Patents of Invention

– EC Regulation No. 469/2009 of May 6 2009, relating to the Supplementary Protection Certificate for Medicinal Products.
– EU Regulation No. 1610/96 of July 23, 1996, relating to the Supplementary Protection Certificate for Plant Protection Products.
– EU Paediatric Regulation No. 1901/06 of December 12, 2006.
– Legislative Decree No. 30 of February 10, 2005 (Industrial Property Code), as amended by Legislative Decree No. 131 of August 13, 2010, by the Decree of November 13, 2019, and by Law No. 102 of July 24, 2023, in force since August 23, 2023.
– Decree No. 33 of January 13, 2010 (Implementing Regulation to the Industrial Property Code).
– Law No. 214/16 of November 3, 2016 on the ratification and execution of the Agreement on a Unified Patent Court (UPC).
– Decree of the Ministry of Economic Development of November 13, 2019.
– Decree of the Ministry of Economic Development of June 1, 2021.

Membership in International Conventions

– Paris Convention for the Protection of Industrial Property, Stockholm Act.
– Convention Establishing the World Intellectual Property Organization (WIPO), since April 20, 1977.
– The Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents (Apostille), since February 11, 1978.
– Strasbourg Agreement Concerning the International Patent Classification, since March 30, 1980.
– Budapest Treaty on the International Recognition of the Deposit of Microorganisms, since March 23, 1986.
– European Patent Convention (EPC 2000).
– Patent Cooperation Treaty (PCT), since March 28, 1985.
– WTO’s TRIPS Agreement, since January 1, 1995.
– Agreement on a Unified Patent Court (UPCA), signed on February 19, 2013, and ratified on February 10, 2017. The Unitary Patent Protection Regulations No. 1257/2012 and No. 1260/2012 were signed in October 2015.

Filing

Applicant (who may be): the inventor or his assignee (individual, firm, company). Applicants residing in Italy must file first in Italy. First filing in Italy is also required when the inventor works in Italy for a multi-national company having its registered office abroad. They are allowed to file abroad only after a sixty-day period from the filing date in Italy. First filing abroad, or filing abroad before expiry of said sixty-day period from the filing date in Italy is admissible provided a preliminary license is obtained from the Italian Patent and Trademark Office, such a license may be requested online from December 1, 2020 through the Italian Patent and Trademark Office website.

Inventor: appointment of inventor compulsory.

Representation before the Patent Office: applicants must be represented by a representative registered on the list of official representatives unless they file the applications directly or in the case of legal bodies, through employees domiciled in the country.

Importation or confirmation patents: not provided for.

Secret patents: secret patents may be granted should this be requested by the Italian Military Authorities.

Patents of addition: abolished as of August 22, 1979.

Novelty: absolute novelty required.

Patentable inventions: the requirements correspond exactly to Art. 52 of the EPC. Patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

Not patentable: (a) discoveries, scientific theories and mathematical methods; (b) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; (c) presentations of information; methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions which are susceptible of industrial application; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods; (d) inventions the publication or exploitation of which would be contrary to “ordre public” or morality; (e) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof; certain biotechnological inventions defined in the IPC are not patentable.

Pharmaceutical inventions: patentable without restriction.

Priorities: multiple and partial priorities admissible; a priority claim may be filed or corrected within sixteen months from the earliest priority claimed; correction of a claimed priority must be requested within four months from the filing date.

Internal priority: admissible.

Territory covered: Republic of Italy, Vatican (Holy See) and San Marino (only in the absence of a corresponding national San Marino patent).

Filing requirements for an application (to be sent to registered resident agent):
1. Unlegalized power of attorney (term for late filing: two months);
2. Abstract and specification in Italian (also accepted in any other language, provided an Italian translation is filed with the Patent Office within a two-month time limit);
3. Appointment of inventor signed by inventor(s) and applicant; however, the form can be filled in and signed by local agent (term for late filing: two months). For applications which do not claim any priority dates, an English translation of at least the claims must be filed as well, within two months after the filing date of the application or, as an alternative, a translation fee (€200) is to be paid within the same time limit;
4. Drawings in triplicate (paper drawings are acceptable) and 1 file copy, size 21 x 30 cm (term for late filing: two months).

Electronic filing: available since June 1, 2006.

For Convention cases only:
5. Certified copy of foreign application (term for late filing: six months);
6. Assignment of priority rights to be executed before the filing date in Italy, only if the applicant in Italy is other than the applicant abroad. When the applicant in Italy is one of the original joint applicants, the assignment is no longer required. Legalization by Consul or by Apostille.

For biotechnological inventions only:
7. A declaration of origin of the animal or plant biological material;
8. In case of a human material, the informed consent signed by the person from whom the material was obtained;
9. Declaration of compliance of genetically modified (micro)organisms with the national and community laws;
10. In case the invention relates to gene or amino acid sequences, the sequence shall be filed in XML electronic format. From July 1, 2022, the XML file shall comply with standard ST.26 as adopted by WIPO.

For a change of name or address: scanned copy of the document attesting the change. Legalization is not required.

Examination

Novelty examination: as of July 1, 2008, a substantive examination has been introduced for first filings only. Applications not claiming any priority dates are forwarded to the European Patent Office which, within about nine months after the filing date, will issue a search report along with a preliminary opinion on patentability. The Italian Patent and Trademark Office issues an official letter requesting the applicant to submit comments and/or amendments to the application in response to the search report. The Italian Patent and Trademark Office may issue an official letter of rejection if the claimed subject matter is still believed to be unpatentable.

Inventive level: required for patentability. An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art.

Inventions in the field of microorganisms: the rules substantially correspond to Rules 31-34 of the Implementing Regulations to the EPC.

Time limits for replying to official objections: applications shall be rejected in case the time limits set forth in the official letter (or their extension) are not complied with by the applicants; further processing may be applied for within two months starting from an unobserved time limit, submitting evidence of the completion of the omitted act.

Reinstatement: provisions are similar to those in Art. 122 of EPC. The applicant who, in spite of all due care required by circumstances having been taken, was unable to observe a time limit shall, upon application, have his rights re-established. The application must be filed in writing within one year from the expiry of the unobserved time limit. The omitted act must be completed within this period. The application must state the grounds on which it is based, and must set out the facts on which it relies. It shall not be deemed to be filed until after the fee for re-establishment of rights has been paid. Said provisions are not applicable to deadlines for dividing applications against which objections based on plurality of inventions have been raised and filing divisional applications.

Laying open to public inspection of patent applications: occurs after a period of eighteen months running from the filing date or the priority date claimed. The period may be shortened to ninety days after the filing date provided a corresponding request is lodged when filing the application.

Amendments to pending applications: the applicant is entitled to rectify or “integrate” also by adding new examples the originally filed specification and drawings. Additions of new matter inadmissible. Grant of a patent covering subject matter beyond the original disclosure is a ground for nullification.

Conversion: the Patent Office is entitled to request that a patent application be converted into a utility model application if this latter kind of protection appears to be more adapted to the subject matter of the application.

Granting

Delivery of document: at present, approximately two and a half years after the filing date. The patent registration certificate is issued in electronic format only.

Beginning of protection: as of the date on which the specification (and drawings, if any) are laid open to public inspection (i.e. eighteen months from the filing date or priority date, if any). Exclusive rights can be enforced even before expiry of said eighteen-month period against any third party to whom a copy of the specification and drawings (if any) have been served.

Duration of protection: twenty years from filing date of the application.

Supplementary Protection Certificates (SPCs) for Medicinal Products: according to EC Regulation No. 469/2009, the term of patents relating to products which, as a medicine, are subject, prior to marketing, to an administrative authorization, may be extended for a period equal to the time lapsed between the filing date of patent application and the date of grant of the Health Authorities’ first marketing approval in any EU member country, less five years. The extension cannot exceed five years (a further six-month paediatric extension is available). The application for such extension must be filed within a term of six months from the issue by the Italian Health Authorities of the first authorization for marketing the product or from the grant of the patent, if this grant is successive to such first authorization. EC Regulation No. 1768/92 entered into force on January 2, 1993, superseding Italian Law No. 349. According to Law No. 349, which applied to applications for SPCs filed from November 19, 1991 up to the date of enforcement of EC Regulation No. 1768/92, the extension period was equal to the time elapsed between the filing date of the patent and the date of grant of the first marketing authorization in Italy and could not exceed eighteen years. According to Article 61 of the Industrial Property Code, the duration of SPCs granted under Law No. 349 shall be reduced by a period equal to six months for each year, starting from January 1, 2004, until complete alignment with EC Regulation No. 1768/92 (superseded by EC Regulation No. 469/2009).

Supplementary Protection Certificates (SPCs) for Plant Protection Products: according to EU Regulation No. 1610/96 the provisions of above-mentioned EC Regulation No. 1768/96, in particular those relating to the scope of protection of the certificate and its duration, are substantially extended also to Plant Protection Products.

Annuities: filing and renewal fees had been abolished for the year 2006. The Italian government, however, reintroduced renewal fees in 2007.

Restriction of the scope of the patent: permissible upon a petition being filed in the Patent Office by the patentee provided no court action for the nullification thereof is pending. The claims of a patent may be limited by the proprietor during an invalidation action before a court.

Marking of patented goods: not compulsory. Recommended marking: “Brevettato” or “Brevetto” or “Brev.”.

Protection

Patent rights: as of November 2016, the Italian Industrial Property Code has been harmonized with the UPCA on infringement issues, by the insertion of a specific provision on indirect/contributory infringement which replicates Article 26 UPCA.

Rights of prior user: those having exploited the invention during the twelve months preceding the filing date or the priority date claimed in a later application are entitled to continue said prior use without exceeding the limits thereof as of said filing or priority date.

Exhaustion of patent rights: patent rights are exhausted once the product covered thereby has been marketed by the patentee or with his consent within the territory of the State or in the European Economic Area (EEA).

Assignments: the deed of assignment must be executed by the assignor and the assignee, respectively, attested by a Notary Public. Consular legalization not required in case The Hague Convention of 1961, is applicable. Fiscal registration required prior to recordal at the Patent Office.

Recordal of license agreements: not compulsory; formal requirements are the same as for assignment. The recordal of a license shall indicate whether the license is exclusive or not, and whether the license covers part of all the rights conferred by the patent.

Working: a patent should be worked by commercial exploitation in Italy within three years of the date of grant or four years from the filing date, whichever of these two terms expires later. Thereafter, working should not be interrupted subsequently for more than three years. Otherwise, any qualified interested party is entitled to request the grant of a non-exclusive compulsory license. An infringer is not entitled to request a compulsory license. Exhibition of the patented article at an official or officially recognized fair or exhibition in this country may be considered a substitute for working provided the article on display has been exhibited for at least ten days, or, if the duration of the fair or exhibition is shorter, for the entire duration thereof. The working requirement is satisfied by the importation of items manufactured in a member State of the European Economic Area or the World Trade Organization.  

Infringement: must be prosecuted by an infringement action brought before one of a limited number of specialized courts.

Penalties: infringement is also a criminal offense and may also be prosecuted by a criminal action.

Modification of Protection after Granting

Opposition to grant of the patent: only by bringing an action before one of a limited number of specialized courts. 

Limitation of the claims of a granted patent: may be applied for by the patentee by filing a petition with the Italian Patent Office or, in the course of a nullity action, by submitting a petition to the Judge. 

Compulsory licenses: may be requested by any qualified person if the working requirements are not complied with, provided the patentee cannot justify non-working for reasons beyond his control. Non-exclusive compulsory licenses may be granted against payment of adequate remuneration to the patentee.

Revocation: only by the decision of a specialized court.

Expropriation: possible under exceptional circumstances (in the interest of the public or national defense).

Grounds for nullification: not patentable subject matter; lack of novelty; lack of inventive step; lack of industrial application; insufficient disclosure; subject matter of the patent as granted extending beyond the scope of the original disclosure of the application; the patentee had no right to a patent.

Conversion: when ruling the nullification of a patent as such, a court may still order that the patent be converted into a utility model if the respective validity requirements are found to be met. The conversion may be applied for in any phase and instance of the proceedings.

The European Patent Convention And Italian Law

Rights conferred by European patent application: exclusive rights may be claimed on the basis of a published European patent application provided an Italian translation of the claims thereof is made available to the public through the Italian Patent and Trademark Office or served to the alleged infringer.

Rights conferred by the European patent: a European patent granted for Italy has the same effect and is subject to the same provisions as Italian patents, provided an Italian translation of the specification is filed at the Italian Patent Office at the latest three months after publication of the mention of the grant in the European Patent Bulletin. It is possible to file the translation of a European patent at the Italian Patent Office before the date on which the mention of the grant is published in the European Patent Bulletin in order to enjoy an anticipated protection. In the case the patent is opposed and maintained in force in amended form, or limited at the request of the proprietor, an amended Italian translation must be filed within three months after publication of the decision to maintain the patent in force in amended form after opposition. According to a decision issued from the Board of Appeals (Commissione dei Ricorsi) the Italian translation of a European Patent may be still validly filed within two months after the expiry of the statutory three-month term by requesting further processing and paying the application fee. 

European patent validation requirements: (a) appointment of a national representative is optional; (b) translation of the full specification into Italian is required; (c) the minimum time period for paying renewal fees due at validation is four months.

Documents required for filing of translations into Italian:
(i) 1 copy of the specification and drawings, if any, translated from the language of the proceedings (English, German or French);
(ii) Copy of the decision to grant the European patent or to maintain it in force in amended form after opposition, or to limit the patent;
(iii) Power of attorney, in Italian, simply executed by the patentee;
(iv) Copy of the first page of the published European patent application (containing the abstract, the translation of which is required by the Italian Patent Office for information purposes only).

PCT Applications

From July 1, 2020, the applicants may designate Italy independently from the designation of the European Patent Office. The time limit for entering the national phase under Chapters I and II of the PCT is 30 months. The claim fees to be paid upon entering the national phase are based on the text as published by WIPO. The Italian Patent and Trademark Office has communicated its withdrawal from the reservations on the restoration of the right of priority and on incorporation by reference from July 1, 2020. From October 1, 2020, the Italian Patent and Trademark Office is also a depositing office (not an accessing one) for the Digital Access Service (DAS) of WIPO, for promoting digital sharing of documents among national and international patent offices.