This exclusive right shall extend also to trade in the product covered by the invention, but shall be exhausted after that product has been put on the market in the territory of Italy by the proprietor of the patent, or with his consent.

The exclusive right conferred by the patent right shall, regardless of the subject matter of the invention, not extend to:

(a) acts done privately and for non-commercial purposes, or for experimental purposes;

1. the extemporaneous preparation for individual cases in a pharmacy of medicines in accordance with a medical prescription and to the medicines so prepared.

Chapter 1: Subject Matter of the Patent (Inventive Step and Industrial Application; Exclusions)

Art. 12. Any new invention involving an inventive step and susceptible of industrial application may form the subject matter of a patent.

The following in particular shall not be regarded as inventions within the meaning of the preceding paragraph:

(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.

The provisions of the preceding paragraph shall exclude patentability of the subject matter referred to therein only to the extent to which the patent application or the patent relates to discoveries, theories, schemes, rules, methods, and programs as such.

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 within the meaning of the first paragraph. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

(Public Order; Morality; Animal Varieties; Biological Processes)

Art. 13. Inventions the working of which would be contrary to public order or morality may not form the subject matter of a patent; the working of an invention shall not be deemed contrary to public order or morality merely because it is prohibited by law or regulation.

Nor may animal varieties and essentially biological processes for their production form the subject matter of a patent; this provision shall not apply to microbiological processes and the products thereof.

(Working of the Invention)

Art. 54.-1. Where, after three years have elapsed from the date of grant of a patent, or four years from the filing date of the application if the latter period expires after the former, the owner of the patent or his successor in title has not worked the patented invention, either directly or through one or more licensees, by producing in the territory of the State or importing goods produced in a Member State of the European Union or of the World Trade Organization, or else has worked the said invention to an extent that is seriously disproportionate to the needs of the country, a compulsory license for the non-exclusive use of the invention may be granted to any person applying therefor.

2. A compulsory license under paragraph 1 may also be granted:

(a) where the working of the invention has for more than three years been suspended or so reduced that it is seriously disproportionate to the needs of the country;

(b) where the patented invention cannot be worked without prejudicing the rights in a patent granted on an earlier application. In that case a license may be granted to the owner of the later patent to the extent necessary for the exploitation of the corresponding invention, provided that the latter represents important technical progress of considerable economic significance in relation to the invention claimed in the earlier patent. Without prejudice to the provisions of paragraph 5 of Article 54bis, the license so obtained shall be non-assignable unless the patent relating to the subsequent invention is assigned with it. The owner of the patent relating to the first invention shall be entitled, in his turn, to a compulsory license on reasonable terms for the use of the patent relating to the subsequent invention.

3. Any person who applies for a compulsory license under the foregoing paragraphs shall prove that he has first approached the owner of the patent and failed to obtain a contractual license from him on reasonable terms and conditions.

4. The provisions of this Article shall not apply to patented inventions belonging to the Military Administration or to those kept secret under Article 41 of this Decree.

(Refusal of the Compulsory License; Equitable Compensation; Counterfeits; Legal Proceedings)

Art. 54bis. A compulsory license shall not be granted if the failure to work the patented invention, or to work it adequately, is due to causes beyond the control of the proprietor of the patent or his successor in title. Such causes shall not include the lack of financial means, and, if the product is widely circulated in foreign countries, the lack of demand on the domestic market for the patented product, or the product obtained by the patented process.

A compulsory license may be granted only against payment of fair compensation by the licensee to the proprietor of the patent or his successor in title, and on condition that the person applying for the license gives the necessary guarantees that the invention shall be worked satisfactorily in accordance with the terms laid down in the license.

A compulsory license may be granted where the working of an invention is intended mainly to supply the domestic market.

A compulsory license may not be granted to a counterfeiter of an invention.

Compulsory licenses may be granted for a period not exceeding the remaining duration of the patent, and, except with the consent of the proprietor of the patent or his successor in title, may be transferred only together with the licensee's business, or with the particular branch of the business in which the license is used.

The grant of a compulsory license shall not prevent the institution of legal proceedings concerning the validity of the patent or the rights deriving therefrom, including actions instituted by the licensee.

(Obligation to Work the Invention; Lapse of the Patent)

Art. 54ter. The grant of a compulsory license shall not exempt the proprietor of the patent or his successor in title from the obligation to work the invention.

The patent shall lapse if the invention is not worked within two years from the grant of the first compulsory license or has been worked on an extent seriously disproportionate to the needs of the country .

Art. 54quater.-l. The decree granting the license shall specify the scope, duration and manner of the exploitation, the guarantees and other conditions to which the grant is subject in relation to its purpose, the amount of the remuneration and the conditions of payment. In the event of opposition, the amount of remuneration and the conditions of payment shall be detemlined by paragraph 2 of Article 50.

2. The license conditions may, by decree of the Minister of Industry , Commerce and Handicraft, be changed at the request of any of the parties concerned where there are reasonable grounds for doing so.

3. Paragraph 3 of Article 50 shall apply to changes in the remuneration payable.

4. A license shall be revoked by decree of the Minister of Industry , Commerce and Handicraft whenever the conditions governing the working of the invention are not complied with or the licensee has not paid the remuneration in the specified amount and manner. If the owner of the patent in respect of which a compulsory license has been granted, or his successor in title, has authorized third parties to use that patent on conditions more favorable than those of the compulsory license, those more favorable conditions shall be extended to the compulsory license at the request of the licensee.

5. The communication of adopted measures to the parties concerned shall be the responsibility of the Italian Patent and Trademark Office.

6. The decree granting the license, that concerning any changes in the licensing conditions and that revoking the license, and the fixing of or any change in the remuneration payable shall be published in the Patent Bulletin and entered in the Patent Register.

Art. 54quinquies.-l. A compulsory license shall also be revoked by decree of the Minister of Industry , Commerce and Handicraft, if and when the circumstances that gave rise to the grant thereof no longer obtain and are unlikely to recur.

1. The patent owner may seek revocation by applying to the Italian Patent and Trademark Office, which shall promptly communicate it, by registered letter with advice of receipt, to the holder of the compulsory license.

The latter may, within 60 days of receiving the registered letter, lodge a reasoned objection to such revocation with the Italian Patent and Trademark Office. Articles 4 and 5 of Presidential Decree No.360 of April 18, 1994, shall apply.

3. In the event of revocation, the person who had previously been granted the license may work the invention on the same conditions within the limits of the prior use or within those determined by genuine and effective preparations.

Title VI
Expropriation

(Military and Public Interest)

Art. 60. Patent rights, inclusive of rights deriving from pending applications, may be expropriated by the State in the interest of the military defense of the country or for other reasons of public interest.

Expropriation may be limited to the right to use the invention in the interest of the State, without prejudice to the provisions of Article 54quater and such subsequent Articles as may be compatible.

When expropriation takes place in the interest of the military defense and concerns patents owned by Italian citizens, it shall transfer to the expropriating administration also the right to apply for patents in foreign countries, unless the administration surrenders or limits this right.