Trademarks in Italy are regulated by the Industrial Property Code and its regulations, in which there are no specific rules governing pharmaceutical trademarks.

Selection, clearance and registration

Trademarks in Italy are regulated by the Industrial Property Code and its regulations, in which there are no specific rules governing pharmaceutical trademarks.

According to Italian law, any sign that is capable of being represented graphically (ie, words, letters, figures, sounds, colours, shapes of goods or their packaging) may be registered as a trademark, provided that such signs are capable of distinguishing the goods or services of one enterprise from those of others. Therefore, trademarks that lack distinctive character – and in particular, those consisting only of generic names of products or descriptive indications referring to the same – may not be the subject of registration. Consequently, a pharmaceutical trademark corresponding to the name of a pharmaceutical substance or an active pharmaceutical ingredient – that is, an international non-proprietary name (INN) adopted by national and international nomenclature authorities – is unregistrable. However, it is a common and popular practice in the pharmaceutical industry in Italy to evoke the active ingredients contained in the product in the trademark: pharmaceutical trademarks often include the corresponding INN in combination with either an invented or fanciful name or the company name of the manufacturer. These trademarks have a low level of distinctiveness and thus are weak, being quite descriptive. According to Italian case law, in the case of a weak trademark, slight modifications or additions may be sufficient to avoid any risk of confusion.

The development of a trademark for a new pharmaceutical product is a complex process that involves legal, health regulatory, linguistic and marketing aspects.

The Italian Medicines Agency (AIFA) is the national authority responsible for drug regulation in Italy. The AIFA controls the sale and marketing of medicines and verifies whether a pharmaceutical product can be safely marketed under a proposed trademark, providing a further level of assurance that the chosen mark can be safely used and will not potentially contribute to medication errors as a consequence of name confusion. With regard to the acceptability of the names of medicinal products for human use, the AIFA adopts the approach of the European Medicines Agency (EMA) and its guidelines. In particular, such guidelines provide recommendations and clarifications on the requirements for the acceptability and presentation of names, including issues relating to international non-proprietary names to be used in the invented name.

The AIFA registration process overlaps with traditional trademark prosecution, with the examination of the Italian Medicines Agency being more focused on consumer safety. Occasionally a proposed name which is available from a legal perspective and has been approved by the Italian Trademark Office may be rejected by the Italian Medicines Agency and vice versa. These differing perspectives can sometimes lead to conflicting results, and the likelihood of confusion between two trademarks can depend significantly on the levels of knowledge of two sets of consumer (end users versus health professionals) and two sets of pharmaceutical product (prescription-only preparations versus over-the-counter preparations).

Parallel imports and repackaging

The parallel import of goods is one of the effects of the free movement of goods in the European Union and this principle is also included in national trademark law under the concept of exhaustion of IP rights.

According to Italian law, the exclusive rights granted in a trademark are exhausted when the products protected by that trademark are placed on the market by the holder or with its consent in Italy or an EU or European Economic Area (EEA) member state. This provision means that once a product protected by a trademark has been put on the market by the proprietor or with its consent, the sale and marketing of the product cannot be prohibited.

Italian law provides an exception to the principle of exhaustion where the parallel importer modifies or alters the condition of the goods after they have been purchased (in this case an infringement action is still possible), or where the rights holder can demonstrate a legitimate reason, such as qualitative differences between the two trademarked products.

European Court of Justice (ECJ) case law in the pharmaceutical field balances the right to use the mark to put products that it protects into circulation for the first time in the European Union, after which that right is exhausted, against the right to oppose any use of the trademark which is liable to impair the trademarked products’ guarantee of origin. In view of this policy, the rights holder cannot legitimately oppose the further marketing of a repackaged pharmaceutical product if:

  • repackaging is necessary to market the product in the country of import;
  • repackaging does not affect the original condition of the product (taking into account some chemical formulations, there can be a real risk that the product inside the package is vulnerable to tampering or to influences affecting its original condition);
  • the new packaging clearly states who repackaged the product and the name of the manufacturer;
  • the presentation of the repackaged product is not liable to damage the reputation of the trademark or its owner by detracting from the image of reliability and quality attached to such a product and the confidence it is capable of inspiring in the public concerned; and
  • the importer gives notice to the rights holder before the repackaged product is put on sale and, on request, supplies it with a specimen of the repackaged product.

These conditions are not cumulative; thus, it is sufficient for one of them not to be met to enable the rights holder to lawfully oppose further marketing of the repackaged product. It is a question of fact for the national court to decide in light of the circumstances of each case.

The role of the Italian Medicines Agency remains fundamental in the distribution of imported medicines. A drug manufactured and marketed in another EU member state is equally subject to authorisation from the Italian Medicines Agency, although the procedure for obtaining authorisation is simplified compared to the standard procedure. It primarily checks the similarity of the product manufactured abroad with the product recorded in Italy. The simplified authorisation procedure includes, among other things, a test of the suitability of the imported product’s trademark. The need to replace the original trademark with a new one to be used in Italy is evaluated on a case-by-case basis, especially if the name of the imported product implies a risk for the consumer or possible confusion with the name of other pharmaceutical products already authorised in Italy. Therefore, pharmaceuticals (both imported and domestic) with the same composition and galenic formulation can be sold and marketed with different trademarks in Italy.

According to Italian law and practice, repackaging is allowed only if necessary – for example, if it is required to comply with national rules on packaging or for health insurance rules in which the reimbursement of medical expenses is subject to certain packaging. In this case, changes to the external packaging are permitted. However, the new packaging must:

  • retain the name of the manufacturer in a clear and visible manner (“in print such that a person with normal eyesight, exercising a normal degree of attentiveness, would be in a position to understand”);
  • state that the product has been repackaged by the importer; and
  • affix the trademark chosen by the manufacturer.

A product may be equipped with an additional external or new label (re-labelling or over-stickering). Further, a product may be sold in new packaging that consists of a different number of blisters, flasks, phials or tablets from the imported product. In this case:

  • the original trademark may be affixed to the back of the packaging (reapplication of the mark);
  • the original trademark may be replaced with a different one (replacement of the mark or re-branding);
  • the original trademark may be made visible in the interior packaging; or
  • the original trademark and the importer’s mark may be co-affixed (or co-branded).

Repackaging must be necessary and should not be motivated solely by commercial interests. An example of repackaging in this context is a case in which there is significant consumer resistance to imported medicines because the imported medicine is sold and marketed in packaging which differs significantly from that already available on the national market, to which the average consumer is accustomed. In this case the repackaging of pharmaceutical products is justified and allowed in order to ensure effective free access to the relevant market, in accordance with the principle of the free movement of goods in the European Union.

Advertising

The advertising of pharmaceuticals in Italy is governed by Decree-Law 219/2006, which aims to “promote the prescription, supply, sale or consumption of medicinal products”. The Italian Medicines Agency is tasked with monitoring pharmaceutical advertising in Italy.

According to the decree-law, there is an absolute veto on the advertising of prescription medicines or medicines that contain narcotic or psychotropic substances. However, over-the-counter products (ie, those medicines that do not require a prescription) can be advertised.

The advertising of a medicinal product must encourage the “rational use of the drug”, showing it objectively and without exaggerating its beneficial properties; in any case, the ad must not be misleading. Any audio or visual ads directed towards the general public must include the instruction to seek the advice of a health professional and to read the packaging leaflet carefully.

In recent years the relevant authority has blocked certain ads for making excessive health claims (eg, the contrast of cellular ageing and improvement of the cardiovascular system, the immune system, the condition of the skin or joints), or including scientific terminology not immediately comprehensible to the average consumer in connection with dietary supplements, yoghurt supplemented with calcium and fermented milk with added phytosterols.

Generic substitution

The generic substitution of pharmaceutical drugs in Italy is governed by the Patent Law and the Health Law Regulations; in particular, the definition of an equivalent or generic substance as specified in EU Directive 2001/83/EC is included in Decree-Law 219/2006.

Generic substitution involves providing consumers with a bioequivalent to the formerly patented pharmaceutical at a lower cost (at least 20% less) than is otherwise available. The generic drug must meet the same standards of quality, efficacy and safety as the original and must have the same qualitative and quantitative composition of active substances. It is possible to produce and sell generic drugs based on one or more active substances whose patents have expired.

The production and sale of generic drugs are subject to the valuation and approval of the Italian Medicines Agency. The basic requirements for authorisation are the same as those for the original medicine, the only difference being that the manufacturers of generic drugs need not repeat and present the studies on safety and efficacy that the originator already carried out and submitted during the first drug safety examination.

The equivalent drug may be either freely available over the counter or prescribed similarly to the medicinal product from which it is derived.

As a general principle, the equivalent drug is identified by the INN of the active ingredient, followed by the name of the holder, instead of an invented or fanciful name. While this structure (INN and holder name) is preferred by the producer from a commercial point of view, Italian law provides that the manufacturer may choose to use an (invented or fanciful) trademark. However, independent of trademark use, these medicines must be identified by the statement “This is an equivalent drug” on the external packaging.

Despite broad legislation on this issue and the obligation imposed on pharmacists to offer a generic substitution at a lower cost whenever the doctor indicates that a prescription drug can be replaced, there is still some ambiguity in Italy regarding the efficacy and safety of generic substitutions. Moreover, the use of different packaging and a different name sometimes causes the average consumer to view generic substitutions as somehow inferior products.

However, according to data from the National Association of Generic Drug Producers from June 2014, the generic market is systematically growing – although this increase is mainly due to the introduction of new generic medicines to the market following the expiry of the original medicines’ patent protection.

Online issues

Italy has implemented EU Directive 2011/62/EC relating to medicinal products for human use. In Italy, the sale of pharmaceuticals is allowed only in pharmacies. The sale of medicines online is strictly prohibited. However, the sale of over-the-counter goods and medicines without prescription is possible in pharmacies, para-pharmacies and online. In recent years, the competent authority has suspended and blocked foreign websites for prescription pharmaceuticals because they exposed consumers, who were encouraged to purchase prescription drugs (mainly for sexual dysfunction) without medical supervision, to serious health risks. Moreover, the medicines shipped to Italian consumers contained instructions, cautions, contraindications and information about dosage and effects in English only. This violated the requirement that medicines sold to the public in Italy have packaging and an attached information leaflet in Italian.

Sabrina Fumagalli.

This article first appeared in World Trademark Review. For further information please visit www.worldtrademarkreview.com.