Patents & Trademarks
All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
Italian legislative decree 30/2005 (Italian Industrial Property Code or “IIPC”) sets out the requirements to obtain patent and trademark protection.
According to Articles 45 and ff. of the IIPC, patent protection may be granted to inventions in any field of technology where such inventions:
- are new;
- involve inventive steps;
- have industrial application;
- are lawful; and
- sufficiently described so that an expert in the relevant technical field may implement it.
Once granted, the patent grants its owner the exclusive right to the invention, including the right to profit from its applications, for 20 years from the date of filing. To this end, the patent owner is entitled to prevent any third party from, inter alia, producing, using, marketing, selling or importing any product implementing the technology covered by the patent, unless consent to perform such activities is granted.
Furthermore, inventions in the pharmaceutical sector may obtain an additional exclusivity period up to five years following expiry of the patent. This additional protection is granted by supplementary protection certificates (“SPC” – in Italian certificato di protezione complementare). In fact, while patents are normally applied for at an early stage of the development of a new medicine, the marketing of the product requires authorization by AIFA or the European Commission to be placed on the Italian market.
The process to obtain marketing authorization is time-consuming and requires consistent financial resources, particularly when involving innovative therapies. Therefore, by the time the authorization is granted, most of the exclusivity period granted by the patent has elapsed. The SPC aims at making up for this reduction in the 20-year protection by adding an extra exclusivity period.
The SPC protection lasts for a period equal to the time passed between the filing of the patent and the granting of the marketing authorization minus five years. In any event the SPC protection may not exceed five years.
According to Article 7 and ff. of the IIPC, trademark protection may be granted to signs, including words, people’s name, drawings, letters, numbers, sounds, product shapes or packaging, colors, provided that they, inter alia:
- differentiate the products and/or services of a company from the products and/or services of other companies;
- are reproduced in the official register in a way that makes the scope of the protection granted by the trademark clear;
- are not identical or similar to signs that are already renowned as trademarks or distinctive signs used by other companies to differentiate their products or services and the identity and/or similarity between those signs and/or products and/or services is likely to confuse the public as to the origin of the relevant product or service from a given company.
Once granted, the trademark grants its owner the exclusive right to use the trademark, except where consent to such use is granted, for ten years from the date of filing. This protection may be unlimitedly renewed for additional periods of ten years. Particularly, the trademark owner is entitled to prevent third parties from:
- using a sign that is identical to the trademark in relation to identical products or services;
- using a sign that is identical or similar to the trademark in relation to identical and/or similar products or services, where such identity or similarity of signs and/or products and/or services is likely to confuse the public;
- using a sign that is identical or similar to the trademark in relation to products and/or services – even when not similar – where the trademark is notorious and the user of the identical or similar sign may improperly benefit from such use.
2. What agencies or bodies regulate patents and trademarks?
The Italian Patent and Trademarks Office (Ufficio Italiano Brevetti e Marchi – “UIBM”) is the national competent agency for:
- examining patent and trademark applications;
- granting patent and trademarks registrations;
- deciding on opposition to trademark applications filed by any interested party.
Furthermore, civil courts are vested with jurisdiction over claims relating to patent and/or trademark rights, including nullity and infringement claims. These actions are typically brought by the owner and/or third parties after the relevant patent or trademark is registered. Precautionary measures are also available. All measures mentioned above can be obtained by the right-owner pending registration of the patent or trademark.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Patent protection is granted for inventions covering the following:
- products (e.g. molecules, active ingredients or a combination of active ingredients);
- methods or processes for the manufacturing of a certain product (e.g. a procedure for collecting data from given samples, a process to synthetize a combination of substances);
- new uses of known products or enhancement of a known process.
Conversely, Article 45 of the IIPC clarifies that the following are not invention and, therefore, may not be eligible for patent protection:
- scientific advances and theories and mathematical methods;
- principles and methods for intellectual, gambling or business activities and software;
- reports of information.
Further, the following, inter alia, are not subject to patent protection:
- diagnosis methods and surgical or therapeutic treatments applied to human or animal body;
- plant varieties.
Trademark protection may be granted to any sign, including words, people’s name, drawings, letters, numbers, sounds, products’ shapes or packaging, colors, provided that they, inter alia:
- differentiate the products and/or services of a company from the products and/or services of other companies;
- are reproduced in the official register in a way that make it clear the scope of the protection granted by the trademark;
- are not identical or similar to signs that are already renowned as trademarks or distinctive signs used by other companies to differentiate their product or services and the identity and/or similarity between the signs and/or products and/or services is likely to confuse the public as to the origin of the relevant product or service from a given company.
Conversely, under Article 9 of the IIPC signs consisting exclusively of the following may not be subject to trademark protection:
- the shape or other characteristic that is dictated by the nature of the product;
- the shape or other characteristic necessary for the product to perform its technical function;
- the shape or other characteristic that forms the substantial value of the product.
Further, the following, inter alia, may not be registered as trademarks:
- signs lacking distinctive character;
- signs that are unlawful or against public morality;
- signs that became of common use in the current language or business practices;
- common names for products or services or indications describing, inter alia, the quality, quantity, value, geographical origin of said products or services
- signs whose use may infringe copyright or industrial property rights of any third party.
4. How can patents and trademarks be revoked?
Courts may revoke a patent if the validity requirements are not met. A patent is null and void when one of the requirements for its registration is missing, and therefore (i) the relevant invention is not new; (ii) it does not involve inventive steps, (iii) it does not have an industrial application, or (iv) it is unlawful or not sufficiently described so that an expert in the relevant technical field is able to implement it.
In case of court proceedings, the claimant requiring the ascertainment of nullity must prove that the challenged patent is null and void.
Similarly to patents, civil courts may revoke a trademark.
Civil courts may revoke a trademark because they found it is either null and void or decayed. Article 25 of the IIPC indicates that trademark is null and void where, inter alia:
- it lacks any of the requirements for its valid registration (see Question 1 above);
- it lacks distinctive character, it being known on market as common name of a given product or service;
- it is likely to deceive the public as to the geographical origin, nature or quality of products or services, among other things;
- it infringes copyright or industrial property rights of third parties;
- it is unlawful or against public morality.
In addition, Article 26 of the IIPC provides that a trademark may decay where, inter alia:
- its holder (or its authorized licensee) did not use the trademark within five years following registration or he/she has stopped using the trademark for five consecutive years without any legitimate reason.
- it lost its distinctive character because it became known on market as common name of a given product or service;
- it became likely to deceive the public as to, inter alia, the geographical origin, nature or quality of products or services.
The claimant must prove that the challenged trademark is null and void or decayed. The holder can prove circumstances that may exclude revocation of the trademark, including that he/she did not stop using the trademark in the course of his/her business.
5. Are foreign patents and trademarks recognized and under what circumstances?
The Italian system does not automatically recognize foreign patents. However, foreign patents may obtain protection in Italy through the following application procedures:
- International patent application procedure (“PCTP”);
- European patent application procedure;
The PCTP was established by the Patent Cooperation Treaty. Following this path, the applicant may apply for multiple national patents by filing a single application. Patent rights according to the PCTP may be granted only in those countries that signed the Patent Cooperation Treaty, including Italy. To this end, the applicant must indicate Italy among the countries where he/she seeks protection.
The European patent application procedure was established by the European Patent Convention (EPC) and grants the applicant patent rights in all member states indicated in the initial application, including Italy. The European application may be filed with the EPO or with the national authority of any member state, which for Italy is UIBM, and it is managed by the EPO. Once granted at the European level, the holder must file a translation of the invention in national language with the national authority to obtain protection in the relevant member state. Once the translation is filed with UIBM, the patent will be recognized under the Italian legislation.
Similarly, the Italian system does not automatically recognize foreign trademarks. However, foreign applicants may obtain trademark protection in Italy through the following application procedures:
- International trademark applications;
- European trademark application,
The international trademark applications were established by the Madrid Agreement and the Madrid Protocol and grant protection in all signatory countries, including Italy. These international paths differ from each other. In fact, the Madrid Agreement may lead to international trademark protection provided that the applicant already owns a national trademark. Conversely, the Madrid Protocol establishes an autonomous procedure which any applicant can access to, regardless of previous ownership of a national trademark. Once granted, both applications grant trademark rights equal to those recognized at the national level.
The European trademark application may be filed with the European Intellectual Property Office (EUIPO). Through this path, the applicant can obtain trademark protection in all European member states with no need to indicate the jurisdictions where protection is sought. In addition, trademark protection will automatically extend to any country that joins the EU after the application is filed.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Italian industrial property law provides another barrier to competition by granting protection to trade secrets. To this end, holders of trade secrets may prevent any third party, including their competitors, from unlawfully acquiring, using or disclosing their confidential know-how and business information.
Article 98, question 1, of the IIPC defines trade secrets as any information that:
- is secret;
- has commercial value because it is secret;
- is subject to reasonable steps by its holder to keep it secret.
In particular, Article 98, question 2, of the IIPC specifies that this information may include data relating to evidence or other secret information which development requires considerable effort and which submission is needed to obtain marketing authorization for medicinal products involving the use of new chemicals. This is the case of data obtained through clinical trials that must be included in the dossier filed with AIFA or the EMA.
Importantly, clinical data must comply with the requirements generally provided for trade secrets in order to benefit from protection under Italian law. This means that clinical data must be:
- secret, meaning that they are not generally known by or of easy access to persons normally dealing with medicinal products and their developments;
- commercially valuable because of their secrecy, meaning that the manufacturer is in a better competitive position than its competitors because it holds those data;
- subject to reasonable steps to keep it secret, meaning that the manufacturer must ensure and implement tools (e.g. secured access to clinical data and studies) which prevent disclosure of confidential data to third parties.
Should these requirements be met, originators can benefit from the protection granted to trade secrets pursuant to Article 99 of the IIPC. Particularly, manufacturers of medicinal products may prevent the unlawful acquisition, use or disclosure of their confidential clinical data by any third party, including competitors, unless consent to perform such activities is granted. Particularly, these activities remain unlawful even where the concerned person did not directly acquire or disclose the information, but he/she knew or, given the circumstances, should have known that he/she obtained the information from a third party who was, directly or indirectly, unlawfully using or disclosing it.
Furthermore, the protection granted to trade secrets also extends against products which design, characteristics, function, manufacturing process or marketing resulted or benefitted from the unlawful acquisition, use or disclosure of such trade secrets. To this end, holders of trade secrets may prevent the production, offering, placing on the market, import, export of storage of these infringing products where the person performing such activities knew or, given the circumstances, should have known that trade secrets were being misused.
On this basis, originators may claim protection of their clinical data vis à vis competitors which did not directly acquire, use or disclose them, but knew or should have known that such data were obtained from a person who unlawfully used or disclosed said data. Importantly, the unlawful activity extends to the products resulting from the use of the clinical data and the originator may claim misappropriation of trade secrets against competitors for, inter alia, producing, marketing, importing, exporting or storing medicinal products obtained by using misappropriated clinical data.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Under the Italian system, medicines and devices may be granted patent and trademark protection under the same conditions and restrictions provided for any other product (see Question 1 above). Among these restrictions, one may be specifically relevant to the medical sector. In fact, Article 45 of the IIPC provides that no patent protection may be granted to diagnosis methods or surgical or therapeutic treatments applied to the human or animal body.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
In Italy, license agreements with foreign licensors do not require any governmental or regulatory approval.
In general, Italian law only requires license agreement to be recorded at the UIBM register. Once recorded, the license agreement may be enforced against third parties by the licensee and licensor.
Finally, Article 23 of the IIPC provides that non-exclusive license agreements on trademarks may only be concluded where the licensee undertakes to use the licensed trademark to differentiate products and services that are identical to those marketed by the holder or other non-exclusive licensees of the same trademark.