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Authors                                         name (ie, one that looks and/or sounds           consumers are likely to be confused into
Susan J Keri and Megan Langley Grainger         similar to another drug) is identified during    thinking that the drugs emanate from the
                                                the review, the manufacturer will be required    same source of manufacture.
                                                to change the name of the proposed product.          By contrast, Health Canada looks at the
Selection, clearance and registration           This is to prevent medical errors resulting      visual and phonetic similarities between the
                                                from the dispensation, use and/or sale of        drug names to determine whether they can
Health Canada                                   one product instead of another when two          co-exist in the marketplace from a safety
In Canada, prescription drugs can be sold       product names look and/or sound alike.           perspective, bearing in mind the likelihood
only once they have successfully completed                                                       of medication errors and the potential for
the drug review process and a notice of         Trademark registration                           harm. For example, the consequences of
compliance (NOC) and drug identification        The drug approval process in Canada is           the patient missing the pharmacological
number (DIN) have been issued. The              separate and distinct from trademark             action of the intended drug and the
Therapeutic Products Directorate of Health      registration. Registration of a trademark for    pharmacological actions and toxicities of the
Canada will assess the safety, efficacy and     a pharmaceutical product name does not           unintended drug will often be considered.
quality of a drug; if it concludes that the     ensure that the name will be accepted by             In addition to issues of confusion,
benefits outweigh the risks, the drug will be   Health Canada. Similarly, even if a product      trademarks are examined for
issued an NOC and DIN. These designations       name is approved by Health Canada, it may        descriptiveness and will be rejected if they
indicate that the drug has been officially      not be registrable as a trademark.               are considered to be the same as, or too
approved for sale in Canada.                        In the case of trademark registration,       similar to, an international non-proprietary
    Under the Canadian Food and Drug            the Trademarks Office considers whether          drug name. This issue is often raised in the
Regulations (Sections C.08.002 and              the use of similar trademarks will create a      course of opposition proceedings initiated
C.01.014.1), the name of a proposed drug        likelihood of confusion as to the source of      by a third party alleging that the mark
must also be provided in the drug               origin of the products. If two drug products     applied for is descriptive of the product.
submission. Health Canada will review all       have similar therapeutic indications and the     For example, in Johnson & Johnson v Taro
proposed drug names as part of its drug         drug names are also similar, then trademark      Pharmaceuticals Inc [(1998), 87 CPR (3d) 338
review process; if a potentially confusing      registration may be refused on the basis that    (TMOB)] the proposed mark MICROZOLE                                                             Pharmaceutical Trademarks 2010/2011 – A Global Guide   13
Bereskin & Parr LLP

   In Canada, a trademark consisting of a colour (or colours)
applied to a particular shape and size of a pharmaceutical
tablet is inherently registrable

was held to be clearly descriptive of               Parallel imports and repackaging                poor-quality medicinal ingredients or
pharmaceutical preparations containing              Pharmaceutical preparations that are to be      insufficient quantities, or can contain toxic
miconazole nitrate.                                 sold in Canada must receive prior Health        or poisonous chemicals.
                                                    Canada approval to market, without which            The magnitude of counterfeit
Non-traditional trademarks                          sales of the product will be prohibited.        pharmaceuticals in Canada remains
In Canada, a trademark consisting of a              Moreover, all such preparations must comply     relatively small in comparison to other
colour (or colours) applied to a particular         with Canadian labelling requirements as         industrialised countries, but nevertheless
shape and size of a pharmaceutical tablet is        set out in the Food and Drug Regulations,       the problem exists. However, the procedures
inherently registrable. Indeed, in 1950 the         including Section C.01.005, which requires      and remedies available to prevent the
Canadian Trademarks Office issued a                 that the inner and outer label of a drug        importation of counterfeit goods at
registration for a blue tablet trademark            display the DIN assigned for that product.      Canadian borders are inadequate.
described as “a blue tablet of spherical            Accordingly, the parallel importation of            The applicable legislation dealing with
triangular shape or shaped somewhat like            pharmaceutical preparations into Canada         border enforcement of counterfeit goods
a heart” (Registration UCA38066). The               that have not received Health Canada            in Canada is the Customs Act, IP statutes
application issued to registration                  approval and that do not bear the requisite     including the Trademarks Act and Copyright
unopposed. Since then, however, virtually           DIN may be illegal, even though the drug has    Act, and the Criminal Code.
all trademark applications for colour tablet        been approved for sale in another country.          The Customs Act permits the Canadian
or capsule marks have been opposed by                   Given the comparatively low cost of         Border Service Agency to detain goods that
third parties, primarily on the ground of           pharmaceuticals in Canada as compared to        are “prohibited, controlled or regulated” by
non-distinctiveness (ie, that the mark              many other countries (due in large part to      an act of Parliament. However, there is no
applied for cannot serve to distinguish the         substantial regulations and price caps on       act of Parliament (legislation) that
product from other products on the market).         pharmaceuticals), Canada has the potential      specifically identifies counterfeit or pirated
     While Canadian courts have consistently        to expand exports of less expensive drugs       goods as being prohibited, controlled or
held that colour applied to a pharmaceutical        into the United States and other countries.     regulated, and hence it is not illegal under
tablet or capsule is inherently registrable,        However, the Canadian Pharmacists               the Customs Act to import counterfeit goods.
there is a high evidential burden on the            Association, the Canadian Medical                   Moreover, Canada does not have a
applicant to establish distinctiveness at all       Association and Health Canada have all          trademark recordal regime at Customs or
consumer levels (including the patient,             produced position papers against the            any regime for the recordal of other IP
pharmacist and prescribing physician),              exportation of cheaper drugs from Canada        rights. As such, customs officials will not
and with respect to other pharmaceutical            into other countries, especially where the      act independently to search and seize goods
preparations available on the market,               patient has no relationship with a Canadian     that violate a trademark owner’s rights.
regardless of the specific medication and/          pharmacist and doctor or where there are            Counterfeit goods can be detained at the
or end uses of the drug. As a result, non-          drug shortages in Canada. Such dialogue         Canadian border only in one of three ways:
distinctiveness continues to be a significant       has resulted in several initiatives that        • a civil action based on a violation of
hurdle in the trademark registration process        have reduced the flow of lower-priced               trademark rights under the Trademarks
for colour tablets or capsules.                     pharmaceuticals out of Canada over                  Act;
     Canadian trademark law will also protect       recent years.                                   • a seizure request directly to Customs
the shape of a tablet or capsule. However,                                                              based on a violation of copyright under
protection can be obtained by way of a              Anti-counterfeiting and enforcement                 the Copyright Act; or
distinguishing guise registration, rather           Counterfeit pharmaceuticals include both        • a violation of criminal law under the
than ordinary trademark protection, since           brand-name and generic medicines that are           Criminal Code.
such marks are now generally considered             deliberately and fraudulently mislabelled
to be the “shaping of the wares or their            with respect to their identity and/or source.      None of these avenues, however,
containers”.                                        They can be produced with incorrect or          provides adequate remedies.

14   Pharmaceutical Trademarks 2010/2011 – A Global Guide                                                  

     The Trademarks Act enables the owner        to prove criminal intent.                          Generic substitution
of a registered trademark to apply for an            There is also very little deterrent value      Both the federal and provincial
interim court order enabling Customs to          in the Criminal Code provisions. Financial         governments regulate the pharmaceutical
seize goods which, if distributed in Canada,     penalties for forgery or passing off of a          industry in Canada. The federal government
would violate the Trademarks Act. However,       trademark include fines of up to C$10,000          has jurisdiction over IP rights of
this remedy is impractical and expensive.        and/or imprisonment for up to two years –          manufacturers and the initial approval and
A civil action under the Trademarks Act          often regarded simply as the cost of doing         labelling of prescription drugs. The
requires knowledge of the impending              business.                                          provincial governments have jurisdiction
importation or release into trade of the                                                            over, and are responsible for, the funding of
counterfeit products, which often is not         Advertising                                        all healthcare services. Each provincial drug
available. Moreover, there are no penal          Section C.01.044 of the Food and Drug              plan sets specific price and other cost-
provisions, making an order obtained             Regulations restricts consumer-related             containment guidelines (eg, drug product
under this legislation relatively toothless.     advertising for prescription drugs to the          substitution laws) with respect to the
In addition, Customs will not enforce the        mention of the name, price or quantity.            pharmaceutical coverage provided.
order without all the requisite information,     Under this regulatory framework, Health                 Drug substitution regulations have been
and the information needed to support            Canada has permitted two types of                  in place in most provinces for many years.
enforcement is very onerous. The                 prescription drug message directed to              These regulations have typically focused on
combination of a lack of enforcement by          consumers: ‘reminder ads’ and ‘help-               promoting the substitution of lower-priced
customs officials, limited border remedies       seeking messages’.                                 generic drugs for brand-name drugs,
available under the Trademarks Act and the           Reminder ads, where only the name of a         through the implementation of product
significant cost of obtaining the order has      prescription drug is mentioned but not the         and price selection rules. Product selection
resulted in very few detention orders under      disease, are interpreted as not going beyond       involves switching from a branded to a
the Trademarks Act being sought and issued.      the name, price and quantity restrictions of       generic drug, whereas price selection
     The Copyright Act contains provisions       Section C.01.044. Help-seeking messages,           involves choosing the least costly
analogous to those found in the Trademarks       where a disease state is discussed but there       generic available.
Act. However, under Canadian copyright           is no reference to a specific prescription
legislation, rights holders can make a seizure   drug product, are considered ‘information’         Online issues
request directly to Customs without resort to    and not ‘advertising’, provided that they          Canada does not prohibit the online sale
the courts or the police. Hence, a court order   meet the criteria outlined in Health               of prescription drugs; however, ordering
is not required before customs officials will    Canada’s policy entitled “The Distinction          prescription pharmaceuticals through the
act. In addition, there is no requirement that   Between Advertising and Other Activities”.         Internet is generally considered risky. In
the copyright be registered, as is the case          Depictions of easily recognisable product      August 2009 the RCMP seized over 15,000
with an order obtained under the                 packages (eg, blister packs, inhalers) that lead   counterfeit erectile dysfunction pills
Trademarks Act. Nevertheless, Customs            to the identification of the therapeutic           containing irregular dosages and
still requires very detailed information to      indication of a prescription drug in reminder      unadvertised ingredients and additives,
act, making seizure requests under the           ads are considered to exceed the consumer          all intended for online sale. Following the
Copyright Act of limited practical value.        advertising limitations described in Section       seizure, Health Canada issued a reminder
     The Criminal Code deals with penalties      C.01.044 of the Food and Drug Regulations          about the risks of purchasing drugs online:
for forgery or criminal passing off of a         and are therefore not permitted in Canada.         “If you order from these sites, you may get
trademark (fraud), and for copyright                 Advertising pre-clearance agencies             counterfeit drugs that may contain the
infringement or piracy. The Royal Canadian       review and pre-clear advertising material in       incorrect dose, the wrong ingredients,
Mounted Police Force (RCMP) may act on           order to help industry to ensure compliance        dangerous additives, or no active
information provided by a trademark holder       with the regulatory provisions of the Food         ingredients at all, which could result in
about incoming shipments of goods which          and Drugs Act and Regulations, the Natural         potentially serious health risks.” WTR
can result in a seizure through Customs. In      Health Products Regulations and the various
practice, however, they will do this only in     Health Canada guidance documents and
respect of registered trademarks and require     codes of advertising. The agencies also offer
much the same information as that required       independent mechanisms to resolve
in the case of an order issued under the         complaints on advertising for authorised
Trademarks Act – much of which is very           health products.
difficult, if not impossible, to obtain.             Canada’s research-based pharmaceutical
Moreover, it is necessary to show                companies also comply with a code of ethics
criminal intent for proceedings under            as a requirement of their membership in
the Criminal Code.                               their trade association, Rx&D. This code
     In 2005 the RCMP investigated a             includes advertising guidelines. Violations
Canadian pharmacist for purchasing and           of the code can result in fines of C$10,000
subsequently dispensing counterfeit              for a first offence during a calendar year and
Norvasc, a heart medication. The product         up to C$50,000 for each offence over the
was found to contain talc and several            third offence in a calendar year. Recidivism
patients died after ingesting the medication.    or deliberate breach of the code may result
However, the pharmacist was ultimately           in the expulsion of a member company
acquitted, as there was insufficient evidence    from the trade association.                                                                Pharmaceutical Trademarks 2010/2011 – A Global Guide   15
                                                                                                   Bereskin & Parr LLP
Biographies                                                                                        Scotia Plaza

Bereskin & Parr LLP
                                                                                                   40 King Street West 40th Floor
                                                                                                   Toronto ON M5H 3Y2, Canada
                                                                                                   Tel +1 416 364 7311
                                                                                                   Fax +1 416 361 1398

Susan J Keri                                        Megan Langley Grainger
Partner                                             Associate                    

Susan J Keri is a partner, barrister, solicitor     Megan Langley Grainger is an associate,
and registered trademark agent with                 barrister, solicitor and registered
Bereskin & Parr LLP. Her practice focuses           trademark agent with Bereskin & Parr LLP.
on trademark prosecution, enforcement               Her practice focuses on trademarks,
and opinion work, and licensing and                 related litigation, licensing, and marketing
commercial transactions involving IP                and advertising law. Prior to attending
assets. Ms Keri is a leader in her field and        law school, Ms Langley Grainger spent
often speaks on IP issues.                          several years gaining valuable industry
                                                    experience in the field of consumer
                                                    packaged goods marketing, while
                                                    managing national brands.

16   Pharmaceutical Trademarks 2010/2011 – A Global Guide                                                

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