Wednesday, 4 April 2012

RSA: landmark pharma judgement - trade marks

Zemax hypertension drug
The South African Supreme Court of Appeal has handed down an important judgement for pharma trade marks. The case of Adcock Ingram v Cipla Medpro reconsidered the notion that pharmaceuticals sold on prescription are less likely to be confused because they are dispensed by trained professionals in regulated circumstances. In doing so the Court questioned the relevance of findings in a 1983 leading case, also involving Adcock, in contemporary society.

The marks at issue are Adock's ZETOMAX (earlier mark) and Cipla's ZEMAX. The goods in question are those covered by their respective registrations in class 5 of the Nice Classification (pharmaceuticals) which are, in part, identical to each other. The Court was called on to decide whether ZEMAX was wrongly remaining on the register because it offended Section 10(14) of the Trade Marks Act (ie so similar to an earlier existing registration ie ZETOMAX that confusion is likely).* The earlier decision had held that there was no likelihood of confusion primarily because they are sold by trained professionals; pharmacists and medical practitioners on prescription, following findings in the 1983 case.

The appeal court first had to correct the earlier court on the proper test to be applied. The earlier court had erred in applying a test that was confined to considering goods in respect of which the marks were used (as opposed to registered) under Section 10(14). The Court had therefore failed to appreciate that not all class 5 goods were sold on prescription. A basic mistake, it must be said.
Once the test had been cleared up by Judge Malan (in the process approving Sabel V Puma's global appreciation test and the oft quoted South Africa judgements of Plascon Evans and Cowbell) he went about analysing whether confusion was likely in circumstances where the notional consumer in a specialist market for prescription drugs was argued to be less likely to be confused - Cipla had all but conceded that a likelihood of confusion could occur for all other goods.

The Court gave short shrift to arguments by Cipla that both the Trade Mark Registry and the Medical Control Council had approved the name ZEMAX, accepting though the Trade Mark Registry's decision held some weight. The Court is "at large to exercise its own discretion"

Both ZEMAX and ZETOMAX are Schedule 3 drugs that, generally, can only be prescribed by a medical practitioner and dispensed with by a pharmacist. Accepting that conditions for the sale of prescription drugs significantly reduce the likelihood of confusion stated in the earlier Adcock case the judge then held that the remark in the same case that it is the"doctor's responsibility as to what a patient should have, and his alone, has a sense of unreality in modern circumstances [Afro Leo's emphasis] where patients are expected to play an active role in relation to their own health. It reduced the patient to a passive bystander.." 

Further, that:

Such an approach is hardly reconcilable with s 8 of the National Health Act 61 of 2003 which gives the patient the right to participate ‘in any decision affecting his or her personal health and treatment’. Patients often discuss their medication among themselves and with their doctors. They exchange information on which product they find most efficacious. This information may then be discussed with their doctors or pharmacists when the issue of substituting a medicine for a generic or the more expensive innovator product is raised. Often they provide the names of their medicines, particularly chronic medication, to the medical practitioners treating them. They discuss the advantages and disadvantages with them. They consider different options. In a case of emergency a Schedule 3 medicine may be sold, for use during a period not exceeding 30 days in accordance with the original prescription, if the pharmacist is ‘satisfied that an authorised prescriber initiated the therapy’13 – clearly on information provided by the patient. Whatever the position may have been in 1983, the patient is no longer a passive bystander when treated and receiving prescribed medication.

[25] The provisions of s 22F of the Medicines and Related Substances Act widen the scope of the enquiry to be made. Section 22F deals with generic substitution or interchangeable multi-source medicines, and, it was submitted, envisages a situation where the patient forms part of the decision-making process thereby increasing the likelihood of deception or confusion. [see explanation in para 27]
Then, after analysing a similar position in Canada, the judge held that:

The question whether ZEMAX is ‘likely to deceive or cause confusion’ as s 10(14) requires must be answered with reference, not to the specialised market of prescription medication only, but with reference to the patient as well. The patient is the ultimate consumer whose wishes may not be disregarded and who has a right to participate in any decision concerning his health and treatment. It may well be that there is little likelihood of the medical practitioner or pharmacist being deceived or confused but the enquiry does not end there.

Having dealt with the notional consumer the marks ZETOMAX and ZEMAX were compared and held to be confusingly similar. For an explanation see paras 31-32. 

Afro Leo agrees with this judgement:
  • The reality is that more and more people do check and question their diagnosis and prescription on the Internet for instance - in fact, a common complaint from doctors.
  • Doctors too often provide (or should) options to their patients eg cancer treatments may have different side effects requiring the patient to become more involved in the decision making process even if they do not want to.
  • There are reports of an increase in abuse of prescribed drugs by pharmacists meaning that scheduled drugs are sold without a prescription (see scandal here, for instance) requiring caution.
  • The risk of the consequences of confusion is heightened by the increasing dangers and prevalence of counterfeit drugs in Africa (see numerous reports on this blog)
  • Further, the possibility of including the "initial interest confusion" doctrine into the infringement tests may well mean that it is irrelevant that the confused patient is then corrected by say, a pharmacist.
* Although S10(12) based on actual use of the ZETOMAX trade mark was pleaded, the case centred on S10(14)

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