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23 October 2017
In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. This update examines the existing issues, as well as the important changes and new opportunities that will be introduced by the amendments to the trademark law that are expected to come into force in 2019.
If drug names are to be registered as trademarks, the trademarks must comply with the same requirements imposed by the Trademarks Act for all other goods. Among other requirements, in order to be registered as a trademark the proposed mark must not be confusingly similar to a mark owned by another party. In other words, consumers should not mistakenly believe that the source of two drugs is the same.
Separate from the trademark registration process, drug name approval for prescription pharmaceuticals is required from Health Canada. Notably, approval of a name by the Trademarks Office does not guarantee approval by Health Canada and vice versa.
Prescription drug names must satisfy a number of criteria to gain approval from Health Canada. One requirement is the need to avoid a situation where relevant members of the public are likely to mistake one drug name for another. Another consideration is how the name will appear in handwriting. If a handwritten rendering of the mark (eg, by a doctor) could be mistaken for another drug name, Health Canada may reject the mark.
Declaration of use requirement
If a Canadian trademark application is based on proposed use, it cannot proceed to registration until a declaration of use (typically confirming sales in Canada) has been filed. However, since prescription drugs cannot be sold in Canada without approval from Health Canada, which can take many years, owners of trademark applications for drug names must often request extensions for several years before they can file a declaration of use.
Challenges when registering shape and colour of tablets and some medical devices
It is possible to register colour marks as applied to goods with a particular shape. For most industries, the Trademarks Office and the Canadian courts have protected such marks without imposing significant obstacles.
However, this is not the case for shape and colour marks for pharmaceutical tablets and pills, among other things. In some decisions, the Federal Court has ruled that despite notable sales, advertising and reputation, the shape and colour of certain tablets is not perceived as an indicator of source.
An example is the blue Viagra diamond-shaped tablet shown in Pfizer's (now refused) Canadian Trademark Application 1,244,118 (Figure 1).
One of the Federal Court's main concerns in that case was that the product as sold included additional features, such as the words 'Viagra' and 'Pfizer' (Figure 2).
The court felt that these additional features, combined with the tablet's shape and colour, were necessary to act as an indicator of source. In other words, the combination of shape and colour alone was insufficient to act as an indicator of source.
Similar challenges have arisen for pharmaceutical companies seeking to register or enforce trademark rights directed to the shape and colour of certain medical devices, such as the unusually shaped two-tone purple Advair inhaler shown in Glaxo's (now expunged) Canadian Trademark Registration TMA687,313 (Figure 3).
Similar to the Viagra case, one of the court's complaints was that, despite the unusual shape and colour combination, the Advair product as sold included additional features, such as the word 'ADVAIR' (Figure 4).
The Federal Court held that despite notable sales, advertising and reputation, the evidence (in the court's view) did not establish that the shape and colour combination of the two-tone purple Advair inhaler was perceived as an indicator of source.
While it may still be possible to register and enforce such marks, pharmaceutical companies must understand that evidence that would be sufficient to establish distinctiveness in any other industry may not be sufficient in these cases. More specifically, whereas evidence of a significant reputation is typically sufficient for any other industry, such evidence alone may not be sufficient in the case of the shape and colour of pharmaceuticals (or related products). To register and enforce such marks, it may also be necessary to establish trademark significance – namely, that patients, doctors and pharmacists recognise the mark (and the mark alone) as an indicator of source.
Description of pharmaceuticals in trademark applications
The Trademarks Act requires that all goods in a trademark application be described in both "specific" and "ordinary commercial terms". While the Trademarks Office is not particularly strict about enforcing the ordinary commercial terms requirement, it does strictly enforce the specific requirement. This means that for a trademark application listing a pharmaceutical, the Trademarks Office typically requires:
The requirement for detail in Canadian pharmaceutical trademark specifications is possibly the strictest of any trademark system worldwide.
An issue closely related to trademarks is that pharmaceutical companies face strict sui generis limitations under the Food and Drug Regulations with regard to how pharmaceuticals may be advertised in Canada.
As noted above, Canadian trademark law will (or is at least expected to) change in 2019. While these changes will not affect only the pharmaceutical industry, a number of changes will have important effects on companies seeking to protect pharmaceutical marks in Canada.
Elimination of need to file declaration of use
Once the new law is in force, it will no longer be necessary to file a declaration of use. When the law changes, any pending applications being delayed because of the need to file a declaration of use will proceed directly to registration on payment of the registration fee. In other words, under the new law, use will no longer be a requirement to obtain a trademark registration.
That said, use will notably remain a fundamental attribute of Canadian trademark law. For example, once a trademark registration is at least three years old, anyone can initiate a Section 45 (summary, non-use cancellation) proceeding, requiring the trademark owner to prove use (typically sales) in Canada within the preceding three years. If there is no evidence of use within the preceding three years, the registration will be saved only on the establishment of 'special circumstances', which are typically circumstances beyond the owner's control. For example, the need to await regulatory approval from Health Canada would likely be considered a special circumstance sufficient to justify maintaining a registration despite a lack of sales within the preceding three years.
New non-traditional marks
At present, it is possible to register only a limited range of 'non-traditional marks', such as shapes, colours as applied to a particular shape and sounds.
When the law changes in 2019, it will, at least in theory, be possible to register any non-traditional mark, such as scents, textures and colours per se. However, it will be necessary to establish 'distinctiveness' (essentially, a secondary meaning) as of the date of the trademark application.
At present, it is possible to register sound marks without the need to establish distinctiveness. As noted above, once the law changes in 2019, it will be necessary to establish distinctiveness as of the Canadian filing date. Therefore, it is significantly easier to register sound marks now than it will be under the new law. For this reason, there is a tremendous advantage to seeking registration of sound marks now, before the new law comes into force.
For further information on this topic please contact Philip Lapin at Smart & Biggar/Fetherstonhaugh by telephone (+1 613 232 2486) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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