Patents & Trademarks
/ Italy
All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.
1. What are the basic requirements to obtain patent and trademark protection?
The regulation of Italian patents and trademarks is mainly contained in the Industrial Property Code (Legislative Decree No. 30/2005, hereinafter “I.P.C.”). Some provisions on patents and trademarks are also contained in the Italian Civil Code.
As regards the patent for invention, which includes the pharmaceutical patent, inventions from any field of technology which are new, involve an inventive activity and are capable of industrial application are patentable (art. 45(1) of the I.P.C.). The requirements for patentability of the invention are: novelty, inventive step, industrial application and lawfulness (Articles 46 to 50 of the I.P.C). Specific rules are provided for certain types of patents, including special rules on the biotechnological patent.
With respect to trademarks, these must first comply with the provisions of Article 7 of the I.P.C., establishing which “signs” can be registered as trademarks. The requirements for registration are: novelty, distinctiveness and lawfulness (Articles 12 to 14 of the I.P.C.).
2. What agencies or bodies regulate patents and trademarks?
The regulation of Italian patents and trademarks is contained in the Italian legislation, which also transposes some EU Directives on the matter. The Italian Patent and Trademark Office, which is part of the Ministry of Economic Development, is the registration office for both patents and trademarks.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
As regards patents, inventions in any field of technology that are new, involve an inventive step, and are capable of industrial application may be patented.
According to article 45 of the I.P.C., if considered “as such”, the following are not regarded as inventions:
• discoveries, scientific theories and mathematical methods;
• schemes, rules and methods for performing mental acts, playing games or doing business and computer programs;
• presentations of information.
Article 45 above also provides that (i) methods for surgical or therapeutic treatment of the human or animal body and methods of diagnosis applied to the human or animal body; and (ii) plant varieties and animal breeds and essentially biological processes for the production of animals or plants, cannot be patented.
With regard to trademarks, pursuant to Article 7 of the I.P.C, all signs, in particular words, including names of persons, drawings, letters, numerals, sounds, the shape of the product or its packaging, color combinations or shades, can be registered as trademarks, provided that they are capable of:
• distinguishing the goods or services of an enterprise from those of other enterprises; and
• being represented in the register in such a way as to enable the competent authorities and the public to clearly and accurately determine the subject matter of the protection granted to the relevant holder.
Limitations on the possibility of registering a trademark are set out in Article 8 on portraits of persons, names, notorious signs, Article 9 on shape marks, and Article 10 on badges, emblems and escutcheons of the I.P.C.
4. How can patents and trademarks be revoked?
Patents may be declared null and void if the invention lacks the requirements for patentability and in the other cases provided for by Article 76 of the I.P.C. Patents may also expire for non-payment of fees (Art. 75 of the I.P.C.).
Trademarks may be declared null and void if the invention lacks one of the requirements set forth in Article 7 and in the other cases provided for in Article 25 of the I.P.C. Forfeiture is also provided for in cases of vulgarization, supervening unlawfulness and non-use (Article 26 of the I.P.C.).
The bodies responsible for performing the relevant checks and declaring the nullity / forfeiture are the Italian Patent and Trademark Office and the Italian judicial authority.
5. Are foreign patents and trademarks recognized and under what circumstances?
Registration titles have territorial validity on the basis of the national registration office chosen. Thus, unless European or international titles include Italy, only Italian patents and trademarks are recognized in Italy.
However, certain rights are given to unregistered but actually used trademarks and a right of priority in case of filing in a Country which is a party to an international convention ratified by Italy that recognizes the right of priority (Art. 4 f the oI.P.C.).
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The recipes, list of ingredients, components, way of manufacturing and any other business information relevant to the medicine / device can be handled by the owner as a trade secret and protected as such when the following conditions apply: (i) the information is not generally known or easily accessible by others; (ii) it has an economic value inasmuch as it is confidential; (iii) it is subject to reasonable measures to preserve its confidentiality.
Obviously, trade secrets are not a suitable tool when reverse engineering allows third parties to replicate the finding.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
No restrictions, save for what indicated above at Question 6 (iii)
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No approval or acceptance is needed, but licenses must be recorder with the Italian Patents and Trademarks Office in order to be enforceable against third parties. Note that licenses on applications that have not yet been published will not be possible until publication.
