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Increased regulation of
pharmaceutical trade marks
June 2013
Increased regulation of pharmaceutical trade marks
Attorney Advertising
02 Norton Rose Fulbright – June 2013
Increased regulation of pharmaceutical trade marks
Contents
04Australia
07
EU and UK
11 China
13USA
16Canada
Norton Rose Fulbright – June 2013 03
Increased regulation of pharmaceutical trade marks
Australia
Overview
There is a move toward increased regulation
of the intellectual property rights of
pharmaceutical brand owners in Australia,
through the proposed standardisation of
medicine packaging and labelling. These
changes, when considered in light of calls
for increased access to generic medicines,
to limit government expenditure and the
approval of ‘plain packaging’ laws in relation
to tobacco products, cause brand owners
understandable concern about the combined
impact of these changes on their IP.
Proposed increased regulation of
packaging and labelling
The Therapeutic Goods Administration
(TGA) is the regulatory authority that
regulates medicines supplied in Australia.
The TGA regulates prescription, OTC, and
complementary medicines. In 2011, the
TGA initiated a review of the regulatory
framework for packaging and labelling
of medicines and in 2012 it released
a consultation paper with eight key
recommendations. The public reason for
this review is to enhance consumer safety by
making the packaging of pharmaceuticals
more standardised and user-friendly.
The key IP related proposed changes are:
• active ingredients be listed on at least
three sides of the packaging, with equal
prominence to the brand name, that is, in
the same font size and position, with the
first letters aligned;
• a ban on look-alike and sound-alike
medicines, for example “BRAND
headache”, “BRAND backache”, “BRAND
joint pain”, with sponsors of new
medicines required to submit evidence of
risk assessment of the proposed labelling
and packaging;
• the introduction of a ‘medicine
information box’ to standardise
information formatting; and
04 Norton Rose Fulbright – June 2013
• designated clear spaces on packaging for
pharmacists to attach dispensing labels to
prescription medicines.
Response to review of packaging
and labelling - the review
continues
Over 100 submissions were filed in response
to the proposed changes.
Strong support existed for changes
regarding: active ingredient prominence;
standardised medicine information
presentation; dispensing label space; and
the creation of a committee to provide advice
to the TGA on labelling and packaging
issues.
Two polarising issues were the prominence
of active ingredient names and use of
umbrella branding and look-alike soundalike names; look-alike packaging; and
look-alike branding. Further discussions
with stakeholders, including consideration
of alternative approaches, will now occur.
The TGA has committed to refining the
initial recommendations to specifically
reflect the needs of registered prescription
and OTC medicines. It is anticipated that
consumer testing will begin in early 2013,
with a revised Therapeutic Goods Order
for medicine labelling introduced in the
middle of 2013. It is proposed that current
medicines will have a transition period of
three years, but new medicines will need
to be compliant as soon as the Therapeutic
Goods Order comes into force.
Issues for brand owners
While pharmaceutical brand owners are
accustomed to complying with existing
packaging and marketing regulation, these
changes, if accepted, will go much further.
Prior to registering a medicine, the TGA has
stated that it is looking into methods of
Increased regulation of pharmaceutical trade marks
electronically screening proposed brand
names against already existing names to
identify look-alike, sound-alike names. It is
unclear how this process will interact with
the Australian Trade Marks Register and
the role IP Australia plays in determining
the registrability of pharmaceutical brand
names.
There are a large number of pending and
registered trade marks in class 5 (covering
medicines and pharmaceuticals) on the
Australian Trade Marks Register. Brand
owners could now be faced with a proposed
brand being approved by IP Australia and
rejected by the TGA.
The changes will also require brand owners
to review the way they use their intellectual
property on medicine packaging, including
the relationship between trade mark
usage on packaging and its corresponding
use in the marketplace. For example, the
changes will curb the current industry
trend of marketing differing formulations
of the same active ingredient for specific
purposes, as it will no longer be possible to
describe medicine as “BRAND headache”,
“BRAND backache”, “BRAND joint pain.”
This will affect the ability of a number of
pharmaceutical companies to use their
series trade mark registrations and family of
marks, and will require a potentially costly
rebranding of existing products.
Move towards greater regulation
of packaging
In contrast to the proposed changes to the
TGA, IP Australia recently relaxed their
approach on pharmaceutical trade marks
which include an International NonProprietary Names (INN) stem. Previously,
any trade mark applied for including an
INN stem was objected to. Recent decisions
before the Office confirm this should now
be qualified to circumstances where the
INN stem is contained within the mark
“in a meaningful way”. For example, in
Boehringer Ingelheim International GmbH
[2012] ATMO 1171 IP Australia raised an
objection to the trade mark ZELCIVOL on
the basis that the trade mark contained the
suffix “-OL” being an INN stem indicating
alcohol or phenol derivatives. Instead of
agreeing to the proposed endorsement,
Boehringer successfully argued that the
suffix “-OL” was not “meaningful” enough to
lead to deception or confusion.
1 Boehringer Ingelheim International GmbH [2012] ATMO 117
These proposed changes through the TGA are
representative of a shift in Australia towards
plain and standardised packaging. Recent
changes to the Australian Food Standard
significantly restricts what claims can and
cannot be made about food and beverage
products.
In addition, the Tobacco Plain Packaging Act
2011 (Cth) (the Act) imposes requirements
for the size, shape and construction of
cigarette packs and cartons. This includes
the colour and finish - a matt, ‘drab dark
brown’ is now mandated. Perhaps most
importantly, the Act limits the use of
any trade marks or designs on cigarette
packaging to a brand or company name,
and a description of the product variant
(menthol, filtered, light, etc.) in a regulated
script.
The government has stated that this
approach to regulation is unique to the
tobacco industry and will not be applied to
other products. Though brand owners in
other areas which have traditionally faced
negative health claims, such as fast food,
alcohol and medicines, are understandably
nervous.
The political environment
In addition to these changes, there is current
political discourse around increased access
to generic medicines.
In the lead up to the federal election this
September, there are proposals from the
Australian Generic Medicines Industry
Association (GMiA) for the Government to
cut Pharmaceutical Benefits Scheme (PBS)
Norton Rose Fulbright – June 2013 05
Increased regulation of pharmaceutical trade marks
costs by preferencing generic brands over
their originators. If these proposals are
accepted, there could be further serious
consequences for pharmaceutical brand
owners and the value of their trade mark and
intellectual property portfolios in Australia.
What happens now?
Significantly, after consideration of the
submissions, the TGA has formed the
view that a single set of requirements for
medicines labelling is not appropriate for
all classes of medicines. Therefore, it is now
proposed that labelling requirements will
be specific to the class of medicine, divided
into:
1. prescription;
2. over the counter (non-prescription
registered); and
3. listed (complementary).
Labelling requirements will be developed in
consideration of the healthcare professional
interaction associated with each class of
medicine. That is, requirements will vary for
prescription only medicine when compared
with a product self-selected in a pharmacy or
supermarket.
Pharmaceutical brand owners should watch
this space for what develops in terms of their
freedom and ability to label, package and
market their pharmaceutical products in
Australia.
06 Norton Rose Fulbright – June 2013
Increased regulation of pharmaceutical trade marks
EU and UK
Introduction
The increased regulation of intellectual
property rights for pharmaceutical brand
owners in Australia is familiar to European
businesses. In Europe there is already
comprehensive regulation of medicinal
product names, labelling and packaging.
Pharmaceutical companies are used to
navigating both intellectual property rights
laws and regulatory requirements when
developing product brands. The Australian
adoption of plain packaging for tobacco,
however, sets a precedent for limiting a
brand owner’s trade mark use based on
product safety risks. This has potential
implications for all brand owners, including
in the European pharmaceutical sector
where safety concerns already drive the bulk
of regulation on product branding.
EU and UK Regulation
In the EU, a pharmaceutical company
can apply for an EU wide marketing
authorisation (a Community authorisation)
via the centralised procedure which is
regulated by the European Medicines Agency
(EMA)). Alternatively an application can be
made to the national regulator for a specific
Member State authorisation, for example
a UK specific authorisation is overseen by
the Medicines and Healthcare Products
Regulation Agency (MHRA)).
Product Name clearance
Under the EU centralised procedure a single
(unitary) product name is authorised2 by the
EMA. The name can be an invented one3.
2 In exceptional cases, where the proposed trade mark has been
cancelled, opposed or objected to under trade mark law in
a Member State, the European Commission may accept the
existence of more than one name for a single product (EMA’s
Guideline On The Acceptability Of Names For Human Medicinal
Products Processed Through The Centralised Procedure
(CPMP/328/98 rev 5))
3 Or it can be a common name (International Non-Proprietary Name,
INN) or scientific name accompanied by a trademark or the name
of the marketing authorisation holder)
Many applicants wish to use an invented
name so that they can also register that
name as a trade mark and take advantage of
the brand recognition and market power that
this delivers.
In those situations the applicant needs
to comply not only with trade mark laws
and registration procedures but also the
additional naming rules that apply to
pharmaceutical product names which are
controlled by the regulator.
Under the EU centralised procedure a single
(unitary) product name is authorised by the
EMA. The name can be an invented one.
Many applicants wish to use an invented
name so that they can also register that
name as a trade mark and take advantage
of the brand recognition and market power
that this delivers. In those situations the
applicant needs to comply not only with
trade mark laws and registration procedures
but also the additional naming rules that
apply to pharmaceutical product names
which are controlled by the regulator.
The overriding consideration of the regulator
for these additional naming rules is whether
the invented name could create a public
health concern or safety risk. In particular,
the invented name must not:
• be liable to cause confusion (when written
or spoken) with the name of an existing
medicinal product (which includes a
consideration of the indications, patient
populations, pharmaceutical forms, route
of administration etc);
• convey misleading therapeutic or
pharmaceutical connotations; or
• be misleading with respect to its
composition.
A medicinal product authorised under the
centralised procedure must have the same
name in all EU Member States.
Norton Rose Fulbright – June 2013 07
Increased regulation of pharmaceutical trade marks
Given the EU wide nature of the marketing
authorisation and the multiple languages
spoken in the EU member states, the
assessment of a proposed invented name
according to the criteria is therefore a
substantial task.
In order to manage the task, an applicant
is required to submit its proposed invented
name(s) prior to submitting the marketing
authorisation application4. The EMA
delegates responsibility for the naming
review task to the Name Review Group (NRG)
which in turn coordinates with the National
Competent Authorities of the EU Member
States, the European Commission and the
World Health Organisation.
Alongside the general rule (that the name
must not confuse or mislead and create
a health or safety risk), there are specific
considerations in relation to the invented
product name. Some of these regulations
echo the proposed changes in Australia in
relation to International Non-Proprietary
Names (INNs) and umbrella-branding (see
previous section), for example:
International Non-Proprietary Names
Community authorisation applicants are
advised not to derive an invented product
name from an INN and not to use INN stems
in invented names5. However, this is framed
as a preference rather than an absolute rule
and there is some flexibility (in line with the
more relaxed approach recently adopted
by IP Australia discussed in the previous
section). For example, the NRG will consider
how close the invented name is to an INN or
how and where an INN stem is included in
the product name and other such similarities
in order to, essentially, assess the risk of
confusion and the risk of harm.
Umbrella Brands
An umbrella brand is a range of products
which all use the same section of an invented
name in their respective product names.
The EMA Guideline does not expressly deal
with the concept of umbrella branding but
it does state6 that the invented name of a
fixed combination medicinal product should
be “sufficiently different” from those of the
individual active substances and/or those
of other fixed combinations containing the
same active substance(s).
The NRG also recommends applicants
not to insert the whole invented name of
the individual active substance(s) in the
proposed invented name for the fixed
combination. The rules are, however, more
relaxed in the context of non-prescription
medicines.
In the UK, the guidance is more explicit7. The
MHRA expressly “encourages” applicants
to develop new product names without
umbrella segments. However, umbrella
branding is not prohibited per se.
Rather the MHRA will assess the proposed
use of an umbrella segment against the
overarching criteria - that the product
name should not cause confusion and
the attendant potential safety or efficacy
concerns.
Concerns may arise if, for example, a new
product in the range contains different
active ingredients, is for use (or has different
safety profiles) in different populations or
has different speeds of onset. However, the
MHRA also recognises that the name is not
the only identifying feature of a product and
that pack design, labelling and the like can
help differentiate products.
Accordingly, in Europe there is a preference
for not using umbrella branding but there is
also a flexibility of approach which contrasts
with the ban proposed by the Australian
regulator on look-alike and sound-alike
medicines.
6 EMA’s Guideline On The Acceptability Of Names For Human
Medicinal Products Processed Through The Centralised Procedure
at 2.3.4 (CPMP/328/98 rev 5))
4 Up to 18 months but preferably 4-6 months before
5 In accordance with WHO World Health Assembly resolution
(WHA46.19)
08 Norton Rose Fulbright – June 2013
7 MHRA Guideline For The Naming Of Medicinal Products And Braille
Requirements For Name On Label 2009
Increased regulation of pharmaceutical trade marks
Packaging and Get-Up
A product name and related trade mark
rights is only one aspect of branding; the
related packaging and get-up is also clearly
important to pharmaceutical brand owners
as for any brand owner.
At EU level, Directive 2001/83/EC lays
down certain minimum particulars to be
included on the outer/immediate labelling
for a medicinal product. There are a few
requirements of the Directive which impact
upon the actual design of packaging
(spacing and format of the pack etc) but the
majority are concerned with the content of
the labelling and in ensuring a degree of
standardisation across the EU.
Requirements that do impact the pure
presentation include the following:
• Where Member States can impose
additional labelling requirements
(for example, the display of price
or reimbursement conditions) this
information must appear on the label in a
boxed area (the ‘blue box’) on one side of
the pack.
• The name of the medicinal product must
be displayed in Braille format on the
packaging.
• There must be a space for the prescribed
dose to be indicated (e.g. for a dispensing
label or hand-written pharmacist
instructions).
• Pack sizes should accord with the
duration of treatment and posology and
should not be too close to one another
(a different pack size for a short course
as opposed to a month course would be
acceptable whereas packs for 28 or 30
days would not be).
In line with the intent to standardise across
the EU (and so minimise confusion and risk
given the nature of the EU free market), the
label text should be identical for all packs
throughout the EU and must be (at least) in
the language(s) of the Member State where
the product is on the market. Any ‘blue box’
should ideally be located in the same place
for all Member States.
Similarly, the pack dimensions must be
identical for all the versions of packs of
that medicinal product throughout the
Community.
The fairly limited nature of the above
requirements as to pure presentation does
not mean, however, that an applicant is
otherwise given free rein. In terms of the
regulatory process, after the authorisation
has been issued, the applicant has to submit
mock-ups and specimens of the outer and
immediate packaging (together with the
package leaflet) to the EMA for review before
commercialisation of the medicinal product.
The EMA has made it clear that it will
conduct the review with the overall intention
behind the Directive (to ensure safety) in
mind.
Whilst the marketing and branding potential
of product packaging is a legitimate brandowner concern, the EMA states that the
primary purpose of labelling and packaging
is to identify the medicine and make clear
the conditions for its safe use. Accordingly,
applicants are required to “make best
use of the space available” to deliver this
information “on prime spaces on the
packaging and in the leaflet” in order to
minimise medication errors.8
The EMA considers that the pure
presentation of the information (print size,
colour, positioning of text and lay-out) is
an important factor in overall ‘readability’
of labelling, and states that this will in
particular be checked on the submitted
mock-ups and specimens.
The European Commission has also issued
specific guidance9 on labelling requirements
which goes into considerable detail, for
example:
8 The Revised Checking Process of Mock-Ups and Specimens of
outer/immediate labelling and package leaflets of human
medicinal products in the Centralised Procedure (EMA Doc. Ref.
EMEA/305821/2006)
9 Guideline On The Readability Of The Labelling And Package Leaflet
Of Medicinal Products For Human Use (ENTR/F/2/SF/jr (2009)
D/869)
Norton Rose Fulbright – June 2013 09
Increased regulation of pharmaceutical trade marks
• Labelling should at least be in font 7
points with 3mm line spacing.
• Colours should ensure a good contrast
between text and background to assure
maximum legibility (reflective packaging
should be avoided).
• Colours should be used to differentiate
(different colours to distinguish different
strengths is recommended but too
many colours is to be avoided for risk of
confusion).
Similarly, the MRHA requires that the full
name of the medicine should appear on at
least three non-opposing faces of the pack to
aid accurate identification of the drug
There is therefore, in reality, both a scrutiny
of the pure presentation of a product and a
relatively prescriptive set of rules. This is not
far removed from the proposals recently put
forward by the regulator in Australia (see
previous section).
Plain packaging for tobacco
Although not without legal challenge,
standardised plain packaging for tobacco
has been implemented in Australia since
December 2012. Plain packaging for
tobacco has also recently been considered
at EU level. The European Commission’s
draft proposal in response (published
in December 2012) does not go so far as
to impose plain packaging; however, it
does enhance the requirements on health
warnings (to 75 per cent of the pack).
Importantly, the proposal also leaves
Member States free to individually consider
plain packaging measures.
In the UK, the UK Department of Health
(DoH’s) issued a consultation on plain
packaging in April 2012. An overwhelming
number of responses were received.
However, despite expectations to the
contrary, the UK government did not include
new legal measures to introduce plain
packaging in the Queen’s speech on 8 May
2013.
10 Norton Rose Fulbright – June 2013
Although there are therefore no imminent
plans to proceed with plain packaging, the
Health Minister insists that the proposal
has not been shelved and that he will be
observing how well plain packaging works
in Australia. There will almost certainly
be legal challenges to the introduction of
plain packaging legislation in the UK if it is
eventually proposed.
In any event, there may be scope for legal
challenge on the European Commission’s
proposal. The result of the expanded health
warnings and certain other mandatory
labelling requirements reportedly leaves less
than 10 per cent of the pack available for the
tobacco companies to affix their branding.
This may constitute an interference with the
tobacco companies’ freedom to exercise their
trade mark rights.
It is not yet known if or how plain packaging
will develop in Europe and there has not
been any indication that the concept, or
the concept of expanded health warnings,
will be developed into other areas such as
the pharmaceutical sector. However, the
European approach is that the safety of
patients is paramount and branding rights
are subsidiary to the need to inform and
protect patients.
Additionally the political and economic
drivers towards generics do not sit easily
with the concept of brand power. Given
the expanded health warnings and the
possibility of plain packaging for tobacco in
Europe, developments in Australia and the
legal challenges to plain packaging will be
watched with interest, and not only by the
tobacco companies.
Increased regulation of pharmaceutical trade marks
China
Overview
As for all other trade marks, pharmaceutical
trade marks are regulated by the China Trade
Mark Law in the PRC; however, due to the
stringent regulation of pharmaceuticals
generally, trade marks used in relation
to drugs are also subject to a plethora of
pharmaceutical-specific rules issued by the
State Food and Drug Administration (SFDA)
and the Ministry of Health (MOH). These
additional rules include Measures for the
Administration of Drug Registration and
Provisions for Administration of Drug Inserts
and Labels.
The overarching requirement on
pharmaceutical trade marks is that all
pharmaceutical products sold in China
must not bear unregistered trade marks.
The regulation or specific requirements
on the use of trade marks in relation to
pharmaceuticals closely correlate to the
regulation of the use of both the generic and
a brand name for drugs.
Generic name
The “generic name” is the product’s
chemical name, or its derivative, indicating
the chemical components of the drug,
which is usually identified from the national
pharmaceutical standards, published by
SFDA, or in the Chinese Pharmacopoeia,
compiled by the Chinese Pharmacopoeia
Commission. All drugs sold in China must
bear their generic name.
Brand name
The “brand name”, “proprietary name” or
“innovator name” are all English terms used
to refer to “Shang Ping Ming” in Chinese,
which means a specific product name
created by the drug innovator. Although
the generic name and brand name are both
referred to as the drugs’ name presented on
the package inserts and labels approved
by SFDA, not all drugs are eligible to bear a
brand name. Unlike the requirement that all
drugs sold in China must bear their generic
name, a brand name may only be used on
the following kinds of drugs:
• drugs with new chemical structures or
new active ingredients and which are still
under protection period, transition period
or monitoring period; or
• a PRC patented compound drug with the
patent still in force.
The brand name for a drug must be
composed only of Chinese characters;
and since a specific brand name can
only be registered and owned by a single
pharmaceutical company, it in practice
serves as a source indicator in the same way
as a trade mark.
Registering trade marks
Although a drug brand name does not
necessarily have to be a registered trade
mark, as a matter of practice, most drug
innovators do register their drug brand
name as a trade mark in China for better
protection. Given trade marks are filed for
registration with the China Trade Mark
Office (CTMO) while the power to approve
pharmaceutical brand names is vested in
SFDA, such a bifurcated registration process
for brand names and trade marks has caused
considerable confusion/conflict. A brand
name can be registered at SFDA by company
A, while the same characters composing
the brand name are registered at CTMO as
a trade mark by company B. To address this
problem, MOH has previously issued rules
requiring that a brand name may only be
applied for registration as a trade mark after
it has been approved by SFDA as a brand
name.
Norton Rose Fulbright – June 2013 11
Increased regulation of pharmaceutical trade marks
Issues for brand owners
The MOH’s rule is not strictly enforced
in practice as CTMO does not require a
submission in support of SFDA’s approval
of the brand name in the course of the trade
mark prosecution process.
Further, from the perspective of pre-emption
doctrine, the rules issued by MOH are at
a lower level of the legal hierarchy than
the China Trade Mark Law, issued by the
National People’s
Congress, therefore cannot take precedence
over the China Trade Mark Law or impose
additional requirements on the approval
process for trade mark registrations.
In addition to such conflicts which can arise
between trade marks and brand names,
there exist other uncertainties as to the use
of a brand name/trade mark if the foregoing
statutory conditions for use of a brand
name are no longer satisfied. For example,
the question of whether a drug that goes
off patent may still use its brand name as
the drug’s name; and is there any special
requirement on the use of such brand name
in the sense of a trade mark. Currently, there
is no explicit requirement for the cessation
of a brand name if the foregoing mandatory
condition is no longer fulfilled. Some take
the view that it is a reasonable inference
that once a drug goes off patent, the drug
is no longer eligible to bear its brand name
previously approved by SFDA and only the
generic name may appear on its labels; while
others argue that the brand name is a onceand-for-all right and should remain effective
for ever after once approved by SFDA.
In the absence of explicit legal provisions,
the legality of using a brand name after such
mandatory conditions are no longer satisfied
is basically subject to SFDA’s discretion.
SFDA’s position at present is fairly flexible
and loose as long as the use of the brand
name, either in its original meaning as a
drug name or in the sense of a trade mark,
has satisfied the mandatory requirements of labelling, which, in principle, requires that
the generic name of a drug be presented
12 Norton Rose Fulbright – June 2013
on labels and inserts in a more distinct
and conspicuous manner, compared to the
presentation of a brand name or trade mark.
However, in practice, we note that some
brand-name drugs have amended their
labels after the relevant patents expired in
China, to reduce the size of their drug brand
name, making it more like a registered trade
mark rather than a brand name.
The PRC legal regime regulating the use
of pharmaceutical brand names and
trade marks is therefore currently slightly
ambiguous and uncertain. It is hoped that
such conflicts or issues will be addressed
through further formal interpretations from
SFDA. In the absence of clear regulations, it
is always advisable to consult with SFDA to
obtain at least unofficial guidance.
Increased regulation of pharmaceutical trade marks
USA
Introduction
As plain packaging requirements are not
currently being considered in the US,
this section identifies the main branding
considerations for pharmaceutical
manufacturers in the U.S. – product name
clearance, labelling and Direct to Consumer
(DTC) advertising.
Product name clearance
To market a pharmaceutical product in the
United States, a US adopted name (USAN)
– a generic non-proprietary name – must
first be obtained. Existing USAN stems that
describe the substance, its action or its use
should be used. The USAN is reviewed by the
World Health Organization (WHO) to ensure
international harmonisation.
In the United States, two government
agencies with independent statutory
authority, purposes and goals oversee the
approval of pharmaceutical trademarks: the
US Patent and Trademark Office (USPTO)
and the Food and Drug Administration
(FDA). The Lanham Act grants the USPTO
the authority to review and register federal
trademarks (15 USC §§ 1051 et seq).
USPTO considerations when assessing
an application include whether the mark
is sufficiently distinctive and if there is
a likelihood of confusion with respect to
other registered marks. The FDA’s authority
to evaluate and regulate promotional and
safety reviews of pharmaceutical brands
is rooted in the Federal Food, Drug and
Cosmetic Act (FDCA). Under the FDCA, a
drug is misbranded when “its labelling is
false or misleading in any particular” (21
USC §352(a)).
Non-mandatory USPTO registration is
awarded to the party which is first to file and
perfect filing by establishing use (or other
basis for registration).
Mandatory FDA approval depends on the
look-alike/sound-alike test and how quickly
the FDA application is processed.
Labelling
The FDA is also the regulatory agency
designated with the responsibility for
regulating the safety and effectiveness of
pharmaceutical products sold in the United
States. The FDA divides that responsibility
into two phases: preapproval (premarket)
and post approval (postmarket). Product
labelling issues are a part of the FDA’s postapproval regulation authority. Under FDA
regulations, a drug product is considered
“false and misleading” if it omits any
required statement or other information or
if it fails to provide adequate directions or
warnings.
The FDA unveiled its last major revision to
the format of prescription drug information
in 2006, (commonly called “the package
insert.”) The requirements dictate that the
prescription information accompanying
new and recently approved products must
meet certain specific graphical requirements
and include the reorganisation of critical
information.
On the enforcement side, the Food and
Drug Administration Amendments Act of
2007 (FDAAA, P.L. 110-85) expanded
and strengthened FDA’s tools regarding
advertising. As a result, the FDA can institute
label changes based on information it
gathers from mandatory industry reports
to its FDA Adverse Event Reporting System
(FAERS) (formely AERS), manufacturersubmitted postmarket studies, and voluntary
adverse event reports from clinicians and
patients. The regulations require a company
to make the label change as soon as there
is reasonable evidence - not proof - of an
association with serious hazard.
Norton Rose Fulbright – June 2013 13
Increased regulation of pharmaceutical trade marks
Direct to Consumer (DTC)
advertising
As noted above, DTC Advertising issues
are somewhat unique to the US as it is one
of only two countries which permit the
marketing of pharmaceutical products to
consumers.
The FDCA requires that manufacturers,
packers, and distributors (sponsors) who
advertise prescription human and animal
drugs, including biological products for
humans, disclose in advertisements certain
information about the advertised product’s
uses and risks. For prescription drugs and
biologics, the Act requires advertisements
to contain “information in brief summary
relating to side effects, contraindications,
and effectiveness” (21 U.S.C. 352(n)).
The resulting information disclosure is
commonly called the brief summary.
Print advertisement
requirements
The prescription drug advertising regulations
(21 CFR 202.1) distinguish between print
and broadcast advertisements. Print
advertisements must include the brief
summary, which generally contains each
of the risk concepts from the product’s
approved package labelling. A provision in
the Affordable Care Act further requires that
the agency weigh inclusion of quantitative
benefits information in print ads.
Broadcast advertisement
requirements
Advertisements broadcast through media
such as television, radio, or telephone
communications systems must disclose
the product’s major risks in either the
audio or audio and visual parts of the
presentation. This is sometimes called the
major statement. Sponsors of broadcast
advertisements are also required to present a
brief summary or, alternatively, may make
“adequate provision ... for dissemination
of the approved or permitted package
labelling in connection with the broadcast
presentation” (21 CFR 202.1(e)(1)). This
is referred to as the adequate provision
requirement. The regulations thus specify
that the major statement, together with
adequate provision for dissemination of the
product’s approved labelling, can provide
the information disclosure required for
broadcast advertisements.
The FDCA implementing regulations further
impose restrictions on the placement,
size and prominence of the proprietary
(brand) name in relation to the established
(common) name. (21 CFR 201.10(g)(1) and
202.1(b)(1)), (21 CFR 201.10(h)(1) and
202.1(c)).
Most controversially, however, the FDAAA
added section 503B to the FDCA, which
requires the FDA’s pre-dissemination review
of DTC TV ads. Section 503B gives the FDA
the authority to require sponsors of human
prescription drugs to submit “any television
advertisement for a drug” no later than 45
days before airing the ad; the FDAAA also
sets out specific requirements for FDA review
and comment on such ads.10
DTC TV advertisement review
process
On March 13, 2012, the FDA released a
draft guidance11 which outlines the specific
submission process and documentation
needed for its review of all new DTC
television advertising claims. While the FDA
has indicated the pre-dissemination review
policy excludes from pre-review TV ads
which cover products “already advertised
on TV”, many manufacturers are cautiously
submitting all ads for review in deference to
a “catch all” category in the draft guidance
which requires for review “any TV ad that is
otherwise identified by FDA as subject to the
pre-dissemination review provision.”
10 See 21 U.S.C. §§ 301-399d (2006); see generally 21 C.F.R. 202.1
(2011).
11 Draft Guidance for Industry on Direct-to-Consumer Television
Advertisement – the Food and Drug Administration Amendments
Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination
Review
14 Norton Rose Fulbright – June 2013
Increased regulation of pharmaceutical trade marks
Industry responders have taken specific
issue with the guidance requirement for the
submission of a final recorded version of
a TV ad in its entirety for FDA review prior
to dissemination, identifying the process
as both time and resource intensive and
bordering on First Amendment violation.
Significantly, however, the guidance only
applies to television ads and not ads
circulated via the internet. As advertising
dollars shift from TV toward digital
channels, the industry anxiously awaits the
FDA’s position on online advertising. In July
2012, Congress gave the FDA two years to
issue guidance “regarding the promotion,
using the Internet (including social media),
of medical products.”
Norton Rose Fulbright – June 2013 15
Increased regulation of pharmaceutical trade marks
Canada
Introduction
As plain packaging requirements for
pharmaceutical products are not currently
being considered by Health Canada, this
section identifies the main branding
considerations for pharmaceutical
manufacturers in Canada from a regulatory
perspective - product name clearance,
labelling and advertising restrictions.
Drug name clearance
Under the Food and Drug Regulations
(the “Regulations”), Health Canada has
regulatory authority over both the approval12
and on-going use13 of brand names for
pharmaceutical products. Health Canada
has recently updated its requirements
and related processes in its Draft Revised
Guidance Document for Industry – Review
of Drug Names for Look-alike Sound-alike
(LA/SA) Attributes (the “Draft Revised LA/
SA Guidance”).14 This recent consultation
document updates and significantly extends
Health Canada’s existing policy with respect
to brand name confusion for prescription
pharmaceuticals.15 Its overarching policy
objective is to ensure that the brand names
assigned to drug products are not misleading
and do not lead to safety concerns arising
from confusion between health products.
Any proposed brand name for a drug must
be included as part of a sponsor’s marketing
authorization application.
12 Food and Drug Regulations, CRC, c 870 [Regulations], ss C.01.014,
C.08.002, and C.08.004.
Health Canada may decline the name when
Health Canada believes the proposed brand
name could place users at risk, impacting the
safety and effectiveness of the drug or other
marketed drug products.16 Sponsors are
responsible for all testing required to satisfy
the requirements of the LA/SA Guidance in
support of these submissions.
The brand name review process applies
to “biologic and pharmaceutical drugs
(prescription and non-prescription) for
human use in which a brand name is
proposed (innovator and generic).17 The
definition of “brand name” under s C.01.001
of the Regulations is broad, meaning “the
name, whether or not including the name of
any manufacturer, corporation, partnership
or individual, in English or French
(a) that is assigned to the drug by its
manufacturer;
(b) under which the drug is sold or
advertised; and
(c) that is used to distinguish the drug”.18
The Current LA/SA Guidance
The current LA/SA Guidance became
effective 1 January 2006 and is based on a
list of three discouraged naming practices
and the requirement that sponsors submit
an analysis of the risks posed by a proposed
brand name.
Under the current LA/SA Guidance, brand
names should not:
13 Regulations, s C.08.006 and C.01.013.
14 Health Canada, Draft Revised Guidance Document for Industry
– Review of Drug Names for Look-alike Sound-Alike (LA/SA)
Attributes (19 February 2013), online: http://www.hc-sc.gc.ca/
dhp-mps/consultation/medeff/_2013/lasa-pspcs/lasa-pspcs-eng.
php [Draft Revised LA/SA Guidance]. See also Labelling Guidance,
infra, s 4.5.
15 Health Products and Food Branch, Health Canada, Guidance for
industry. Drug name review: look-alike sound-alike (LA/SA) health
product names (Ottawa: Minister of Public Works and Government
Services Canada, 2005), online: http://www.hc-sc.gc.ca/dhp-mps/
brgtherap/applic-demande/guides/drugs-drogues/lasa_premktnoms_semblables_precomm-eng.php [LA/SA Guidance].
16 Norton Rose Fulbright – June 2013
16 A manufacturer may instead choose to include an identifying
name or code (e.g., the proper name of the drug): Regulations, ss
C.08.002(2)(b) and C.01.014.01(2)(f).
17 Draft Revised LA/SA Guidance, s 1.4; see also LA/SA Guidance, s 3.
18 The brand name is to be distinguished from the non-proprietary
names defined in s C.01.001 of the Regulations, the “proper
name” and the “common name”, to which the Draft Revised LA/
SA Guidance does not apply. As described below, brand names
containing the non-proprietary name of the product in dosage
form, together with the manufacturer’s name or its acceptable
abbreviation, do not require a full LA/SA Assessment.
Increased regulation of pharmaceutical trade marks
1. have the same or a similar brand name
to another product, particularly if
that product has a different medicinal
ingredient, or contain a suffix,
qualification, or abbreviation (unless
a specific distinguishing function is
served);
2. be similar to a generic name for a
product containing different medicinal
ingredients; or
3. be named using a “product line
extension”, i.e. the use of an existing
brand name with a prefix or suffix to
denote the new product, particularly
where the medicinal ingredient(s) differ
from the original product.19
Health Canada conducts its review on the
basis of (1) the proposed brand name and
up to two alternates and (2) a risk analysis
of the proposed name(s). Under the current
LA/SA Guidance, the specific format of the
risk analysis to be conducted by the sponsor
is not prescribed. Instead, it provides a
non-exhaustive list of testing modalities that
correspond to those detailed in the pending
LAS/A Assessment under the Draft Revised
LA/SA Guidance, described below. Where
its initial review of marketed and proposed
drug products reveals similarities warranting
further scrutiny, Health Canada will consider
a number of contextual “contributing
factors” in determining whether the
similarity of the brand names is problematic,
as well as the potential for harm arising from
any confusion.20
The current LA/SA Guidance does not
address post-market authorization review of
brand names, although the enabling sections
of the Regulations are currently in force (see
section “Post-authorization issues”).
19 LA/SA Guidance, s 5.
20 LA/SA Guidance. s 6.
The Draft Revised LA/SA
Guidance
According to Health Canada, a need to
extend the current Draft Revised LA/SA
Guidance has been identified both internally
and from industry stakeholders. In order to
provide greater certainty for sponsors and
more objective, standardized information for
Health Canada’s review, the Draft Revised
LA/SA Guidance (published 19 February
2013) contains a significantly expanded
procedure for a sponsor’s brand name
review.
Pre-authorization submissions
Under the Draft Revised LA/SA Guidance, all
brand names must undergo an Initial Brand
Name Review. The sponsor must go further
and conduct a Look-alike Sound-alike Brand
Name Assessment (LA/SA Assessment) in
respect of biologic, prescription, and nonprescription drug submissions proposing
a new or altered brand name, except those
comprising the proper or common name in
final dosage form together with the full or
abbreviated manufacturer’s name, and all
prescription to non-prescription switches.
Non-prescription drug submissions will also
be exempt from the LA/SA Assessment where
the name is exclusively descriptive.
Initial Brand Name Review
The Initial Brand Name Review is directed
at satisfying the requirement that
pharmaceutical brand names should not be
misleading.21
The criteria consist of two banks of
questions. The first eight address indicia
related to promotional or potentially
misleading implications, abbreviation or
truncation of the proper or common name,
and existence of authorized products with an
identical brand name but different medicinal
ingredient(s).
21 Food and Drugs Act, RSC 1985, c F-27 [Act], s 9; Regulations, s
C.08.006.
Norton Rose Fulbright – June 2013 17
Increased regulation of pharmaceutical trade marks
A positive answer to any of these eight
questions will result in an automatic failure
of the proposed brand name (subject to
formal appeal) and termination of the review
process, including any subsequent LA/
SA Assessment. The subsequent questions
address further indicia that a proposed
name is confusing, including abbreviations,
modifiers, and the use of the brand name
in connection with either a discontinued
product in Canada or a different product in
a foreign jurisdiction. A positive response to
any of these questions does not result in an
automatic failure. Rather, the sponsor must
address the issue(s) in either a rationale or, if
one is conducted, a LA/SA Assessment. 22
LA/SA Assessment
The LA/SA Assessment comprises a threestage analysis:
Search. At the “Search” stage, the sponsor
must conduct a search of the Health
Canada Drug Product Database and the
Health Canada Licensed Natural Health
Products Database using a commercial
search engine running the ALINE algorithm
and submit health product names with a
similarity score of 65 per cent or greater,
as well as the five most orthographically
and five most phonetically similar names.
The sponsor must also attempt to identify
name confusion errors reported in any
other countries where the drug is marketed.
The raw data must be provided to Health
Canada, which also conducts a search of the
Drug Submission Tracking System for any
potentially confusing parallel submissions.23
Simulate. The “Simulate” stage comprises
a series of screen-based and process
simulations based on a detailed process
map charting the various actors who come
into contact with the drug and the uses they
make of it, including computers. The screenbased psycholinguistic tests assess visual,
auditory, and short-term
memory confusion in a representative
sample of the user populations from
the process map. In the medication-use
simulations, the key interactions between
actual members of the user groups are
studied to provide a qualitative assessment
of potential confusion arising from
various modes of communication. The raw
information must be submitted to Health
Canada.24
Synthesise. In the final stage, the sponsor
must synthesise the information gathered
in its searches and simulations to prepare
a Failure Mode and Effect Analysis (FMEA).
The FMEA outlines all failure modes (i.e.
things that can go wrong) associated with
the proposed name. It is conducted by a
panel of experts, who consider the process
maps, simulation data, and potentially
confusable names generated or identified
in the first two steps in order to identify
failure modes, the ease with which they can
be avoided, and the consequences if they
transpire.25
The sponsor must present Health
Canada with a final report and rationale
summarising the LA/SA Assessment, listing
all potentially confusable names identified
in the process, and justifying approval of
the proposed name. Health Canada reviews
this report and retains discretion to require
additional information or tests in order to
satisfy the requirements of the Regulations. If
it concludes that “the name is likely to cause
confusion with other health products, or is
misleading with respect to the therapeutic
effectiveness, composition or safety of the
product”, it may reject the name.26
Post-authorization issues
Health Canada retains jurisdiction to review
brand names that pose potential health risks
once the product is on the market. Under
these circumstances, Health Canada will
“work with the sponsor to address the issue”
on a “case-by-case basis”.27
22 Draft Revised LA/SA Guidance, s 2.3, Table 1.
23 Draft Revised LA/SA Guidance, s 2.4.1.
24 Draft Revised LA/SA Guidance, s 2.4.2.
25 Draft Revised LA/SA Guidance, s 2.4.3.
26 Draft Revised LA/SA Guidance, s 2.5.
18 Norton Rose Fulbright – June 2013
27 Draft Revised LA/SA Guidance, ss 1.4 and 2.5.
Increased regulation of pharmaceutical trade marks
In the event that the risk cannot be mitigated
in a sustainable fashion, Health Canada may
request a name change and, under certain
circumstances, can either suspend the
sponsor’s marketing authorization or order
the manufacturer to stop selling the drug.28
Labelling requirements
Health Canada regulates drug labelling,
including the use of brand names on
drug labels.29 A drug product need not
be marketed under a brand name, but if
a Health Canada-approved brand name
exists, it must appear on the main panel
or principal display panel of an inner or
outer label.30 Where a Health Canadaapproved brand name is used, it must (1) be
presented in a continuous and uninterrupted
fashion on the label, (2) be clearly evident
to consumers and patients, and (3) be
immediately preceded or followed by proper
or common name of the drug, printed in
type not less than half the size of the brand
name.31
Co-packaged products (i.e. two drugs or a
drug and a non-drug) must be labelled in a
manner that complies with the requirements
for each individual product, and should
not be marketed without prior consultation
with Health Canada.32 Where the full set of
requirements for an inner label cannot be
met due to the small size of the container,
the inner label does not need to include the
brand name unless the drug contains more
than one medicinal ingredient (and provided
there is a fully-compliant outer label).33
“Special containers” that are too small for
even the “small container” inner
29 Health Products and Food Branch, Health Canada, Guidance Draft
Guidance Document: Labelling of Pharmaceutical Drugs for
Human Use (Ottawa: Minister of Public Works and Government
Services Canada, 2010), online: http://www.hc-sc.gc.ca/dhp-mps/
consultation/drug-medic/draft_ebauche_label_guide-eng.php
[Labelling Guidance].
30 Regulations, s C.01.004. The “inner label” is the label affixed to
the immediate container of the drug. The “outer label” is any
label affixed to the drug packaging, other than a shipping carton:
Labelling Guidance, ss 3.2-3.3; Regulations, ss A.01.010 and
C.01.006.
31 Regulations, s C.01.004(a) and Labelling Guidance, s 3.4.
32 Labelling Guidance, s 3.6.1.
33 Labelling Guidance, s 3.6.2; Regulations, s C.01.004(3).
label requirements may contain even less
information, but must include the brand
name if one exists.34 In this case, a brand
name distinctive to a particular potency
of a drug product containing multiple
medicinal ingredients is an alternative to
the requirement that a quantitative amount
of each ingredient appear on the label.35
Proposed labels accurately representing the
final labels to be used must be submitted to
Health Canada for pre-market review and are
subject to the review and approval by Health
Canada.36
Advertising restrictions
The Act and Regulations contain several
provisions regulating drug advertising and
substantially prohibit direct-to-consumer
advertising of prescription drug products. An
advertisement is defined broadly to include
“any representation by any means whatever
for the purpose of promoting directly or
indirectly the sale or disposal of any food,
drug, cosmetic or device”.37 Pursuant to the
Act, a drug product may not be advertised
in a manner that is considered to be “false,
misleading or deceptive or is likely to create
an erroneous impression regarding its
character, value, quantity, composition,
merit or safety.”38
There are three principal restrictions for
advertising prescription drug products:
• advertising a drug product prior to the
issuance of a marketing authorization
from Health Canada is prohibited;39
• with the exception of name, price
and quantity, advertising prescription
drug products to the general public is
prohibited;40 and
• advertising a drug to the general public
for the treatment, prevention (for
prescription drugs only), or cure of
specified diseases is prohibited.41
34 Labelling Guidance, s 3.6.3.
35 Labelling Guidance, s 3.6.3.
36 Labelling Guidance, s 2.10; Regulations, s C.01.014.1(2)(m).
37 Act, s 2.
38 Act, s.9.
39 Act, s 9; Regulations, s C.08.002.
40 Regulations, s C.01.044.
41 Act, s 3; Regulations, s A.01.067.
Norton Rose Fulbright – June 2013 19
Increased regulation of pharmaceutical trade marks
In addition, depending upon the context,
intended audience, frequency and content
of message and involvement of the
manufacturer, the use of a brand name
in connection with certain activities and
representations (i.e. press releases, help
seeking announcements, continuing
medical education, etc…) may be considered
advertising. Any use of the brand name in
connection with other information should
be reviewed to determine whether it is
promotional and whether it falls within one
of the prohibited categories of advertising
under the Act and Regulations.
20 Norton Rose Fulbright – June 2013
Increased regulation of pharmaceutical trade marks
Norton Rose Fulbright – June 2013 21
Increased regulation of pharmaceutical trade marks
Contacts
If you would like further information please contact:
Austin
Washington DC
Alicia Groos
Partner
Fulbright & Jaworski LLP
Tel +1 512 536 3091
alicia.groos@nortonrosefulbright.com
Tara Vold
Counsel
Fulbright & Jaworski LLP
Tel +1 202 662 4657
tara.vold@nortonrosefulbright.com
London
Hong Kong
Jonathan Ball
Partner
Norton Rose Fulbright LLP
Tel +44 20 7444 5560
jonathan.ball@nortonrosefulbright.com
Justin Davidson
Partner
Norton Rose Fulbright Hong Kong
Tel +852 3405 2426
justin.davidson@nortonrosefulbright.com
Toronto
Sydney
Jane Caskey
Partner
Norton Rose Fulbright Canada LLP
Tel +1 416 216 1899
jane.caskey@nortonrosefulbright.com
Frances Drummond
Partner
Norton Rose Fulbright Australia
Tel +61 2 9330 8007
frances.drummond@nortonrosefulbright.com
22 Norton Rose Fulbright – June 2013
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