Pharmaceutical Trademarks 2018/2019 - A Global Guide - France - DLA Piper
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France
DLA Piper
Karine Disdier-Mikus
Pharmaceutical
Trademarks
2018/2019
A Global Guide
DLA PIPER AND
TRADEMARKS
Our trademark practice is one of the best in the world
DLA Piper has a unique market offering for trademark matters,
with a global trademark platform across multiple jurisdictions, and
a truly industry focus.
In Paris, we have a team of highly-skilled lawyers, formerly European
intellectual property lawyers, specialized in intellectual property
law, trademark management and prosecution, related disputes, as
well as any related matters concerning designs and domain names.
The Paris trademark team is part of DLA Piper dedicated life-science
team comprising a range of skill sets and practitioners including
lawyers, and law professors, all of whom work in close collaboration
with experts from the various DLA Piper offices across the globe.
With a focus on providing strategic, business-oriented advice, our team
members essentially become extensions of our client’s business with a
thorough understanding of their businesses and industries.
Contact us: trademark_paris@dlapiper.com
www.dlapiper.com
DLA Piper | 27 rue Laffitte 75009 Paris
T +33 (0)1 40 15 24 00 | F +33 (0)1 40 15 24 01
DLA Piper is a global law firm operating through various
separate and distinct legal entities.
Further details of these entities can be found at www.dlapiper.com
France
DLA Piper
Author
Karine Disdier-Mikus
Selection, clearance and registration it must not give substantial value to the goods.
Like all trademarks, pharmaceutical In practice, many shape marks fall within one
trademarks are subject to general trademark of the excluded categories – especially in the
rules regarding validity and use. field of pharmaceutical products, in which no
Until recently, both French and European trademark application representing the shape
law required a trademark to be capable of of a product has yet been considered valid.
graphical representation. This requirement In any case, under Article L5121-10-3 of
allowed the registration of shapes, colours the Public Health Code, the holder of IP rights
and sounds, but excluded signs such as in the shape or texture of a pharmaceutical
smells. The European trademark law reform, product cannot prohibit the use of an
comprising EU Directive 2015/2436 and the identical or similar shape for a generic
EU Trademark Regulation (2017/1001), deleted product. EU law provides no such exception.
the graphical representation requirement A pharmaceutical trademark must be
from trademark law. This change marks a distinctive. Therefore, a descriptive or generic
dramatic step forward in trademark law and mark will not be considered valid. The law
could make it easier to register smells and also specifically excludes certain marks and
other non-traditional trademarks. provides that marks that are misleading
A trademark must be capable of or contrary to public policy cannot be
distinguishing the goods or services of one considered valid.
undertaking from those of others. It serves as In addition to these absolute grounds for
a guarantee of origin for the goods or services refusal, the trademark must not infringe prior
at hand. In this regard, the shapes of products rights. The prior rights listed in Article L711-4
have been the subject of heated debate. For a of the IP Code, and supplemented by case law,
shape to be registered as a trademark, it must include:
not be determined solely by the nature or • trademarks;
function of the product in question. Further, • company names;
www.WorldTrademarkReview.com Pharmaceutical Trademarks 2018/2019 | 32
FRANCE DLA PIPER
• trade names and shop signs; considered autonomously (General Court,
• designations of origin; GlaxoSmithKline v OHIM; T-493/07, T-26/08
• copyrights; and T-27/08, September 23 2009; Paris Civil
• designs; Court, 11/16569, January 10 2014). Therefore,
• names or images or persons or personality if a trademark owner is exploiting products in
rights; one sub-category only, it may not be deemed
• the names, images or reputations of to have exploited products for the entire
territorial collectivities; and category of pharmaceutical preparations.
• domain names, provided that the website
in question: Regulatory approvals
is operational before the application; In order for a pharmaceutical trademark to
and be registered, no prior authorisation is needed
applies to the same or a similar field per se. Unlike in other countries, in France
of activity. the trademark owner is independent from
the party exploiting the trademark
The registration of a pharmaceutical and need not possess a particular quality
trademark must not create a risk of confusion (eg, be a pharmacist or be authorised to sell
with any of the prior rights listed above. the product).
The risk of confusion must be assessed in However, prior authorisation is required in
consideration of the relevant public, usually order to exploit a pharmaceutical trademark;
comprising medical professionals and in practice, this is often sought at the same
patients (European Court of Justice (ECJ), time as the trademark application is filed.
Alcon v OHMI-Biofarma, C-412/05, April 26 Authorisation can be issued by the European
2007; General Court, Ferring v OHIM – Tillotts Medicines Agency (EMA) or the Agence
Pharma (OCTASA)T‑502/12, April 9 2014). The Nationale de Sécurité du Médicament et des
risk of confusion must take into account the Produits de Santé (ANSM). A delay in the
weak distinctive character of the elements issue of this authorisation may constitute a
that comprise pharmaceutical trademarks, legitimate excuse for the trademark owner
which is due to the fact that they usually refer not exploiting the trademark within five years
either to the active components of the product (Paris Court of Appeal, 89/023824, November
or to the area of treatment (March 30 2011; 12 1991).
Court of Cassation, Commercial Chamber,
Laboratoires Brothier v Ipsen Pharma, Confusion with INNs
10-18141, April 27 2011; Paris Court of Appeal, The aim of international non-proprietary
2014/03379, June 18 2015). names (INNs) is to facilitate the identification
For example, in the field of allergy of pharmaceutical substances and active
treatments, the prefix ‘Allerg-’ is commonly pharmaceutical ingredients. Each INN is
used in France. Case law tends to take this a unique name that is globally recognised
reality into account, concentrating on the and is public property. It is also known as a
other elements while disregarding the generic name.
identical but common use of these prefixes Article R5121-2 of the Public Health Code
(Paris Court of Appeal, Allergan v Directeur de provides that a pharmaceutical trademark
l’INPI & Sté Santé Nature Distribution). must not create a risk of confusion with an
After five years, a trademark may be INN. This requirement is taken into account
subject to revocation for non-use. The by national and European trademark offices,
trademark owner must therefore prove which consider whether an applied-for
that it is exploiting the trademark for trademark is likely to be confused with an
all goods and services designated in the INN during the examination process. Should
registration. European and French case law this be the case, the trademark application
consider the category of ‘pharmaceutical will be rejected.
preparations’ to be sufficiently broad to Even if the trademark application is
divide into sub-categories, each of which is accepted by the relevant trademark office,
33 | Pharmaceutical Trademarks 2018/2019 www.WorldTrademarkReview.comDLA PIPER FRANCE
there remains the risk of cancellation by a holder to prove otherwise.
court should it identify possible confusion Regarding packaging, the EU Falsified
between the trademark and an INN (Lyon Medicines Directive (2011/62/EC) provides
Court of Appeal, Merial v Virbac, 13/08055, new control measures for preventing the
May 13 2015). distribution of falsified pharmaceutical
products. Member states have transposed
Parallel imports and repackaging the directive into national law and had
Parallel imports within the European Union to implement the new control measures
are governed by the rule of exhaustion by 2017. These include tracking measures
of rights, which provides that once a based on the serialisation of products and
trademarked product has been offered cover all pharmaceutical products subject to
for sale on the European market by the prescription. In France, the directive has been
trademark owner or with its consent, the applicable since July 1 2017 (Ordinances 2016-
product may freely circulate within the 1729 and n°2012-1427 and Decree 2012-1562).
market. There is no exception to this rule for
pharmaceutical products. Anti-counterfeiting and enforcement
However, the issue of repackaging is Trademark infringement is punishable by
important for pharmaceutical products. both civil and criminal penalties. The aim
Indeed, since the sale of such products is is to fight infringements more efficiently by
strictly regulated, packaging requirements strengthening the powers and resources
differ between countries (as exemplified of Customs.
by the issue of translation of instructions
on packaging). Customs measures
The courts have considered this issue and In its most recent reports, Customs stated
have held that, in principle, the trademark that the number of goods seized for IP
owner has a right to oppose the repackaging of infringement has increased dramatically. This
its products. However, the right of opposition trend is not apparent in the pharmaceutical
yields in certain circumstances. The following sector, however: while in 2014 Customs seized
conditions must be met, set out in Bristol twice as many pharmaceutical products
Myers Squibb (C-427/93, C-429/93 and (2,580,793) as it had in 2013 (1,354,705), the
C-436/93, July 11 1996) and further interpreted number of pharmaceutical products seized in
in Boehringer Ingelheim (C-348/04, April 2016 dropped significantly, to 189,539.
6 2007): This is partly due to the implementation
• The repackaging must be necessary to of Law 2014-315, which strengthened the
permit imports; measures available to Customs to fight IP
• The repackaging must not: infringement by aligning French law with EU
adversely affect the original condition provisions. These measures include:
of the product; or • a simplified new procedure for the
damage the reputation of the destruction of illegal products;
trademark or its owner; • a longer timeframe for the rights holder to
• The repackaging must indicate the names of: request customs intervention; and
the party by which the product has • the extension of retention measures to IP
been repackaged; and rights other than trademarks.
the manufacturer of the product; and
• Prior notice must be given to the According to French law, these measures
trademark owner. can also be taken on Customs’ own initiative,
without a request by the rights holder (Article
The importer has the burden of proving L716-8-1 of the IP Code).
compliance with all conditions. Should it fail
to do so, the rights holder will have the right Transit: new solutions
to oppose import. However, should it prove Article 11 of the EU Trademark Regulation
compliance, the onus will rest with the rights and Article 10(4) of EU Directive 2015/2436
www.WorldTrademarkReview.com Pharmaceutical Trademarks 2018/2019 | 34FRANCE DLA PIPER
provide that Customs can seize infringing similar solutions will be extended to other IP
products that are in transit and have not been rights in the future.
introduced on the European market. In order
to oppose the seizure, the holder of the goods Advertising
must prove that the rights holder has no right Advertising of pharmaceutical products that
to prevent their commercialisation in the targets the general public is strictly regulated
country of final destination. These provisions by the Public Health Code.
will increase the volume of goods seized by Only certain products can be advertised.
Customs and assist trademark owners in Several conditions must be met:
fighting infringement. • The product must not:
At present, this solution applies only to EU require a medical prescription; or
trademarks. The directive must be transposed be reimbursed by mandatory health
into French law before it can apply to French insurance schemes; and
trademarks. ECJ case law will be significantly • The marketing authorisation must not
modified as a result and it is expected that include any prohibition against advertising
to the general public due to public health
risks (eg, where the product is not suitable
without medical intervention).
Ads for pharmaceutical products may not:
• state that:
medical consultation is unnecessary;
the product is guaranteed to have the
relevant effects, can be used without
side effects or is better than another
treatment; or
good health might be improved by use
or adversely affected by non-use;
• liken the product to food products or
Karine Disdier-Mikus cosmetics;
Partner • play on fear in a major sense or mislead in
karine.disdier.mikus@dlapiper.com any way; or
• target children only.
Karine Disdier-Mikus is a partner in DLA
Piper’s IP and technology department in Paris. Regarding products that are subject to
She heads the IP practice. She has a master’s medical prescription, advertising may be
degree from a French university and an LLM targeted at health professionals only.
from McGill University, Canada. She is a former In recent years, comparative advertising
European trademark and design attorney has become an issue. Comparative advertising
and has more than 15 years’ experience is permitted under French law, provided
in trademark and design prosecution and that it objectively compares characteristics
litigation, brand protection, anti-counterfeiting that are essential, relevant, verifiable and
and brand enforcement, especially in the representative of the relevant goods or
pharmaceutical and life sciences sectors. She services. Comparative advertising can
has also developed significant expertise in mention a trademark in order to identify the
domains, Uniform Domain Name Dispute products with which the comparison is being
Resolution Policy proceedings and new generic made. Given the above limits imposed on the
top-level domains. She is an active member of advertising of pharmaceuticals, comparative
the International Trademark Association and advertising in this field is minimal.
the Association of Trademark and Design Law The courts considered whether it
Practitioners. is possible to mention the name of a
trademarked pharmaceutical product when
35 | Pharmaceutical Trademarks 2018/2019 www.WorldTrademarkReview.comDLA PIPER FRANCE
advertising the generic version of that • The website must be managed by a
product. The Supreme Court held that the pharmacist;
presentation of a product as the generic • The pharmacist must obtain authorisation
version of a trademarked product from the Regional Health Agency; and
is considered legitimate comparative • The pharmacist must inform the Order of
advertising (Sandiz v Beecham Group, Pharmacists of his or her intention to sell
09-70.722, May 24 2011). pharmaceutical products online.
Generic substitution Non-compliance with these conditions
Article L5125-23 of the Public Health Code will lead to penalties ranging from temporary
provides that pharmacists can substitute a closure of the website to an administrative
medically prescribed trademarked product fine. A list of authorised websites can be
with a generic version that fulfils the found on the Order of Pharmacists’ website.
relevant conditions (eg, bioequivalence in The general rules for advertising also
accordance with Article L5121-1 of the Public apply to online advertising.
Health Code). However, the substitution
of a trademarked product with another Domain names
trademarked product is prohibited and A pharmaceutical trademark can be
punishable by three years’ imprisonment registered as a domain name. However,
and a €300,000 fine (Article L716-10 of the IP the ANSM sets out specific conditions
Code). This was upheld by the Supreme Court enforcing compliance of the corresponding
in a case in which a pharmaceutical company website with the rules on advertising. For
presented its product as generic even though instance, the ANSM explicitly provides
it was an original trademarked product; the that if a website corresponds to a domain
substitution was therefore unlawful (Mylan v name which includes a pharmaceutical
IPSEN Pharma, 11-20.725, October 9 2012). trademark designating a medicine or a
medical device for which advertising to the
Online issues general public is prohibited, it must have a
E-pharmacies secure home page. WTR
In principle, pharmaceutical products can be
sold in pharmacies only (Article L4211-1 of the
Public Health Code). This provision is strictly
enforced and any violation is considered a
criminal offence. However, in order to take
into account the development of online sales
of goods, the EU Falsified Medicines Directive
(2011/62/EC), transposed into French law,
provides that owners of pharmacies can sell
certain over-the-counter products online.
Prescription-only products cannot be DLA Piper
sold online. 27 rue Laffitte
Online sales of pharmaceutical products Paris 75009
are strictly regulated and are subject to the France
following conditions: Tel +33 1 40 15 24 00
• There must be a physical pharmacy behind Fax +33 1 40 15 24 01
the website; Web www.dlapiper.com
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