courts may decide that an infringement or invalidity case needs to be either stayed or postponed pending the outcome of parallel opposition proceedings. However, this happens on a case-by-case basis and only when the party can make the case that the decision of the opposition proceedings is imminent and will have a substantial impact on the scope of the protection of the patent or on the parties’ respective arguments. Italian courts are normally hesitant/resistant to staying or postponing the case on account of pending EPO oppositions. 

Patent infringement and invalidity actions are instituted under and governed by the Italian Civil Procedural Code, with the addition of some special procedural provisions contained in the IP Code. The Italian Civil Procedural Code underwent a major reform with the entry into force of Legislative Decree No 149 of 10 October 2022 (the so-called Cartabia Reform), which led to a substantial revision of the structure of main proceedings.

Main proceedings are instituted via service of a writ of summons on the defendant. The writ must carry a fairly detailed summary of the plaintiff’s arguments and a precise indication of the plaintiff’s requests to the court, including an indication of the specific remedies that the plaintiff intends to pursue. The plaintiff needs to subsequently lodge the writ of summons with the court within ten days of applying for service, along with any exhibit/document mentioned in support. The case is then assigned to an instructing judge.

In the writ of summons the plaintiff must also indicate a first hearing date allowing a “space” between service of the writ and the date of the hearing of either 120 days (if service has to take place in Italy) or 150 days (if service has to take place abroad). If the defendant wishes to file a counterclaim, call third parties or raise any procedural or substantive defence that the court could not raise ex officio, it must file a statement of defence at least 70 days before the above-mentioned hearing. The judge carries out preliminary checks and confirms (or postpones up to a maximum of 45 days) the date of the first hearing with a decree that the judge must issue within 15 days from the filing of the defendant’s statement of defence. 

Proceedings are subsequently fragmented in three sets of briefing notes exchanged between the parties, each of which is due in, respectively, 40, 20 and ten days prior to the first hearing. These rounds of briefing notes are intended for the submission and presentation of evidence/evidentiary requests, such as witness testimonies. The second of these rounds (due 20 days before the first hearing) also marks the cut-off deadline to present evidence that is purely factual (ie, non-technical nor related to technical aspects around validity and infringement, see below).

Further to the Cartabia Reform, the first hearing is now a more substantive hearing whereby the judge not only sets out the calendar of the case, but also gives specific directions as to how the judge intends to manage the case from the perspective of evidence. Importantly, having had the benefit of seeing the evidence before the judge and the parties’ evidentiary requests before the first hearing, the judge is now in a position to either recommend or direct the parties to a settlement already at the first hearing. 

Unless the parties either reach or initiate settlement discussions, the first hearing will in most cases see the judge opting for the appointment of a CTA to provide for a non-binding opinion dealing with the technical aspects underlying both validity and infringement of the patent(s) at issue, which the Panel will then use as a guidance to adjudicate the case. The procedural aspects mirror those set out above in relation to PI proceedings, the only difference being that the timeline up to a CTA opinion is less condensed than in preliminary, urgent proceedings. 

Additional means of evidence (such as witness testimonies) that the judge may believe to be relevant are dealt with in parallel or – more often – after delivery of the CTA opinion.

Having dealt with the above, a final hearing will then be scheduled, which shall be preceded by:

(i) the parties confirming their final requests to the court (60 days before the hearing);

(ii) the parties submitting final written pleadings (30 days before the hearing); and

(iii) the parties submitting a final brief in reply (15 days before the hearing).

Upon confirming their final requests to the court under (i), parties may request that submission of the final briefs in reply under (iii) be substituted by oral pleadings that shall take place before the panel of three judges, who will eventually adjudicate the case. The average timeframe for first instance main proceedings is between two and two and a half years depending on the seized court and its workload.

Validity and/or infringement actions can always be filed provided the claimant retains an interest and a statute of limitations of five years applies to claims of damages arising from patent infringement, whereas the case law has clarified that claims for the return of profits are subject to the “general” longer statute of limitation of ten years.

Damages and return of profits are normally the subject of proceedings that take place subsequently to a finding of infringement, either in the form of sub-proceedings following on from the main case (if damages/return of profits have been applied for at the outset) or as separate, autonomous main proceedings.

Italy is one of the few jurisdictions where patents can be enforced at the application stage, both in preliminary as well as in main proceedings. While preliminary measures, including preliminary injunctive relief, can be granted based on patent applications, Italian courts have to wait until patent grant before issuing a judgment in main proceedings.

As far as patent applications are concerned, a condition for their enforcement is that they must either be published or, if not yet published, officially served on the defendant before the action is actually filed. Further, and importantly, in the case of EPO or international patent applications, a translation of the claim set needs to be filed with the Italian PTO before enforcement. A translation requirement also exists with respect to granted patents stemming from EPO or international applications: ie, an Italian translation of the patent specification (description and claims) as granted needs to be filed with the Italian PTO for the patent to be validated and enforceable in Italy.

The filing of an infringement action requires the existence of an infringing activity occurring in the national territory or, in the case of actions for preliminary relief, a reasonable case that there is a risk of an infringing activity being started in the national territory and that such activity carries the risk of the patentee suffering an irreparable harm in the absence of a PI. The general view shared by Italian courts is that obtaining a marketing authorisation and/or applying for price and reimbursement is not sufficient to justify an infringement claim (ie, a commercial exploitation of the patented invention) and/or a threat of infringement and the consequent irreparable harm and that further elements (such as, for instance, refusals to enter into an undertaking not to launch) are required.

Patent infringement proceedings follow the general principle according to which each party bears the burden of proof with respect to its own claims. Accordingly, it is for patentees to bring forward evidence that the targeted product, device or process infringes the patents. Italian courts are normally careful in not allowing “fishing expeditions”. One exception is provided for with respect to process patents. A product identical to that obtained through the patented process is presumed to have been directly obtained by the use of the patented process if either of the following alternatives apply, namely (i) the product obtained through the patented process is new or (ii) there is a reasonable likelihood that the same process was used and the patentee was incapable of determining the process used by the infringer by using reasonable efforts.

Italy has no pretrial discovery, at least not in a US manner of speaking (see 1.8 Search and Seizure Orders).

Search and seizure orders are available in Italy. Search orders are saisie-type measures by means of which the competent court issues – on an ex parte basis – an order authorising the patentee to forcefully (ie, with the aid of a court bailiff) access the premises of the infringer and collect evidence of the infringing conduct in cases where such evidence cannot reasonably be obtained other than by accessing the infringer’s premises. This criterion (which is typically met in cases where the infringing product is not (yet) on the market or is not easily retrievable from the market as well as in cases where infringement consists of the implementation of a patented process) is the one threshold that the patentee must meet when presenting its case for a search order before the court. Italian courts perceive search orders as evidentiary means only, ie, they will generally not look into validity or into the merit of the infringement case before granting one.

One upside of Italian search orders is that their actual execution and any connected activity that might need to be performed at the infringer’s premises is court-mandated. While parties are authorised to attend the operations via their attorneys and patent counsels, the actual collection of evidence (including any appropriate investigation) is handled by the court bailiff and a court-appointed technical adviser, who is normally a patent attorney. This reduces to a great extent the risk of objections being raised by infringers who might want to leverage on potential procedural abuses when opposing validation of the search order.

In granting the search order the judge also schedules a hearing for the validation of the search order, upon which the defendant is entitled to present its arguments and potentially oppose validation. The hearing takes place after the search operations, within 15 days from the issue of the search order.

Once the search order is validated, the collected evidence can be used to institute main infringement proceedings, which must be commenced within 31 calendar days or 20 working days (whichever accounts for the longest period) from validation. Failure to comply with these deadlines will extinguish the search and invalidate all the collected evidence. The collected evidence can also be used for the filing of parallel infringement proceedings in foreign jurisdictions.

The motion for search may also include a request that the court issues a seizure of the infringing goods or a preliminary injunction, which the patentee can subordinate to the outcome of the search proceedings. In case of positive outcome, the proceedings can then flow through the assessment of validity and infringement on an inter partes basis. In this case, the deadline to file main infringement proceedings runs from the date on which a final order is issued on these additional remedies.

Declaratory actions can be pursued both in the form of merits proceedings aimed at ascertaining non-infringement with a judgment susceptible to become res judicata, as well as in the form of urgent proceedings aimed at the grant of preliminary declaratory relief, ie, an order declaring on a preliminary and urgent basis that the allegedly infringing product or process does not infringe. In both cases, declaratory relief can be applied for based on pure non-infringement arguments as well as on pure invalidity arguments (ie, the product or process at issue does not infringe in that the patent is invalid).

The threshold to access declaratory relief in the form of main proceedings is low as it will generally be sufficient for the alleged infringer to demonstrate that it holds and/or plans to develop an allegedly infringing product or process and to bring arguments supporting non-infringement and/or invalidity. The threshold to access declaratory relief in the form of preliminary proceedings (which are de facto reverse PIs) is higher in that the petitioner needs also to establish a risk of suffering an irreparable harm in the absence of the requested declaratory relief. This threshold is typically met by making the case that the allegedly infringing product is either being developed or inching closer and closer to launch and that the patentee has either implicitly or explicitly threatened infringement proceedings, including the filing of PI motion(s) from which the alleged infringer needs to be shielded.

Arrow declarations, ie, declarations aimed at obtaining an assessment that an allegedly infringing product or process would implement prior art and therefore cannot infringe are not a reality in Italy. Arrow declarations have been devised (in the UK) for those situations where the feared infringement was in respect of a patent that was still at the application stage/awaiting formal grant, which made it impossible to file for declaratory relief as the latter would only become available upon patent grant. In Italy, declaratory preliminary relief can, however, be sought with respect to patent applications (just as much as PI relief can be obtained based on patent applications). This makes arrow declarations moot in the Italian jurisdictions.

The doctrine of equivalence is available in Italy and the subject matter of a specific statutory provision, according to which, “when determining the scope of protection conferred by a patent [based on the patent claims interpreted in light of both description and drawings] due account must be taken of any element that is equivalent to the elements identified in the claims” (see Article 52(3bis) Italian IP Code).

Italian case law has developed and applied several tests over the years. The test most widely used in the past relied on the identification in the accused product of the same “inventive idea” or same “core” of the patented invention. Nowadays, the two main criteria to assess equivalence followed 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 wording 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 literally 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 literally recited by the claim.

Italy does not have a prosecution history estoppel, although discussions over statements rendered to the EPO examiner during prosecution often arise in patent litigation as to determining the scope of protection. Italian courts have a trend of considering the patentee’s statements during prosecution not necessarily relevant for the purposes of shaping 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 which were necessary to differentiate the claims from the prior art and overcome objections of novelty or inventive step. In contrast, amendments intended to overcome 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.

There is no obligation of “clearing the way” ahead of a new product launch, although having taken appropriate 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 proceedings ahead of a new product launch is indeed standard practice for generics or biosimilars, at least in cases of patents that are at high risk of being enforced.

In Italian patent litigation, either in preliminary or merits proceedings, the evaluation of the relevant 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 written 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 process. 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 technical 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 CAE even after the expiry of the deadline for the submission of evidence to the judge. The CAE may also conduct experiments or inspections to which the parties have a right to attend. After the technical discussion is completed, the CAE produces a preliminary opinion and asks the parties to comment on the same. The parties review said opinion and provide their own comments (once again, mostly in writing). Further to this, the CAE produces a final opinion to the court and another hearing takes place to discuss it.

The findings of the CAE are significant as they serve as a “primer” or guidance for the judge to adjudicate the case. Therefore, the technical phase before the CAE is crucial and must be conducted with the necessary care and deployment of effort by the parties. However, the CAE opinion is not binding and the court retains the right to overrule it and/or to appoint another CTA to discuss the same technical issue.

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 co-operate with lawyers when preparing arguments for the CAE.

Experiments can be conducted (i) during the technical phase, by the CAE or (ii) “out-of-court”, by the parties. In (i), the CAE and the parties agree on the specific mechanisms to perform the experiments and the results thereof are included in the CAE report. The process is normally long and complicated as it entails agreeing on potentially complex experimental protocols, including the selection of an independent facility suitable to run and record the experiments. Costs can also become significant.

While (i) can be the one and only way in some cases, a party can submit its own experiments and related experimental report, which more often than not can become the basis for the discussion with the CTA, provided that the other party is given a chance to review the experimental protocol and raise potential objections/criticism. In this connection, Italian courts favour co-operation between the parties and are normally not impressed by defences that merely leverage on the non-independent nature of a party’s own experiments whilst not clarifying the specific technical reasons as to why these should not be held as reliable. Defences of this kind have sometimes been stigmatised as “reverse-fishing expeditions”, ie, tantamount to asking the court to disprove the adversarial evidence.

Disclosure of documents relevant for assessing validity and/or infringement issues usually occurs voluntarily by the parties or upon the issue of a specific court order. In the latter case, the interested party must have established that its claims are reasonably well-founded. Also, the documents or specific piece of information for which disclosure is requested must be specifically identified, ie, the disclosure order cannot become a fishing expedition.

Disclosure orders are also commonly issued (at the request of the interested party) with respect to the infringer’s books and accounting records, when the time comes to calculate damages or infringer’s profits.

Disclosure may take place through the acquisition of witness depositions or formal interrogation of the party or its legal representative; however, only with reference to certain, specific pieces of information relating to the origin and the distribution network of the infringing goods or services.

Typical defences against infringement are non-infringement, invalidity and 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, ie, at achieving new inventions.

The Bolar exemption instead covers studies and experiments directed at obtaining a marketing authorisation (MA) 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 in Italy, 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. The 2018 judgment was confirmed by the Milan Court of Appeal in 2021.

Other available defences are the prior-user right defence, patent exhaustion and violation of competition law and/or the contractual promise to offer FRAND licences, while compulsory licence is generally not a defence as Italian law expressly indicates that there is no obligation of a compulsory licence in favour of an infringer. As regards the prior-user right, the impact of this defence is rather limited as the law establishes that the prior user may continue to use the patented invention as long as such use remains within the limits of the prior use. According to the case law, this means that the prior user will not have the possibility to expand the use of the invention beyond the specific use previously made, both from a quantitative and a qualitative perspective. Patent exhaustion may be used when the product claimed by the patent was put into the market by the patent holder or with its consent in the EEA territory. Finally, as stated above, violation of competition law and/or the contractual promise to offer licences on fair, reasonable and non-discriminatory (FRAND) terms may be a defence in the case of standard essential patents, depending on the specific remedy sought. In particular, an Italian court would follow the CJEU case law in determining the circumstances in which an injunction may be granted based on a standard essential patent.

Italian patent law does not contain any provision requiring the stay of infringement or invalidity proceedings due to the existence of opposition proceedings pending before a patent office or foreign proceedings, unless both parties so request. Italian courts remain fairly independent in the face of foreign judgments, but may in any event be inclined to consider and potentially draw guidance from decisions issued in parallel litigation abroad. Greater relevance is usually given to decisions rendered by European courts whose procedural rules are more similar to the Italian ones.

A patent in the midst of litigation can be amended either by means of an application filed directly with the Italian Patent and Trademarks Office (ITPTO) or, if the litigation includes a claim of invalidity, directly in court by means of a declaration submitted to the judge. There are no time limits to do so. The Italian system does not contemplate the filing of auxiliary requests. No matter whether it is filed before the ITPTO or in court, an application to amend is a dispositive withdrawal of the broader scope of protection defined by the previous claim set.

Commercial chambers instituted in the 23 main court districts have exclusive jurisdiction over intellectual property cases, including pharma/life sciences cases. If the proceedings involve a foreign party, only the following 11 district courts have jurisdiction, namely: Bari, Bolzano, Cagliari, Catania, Genoa, Milan, Naples, Rome, Trento, Turin and Venice. Italian commercial judges are usually selected among senior members of the judiciary system and, despite having a legal, non-technical background, most of them are specifically skilled in intellectual property 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 or took place (ie, locus commissi delicti). In case of invalidity/revocation actions, territorial jurisdiction is determined by reference to the right holder’s elected domicile. These criteria allow the parties to forum shop to their courts of choice. The main, and more experienced, commercial chambers are those of the courts of Milan, Rome and Turin.

Every act that involves putting the patented invention into effect and earning a profit or commercial advantage out of it can qualify as direct patent infringement. Acts of direct infringement typically consist of manufacturing, using, offering for sale, marketing, importing and exporting the allegedly infringing goods.

Infringement proceedings can also consist of indirect or “contributory” infringement acts. A finding of contributory infringement is subject to two conditions: (i) the supply of means that are essential to put the patented invention into effect in a country where the invention enjoys patent protection; and (ii) the fact that the contributory infringer is aware, or should be aware using normal diligence, that those means are intended to be used for putting the invention into effect. Contributory infringement thus 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, and even when directed to persons or entities shielded by a patent exemption, such as the experimental exemption or Bolar exemption. On the contrary, there is no finding of contributory infringement if the supplied means are staple commercial products, unless the supplying party has induced the supplied person or entity to carry out infringing conducts.

With specific reference to small molecule products, marketing and pre-marketing activities (eg, informative campaigns, distribution of advertising material, pre-order sales to wholesalers, distributors or pharmacies and storage), including listing of the product as available in the market in commercial databases (eg, Farmadati), as well as the submission of a public or private tender offer and, a fortiori, the award of a tender amount to acts of infringement. On the contrary, the mere submission or grant of marketing authorisation applications, start of reimbursement price negotiations or the approval of a reimbursement price do not per se represent grounds for initiating infringement proceedings in the absence of evidence of an imminent market launch.

With regards to second medical uses, carving out (ie, skinny labelling) is not considered sufficient to rule out infringement of a second medical use patent. In the recent case of Novartis v Medac, 10 January 2022, the Court of Milan issued an injunction specifically ordering the generic to not only carry out and maintain a carve-out of the protected indication from the SmPC and PIL, but also to take further steps to inform the various stakeholders in the market that the product could not be used in the protected indication.

With regards to data and market exclusivity, Directive (EC) 2001/83 and Regulation (EC) No 726/2004 apply. Accordingly, medicinal products intended for human use benefit from an eight-year period of data protection and a ten-year period of marketing protection (the latter being extendable up to 11 years if the MA holder obtains an authorisation for a new therapeutic indication which brings a significant clinical benefit compared to other therapies).

Orphan medicinal products are regulated by the Regulation (EU) No 141/2000, which provides for a market exclusivity lasting ten years, to which two additional years may be added if the product is compliant with paediatric investigation plan (PIP).

Challenges to data and market exclusivity are not common. Two different fora could be relevant: if the challenge is brought against the regulatory authority which granted the MA in breach of the regulatory exclusivity, the forum would be the Administrative Court. In the case of a challenge against a generic violating the regulatory exclusivity regime, the ordinary courts would be competent.

Italian law contemplates two different exempted uses of the patented product. First, Article 68(1) (a-bis) of the IP Code establishes that the exclusive right of the patentee shall not extend to acts that are performed for purely experimental purposes relating to the subject matter of the patented invention and to the use of biological material for the purpose of breeding or discovering and developing other plant varieties. An experimental purpose is deemed to exist whenever the activity aims at achieving technical progress that wins over the patented invention and its shortcomings, ie, at obtaining new inventions. Although rarely discussed before Italian courts, it is generally accepted that the experimental use exception also applies when the experimental activity is carried out in the framework of a business activity and not just for the purpose of pure research.

Second, Italian law has also implemented Article 10(6) of Directive 2001/83/EC by introducing the Bolar exemption under Article 68(1)(b) of the IP Code. The Bolar exemption covers studies and experiments directed at obtaining a marketing authorisation 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 in Italy, 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. The 2018 judgment was confirmed by the Milan Court of Appeal in 2021.

Granted MAs are published on the Official Gazette of the Italian Republic, whereas information regarding pending MA applications is usually published on the official website of the Italian Medicinal Agency (AIFA). This information usually includes the MA applicant, the active ingredient and the name of the medicinal product. Both these platforms are public and are therefore freely available.

Italy has no patent linkage, ie, market approval by the competent regulatory agencies (the EMA or AIFA, the Italian medicines agency) is not subject to the relevant product being clear of third parties’ patent rights. Further, no communication is due to the patent holder regarding the details of pending MA applications. The patent holder can nevertheless submit Freedom of Information letters with the competent regulatory agency in order to obtain said information.

While Italian law does not have patent linkage mechanisms (see 2.4 Publicly Available Drug and Patent Information), it does contemplate a provision according to which generic drugs can enter into price and reimbursement negotiations with AIFA, but will not become NHS-reimbursable until expiry of the related compound patent or supplementary protection certificate. In spite of being rather controversial and often referred to as establishing some sort of otherwise prohibited patent linkage, this provision – which was first introduced in 2012 – survived a significant legislative reform in 2022 and is still in place.

See the response set out at 2.1 Infringing Acts.

See the response set out at 2.2 Regulatory Data and Market Exclusivity.

See the response set out at 2.3 Acceptable Pre-launch Preparations.

See the response set out at 2.4 Publicly Available Drug and Patent Information.

The provision discussed in 2.5 Reimbursement and Pricing/Linkage Markets is worded so as to explicitly apply to “equivalent products”, ie, generics only. It is unclear whether it should also apply to biosimilars, as these are not “equivalents” by definition.

Supplementary Protection Certificates (SPCs) are available in Italy for medicinal products under the conditions set forth in EC Regulation No 469/2009. 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 1990s. As of today, the most controversial requirement is arguably Article 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 referral (C-631/13).

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 authorisation. While it is known that this ground is 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. With regards to Article 3(c) of the SPC Regulation No 469/2009, Italian case law has followed the ECJ’s reasoning set out in the Actavis case (C-443/2012), stating that said article must be interpreted as precluding the patent holder from obtaining two separate SPCs: one in relation to the active ingredient of a medicinal product and another for the active ingredient in combination with a different active ingredient and marketed as a different medicinal product (see Court of Milan, 8 August 2014, in Darts-IP).

The implementation of the European legislation regarding SPCs also extends to the so-called SPC waiver introduced with EU Regulation No 2019/933. In particular, Article 5(2) lists a number of acts which do not require the SPC holder’s consent, such as:

• the manufacturing of a product or medicinal product when aimed at export to third countries (so-called manufacturing waiver); and
• the manufacturing of a medicinal product for the purpose of storing it in the Member State of making until the exclusive rights have expired (so-called stockpiling waiver).

In order for the above-mentioned activities not to be infringing on the SPC, the interested party must fulfil certain requirements, such as notifying the SPC holder and the Italian Patent and Trademark Office (IPTO) at least three months prior to the commencement of the manufacturing process.

Paediatric extensions are available in Italy, in line with Regulation (EC) No 1901/2006. Said Regulation established that the duration of the SPC for a medicinal product may be further extended for six months, if the medicinal product has to undergo a series of clinical trials under the Paediatric Investigation Plan (PIP), ie, a research and development programme aimed at providing clinical data to verify the usability of the medicinal product in the paediatric field.

Italian law does not require the patentee to give any undertaking as to damages in exchange for a preliminary injunction. However, 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 where the PI is granted and subsequently lifted following a finding of invalidity/non-infringement. Findings of liability on the part of the petitioner are only reached in exceptional cases of negligence and bad faith, ie, when it can be demonstrated that the latter has taken legal action out of due diligence.

Regardless of the type of proceedings (either ex parte or inter partes), PIs are immediately enforceable and the possible subsequent appeal does not suspend the execution of the preliminary decision. However, the appeal judge may suspend the measure or order the petitioner to provide a bond, where the PI would cause serious harm to the defendant due to supervening circumstances. The amount of the bond may vary depending on the value of the case.

Italian PIs are “stable”, ie, there is generally no need to file subsequent main proceedings to stabilise the PI if the latter has been requested or granted without ancillary measures (such as saisie-type measures or seizures). When merits proceedings are necessary because the PI is coupled with those other measures, then the deadline for commencing them may be set by the judge granting the PI. If the judge does not set such a deadline, merits proceedings must be commenced within 20 working days, or 31 calendar days if longer, from the grant of the order or its subsequent communication to the parties.

PIs are self-executing orders and there is no need for the patentee to attend to any additional formality (such as making a payment) to enforce a PI. PIs often also include penalties.

Enforcement of final injunctions follows the same rules as those outlined in 5.1 Preliminary Injunctive Relief and applicable to enforcement of preliminary injunctions. Final injunctions are also immediately effective, although the defendant may file, together with the appeal, a motion requesting the Court of Appeal to order that the appealed judgment be stayed. The Court of Appeal decides whether or not to grant the request by assessing if there are serious and well-founded reasons (eg, the risk of insolvency of one of the parties). The decision on the suspension usually takes place during the first oral hearing. Upon showing an actual urgency, the defendant may file an ex parte motion before the President of the Panel asking for an early decision on the matter. In this case, the President can suspend enforcement of the decision even prior to the first hearing. Regardless of the moment at which the court states on the stay of the order (ie, prior or during the first oral hearing), the decision is not appealable. The court may provide for the payment of a bond, the amount of which may vary depending on the value of the case.

Although Italian law does not specifically contemplate the possibility of limiting/eliminating the scope of injunctive reliefs, Italian case law is quite responsive in applying a balance of convenience between the rights of the patentee and the interests of the parties affected by the injunction, including the interest of third parties such as healthcare providers or patients. These concerns are normally dealt with by the court allowing phase-out periods, ie, a given timeframe during which the enjoined party can continue selling the infringing product or device, however, in such a way as to gradually exit the market. Phase-out sales, of which the injuncted party must notify the patentee, are normally taken into account when establishing damages/return of profits. Cases where injunctive relief was denied as a whole on account of proportionality/public interest concerns are unheard of.

Damages are calculated mainly 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 sales. 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 licence on the patent. The reasonable royalty awarded in patent infringement proceedings is normally “punitive”, ie, it is increased as opposed to market standard royalty rates to take a deterrent effect on board.

As an alternative to damages or in any event to the extent that they exceed lost profits, the patentee can always request the court to order the infringer to return all the profits it scored on the infringing sales/activities. The determination of the patentee’s lost profits and/or reasonable royalty and the infringer’s profits is normally assigned to a Court Accounting Expert, in the framework of damage proceedings that are often separate/taken up after the issue of a first instance judgment on the merits of the case. The Italian system does not contemplate the award of exemplary/punitive damages.

The successful party generally has a right to obtain reimbursement of the legal costs incurred in the course of the proceedings, namely:

• court fees;
• party expert fees; and
• part of the attorney fees.

These legal costs are assessed directly by the judge and reported in the order/judgment. Immediately after the publication of the decision, the party can forward the losing party a corresponding request for payment. With reference to the attorney fees, Italian courts have a history of awarding them based on rates set forth by the Ministry of Justice. Recent legislative amendments have increased the discretionary power of Italian judges in awarding attorney’s fees, leading to a marked improvement of the legal cost awards, although these are still a fraction of the costs that a party is likely to bear for its attorneys.

Courts often take into account the claimant’s conduct prior to the commencement of the proceedings, especially when dealing with PI proceedings. In such cases, claiming an alleged irreparable harm (ie, one of the requirements to obtain a PI) after having, for example, delayed in seeking relief or shown tolerance with respect to the infringer’s conduct could undermine the possibility of obtaining the requested measures. Refusal to attempt amicable solutions is also a conduct that may be assessed negatively by the court, especially when it comes to merits proceedings.

In Italy, trade marks disputes in the pharmaceutical and life sciences sector are quite common. As regards pharmaceutical trade marks, in addition to the provisions of the IP Code, one should also consider Legislative Decree 219/2006, by which Directive 2001/83/EC was implemented in Italy, and some other provisions provided in non-binding regulations, such as Article 25 of the Italian Code of Marketing Communication Self-Regulation or the Guidelines of the Ministry of Health.

For public health protection purposes, the name of the medicinal product must be submitted to AIFA (Italian Medicines Agency) for approval before its product is marketed. It may be either a creative name or a common or scientific name, but the creative name shall not lead to confusion with the common name (International Non-proprietary Name (INN) or, in the absence of the INN, the usual common name).

Copyright matters are governed by Law No 633/1941. Copyright disputes are very rare in life sciences and pharma sector and may concern images used on the packaging, leaflets and advertising material of medicinal products.

The rules governing trade secrets are Articles 98 and 99 of the IP Code, which identifies what can be regarded as a trade secret and the scope of protection thereof. Disputes on this matter in life sciences and pharma sector are rare.

Appeals against PI orders must be filed within 15 days from the communication of said order, by submitting a motion for appeal and the relevant evidence in court. Appeal proceedings are held before a Panel of three judges, with no leave to appeal. Once an appeal against a PI order is filed, the President of the Panel schedules by decree the hearing to discuss the appeal (which is usually held one month after the filing of the appeal) and grants the other party a deadline to file its brief in reply and relevant evidence. Appeal proceedings are generally shorter than first instance preliminary proceedings and the order is usually issued two or three weeks after the hearing. Appeal proceedings involve a full review of the case on the points raised by the parties in their briefs and it is also possible that the Panel deems it necessary to reopen the technical discussion of the case, appointing a new court expert. The Panel may also take into account possible circumstances and grounds that have arisen after the PI order and the parties may file new (ie, supervened) evidence, provided that the other party is given the possibility to counter-argue. The decision issued by the Panel is final and cannot be further appealed.

On the other hand, the term for appealing a first instance judgment is twofold:

• where the winning party serves the judgment on the losing party, the appeal must be filed within 30 days from said service (the so-called short appeal time limit); or
• in the absence of any service of the judgment, within six months from the issue of the first instance judgment (the so called long appeal time limit).

Unlike appeals against preliminary orders, main appeal proceedings are instituted by the service of the writ of summons and the statement of appeal on the other parties. Within ten days from such a service, the writ of summons and the relevant evidence have to be filed in court. The other parties may file an interlocutory appeal or a statement of defence, along with the relevant evidence, within 20 days before the first case conference.

The filing of the appeal does not stay the execution of the first instance decision, which is always immediately enforceable. However, when serious and grounded reasons exist, also relating to the possibility of insolvency of one of the parties, the Court of Appeal may stay the execution of the appealed first instance decision, with or without ordering the posting of a bond. In addition, appeals are subject to a preliminary scrutiny by the competent Court of Appeal on point of compliance with the relevant procedural requirements, inadmissibility or manifest unfoundedness. Legislative Decree No 149 of 10 October 2022 amended said preliminary scrutiny and Article 350bis of the Italian Civil Procedural Code now provides for a simplified procedure to be followed when the appeal is considered inadmissible, manifestly unfounded or, on the contrary, manifestly founded, or when the appeal is deemed of minor complexity or urgent.

The Panel carries out a revision on point of facts and law of the parts and points of the appealed decision that have been challenged by the parties in their briefs. The parties are not allowed to bring evidence or documents additional to those already filed in the first instance proceedings, except in the case of new (ie, supervened) documents or documents that were not filed within the specific deadlines for reasons that are not imputable to the parties. In these two latter cases, the filing of new documents may be authorised by the court.

Appeal proceedings are generally shorter than first instance preliminary proceedings, usually lasting one to two years, and Courts of Appeal do not usually reopen the technical discussion, unless absolutely necessary.

If a preliminary or final injunction decision is overturned on appeal or the patent is revoked, the relevant injunction is automatically lifted. Unlike in other European jurisdictions, there is no automatic liability for the petitioner where 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 the writers are aware, findings of liabilities were reached only in exceptional cases of negligence and bad faith.

Patent litigation appeals are heard and decided by a panel of three judges (comprising a rapporteur judge and a chairman). In case of appeals against PI orders, the panel includes judges of the same Commercial Chamber to which the judge who issued the appealed preliminary order belongs, excluding the latter. In the case of appeals against first instance decisions, the panel comprises three judges of the Court of Appeal that is territorially competent.

Intellectual property proceedings are subject to the general provisions on appeal proceedings laid down by the Civil Procedural Code. There are no special provisions for Intellectual Property Proceedings.

In Italy, there are no particular forums/procedures relevant to life sciences and pharma IP litigation, which are subject to the provisions regulating IP proceedings in general. Following the ratification of the UPC agreement, from 1 June 2023, European patents are also subject to the jurisdiction of the Unified Patent Court unless the patentee has opted out their patent.

Alternative dispute resolution, such as arbitration proceedings and mediations, are possible in life sciences and pharma disputes. However, ADR is not a common way of starting or settling a life science case and there is little or no practice in this respect. As regards arbitration proceedings, besides it being costly, it is also debated whether decisions on patent validity can be referred to arbitrators. It is to be noted that by Legislative Decree No 149/2022, the powers of arbitrators have been extended to the issue of preliminary measures in the course of arbitration; however, before the arbitration starts, the court maintains exclusive jurisdiction to issue preliminary measures.

There is no specific consideration or particular scrutiny that is worth mentioning relating to the Italian jurisdiction.