Published article on World Trademark Review (n.13 May – June 2008)

There are no specific rules governing pharmaceutical brands in Italy. This matter remains subject on the one hand to general legislation on Industrial Property (Italian Industrial Property Code); on the other hand, as to the authorization to market pharmaceutical products (AIC), to the Italian Drug Agency (AIFA) that operates on the basis of guidelines and supervision of the Ministry of Health  for monitoring and protection of public health. The present article intends to focus on Industrial Property legislation and case law.

Italian trademark law applies indifferently to signs irrespective of  the kind of products or services they are registered for. According to the Italian provisions about trademarks protection (art.12 and 13 of the Industrial Property Code), the trademarks must be different one from another and not consist in a generic indication of the product or the service that the trademarks identify or in descriptive indications referring to said products and services.Therefore, pharmaceutical trademarks corresponding to the generic name (INN, International Non-proprietary Names, stems) of the compound or combination of compounds of the drug or consisting exclusively of descriptive indications (such as the disease they are intended to be used for)  would be invalid.

However, a typical characteristic of pharmaceutical brands is the presence of a strong descriptiveness of the nature, composition or therapeutic effect of the product. In the pharmaceutical field, indeed, due to the necessity to distinguish the products of the pharmacopoeia, drugs are normally identified through trademarks which suggest more or less explicitly their compounds or function. The use of the name of the active ingredient with modest variations (prefix, suffix, insertion of single letters, etc.) is a known and frequent phenomenon. This responds to obvious needs of immediate recognition of the medicinal product and its main property.
Consequently, most of the pharmaceutical trademarks can be regarded as valid trademarks, but falling within the category indicated by the Authors and the Case Law of  the “weak” trademarks, as they are being provided with a low degree of distinctiveness of the product with the consequence that the standard of differentiation required from the competitors is lower and the judgment on the likelihood of confusion among these marks has to take into consideration less strict criteria than the ones applied for fancy trademarks. More specifically, according to Italian case law, the distinction between strong and weak trademarks influences the extent of protection of the same. In case of a weak trademark, having a less distinctive character, slight modifications or additions may be sufficient to avoid a likelihood of confusion (see for example, Court of Milan 17.4.1986, Istituto Franco Tosi v. Ausonia Farmaceutici, where the trademarks “REUMOFIL” and “REUMUCIL” have been considered not confusingly similar; Court of Appeal of Milan October 27, 2005, Chiesi Farmaceutici v. Farmila Farmaceutici Milano S.p.A., confirming Court of Milan March 23, 1992, where the trademarks “RIACEN” and “RIAVEN” have been found not confusingly similar; Court of Milan, April 29, 1996, Evapharm S.r.l. v. N.B.F. Lanes S.r.l., where the trademark “EVASEN” has been considered phonetically different from the trademark “EPASEN”. This last decision was also motivated by giving emphasis on modalities of use of trademarks, meaning the lettering and colors, and especially the composition, the modalities of consumption and function of the products being partially different. The appreciation in the concrete of the likelihood of confusion between brands, in particular for pharmaceutical trademarks, seems in line with the opinions of some Italian Authors. In this regard, however, it does not seem appropriate to exclude the likelihood of confusion by taking into account the circumstances pertaining to the modalities of use of trademarks (lettering and color) and the characteristics of the products (such as packaging or the form of the drug) that may change with time, because otherwise the right of the owner to use the trademark in a different manner from the actual one or products of the same kind but with different characteristics would be too compressed.

It is commonly stated that weak trademarks may be protected only if integrally reproduced or imitated in a close way. On the contrary, in case of trademarks represented by fancy signs, which are defined “strong”, any modifications and variations which let their conceptual identity persist have to be considered as interfering (see Court of Catania 18.2.2005, Laboratoires Pharmaceutiques Biorga v. C&RF) .

The problem of compatibility with art.13 of the Italian Industrial Property Code is predominantly settled by case law with great indulgence. The presence of distinguishing ability and the validity of an expressive word trademark is usually assessed provided that the generic or descriptive indication therein is equipped of prefixes or suffixes or has been combined with other words in an innovative way. For example, the order of the Court of Milan of February 5, 2004, Allergan v. Skelebert, stated that “The full description of the claimant’s trademark which constitutes the active ingredient, although not compromising its validity, is such as to affect its capability to be protected as an exclusive right against signs having the same inspiration, although not identical. Therefore the re-proposition of the descriptive component “Boto”, does not justify the illicit interference complained of by the applicant, otherwise there would be an unacceptable monopoly belonging to the first operator that used it” and, in the same way, the order of the Court of Milan of February 19, 2004, Dermagib v. Allergan, considered BOTOX as a valid trademark, notwithstanding it clearly refers to the drug compound vegetable botulina (clorostridium botolinum). Of course, since it presents a low degree of originality and distictiveness, it is protectable only against perfect copies. Therefore the trademark “BOTOX”  has been found not infringed by the trademark “BOTOSKIN”. Moreover, on March 28, 2002, the Court of Turin, in the case Easytech S.r.l. v. Doc Medica S.r.l. and Publisintesi S.r.l., considered valid the trademark “DOCMEDICA” registered for “equipment for motor rehabilitation”, because the term “MEDICA”, which is descriptive of the function of the product, is joint to the word “DOC”. Irrespective of the assessed descriptivity of the word MEDICA, the same decision stated that “adding the term “MEDICA” constitutes, both visually and phonetically, sufficient differentiation between brands “DOC” and “DOC MEDICA” and therefore judged the trademark DOC not infringed by DOCMEDICA. In Court of Rome, December 17, 1991, SIRC S.r.l. v. Dicofarm S.p.A. e Maggion-Winthrop S.p.A., the trademarks “DICOMAN 5” and “DIETOMAN” were judged not confusingly similar, because, on the one hand the suffix “man” evokes the main component of the products tagged (fibre-based glukomanan), but on the other hand the two marks are different in terms of literal component, sound and semantic reference (“diet” for “DIETOMAN” and the name of the producer for “DICOMAN”). Court of Milan 9.3.2000, Laboratori Guidotti v. LPB Istituto Farmaceutico-Helsinn Healthcare, stated that both “MESULID” and “NIMESULENE” shall be considered valid trademarks, but, since they are closely linked to the name of the active ingredient (nimesulide) of the pharmaceutical product, they are weak. Any risk of confusion or association between the brands has therefore been excluded, since they have been considered sufficiently dissimilar.

Differently from the above mentioned cases,  Court of Rome, November 10, 1996, Shering AG v. Shering S.p.A., stated that the weak trademark “AZELAC”, adopted for a pharmaceutical product based on azelaic acid, has been regarded as confusingly similar to the trademark “AZELAIC 10”. In this particular case it has been concluded that the trademark AZELAIC 10 slavishly and almost completely follows the mark “AZELAC”. In another case, EUCARBON has been considered violated by CARBON DIFER, both trademarks registered and used for coal plant based laxative sold in packs of equal size, texture and shape and on which the marks were written in the same color and peculiar absolutely identical typographical characters (see Court of Trieste 24.9.1999, Trenka Chemisch-pharmazeutische Fabrik v. Trenka Difer International).

The assessment of the likelihood of confusion is made after having defined the relevant customer. In the pharmaceutical field it is discussed whether the consumer to be taken into consideration in assessing the likelihood of confusion is the final customer or the medical operator (doctor or pharmacist). “Of course, a high ability to distinguish pharmaceutical trademarks can be credited to pharmacists and, in general, to the operators of the pharmaceutical field, even if operating on a purely commercial level. Said ability, nonetheless, can be taken into account only in connection with those drugs that can be sold under medical prescription and that are actually exclusively sold upon submission of medical prescription; when evidence of said last circumstance is unavailable, the average consumer identifies with the last user of the drug”. In this sense see Istituto Franco Tosi v. Ausonia Farmaceutici, quoted above; the same approach is shown in Laboratori Guidotti v. LPB Istituto Farmaceutico-Helsinn Healthcare, in Court of Milan, Dermagib v. Allergan (where it has been stated that “in the judgment of likelihood of confusion between brands the destination of the product to a category of consumers particularly qualified assumes significance”, both decisions quoted above, and in Court of Rome, 10.2-2.3.2006, prel. ord. Mediolanum Farmaceutici v. Johnson & Johnson Medical in which the relevant consumer has been identified in the physician since one of the two pharmaceutical products at issue was sold on prescription although the other one was for free sale. In the case Trenka Chemisch-pharmazeutische Fabrik v. Trenka Difer International, quoted above, the Court of Trieste stated that the relevant consumer is the final customer when both products (self medication) are freely sold without the necessity of a medical prescription.”

The Court of Justice of the European Communities on April 26, 2007, in case  C -412/05, Alcon Inc. v. Biofarma SA, stated that “when products covered by the two conflicting marks are medicines that require a prescription of the medical doctor before the sale in a pharmacy, the relevant public is constituted by both the final consumers and health professionals and particularly by doctors who prescribe the medicine and pharmacists selling the medicine prescribed.” However, this conclusion leaves some doubts, with reference to the cases in which the illness of a patient requires medical care of a phisician and his medical prescription of the suitable drug. In that cases, the consumer is not given the choice to purchase different products, differently to what happens in case of over-the-counter (OTC) products, that may be sold without a prescription, visually selected or orally asked to the pharmacist.


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