Procedures and strategies for pharmaceutical brands: Italy
Selection, clearance and registration
Pharmaceutical trademark owners face a variety of issues that are not seen in other sectors, including health regulatory requirements, linguistic marketing issues and political factors. Finding an effective and acceptable pharmaceutical brand name can thus be an intense and sometimes complex procedure.
Trademarks are governed by the IP Code. Since the code contains no specific rules concerning pharmaceutical trademarks, they are covered by the general laws on trademarks.
All pharmaceutical products are identified by an international non-proprietary name (INN) – a global nomenclature used to emphasise the presence of an active ingredient in the drug. This is particularly helpful for healthcare professionals who need to recognise a drug’s pharmaceutical properties when prescribing medication.
According to the World Health Organisation, INNs cannot be used as pharmaceutical trademarks, since doing so would cause confusion to the public and have consequences for patients’ health.
However, many pharmaceutical trademarks contain at least part of the name of the active ingredient, sometimes in combination with an invented name or the name of the manufacturer, in order for them to be more easily recognisable by consumers. Although a certain degree of distinctiveness is normal in the pharmaceutical field – since it helps consumers to find the right medication – pharmaceutical trademarks are often weak marks. Consequently, as Italian case law suggests, even slight modifications, amendments or additions can prevent the risk of confusion.
Pharmaceutical trademarks can also be completely or partially fanciful marks. Completely fanciful marks have no immediately apparent conceptual link with their active ingredient; they are thus strong trademarks with a high level of distinctiveness. However, weak trademarks represent the vast majority of the marks in the pharmaceutical field.
The existence of many trademarks referring to the same active ingredients makes it more difficult to find an appropriate name for registration. Global pharmaceutical trademark clearance searches (not limited to national trademark databases and including online use) are therefore a vital preliminary to the registration process.
As with other trademarks, pharmaceutical trademarks can be registered at:
- the Italian Patent and Trademark Office;
- the EU Intellectual Property Office (formerly the Office for Harmonisation in the Internal Market); and
- the World Intellectual Property Organisation.
Pharmaceutical products need marketing authorisation to be marketed and sold. Thus, administrative and health authorities are also involved in the choice of a drug’s name – namely, the Italian Pharmaceutical Authority (AIFA) and the European Medicines Agency (EMEA).
A marketing authorisation application must contain the name of the medicinal product. This can be an invented name, a common name or a scientific name (where available, the INN) accompanied by its trademark or by the name of the marketing authorisation holder.
The EMEA and the AIFA approve the names of medicinal products on the basis of the EMEA Guidelines, which establish requirements for the registration of names and the use of INNs.
Hence, two distinct paths must be followed in choosing the name of a pharmaceutical product: the trademark registration process and the administrative and regulatory process. While trademark registration authorities focus on traditional trademark requirements and the risk of confusion in the public, health authorities generally focus on consumer safety and health protection. Thus, for pharmaceuticals, the protection of industrial property must be accompanied by the protection of the constitutional right to health. There is little coordination between the two bodies, which sometimes leads to inconsistent decisions.
Parallel imports and repackaging
Parallel imports occur when genuine (ie, non-counterfeit) products are imported from one country to another, usually because of the price difference.
In the European Union, parallel imports are an aspect of the free movement of goods – one of the four freedoms on which the EU internal market is based. While IP rights are basically territorial (ie, subject to national boundaries), the European Union has created a harmonised market throughout its member states. Therefore, a conflict exists between trademark rights and the free movement of goods. However, EU law states that there can be exceptions to the free movement of goods based on the “protection of industrial and commercial property”, in order to protect the interests of trademark owners.
Hence, in order to establish when a trademark right ceases, allowing for the free movement of goods, it is essential to determine when the trademark right becomes exhausted.
Article 13 of the EU Trademark Regulation (2015/2424) states as follows:
1. An EU trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Economic Area under that trade mark by the proprietor or with his consent;
2. Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialization of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.
A trademark owner has the right to put the goods on the market for the first time. In the absence of the owner’s consent, the trademark is exhausted in the whole region (ie, the European Union) following the first act of sale (ie, regional exhaustion). After that, the importer can advertise and sell the same products within the region. By contrast, when the goods come from outside the European Union, there is no international exhaustion and the importer must obtain the trademark owner’s consent.
The European Court of Justice (ECJ) has gone further to facilitate the free movement of goods, allowing the importer to repackage goods in a way that will allow them to be sold on the new market (eg, adding additional information, translating information into a different language or putting different trademarks on the packaging). Since repackaging can affect the integrity of a trademark as a badge of origin and create confusion, it is allowed only in limited circumstances.
In Bristol-Myers Squibb v Paranova A/S (C-427/93) the ECJ developed the so-called ‘BMS test’, according to which the trademark owner can oppose repackaging unless:
- the owner’s use of the trademark, having regard to the marketing system which it has adopted, will contribute to the artificial partitioning of the markets between member states;
- the repackaging cannot adversely affect the original condition of the product (eg, over-labelling is preferable);
- the trademark owner receives prior notice before the repackaged product is put on sale;
- the new packaging identifies the party which has repackaged the product; and
- the repackaging will not discredit the reputation of the trademark owner.
The above principles also apply to pharmaceutical trademarks. Indeed, the requirement not to discredit the trademark owner’s reputation is particularly onerous in the pharmaceutical sector, where consumers are especially demanding.
Parallel imports of pharmaceutical products are governed by the Ministerial Decree of August 29 1997.
Parallel-imported drugs must have marketing authorisation in the original member state and obtain authorisation from the AIFA. The importer must file an application:
- the name of the pharmaceutical product;
- its qualitative and quantitative composition;
- its therapeutic indications;
- its dosage;
- its pharmaceutical form; and
- the method of administration;
- including a summary of its characteristics; and
- illustrating the final packaging in Italian.
The Ministry of Health will issue its authorisation within 45 days of validating the application.
Further, under Legislative Decree 219/2006, a parallel importer must inform the owner of the marketing authorisation, the Ministry of Health and the AIFA at least 45 days before the launch of a parallel-imported drug.
Since parallel imports are genuine goods, authorised and bearing registered trademarks, it can be difficult to distinguish them from the originals – especially after repackaging. In order to distinguish them, attention should be paid to the indication of the importer’s name or the manufacturer’s address.
Anti-counterfeiting and enforcement
Pharmaceutical trademark infringement involves both civil and criminal liability.
From a civil law perspective, it is key that most counterfeit products enter the EU market from outside the European Union.
Italy is bound by the EU Customs Enforcement Regulation (608/2013). When Customs identifies goods that are suspected of infringing an IP right, it suspends the release of the goods or detains them, providing the rights holder with details of the actual or estimated quantity of goods and their actual or presumed nature, including images.
On request and where possible, Customs will inform the rights holder of:
- the names and addresses of the consignee, the consignor and the declarant or holder of the goods;
- the customs procedure; and
- the origin, provenance and destination of the seized goods.
Customs will give the rights holder the opportunity to inspect the seized goods. Customs may take samples of the goods.
The rights holder then has 10 working days (extendable by a further 10 days) to communicate whether the goods infringe its trademark. If the rights holder considers the goods to be counterfeit, Customs will transmit the relevant information to the public prosecutor, which will instigate criminal proceedings and commence investigations. If the rights holder does not deem the products to be counterfeit, it should communicate to Customs that the goods can be released.
The Criminal Code sets forth several examples of counterfeiting, which cover the alteration or infringement of trademarks, their introduction into the country and the domestic and international marketing of counterfeit products.
Regarding enforcement, Italy is bound by the EU Enforcement Directive (2004/48/EC). The directive was implemented in Italy by Legislative Decree 140/2006, which amended the IP Code, among others. Therefore, enforcement measures regarding pharmaceutical products do not differ from those concerning other trademarks.
Medicinal products are not common consumer goods, since their purpose is to safeguard people’s health. Hence, advertising of medicines is subject to specific rules, set out in Legislative Decree 219/2006. The reason for advertising in this area is to “promote the prescription, supply, sale or consumption of medicinal products”. Advertising is allowed only for over-the-counter (OTC) drugs, while advertising of prescription drugs to the general public is strictly prohibited.
Every drug to be advertised must obtain marketing authorisation and the ad must be authorised by the Ministry of Health. The AIFA monitors drug advertising.
Drug advertising must contain elements taken from the summary of the product characteristics and include, at a minimum:
- the name of the product or its active ingredient;
- essential information for the correct use of the product; and
- clear instructions for the purchaser to read the leaflet.
It must encourage responsible use of the medicinal product by presenting the product objectively, without enhancing its properties. It must not be misleading.
Generic substitution is regulated by the EU Human Medicines Directive (2001/83/EC), implemented by Legislative Decree 219/2006.
The decree defines a ‘generic drug’ as “a medicinal product with the same qualitative and quantitative composition of active ingredients and the same pharmaceutical form of the reference medicinal product, as well as a bioequivalence with the reference medicinal product, demonstrated by appropriate bioavailability studies”.
A generic drug is usually identified by its INN, followed by the name of the manufacturer or distributer. However, the manufacturer can decide to sell the product under a different, fanciful trademark. In any case, the packaging of each generic drug must bear a statement indicating that it is an ‘equivalent drug’.
Marketing authorisations for generic drugs are different from those for originators, since the law establishes a simplified procedure under which the applicant need not provide experimental evidence (ie, the results of pre-clinical tests and clinical trials) if it can demonstrate that the product is a generic of a medicinal product that has been authorised for at least eight years in an EU member state or across the European Union.
Sales of pharmaceutical products that require a prescription are allowed in pharmacies only. Online sales are strictly prohibited. Violation of this rule is a criminal offence. OTC products can be sold in pharmacies, in para-pharmacies and online (although not by wholesale distributors), because they are normally used for a short period and the intervention of a doctor is not required. A sticker applied to the packaging identifies OTC products to the public.
Online sales must receive regional or provincial authorisation. Once authorisation has been granted, the owner of the pharmacy must register on the list of entities authorised for distance sales of medicinal products, indicating its website. Only pharmacies or para-pharmacies which already have an offline shop or selling point can obtain this authorisation. The website must include the national identifying logo specified by the Ministry of Health on every webpage, in a visible way. This logo was first introduced by the EU Falsified Medicines Directive (2011/62/EC), as transposed into Legislative Decree 17/2014, then codified at the domestic level by the Ministry of Health in 2015. It incorporates a link to the Ministry of Health’s website, where it is possible to verify whether the online vendor is registered as authorised.
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