Patents insight

Italian patents

INVENTIONS

An invention is an original solution to a technical problem. This definition of invention is the most widely accepted today in Italy and abroad. However, it is a definition which seems – particularly in this current era of continuous and rapidly broadening technical/scientific horizons and the consequent creation of inventions introducing new typologies (take two fields, software or microorganisms, for example) – to have a more descriptive value than a practical one. Nevertheless, the advantage of this definition is that it highlights the difference between technique and science: inventions belong to technique, discoveries to science. The former are patentable, the latter no.

FUNCTION OF THE PATENT

The patent can be defined as the legal institution which allows the proprietor of the said patent (whether this is the inventor or the party to whom the invention belongs) to claim the right to make sole use of their invention for a certain length of time. Note that the “right to use” an invention must be understood as both the sole right to implement the invention and the sole right to market it.

WHY PATENT?

A patent can be considered, quite simply, an “agreement” between the proprietor and society: the proprietor of a patent discloses his invention to society through its description and society, by means of the role of guarantor played by the governmental authority which issues the patent concession certificate, rewards the proprietor of the latter by granting him the right to exploit the invention in economic terms, granting sole rights for a set period of time.

Should the inventor decide not to patent his invention, keeping it secret, there are two possible negative consequences for society: on the one hand, society could experience a much longer monopoly than the term of the patent exclusive right, i.e. twenty years and, on the other, in the event of the inventor’s death and that the secret is kept, society could miss the opportunity to make use of knowledge which is beneficial for its progress and wellbeing. With regards to the latter possibility, it should be emphasised that a patent is only issued if a detailed description of the invention is submitted, therefore the invention is acquired in full by society.

What is more, patenting is worthwhile for the inventor: in fact, if the inventor does not manage to keep his invention secret – and it is far likelier that the invention is revealed than kept secret - the inventor will no longer be able to make sole use of the fruit of his or her creativity. Patenting, therefore, is worthwhile for both the inventor and society.

WHAT CANNOT BE PATENTED?

According to the legal system, all new inventions which involve inventive activity and are designed for application in industrial fields can be patented. Obviously, a definition of this kind is exemplificative, therefore it is quicker to provide the list of items that cannot be patented as it is accepted by prevailing law as absolute. This list contains both items which are not considered inventions and those which are but, by law, cannot be patented.

On no account can the following be patented:

• discoveries, scientific theories and mathematic methods;
• plans, principles and methods for intellectual activity, games or business, and computer programs;
• presentations of information;
• methods for surgical or therapeutic treatment of the human or animal body and diagnosis methods applied to the human or animal body ;
• inventions whose implementation would be contrary to public policy or accepted principles of morality

WHAT TYPE OF PATENT?

Patents, according to Italian laws, are divided into patents for Industrial Inventions and patents for Industrial Utility Models. It is worth remembering that few countries provided for the latter in their legislation - of those that do, Germany and Japan have the highest technological and market profiles.

PATENTS FOR INDUSTRIAL INVENTIONS

Traditionally, this applies to patents for which the invention represents a new solution to a technical problem. These can concern both goods and procedures.
This type of patent has a term of twenty years, as of the patent application filing date. During this time, the proprietor of the patent can enjoy sole rights to the utilisation of his invention; the twenty-year term is in force almost worldwide.

PATENTS FOR INDUSTRIAL UTILITY MODELS

According to Italian law, this type of patent applies to creations designed to render machines, or parts thereof, instruments and tools, and general articles for use, particularly efficient or easy to apply or use. These patents can only apply to goods, not procedures.
According to the current and prevailing interpretation, these are patents for which the subject-matter of the invention pertains to the improvement of an existing object. By its very nature, this type of patent, for Utility Models, are very often connected with the form of the goods in question. Take one example, that of the handgrip on a tool: if its shape is improved, e.g. rendered more ergonomic, the said tool will be safer to use, handier and will contribute to increased productivity.
This type of patent has a term of ten years, as of as of the date on which the patent application is filed.

PATENTABILITY REQUIREMENTS

To ensure a patent registration is valid, the invention described and laid claim to in the wording of the patent must meet three fundamental legal requirements: novelty, originality and industrial applicability.

NOVELTY

The text of Italian laws are perfectly clear on this matter, stating that an invention is considered as new if it has not already been disclosed to the public either in Italy or abroad prior to the date on which the patent application is filed. This includes disclosure of the description by mouth or in writing, by use or by any other means.

When judging whether an invention is new, on the basis of the existence of earlier documents on the same topic, what counts is that the invention is not exactly the same as an earlier one: in other words, if there are partial similarities with one document and partial similarities with at least another one, then the invention is judged as new.

ORIGINALITY

This purpose of this requirement, also called “inventive activity” or the “inventive step”, is to differentiate between all the new creations, those which an inventor cannot achieve in obvious way or by applying ordinary transformations of knowledge and technology.

The law applies this important requirement to prevent, above all, patent applications being filed whose contents are obvious and within any lay person’s reach. What is more, meeting this requirement allows society to reward the efforts of those inventors who have really employed time, energy, intellect and money to create and perfect their invention and finally, it also prevents an enormous number of patent applications being filed. Clearly the second requirement differs from the novelty requirement, if nothing else, in the effort required for the judgement, which involves a great deal of energy and a variety of skills.

INDUSTRIAL APPLICABILITY

Current regulations stipulate that an invention meets this requirement when “its subject can be manufactured or used” in any type of industry, including agriculture. Note that the manufacture provided for by the law does not exclude inventions implemented by craft means rather than mass production, i.e. implemented by persons rather than machinery; however the said implementation must be repeatable an indefinite number of times, nevertheless, and always with the same results.

CERTIFICATE OF COMPLEMENTARY PROTECTION (CCP) FOR DRUGS

This certificate is connected to patents concerning a medicine, a product which is an ingredient of the said medicine, the use of a product as a medicine or a procedure for its production.

In certain fields, in particular pharmaceuticals, the introduction of new products on the market is delayed by regulations ordering experimentation and checks before authorisation is granted for the product to be put on sale: in practice, the time from the application filing date to the date of the authorisation of the sale of the drug can lead to an erosion of the (twenty-year) term of the patent right. The purpose of the Certificate of Complementary Protection is to extend the term of the patent’s sole rights.

The following regulations are applicable to the issue:

• for Italy: Law n. 349 dated 19 October 1991;
• for the European Community : Regulation n. 1768/92/CE dated 18 June 1992;
• for Italy: Law n. 112 dated 15 June 2002.
• EC regulations override Italian legislation, which remains in force for CCPs issued prior to the entry in force of the said EC regulation. The two bodies of legislation seem extremely similar and the most substantial difference is the term, which is longer in the case of national legislation; nevertheless, the said Italian Law n. 112 is designed to reduce the term at a rate of six months per year as of 1st January 2004.

PROCEDURE

Applications for the CCP must be submitted within six months of the first authorisation for sale of the drug if the first authorisation is dated after the patent has been granted, or within six months of the patent being granted if the date of the first authorisation for sale of the drug is prior to the said grant date. The CCP’s twenty-year term, which begins when the patent application is filed, is extended by the amount of time that passes between the patent application filing date and the date of the drug’s first authorisation for sale of the drug, reduced by five years.

PATENTING BIOTECHNOLOGIES

In Italy (and other countries), it has been confirmed that biotechnological inventions are patentable, e.g. the creation of new microorganisms, new viruses, the decoding of genes or gene sequences for immediate use, the production of a protein etc.; however, there is a great deal of controversy around the lawfulness of certain patents, those concerning human cloning, for example.

It should be stressed that this field of research, still at the teething stage, has implications of a moral nature and affects all people differently. It is only natural then that the most recent directives on the matter should be complex and full of compromise; another aspect that should not be underestimated is that the biotechnology field, by virtue of its own particular features, appears to require different bodies of legislation to those which apply to more tradition fields of technology, in particular, mechanics, which has always constituted the basis of industrial sole property rights.

European patents

WHAT IS A EUROPEAN PATENT?

It is a single procedure which results in the granting of a single right, the European patent, which is valid in all the member states of the European Patent Convention – undersigned in Munich on 5th October 1973. It must be emphasised that the patent right granted is not a single right but a bundle of national patents each of which is subject to the regulations of the individual countries designated by the applicant.

PATENTABILITY REQUIREMENTS

These are constituted of novelty (worldwide), originality and industrial applicability, as in the possibility of implementing the invention.

PATENTING PROCEDURE

Unlike in other countries, according to Italian law, “natural or legal persons with domicile or a branch in Italy must submit the European patent application at the Italian Patents and Trade Marks Office only”.

There are two exception to this rule:

1. when the European patent application claims the priority of an Italian application which was filed in Italy over ninety days previously and was not subject to the secrecy restriction and
2. in the event that the a divisional European application is submitted (in which case it is actually compulsory to file the application at the European Patents Office).

The European patenting procedure is structured as follows:

• the applicant files the patent application: this is composed of the European patent grant application, the applicant’s details, the description of the invention and the claims pertaining to the characteristics of the invention for which patent protection is being sought; the European patent grant application must contain the Designated States specification, i.e. it must state the countries in which the applicant wishes the invention to be protected. Note that in the cases of Switzerland and Liechtenstein, if the applicant specifies one of the two countries only, the other will be considered designated automatically. The application and clearance search fees must be paid within a month of the application filing date.
• Publication of the application: this occurs 18 months after the application filing date or 18 months after the national priority date claimed;
• earlier documents search followed by the issuance of a Search Report;
• applicants are given the opportunity to withdraw the European patenting procedure in the event that earlier inventions are found to be particularly destructive for his invention, or to continue the said procedure, modifying the patent wording if necessary in response to any earlier inventions that may have emerged. These modifications cannot extend the scope of the patent beyond its original content;
• should the applicant decide to proceed with the application for a European patent, he or she must submit an application for a substance examination, accompanied by the payment of the relative fee;
• substance examination: at this stage, the Examiner will raise any objections deemed necessary, to which the applicant can respond by offering explanations and suggesting amendments to the text as it was filed, remaining of course, within the scope of the patent as it stood when the application was filed;
• if the European Patents Office informs the applicant of its intention to grant the patent: within a set time the applicant must submit a translation of the claims into the other two official languages, pay the grant fee and, where required, the charge for each page of the patent text exceeding the limit of thirty-five pages and the charge for each page of claims that exceeds the limit of ten pages;
• official publication of the decision to grant the European patent;
• official publication of the granted European patent file;
• nationalisation of the European patent, i.e. the text of the European patent granted is filed in the designated states, and the respective national filing fees are paid;
• application is opened to opposition from third parties.

Therefore, the most important features of the European Convention patenting procedure are that a search is carried out for earlier documents (patent texts and also various items of technical literature, from both in and out of Europe), a substance examination of the application and the opportunity given to third parties to raise objections.

The search for earlier documents results in a Search Report indicating the earlier documents constituting the so-called “background art”. This report and the documents indicated therein are then forwarded to the European patent applicant, who can then view the earlier implementations and decide, on the basis of these observations, whether or not to proceed with the European patenting.

The examination of the application’s substance allows the examiner and the applicant to enter a new stage, that of the discussion: the former will raise objections pertaining both to whether the formalities have been fulfilled and to whether the aforesaid patentability requirements of the patent text for which the applicant is seeking the European patent have been met; the applicant will be given the opportunity to respond to the examiner, offering explanations and suggesting amendments to the original wording of the patent filed.

The notice of opposition must be filed within and no later than nine months of the publication date of the mention of grant of the European patent and it is not considered submitted until the relative fee has been paid.

The following reasons can be cause for a notice of opposition to be filed against a granted European patent:

• one or more of the three patentability requirements have not been met;
• if the subject of the patent is expressly excluded by the European Patent Convention;
• if the presentation of the invention is insufficiently clear or incomplete, which is why it should not be drafted by a lay person;
• if the patent no longer remains within the scope of the original application filed.

LANGUAGE OF THE PROCEDURE

There are three official languages, English French and German, and the official language of the procedure is the one in which the application was filed and must remain as such for the duration of the said procedure.

INTERNATIONAL APPLICATION – PCT CONVENTION

WHAT IS THE PCT?

The PCT (Patent Cooperation Treaty) is an international convention that allows application to be filed by means of a unified International Application procedure, through which the applicant makes a reservation to apply for patent protection in any of the member states – there are currently over 120 - which can be designated a later date. The patents are granted in the individual designated countries by the relative national authorities.

The main advantages of the international filing lie, above all, in the fact that the examination by the individual states is facilitated since – as outlined later in the paragraph on procedure - an earlier documents search is required, and a Preliminary Substance Examination can be requested by the applicant. Furthermore, the examination rules and criteria have been harmonised.

This reveals a considerable difference between the PCT Convention and the European Patent Convention: the latter leads to a patent being granted which overrides those of the individual members states and must be regularised in each individual state, while the PCT Convention defers to all the individual states for the relative patent rights to be granted.

Note that the members of the PCT Convention are not only individual countries but also sets of states united by international conventions which operate at a regional level. A typical example of Regional Organisation is that of the European Patent Convention (EPC); if the EPC is designated, all the EPC member states are designated at once through the PCT.

PATENTABILITY REQUIREMENTS

These are constituted of novelty (worldwide), originality and industrial applicability, i.e. possibility of implementing the invention.

WHO CAN FILE AN INTERNATIONAL APPLICATION?

Anyone domiciled in any of the countries in the agreement and any citizen of any of the countries in the agreement.
However, it is possible for persons domiciled in or who are citizens of countries which have not undersigned the PCT Convention but are members of the Paris Convention to file International Applications; applications of this kind are subject to the approval of the PCT Assembly

PROCEDURE

The procedure is basically structured as follows:

• the applicant files the International Application, at a Receiving Office; the application form must be accompanied by a description of the invention, one or more claims, one or more drawings and an abstract. The said application, in its turn, must contain the designation of one or more states in which the applicant is seeking patent protection (followed by payment of the relative fees), the applicant’s details, the title of the invention and the inventor’s details;
• the Receiving Office sends a copy of the International Application to the International Office (this copy is considered the original) and another copy to the authority appointed to carry out the International Searches;
• the International Searches are carried out, then an International Search Report is drafted and a Written Opinion issued, which will be considered the Preliminary International Report on Patentability;
• the applicant is given the opportunity to amend the claims;
• the application for the International Preliminary Examination is filed by the applicant either within three months of the International Search Report and Written Opinion being sent to the applicant or within twenty-two months of the date of priority, whichever is later;
• the International Application is published as quickly as possible once the required period of eighteen months have passed since the said Application filing date or the priority date. In the event that the claims have been amended prior to the publication, these will be published along with those filed originally;
• the applicant is allowed thirty months, as of the priority date, to decide whether or not to embark on the national stages (thirty-one months in the case of the European regional stage);
• the authority in charge of the International Preliminary Examination sends the applicant at least one written opinion, to which the applicant can respond;
• a Preliminary Examination Report is issued, generally within twenty-eight months of the filing date or the priority date if it is claimed and drafted in the language in which the International Application was published. Note that the said report is not binding for the national/regional authorities which will be called upon to actual grant the patent right.
• With regards to the notice from the authority in charge of the International Preliminary Examination, note that if the latter finds that the wording of the patent in the International Application does not meet the unity of invention requirement (i.e. the patent text contains at least two inventions), the applicant is invited to either limit the claims or submit divisional applications.
• Should the applicant fail to respond, the Preliminary Examination Report will be drafted on that which, according to the examining authority, constitutes the main invention.

FEES

• The applicant must pay the following fees when the application is filed: international filing fee (this includes the former standard fee plus the designation fee) and a charge per extra page for patents of over thirty pages.
• When the International Preliminary Examination Application is filed, the relative examination fee must be paid.
• A charge is also payable for divisional applications submitted.
• With regards to the costs, it should be emphasised that the PCT procedure offers applicants the chance to defer certain stages involving major costs (e.g. the translations of the patent texts) allowing them the opportunity to assess the situation of their invention beforehand.
• In fact, if for example the Search Report and the Preliminary International Examination Report are not particularly favourable, the applicant can limit the number of states originally designated or, in more extreme cases, s/he can even decide to withdraw from the patenting procedure without having to cover all the expenditures which would have been unavoidable if they had opted for the individual national procedures instead of the unified PCT procedure.