If you return from the supermarket to find that you have purchased Bertorelli's Pasta Sauce by mistake, having meant to buy Bottocelli's Pasta Sauce, you may be irritated, but it is unlikely to be a matter of life or death. However, being given the drug Priadel, instead of Pardale, can be a matter of life or death and in at least one recorded incident it led to the death of the patient who had been prescribed the wrong drug.
Given the potentially very serious consequences which arise through confusion of pharmaceutical trade marks, what should be the approach of a trade mark registry when considering an application for a trade mark which is going to be used for a pharmaceutical preparation? The UK Registry traditionally erred on the side of caution when considering similarity between pharmaceutical marks in order to protect the public, even refusing to accept letters of consent from prior rights holders. In doing so, the UK Registry's approach was to consider all the factors which could give rise to potential confusion, including doctors? notoriously bad handwriting on the prescription, in order to adopt an approach which would best protect the public. The position which has been adopted by OHIM is radically different.
In over 50 opposition decisions concerning Class 5 trade marks, OHIM have consistently applied the standard that there is a higher threshold to be reached before confusion can be established when pharmaceutical trade marks are concerned. Their reasoning for this can be seen in the following opposition decisions.
This involved the opposition to EPIGEN based on the prior mark EPIVIR. The Opposition Division held that when dealing with marks to be used in connection with pharmaceutical products, some special considerations are applicable. Even if the average consumer does not have any specialised knowledge in the field of medicine, he is particularly cautious regarding the nature of these products, as they involve health. Moreover, it was held that the consumer would normally have the assistance of qualified professionals even for those pharmaceutical products which did not require a prescription, as they were normally sold by a chemist. This made the possibility of confusion less likely. In the opinion of the Opposition Division, the average consumer of pharmaceutical products is very attentive to slight differences between marks and is very vigilant in avoiding confusion of different pharmaceutical products. Therefore, there is a high threshold before confusion can be established in comparing these kinds of marks.
Comment: It does not appear that there was any evidence submitted to demonstrate the consumer's approach to the purchase of pharmaceutical products. The Opposition Division came to this opinion based on their own belief that people would be more careful. Given that EPIVIR is a prescription only drug, it is not clear why the Opposition Division decided to focus its attention on the consumer as if the consumer was selecting the two products off the shelf. The caution the Opposition Division was eager to attribute to the consumer when purchasing products for him or herself, is certainly less likely to extend to questioning the product which is handed to him by the chemist. It is encouraging to note that a different unit of the Opposition Division held in favour of the opponent when the prior mark in question was extremely similar to the application ie EPOGEN/EPIGEN2.
The opponent in this opposition had rather an uphill struggle to start with as they were relying on MOXON to oppose a figurative application for OXON ITALIA. Nevertheless, the Opposition Division's comments in relation to the opponent's submissions on the basis of doctors' handwriting often being difficult to read, is interesting. They held that "[T]he Office does not share the opponent's opinion that the handwriting of medical prescription may lead to confusion. In fact prescriptions are always read by pharmacists who are also a highly qualified category of professionals."
Comment: Doctors and pharmacists are highly qualified. However, doctors often do have barely legible handwriting, which in the past has led to the wrong drugs being prescribed where the drug names themselves are not at all similar. For example, LORAZEPAM was dispensed for MAGNAPEN, which led to the patient crashing his car; DAONIL was dispensed for AMOXIL, which led to irreversible brain damage. How much more likely is confusion due to badly written prescriptions where the two trade marks are similar to start with?
The opponent argued that its mark KITERAD was pronounced identically to the applicant's KYTERA mark in French. The Opposition Division considered the two marks to be similar, especially in the relevant territory of France. However the Division's comments on the health risk argument are of interest. Despite the fact that OHIM has effectively made a special case of pharmaceutical marks, requiring opposing marks to be more confusingly similar than is normally the case, due to the special circumstances involved (well trained professionals either prescribing or deemed to be on hand to advise), the Division held that it would not address the opponent?s argument that the health risks involved in the wrong use of pharmaceuticals should be taken into account.
The opponent relied on its prior Class 5 mark OSTAC to oppose the application for ONTAK in relation to "Pharmaceutical preparations for the treatment of cancer". In comparing the two marks the Opposition Division commented that:
"preparations for the treatment of cancer are likely to be bought and used with considerable care. Both the medical experts responsible for dispensing such medicines and the patients who consume them will be informed users. Given the importance which attaches to this field of medicine it is unlikely that such users will confuse "Ostak" with ONTAK. People's perceptions of goods for use in the treatment of cancer are likely to be extremely acute. It is difficult to think of any area of activity where imperfect recollection is less likely to arise."
As a result of this reasoning, it was held that the similarities between the two marks were unlikely to lead to confusion.
This is one of the two cases in this area which has proceeded to the Board of Appeal. It concerned an opposition based on the German mark AGAROL, used in relation to "laxatives", against ACAMOL for "pharmaceutical preparations for the relief of pain and fever". The Opposition Division held that although the goods were of the same nature (to alleviate pain and physical inconveniences) the specific purpose of the goods was different. The Division did recognise that both products could take the same form (eg pills) and be taken in the same manner (eg orally) and could also be purchased over the counter without the intervention of qualified professionals. On that basis they considered the goods to be similar and on the basis of the high degree of verbal and visual similarity of the marks, held that there was a likelihood of confusion and found for the opposing party.
The Applicant (Teva Pharmaceutical Industries Limited) appealed to the Board of Appeal, who reversed the decision, holding that the second and fourth letters in both the marks were clearly different, rejecting the Opposition Decision's finding that the letters "G" and "C" were similar. Further they held that the ending "-ol" was common with pharmaceutical trade marks and therefore less weight should be attached to that element when appraising the overall similarity of the marks. In relation to the similarity of goods, they thought that there was a real difference between painkillers and laxatives and that they would not be placed together on a display shelf. They accepted that it was arguable "that in relation to certain pharmaceutical products there is an exceptional need for clear differentiation between trade marks, on account of the grave consequences of consuming the wrong product. However, that consideration is not relevant to the present case, since the consequences of taking a pain-killer instead of a laxative, or vice versa, do not appear to be serious". This final comment would probably not be shared by someone with a headache who had made the error just prior to a long coach journey!
This case is under appeal to the ECJ, and it will be interesting to see whether the general approach being adopted by OHIM as regards pharmaceutical marks is approved by the Court.
Applying the same criteria as in set out in the above cases, the Opposition Division has held the following marks to be dissimilar:
Earlier Mark Opposed Application
Despite the stricter test to establish a likelihood of confusion which OHIM have applied to Class 5 marks, so far, most of the decisions seem reasonably fair and would probably have been decided had a more cautious approach to conflicting marks been adopted. The number of prior marks which have successfully opposed class 5 applications are relatively few, but include:
Earlier Mark Opposed Application
Quantor Kontor 7
Despite the fact that the decisions to date by OHIM do not appear to have led to any dangerous decisions, given their approach it may only be a matter of time until a trade mark is accepted which under the normal test of confusing similarity, would be rejected on opposition. Given that research has shown that confusing similar drug names in prescribing is one of the most common errors in the medical profession8, and given the long hours and extreme pressure which many of the medical profession have to work, is OHIM doing the medical profession any favours when it effectively ignores reality and determines that doctors are so well trained that they will not make mistakes? In addition to the Priadel/Pardale confusion referred to at the start of this article (which led to the patient's death), confusion between similar drug names has been documented, including the following examples:
Daonil was confused with De-Nol: the patient spent four days in hospital;
Inderal was mistaken for Intal: the patient died;
Trisequens was written instead of Tripharil (an oral contraceptive): the patient became pregnant;
Papaveretum was written instead of Papaverine: the patient realised the error9.
OHIM argue that the trade mark registry is not the appropriate forum to protect public safety. Certainly, it is true that the trade mark system, even in the UK has moved a long way from its "nanny-like" tendencies under the 1938 Act, and it is not as if OHIM is the only hurdle which a pharmaceutical must overcome in order to be placed on the market.
One of the reasons why it is becoming so hard to find an appropriate trade mark for a new pharmaceutical product, is the requirement of the EMEA that all pharmaceuticals authorised under the central marketing authorisation route, must use the same trade mark in all member states of the European Union. Despite the fact that there is little or no basis for this requirement in law, in fact, due to the Commission's belief that multiple trade marks for the same pharmaceutical inevitably restricts trade by acting as a restraint on parallel imports, all applications under the central procedure must have just one trade mark10.
The difficulties of finding a mark which can be cleared in all 15 member states has led to a doubling in the number of registrations which pharmaceutical companies have to register. Whereas previously, the minimum number of applications most companies would safely have made, would have been two: one as a main mark and one as a back up, the new regime has led to a practice where the minimum is usually four. This means that although there may often appear to be a conflict on the register, in the market place there may not be a problem as both marks may never be commercialised. This fact may have supported a more relaxed approach to a search conducted on relative grounds (ie a check of the registry for potentially conflicting marks) but as OHIM does not carry out such a search, this is not the issue. OHIM are taking this approach when dealing with oppositions, which generally involve a mark which is in use, and even where the mark is not currently in use, demonstrates that the proprietor of the earlier right has not abandoned the mark as they are prepared to go to the trouble of an opposition.
Of course receiving the green light from OHIM, is not an end to the matter. The mark has to be cleared by the CPMP (Committee on Proprietary Medicinal Products) who are the scientific advisory committee to the EMEA, before it can be approved for use in relation to a new pharmaceutical. The CPMP has a representative from each member state, and the names of pharmaceutical products authorised in each country will be checked. If a conflict is found, then the CPMP will refuse to clear the mark. How strict the CPMP are in determining whether there is a conflict can vary depending on the country and representative involved, but the fact that OHIM rejected an opposition based on the conflicting mark is unlikely to convince the CPMP that there is not a problem.
OHIM's approach to pharmaceutical trade marks, although on one front attractive to the pharmaceutical industry in that it gives them a greater chance of obtaining a CTM, may be storing up trouble for them in the long run. It is far better to lose your application at opposition, when there is likely to still be several years before the drug is launched, than to have your single mark rejected by the CPMP, sometimes only a matter of months before the regulatory approval procedure is completed. Not so bad if you have a back-up waiting in the wings, but otherwise it can be a tense few months for the trade mark department as they struggle to clear new marks to avoid a delay in putting the product on the market.
In conclusion, the policy that has been adopted by OHIM in setting a higher hurdle of confusion for pharmaceutical products, whilst ignoring the safety considerations, may well turn out to be something which disadvantages the pharmaceutical companies, the medical profession and the public.
1 Decision No 855/2000 of 27/04/2000 Ruling on Opposition No B 51831
2 Decision No 1094/2000 of 29/5/2000 Ruling on Opposition No B51625
3 Decision No 28/01/2000 of 28/01/2000 Ruling on Opposition No B 11140
4 Decision no 484/2000 of 15/03/2000 ruling on opposition no B116014
5 Decision No 1266/1999 of 30/11/1999 ruling on opposition no B38457
6 Decision No 387/1999 of 21/6/99 ruling on Opposition No B 12601. Board of Appeal: R 501/1999-1
7 This decision was appealed to the Board of Appeal and rejected.
8 Leape LL, Bates DW, Cullen DJ et al. Systems analysis of adverse drug events. JAMA 1995; 274: 35-43
9 Examples taken from Errors in Prescribing, Journal of the Medical Defence Union 1992, Number 3.
10 This is currently under challenge in the case of Dr Karl Thomae GmbH v The Commission T-123/00