Applying for a patent

Patentability
What are the criteria for patentability in your jurisdiction?

An invention is patentable if it is novel, involves an inventive step and has an industrial application. An invention is novel if it has not been disclosed before the date of filing or the date of priority of the application. An invention involves an inventive step if, at the time of filing or at the time of priority, it is not obvious to a person skilled in the art due to an existing art or general knowledge. An invention is capable of industrial application if it has a utility that can be regularly reproduced. Finally, a patent must disclose the invention in sufficient detail to enable a person skilled in the art to practise the patent without making any inventive effort.     

What are the limits on patentability?

Generally speaking, an invention is patentable if it is not contrary to public order or accepted principles of morality. The following subject matter is not patentable:

mathematic and scientific discoveries or theories;
plans, principles or methods for intellectual activities, games or business;
computer programs; and
the presentation of information.

Plant varieties and animal breeds are also not patentable. Further, therapeutic and surgical methods are not patentable (although pharmaceuticals and surgical tools and equipment are). Finally, the human body or its parts – including partial gene sequences, any invention whose use is contrary to human dignity and any procedure using human stem or embryo cells – are not patentable.

To what extent can inventions covering software be patented?

Software is not patentable per se. However, an invention that solves a technical problem in a new and inventive manner is patentable even if the problem is solved using a computer program.   

To what extent can inventions covering business methods be patented?

Business methods are not patentable. However, new and inventive tools to implement a method can be patented.  

To what extent can inventions relating to stem cells be patented?

Under Italian law, where the implementation of an invention requires the use of cells that originate from a human embryo – including stem cells –  the invention is not patentable. This principle derives from EU Directive 98/44/EC. Article 6(2)(c) of the directive excludes the use of human embryos for industrial or commercial purposes from patentability.

The European Court of Justice (ECJ) interpreted the directive in Case C-34/10, holding that the term ‘human embryo’ includes any organism that is “capable of commencing the process of development of a human being”. Further, the ECJ ruled that human embryos are used within the meaning of Article 6(2)(c) if implementation of the invention requires the destruction of human embryos, even if the patent claims do not refer to the use of human embryos. The ECJ further ruled that destruction at any stage would be considered, including before implementation of the invention.   

Are there restrictions on any other kinds of invention?

No.  

Grace period
Does your jurisdiction have a grace period? If so, how does it work?

No.  

Oppositions
What types of patent opposition procedure are available in your jurisdiction?

There is no opposition procedure.     

Apart from oppositions, are there any other ways to challenge a patent outside the courts?

No.  

How can patent office decisions be appealed in your jurisdiction?

Any party aggrieved by a Patent Office decision can appeal to the Board of Appeals (Commissioni dei Ricorsi). The Board of Appeals is an administrative/judicial body that does not fall within the Patent Office’s jurisdiction and is composed of independent judges. Decisions of the Board of Appeals can be appealed to the Court of Cassation on points of law.  

Timescale and costs
How long should an applicant expect to wait before being granted a patent and what level of cost should it budget for?

A patent will be issued about 12 months from the date of filing. The Patent Office will provide a search report and a patentability report to the applicant, prepared by the Search and Examination Division of the European Patent Office. The Patent Office does not carry out a substantive examination of the application. Applicants should budget for between €500 and €1,500 for the grant of a patent.  

Enforcement through the courts

Strategy
What are the most effective ways for a patent owner to enforce its rights in your jurisdiction?

Patent owners can enforce their patents in both civil and criminal courts; if necessary, both actions can be accompanied by administrative measures (eg, customs surveillance and detention of infringing products). Enforcement in civil courts is far more common, since it enables patentees to recover damages and is not limited to those cases in which the infringer acted wilfully. In cases that can also be prosecuted before the criminal courts (eg, when a former licensee continues to practise the patent after expiration of the licence, thus creating an arguable case that the infringement is wilful), enforcement through the public prosecutor can be effective.  

What scope is there for forum selection?

There is ample room for forum selection. Patentees can initiate proceedings before any of the 20 courts that have jurisdiction in patent matters (11 courts have jurisdiction if one of the parties is a foreign entity) where the alleged infringing item is sold or offered for sale. Conversely, the party accused of infringement can commence an action for declaratory judgment before any court where the infringing products are sold or offered for sale. This often leads to a rush to be first in the forum that is considered more convenient.  

Pre-trial
What are the stages in the litigation process leading up to a full trial?

A patent case on the merits in civil court is characterised by four stages:

  • opening;
  • gathering of evidence;
  • expert determination; and
  • final judgment.

Litigation opens when the plaintiff serves the writ of summons on the defendant. The summons must contain a brief description of the facts, evidence and a list of claims and remedies sought. The proceedings start with the filing of the defendant’s answer, statement of defence and, if appropriate, any counterclaims. Once these pleadings are on record, a first oral hearing is set, at which point the court will decide on any preliminary procedural objections (eg, lack of jurisdiction, improper venue and lack of standing to sue/be sued). If all preliminary issues are disposed of, the case will move to the evidence gathering phase.

During the gathering of evidence, each party produces documentary evidence or requests that the court order the gathering of other types of evidence (eg, oral testimony, inspection of sites, disclosure of documents or other items from the other party) considered necessary or appropriate to support claims or defences or to disprove the claims or defences of the other party. The duration of this stage is regulated by the rules of procedure. No more than 80 days can pass from the first round of briefs to the third and fourth rounds. Once the parties have produced all evidence and made applications for further evidence gathering, together with a brief explaining the purpose and relevance of such evidence, a hearing is scheduled before the court. The hearing determines what evidence is admissible and which applications for evidence the court will allow.

In order to evaluate technically complex evidence, the court usually appoints an independent expert to review these aspects of the case and advise on the validity and infringement of the patents at issue. Both parties also appoint their own experts, who make submissions in the form of technical briefs setting out their positions to the court-appointed expert. At the end of this stage, the court-appointed expert submits its non-binding conclusions to the court and the case moves to the final phase.

The final phase begins when the parties submit a brief finalising their respective claims and defences (parties usually drop claims that are overly difficult to support with the evidence collected) and a subsequent rebuttal of the other party’s final claims, followed by a one-day hearing. The judgment will then be issued in 30 to 60 days. 

How easy is it for defendants to delay proceedings and how can plaintiffs prevent them from doing so?

In theory, the pace of the proceedings is dictated by the rules of procedure and the court’s agenda. However, the parties have some tools at their disposal, which they can use to create delays in the proceedings. The most common tactic used by alleged infringers is to serve a summons on a party that is contributing to the alleged infringement (eg, the supplier of the infringing products) containing a claim for indemnification. This automatically extends the case by 120 days if the third party is located abroad; if the party is located in a country where serving a summons is difficult, slow or unreliable, the deadline can be extended to permit completion of service. It is difficult for a plaintiff to prevent this from happening, and courts are willing to proceed with the case without further delays only after two failed attempts to serve the summons on the third party and the plaintiff’s refusal to agree to a third attempt.

Another way in which defendants seek to delay proceedings is by failing to comply with the deadlines set by the court-appointed expert for submission of the technical briefs. These deadlines are not strictly mandatory, and court-appointed experts do not have the authority to expunge a late technical brief from the records. If one of the parties is late (typically the accused infringer), the only remedy available for the plaintiff is to apply to the court to set a final term, non-observance of which permits the court expert to move on without waiting for the filing.

How might a party challenge the validity of a patent through the courts in anticipation of a potential suit for infringement being issued against it?

The only option available to challenge the validity of a patent is to initiate an action for invalidity. Unlike infringement actions and actions for declaratory judgment, an action for invalidity can be commenced only before the court with territorial jurisdiction over the place indicated as the patent’s address of record. Normally, this corresponds to the address of the patentee or the patent attorney representing the patentee in respect of the challenged patent.  

At trial
What level of expertise can a patent owner expect from the courts?

In Italy, 20 courts have jurisdiction over patent cases, but few have the actual experience to offer a high level of expertise. Milan and Turin are considered the most experienced courts, followed by Bologna and Venice. At the other end of the spectrum, most of the courts located in southern Italy have limited experience in patent litigation and, if possible, litigants should try to avoid them.  

Are cases decided by one judge, a panel of judges or a jury?

Cases involving infringement are heard by a single judge, while a panel of three judges decides all cases involving – or also involving – a validity claim. However, the panel convenes only to issue decisions; while the organisation of the case and its handling are delegated to a single judge, known as the ‘instructing judge’.  

If jury trials do exist, what is the process for deciding whether a case should be put to a jury?

There is no jury trial procedure.   

What role can and do expert witnesses play in proceedings?

There are two types of expert in Italian litigation: the parties’ own experts and those appointed by the courts. The role of the parties’ experts is to offer credible technical arguments in support of the position of each party. They do not give evidence, insofar as their statements are not made under oath; their primary role is to assist the party’s attorney (who usually has little or no technical education) in fully understanding the case that he or she is presenting to the court. In turn, the court is composed of judges who also have little or no formal technical education; thus, the court appoints an independent expert to help assess the technical issues relating to the validity and infringement of the patent.  

Does your jurisdiction apply a doctrine of equivalents and, if so, how?

Yes – the Code of Industrial Property specifically provides for the application of the doctrine of equivalents in defining the scope of protection of a patent, but it gives no specific guidance as to how to apply it. The trend in Italian jurisprudence is to rely on the following test:

Does the allegedly equivalent infringing solution perform substantially the same function as the invention?
Would a person skilled in the art and with the common general knowledge have realised at the priority date that such allegedly infringing solution was substantially the same as that of the invention?

Would the allegedly infringing solution at the priority date be obvious to the skilled person when compared to the invention?  

Is it possible to obtain preliminary injunctions? If so, under what circumstances?

A patentee can obtain a preliminary injunction if it satisfies the following conditions:

On the basis of a preliminary assessment of the case, it is apparent that the claim for infringement is likely to succeed on the merits.

The patentee would likely suffer irreparable damage if it had to wait until the end of the proceedings on the merits to obtain an injunction.

Although the balance of convenience test has not traditionally been used in patent cases, this trend is now changing and, in particular, respondents are using this argument to fight against an application for preliminary injunction. 

How are issues around infringement and validity treated in your jurisdiction?

Infringement and invalidity claims are usually dealt with together by the same court. As a rule, a claim for infringement is followed by a counterclaim for invalidity and vice versa, unless at the time the invalidity claim is filed the plaintiff has not yet started to use the invention. The court submits both validity and infringement questions to the court-appointed expert and the expert’s report will address and issue conclusions on both.   

Will courts consider decisions in cases involving similar issues from other jurisdictions?

Italian courts consider decisions from other European jurisdictions, but do not give them substantial weight. However, if an Italian court disagrees with a European judgment in a parallel case, it usually sets out the reasons for its dissent.  

Damages and remedies
Can the successful party obtain costs from the losing party?

As a rule, the successful party can recover 30% to 50% of the actual costs of the litigation. The court does not consider the actual costs borne by the prevailing party, but rather calculates the costs in accordance with a standard table prepared by the Ministry of Justice. The value of the case plays an important role in determining the amount to be awarded as costs. Thus, a party can recover more than what it spent in a highly valuable but simple case. 

What are the typical remedies granted to a successful plaintiff?

The typical remedies granted to a successful plaintiff are:

  • a permanent injunction against use of the invention until the patent expires;
  •  delivery or destruction of infringing items and tools and equipment exclusively used to make them;
  • a fine for any violation of the court order or delay in complying with it (in addition to the penalties for being in contempt of court);
  • publication of the judgment in the press at the infringer’s expenses;
  • damages (calculated on the basis of the patentee’s loss of profit or the infringer’s profits or, if these criteria do not apply or cannot be relied on with certainty, based on the reasonable royalty); and
  • attorneys’ fees.     

How are damages awards calculated? Are punitive damages available?

Only compensatory damages are available. Damages are calculated as the profit lost by the patentee or the profit made by the infringer, whichever is greater.

If these criteria are unhelpful (eg, if the patentee does not use the patent and the infringer made no profit), the court will calculate damages as a reasonable royalty on the infringer’s revenues generated by the use of the patented invention.

How common is it for courts to grant permanent injunctions to successful plaintiffs and under what circumstances will they do this?

Permanent injunctions are the typical remedy and courts will grant them in all cases in which the patent has not expired. However, there is a potential exception to this rule where the enforced patent is standard essential. If the alleged infringer expressed its willingness to take a licence on fair, reasonable and non-discriminatory terms, but no agreement was reached, in the subsequent litigation the patentee’s request for a permanent injunction is unlikely to be allowed. However, the law on this issue is not yet fully developed and thus uncertainty still exists.  

Timescale and costs
How long does it take to obtain a decision at first instance and is it possible to expedite this process?

The duration of first-instance proceedings can vary substantially from court to court, although as a standard, courts seek to conclude patent cases within three years of filing. The Turin and Milan courts meet this target more consistently, with the Rome and Florence courts among the slower venues. Therefore, it is important to select the right court. Once the court is selected, expediting the process is difficult.  

How much should a litigant plan to pay to take a case through to a first-instance decision?

 The costs of patent litigation depend on a number of factors (eg, the area of technology, the number of patents involved and whether lab tests are necessary). On average, in most fields of technology, the total cost of patent litigation relating to one patent is around €150,000, with an additional €100,000 for each additional patent.  

Appeal
Under what circumstances will the losing party in a first-instance case be granted the right to appeal? How long does an appeal typically take?

The aggrieved party has the right to file an appeal with the court of appeal, seeking a full review of the first-instance decision on both facts and law. The duration of an appeal varies substantially from court to court – from less than one year in Turin to three years in Rome or Florence.   

Options outside court
Are there other dispute resolution options open to parties that believe their patents to be infringed outside the courts?

Parties can agree to arbitration or mediation. Although neither is common in patent disputes – other than disputes relating to ownership of a patent – the law imposes no limit on claims relating to patents that can be subject to arbitral jurisdiction, other than claims relating to the fair award due by the employer to the inventor/employee.