No Remedy Yet for Prescription Drug Confusion

When weighing marks for confusing similarity, it is the average consumer who counts. Just who is the average consumer is not always clear, however, and in the realm of pharmaceuticals such uncertainty can have serious consequences. The Advocate-General recently considered this matter on appeal from OHIM in Alcon Inc. v. OHIM (Case C-412/05 P). At issue were questions of who is the average consumer of prescription versus over-the-counter drugs, and how conflicts between drug marks of these different types should be resolved.

 

Biofarma’s Opposition

The dispute arose from an opposition before OHIM.

Alcon had applied to register TRAVATAN as a CTM for “ophthalmic pharmaceutical preparations” in Class 5. Biofarma S.A. opposed on the basis of an earlier Italian registration for TRIVASTAN, in respect of which it proved genuine use for a prescription-only “peripheral vasodilator intended to treat peripheral and cerebral vascular disturbance and vascular disorders of the eye and ear.”

The opponent succeeded before the Opposition Division, Board of Appeal and Court of First Instance, on the grounds that TRAVATAN and TRIVASTAN were confusingly similar in respect of the goods claimed. Alcon, the applicant, appealed to the ECJ.

 

Alcon’s Arguments

On its final appeal, Alcon argued that OHIM and the CFI had incorrectly compared the marks without proper regard to the nature of the average consumer. Alcon contended that the average consumers of the goods at issue were doctors and other specialists, since the pharmaceuticals in question were available on prescription only.

Alcon asserted that such specialist consumers would be more experienced and cautious in identifying products. That less experienced end users might not exercise the same caution or might otherwise confuse the brands was irrelevant since the goods were not marketed directly to them and could not be purchased without a prescription from a specialist who was unlikely to confuse the marks.

Biofarma argued, on the contrary, that end users were still relevant because of the potential for confusion in the medicine cabinet at home.

 

The Advocate General’s Prescription

In his opinion handed down in late October, the Advocate General favoured Alcon’s submissions as appropriate to cases where the comparison was between two marks for prescription-only drugs. In his view, the relevant consumers of such goods were in fact prescribing healthcare professionals, since prescription-only drugs were marketed to, and could only be prescribed by, them. Indeed, Community legislation prohibited the advertising of prescription-only drugs to the general public under the first indent of Article 88 (1) of Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.

An end-user seeking to buy a prescription-only drug would only succeed if he had a prescription, which could only be written by a specialist healthcare professional. Consequently, an end-user was unlikely to be confused between two prescription-only drugs at the point of sale. Other, later points at which end users might be less attentive, for example when sorting through medicines at home, were regarded as of secondary importance since trade mark law was concerned with confusion prior to and at the point of sale, not after.

As the nature of the average consumer might differ depending on the nature of the drugs claimed, therefore, the CFI’s decision was deficient in that it contained inadequate reasoning on its identification of the average consumer in that case. Consequently, the Advocate General found that the CFI had erred in failing to deal with how the relevant public was to be defined for the purposes of determining likelihood of confusion.

This partial support must have given heart to Alcon, who had made efforts to further distinguish the marks through a specification restriction before the Board of Appeal. In particular, Alcon had expressed its willingness to restrict its CTM to “ophthalmic pharmaceuticals for the treatment of glaucoma.” However, Alcon’s overture was not accompanied or followed by unambiguous wording making it clear that a restriction was actually entered. The Board of Appeal did not seek clarification, and the specification was regarded as not having been restricted. The Advocate General observed that it would have been helpful had OHIM been more proactive in discerning the applicant’s intent, but it considered that OHIM was under no obligation to do so. The burden of getting restrictions right was firmly on the party entering them.

In any event, however, Alcon’s restriction would not have gone far enough. Biofarma’s earlier mark was held to be registered for a specific type of drug which the evidence showed had been available on prescription only. However, neither of Alcon’s specifications included any restriction to prescription-only drugs. Hence, the average consumer in this case was not just the healthcare professional, but also the end user who was able to buy over-the-counter drugs directly. The latter was less experienced than healthcare professionals in discerning between similar marks and the consequences of mistakes at the point of sale could have a bearing on the health of the end user.

The Advocate-General recommended that the ECJ find in favour of the opponent and uphold the earlier findings of likelihood of confusion.

 

Comment

This opinion is uncontroversial on the facts. TRAVATAN and TRIVASTAN are probably confusingly similar to most observers, and the ECJ may be expected to follow the Advocate General’s advice.

A cautious approach to likelihood of confusion for pharmaceuticals indeed is appropriate given the potential for serious consequences where confusion occurs.

Although the result in the case seems right, however, the Advocate General’s remarks appear to signal a less cautious approach in the case of prescription-only drugs. Whilst the point of sale may be the relevant time for considering likelihood of confusion, the nature of pharmaceuticals and their availability to end users arguably require broader considerations.

End users are traditionally given prescriptions by healthcare professionals and are not normally targeted by prescription-only drug advertising in Europe. However, more and more patients are learning of prescription-only drugs from advertising internationally and the Internet, and a drug that is prescription-only in one market may be sold over the counter in another. Patients also more commonly seek medicines through non-traditional routes such as Internet-based services, and these cannot always be relied upon to offer the same caution and expertise in distinguishing similar brand names that doctors may have.

It is not hard to see how end users can be confused at the point of sale even with prescription-only medicines, with potentially serious consequences. Hence, there is a strong argument that where pharmaceuticals are concerned, the average consumer should always include the end user, even if it also includes the specialist.

Meanwhile, CTM applicants would do well to take to heart the lessons in this case on the careful drafting of specifications. Given the Advocate-General’s views on the average consumer, a specification that distinguished between prescription-only drugs and over-the-counter drugs might have won Alcon some protection because it would have allowed OHIM to carve out the registrable goods from the non-registrable ones under Article 43 (5) of the CTM Regulation.

For Alcon, the ECJ’s expected decision may be a bitter pill to swallow. For others, its guidance on restrictions is perhaps the spoonful of sugar that helps the medicine go down (in the most delightful way, for Biofarma at least).