Snapshot: the essentials of pharmaceutical trademarks in France

Overview

Legislation

What is the primary law governing trademarks in your jurisdiction?

The Intellectual Property Code (IPC).

Agencies

Which agency is responsible for the grant and registration of pharmaceutical trademarks?

The National Industrial Property Institute (INPI).

Regulators

What are the relevant national and international regulatory bodies and requirements that need to be considered when clearing a pharmaceutical trademark?

The Public Health Code imposes specific rules on applicants and holders of marketing authorisations with regard to names. The name of a medicinal product may be either a fancy name or a common or scientific name accompanied by a brand name or the name of the manufacturer; the fancy name may not be confused with the common name of the medicinal product (Public Health Code, article R. 5121-2). However, in practice, certain trademarks are often evocative of common scientific names or common names (for example, the trademark ‘Hexomedin’ for the common name ‘hexamidine’).

The provisions of article R. 5121-3 of the Public Health Code also require that the fancy name of a medicinal product be chosen in such a way as to avoid any confusion with other medicinal products and not to mislead as to the quality or properties of the specialty. Consequently, it is up to the Director-General of the French Medicines Agency (ANSM), upon receipt of a request to modify the name of a medicinal product, to reject this request on the grounds that the proposed new name presents strong orthographic and phonetic similarities with another medicinal product having different therapeutic indications and, moreover, registered on the list of poisonous substances (CE, 30 December 2003, No. 256294: JurisData No. 2003-066348).

Non-traditional trademarks

What non-traditional trademarks are available in your jurisdiction and how are they registered?

Non-traditional trademarks including sound, colour and shape marks as well as motions, multimedia, holograms and patterns are available in France.

The erstwhile requirement for graphical representation of trademarks was removed by Directive (UE) 2015/2436 of 16 December 2015. Accordingly, as of 11 December 2019, the IPC defines a trademark solely with reference to its indication of origin function. 

However, a trademark must still be capable of being represented precisely and clearly on the national trademark register. The INPI advises that this condition is technically difficult to satisfy in the case of olfactory and taste marks, thus preventing at present their registration as trademarks.

Sound, motion and multimedia marks are registered based on the sound, video or multimedia files provided at the time of filing, if considered admissible.

Cannabis-derived products

Does your jurisdiction allow the registration of cannabis-derived products?

In accordance with the provisions of the Single Convention on Narcotic Drugs of 1961, and the amended decree of 22 February 1990 establishing the list of substances classified as narcotics, cannabis is classified as a narcotic in France. Under French regulations, all operations involving cannabis are prohibited, including its production, possession, import, export, and use. However, article 43 of Act No. 2019-1446 of 24 December 2019 on Social Security Financing for 2020 authorised the experimentation of the medical use of cannabis under the supervision of ANSM. This experimentation has started on 31 March 2021 for two years. A decree in Council of State of 17 February 2022 No. 2022-194 was also adopted with a view to allowing the cultivation of medical cannabis in France and the production of medicinal products containing it. Subsequent decrees are expected to fully authorize it.

There are no restrictions per se on registering trademarks for cannabis-derived products. 

INPI is no longer systematically refusing registration to trademarks covering cannabis-derivative products, or containing the words ‘cannabis’ or a visual representation of cannabis. It may however request that the cannabis-derivative products claimed be limited to medical use in class 5. However, the Paris Court of Appeal found the mark CANNABIA designating foodstuffs and drinks contrary to public policy on the grounds that it presented cannabis in a favourable light and conveyed the impression that it was no longer prohibited (Paris Court of Appeal, 4th chamber, 18 October 2000). 

Also, in a case where the Director of INPI rejected an application for registration consisting of the juxtaposition of the term ‘hemp’ and the graphic representation of a hemp leaf for sparkling, non-alcoholic drinks made from hemp, the appeal against this decision was dismissed pursuant to article L. 711-3(b) of the IPC. Although the sale of the product did not constitute a criminal offence in this case (the hemp content in the drink was very low), the sign-in question, applied to a food product, was likely to give rise to the belief in the mind of the moderately well-informed consumer that the consumption of hemp as a psychotropic substance would no longer be prohibited in France. It was the protection of public order that justified the refusal of protection (CA Rennes, 12 March 2002: PIBD 2002, No. 743, III, p. 247).

Parallel imports

Regulation

What are the rules governing parallel imports of pharmaceutical goods?

Parallel imports within the EU are governed by the rule of exhaustion of rights. Once a trademarked product has been offered for sale on the European market by the trademark owner or with its consent, the product may freely circulate within the market. There is no exception to this rule for pharmaceutical products.

However, the issue of repackaging is important for pharmaceutical products since the sale of such products is strictly regulated, for example in relation to the translation of instructions on packaging. The courts have held that, in principle, the trademark owner has a right to oppose the repackaging of its products. However, the right of opposition is tempered in certain circumstances:

• the repackaging must be necessary to permit imports; 
• the repackaging must not: 

• • adversely affect the original condition of the product; or
  • damage the reputation of the trademark or its owner; 

• the repackaging must indicate the names of: 

• • the entity that has repackaged the product; and 
  • the manufacturer of the product; and

• prior notice must be given to the trademark owner. 

 

Regarding packaging, the EU Falsified Medicines Directive (2011/62/EC) of 8 June 2011 provides new control measures for preventing the distribution of falsified pharmaceutical products. The directive has been transposed into French law and been applicable since 1 July 2017. The new control regime includes tracking measures based on the serialisation of products and covers all pharmaceutical products subject to prescription.

Strategies against parallel imports

What strategies are available to police and enforce against parallel imports?

Not applicable.

Anti-counterfeiting and enforcement

Types of proceedings

What types of legal or administrative proceedings are available to enforce against infringing products?

Civil and criminal proceedings are available against infringing products in addition to border enforcement measures.

Remedies

What are the available remedies for infringement?

The Intellectual Property Code (IPC) provides for civil and criminal penalties for trademark infringement.

Civil remedies include:

• damages covering:
  • material losses and loss of earnings;
  • non-pecuniary harm, such as harm to the trademark’s distinctive character, renown or prestige; and
  • the counterfeiter’s financial benefit resulting from the counterfeit goods;
• prohibition on manufacture, importation, exportation and sale of counterfeit goods;
• Withdrawal from the market and destruction or confiscation of counterfeit goods as well as the materials and implements used in their manufacture (at the expense of the counterfeiting party);
• publication in print or online of the judgment in favour of the injured party (at the expense of the counterfeiting party); and
• reimbursement of the injured party’s costs and disbursements.

 

Criminal offences and penalties include:

• industrial manufacture, import, export, reexport, transshipment of goods presented under a counterfeit trademark: four years’ imprisonment and €400,000 fine;
• possession without legitimate reason or sale of goods presented under a counterfeiting trademark: three years’ imprisonment and €300,000 fine;
• reproduction, imitation, use, affixation, deletion or modification of a registered trademark: three years’ imprisonment and €300,000 fine;
• knowingly delivering a product or providing a service other than that requested under a registered trademark: three years’ imprisonment and a €300,000 fine; and
• aggravating circumstances: seven years’ imprisonment and a €750,000 fine for offences committed:
  • in an organised gang;
  • on an online, public communication network; or
  • where the goods in question are dangerous to the health, safety or security of humans or animals.

Border enforcement

What border enforcement measures are available to halt the import and export of infringing goods?

Both EU regulation and the IPC provide for border enforcement measures. Pursuant to these measures, a rights holder or an exclusive license holder may request Customs to surveil imports and detain suspected counterfeit goods. The resulting customs watch is valid for a period of one year renewable and covers goods imported onto French territory from other EU member states as well as goods imported into the EU from non-EU countries.

Goods identified by Customs and confirmed as counterfeit by the rights holder are seized by Customs. Following seizure, the rights holder must (within 10 working days) either commence legal proceedings or obtain proof of the goods’ counterfeit nature by engaging a bailiff to seize the goods or to establish an official report describing the goods. Failure by the rights holder to act within that delay will result in Customs releasing the goods. 

In the majority of cases, Customs may additionally destroy the seized goods where:

• the rights holder confirms in writing the goods’ counterfeit nature and that it consents to assuming legal responsibility for their destruction; and
• upon receiving notice of the goods’ seizure, the party in possession of the goods either confirms in writing its consent to the goods’ destruction or fails to respond to the notice.

 

However, where the party in possession of the goods indicates its opposition to the seized goods’ destruction, the rights holder must act as described above, failing which Customs will release the goods.

Additionally, the rights holder may request an accelerated seizure and destruction regime applying to certain small packages. Suspected counterfeit goods sent by post or courier weighing less than 2kg and containing fewer than three items may be seized and destroyed by Customs unless the party in possession of the goods expressly refuses (within 10 working days) to consent to their destruction. In the case where consent is so refused, the rights holder must act as described above, failing which Customs will release the goods.

Moreover, article 9 of the EU Trademark Regulation of 14 June 2017 and article 10(4) of EU Directive 2015/2436 of 16 December 2015 provide that Customs may seize infringing products that are in transit and have not been introduced on the European market. In order to oppose seizure, the holder of the goods must prove that the rights holder has no right to prevent their commercialisation in the country of final destination. These provisions have been transposed into French law and took effect on 11 December 2019. This new transit regime has increased the volume of goods seized by Customs and assists trademark owners in fighting infringement.

Finally, even in the absence of a customs watch requested by a rights holder, Customs may also detain suspected counterfeit goods of its own initiative.

Online pharmacy regulation

What rules are in place to govern online pharmacies?

In principle, the Public Health Code restricts the sale of pharmaceutical products to bricks and mortar pharmacies only. 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) of 8 June 2011 as transposed into French law provides that owners of pharmacies can sell certain over-the-counter products online. 

Note that this reform does not apply to prescription-only products, the sale online of which remains prohibited. Online sales of non-prescription products are strictly regulated according to the following conditions: 

• the website must be managed by a registered pharmacist;
• the pharmacist must maintain a physical pharmacy;
• the pharmacist must possess authorisation to operate online from the Regional Health Agency; and
• the pharmacist must inform the Order of Pharmacists of his or her intention to sell pharmaceutical products online.

 

Non-compliance with these conditions will lead to penalties ranging from the temporary closure of the website to an administrative fine. Moreover, online pharmacies legally operating within other EU member states similarly may only sell to French consumers non-prescription medicines carrying marketing authorisation for France.

A list of authorised websites (currently more than 800) can be found on the Order of Pharmacists’ website. Online pharmacies must clearly identify the bricks-and-mortar pharmacy operating the website as well as the owner. In addition, online pharmacies must display a common EU verification logo on each page allowing users to click through to the Order of Pharmacist’s website to check the online pharmacy in question against the official list of authorised websites.

Recent cases

What are the most notable recent cases regarding the enforcement of pharmaceutical marks?

In a decision of 27 May 2021 No. 19-16676, Sté Mérial c/ Sté Virbac, the Commercial Chamber of the Supreme Court (Cour de cassation) held that an invalidity action initiated against a pharmaceutical trademark alleged to be contrary to public order was admissible even if this trademark had not been prohibited from use by the health authorities. 

The pharmaceutical company Merial (now Boehringer Ingelheim Animal Health France), owner of the trademark ‘Frontline’ for an antiparasitic product for veterinary use composed of an active ingredient called ‘friponil’, summoned the company Virbac, one of its competitors, for infringement and violation of its reputed trademark ‘Frontline’ owing to the registration and use of the trademark ‘Fiproline’ that covers a product with the same active ingredient. Merial was alternatively seeking the invalidity of the trademark based on article R.5141-1-1 of the Public Health Code and article L. 711-3 b) of the IPC (now article L. 711-2, 7° of the IPC).

Article L. 711-3, b) of the IPC prohibits the registration as a trademark of a sign ‘the use of which is legally prohibited’. This prohibition stems from article R.5141-1-1 of the Public Health Code, which provides that ‘the fancy name may not be confused with the common name’ of the medicine. The same prohibition exists for brands of medicines for human use pursuant to articles R. 5121-2 and R. 5121-3 of the Public Health Code. 

The case was already the subject of a decision of the Cour de cassation rendered in 2018 (Com., 31 January 2018, No. 15-20.796). In this decision, the Court overturned the decision of the Court of Appeal (Lyon, 13 May 2015, No. 13/08055) insofar as the latter had cancelled the trademark ‘Fiproline’ for lack of distinctiveness and insofar as it had admitted infringement of the reputed trademark based on the similarity in the method of packaging of the products rather than on a comparison of the word marks themselves.

The second Court of Appeal of Lyon issued a judgment in 2019 denying infringement and declaring the invalidity action on absolute ground inadmissible as the disputed trademark had not been « the subject of any prohibition of use by the health authorities, so that it cannot be considered contrary to public policy ». 

The Cour de cassation in its decision issued on 27 May 2021 confirmed the Court of Appeal decision on the absence of infringement, but disagreed with the Court of Appeal’s ruling regarding the invalidity declaration as it considers that ‘the admissibility of an action for invalidity of a trademark based on articles L. 711-3, b), of the IPC and R. 5141-1-1 of the Public Health Code is not conditional on the prior prohibition of the trademark by the health authorities’. It is, therefore, perfectly possible to seek the invalidity of a registered pharmaceutical or veterinary trademark on absolute grounds, even if the health authorities have approved the release of the drug under the branded name in question.

Advertising

Regulatory bodies

Which bodies are responsible for oversight of pharmaceutical advertising in your jurisdiction (and what are their powers)?

The National Agency for the Safety of Medicines and Health Products.

Advertising rules

What specific rules are in place regarding the advertising of pharmaceutical products?

Advertising of pharmaceutical products that target the general public is strictly regulated. These rules for advertising pharmaceutical products apply equally to online advertising.

Under the Public Health Code, only certain pharmaceutical products can be advertised and only under specific conditions: 

• the product must not: 
  • require a medical prescription; or
  • be reimbursed by mandatory health insurance schemes; and
• the product’s marketing authorisation must not prohibit advertising to the general public by reason of public health risks (eg, where the product is not suitable for use without diagnosis, instruction or monitoring of treatment by a doctor).

 

An exception is made in the interest of public health for certain vaccines (designated by the Minister of Health) and tobacco addiction treatments, which may be advertised, to the general public.

Advertisements 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 cosmetics; 
• play on fear in a major sense or mislead in any way; or
• target children only.

 

Regarding products that are subject to medical prescription, advertising may be directed at health professionals only. 

Comparative advertising is permitted under French law, provided that it objectively compares characteristics that are essential, relevant, verifiable and representative of the relevant goods or services. Moreover, comparative advertising may mention a trademark in order to identify the products with which the comparison is being made. However, given the limits described above imposed on the advertising of pharmaceuticals, the amount of comparative advertising in this field is minimal. 

French courts have considered whether it is possible to mention the name of a trademarked pharmaceutical product when advertising the generic version of that product. The Cour de cassation has held that presenting a product as the generic version of a trademarked product is considered legitimate comparative advertising (Sandiz v Beecham Group, 09-70.722, 24 May 2011). 

Generic substitution

Legality

Is generic substitution permitted in your jurisdiction?

Yes.

Regulations

Which regulations govern generic substitution by pharmacists of brand-name drugs?

Pharmacists may substitute a medically prescribed trademarked product with a generic version that fulfils the relevant conditions (eg, bioequivalence) as long as the prescription does not specify the use of the brand name product only. However, the substitution of a trademarked product with another trademarked product is prohibited and punishable by three years’ imprisonment and a €300,000 fine. This was upheld by the Cour de cassation in a case in which a pharmaceutical company presented its product as generic even though it was an original trademarked product. The substitution was, therefore, unlawful (Mylan v IPSEN Pharma, 11-20.725, 9 October 2012).

Update and trends

Key developments and future prospects

What were the key judicial, legislative, regulatory and policy developments of the past year in relation to the protection and enforcement of pharmaceutical trademarks? What are the prospects for future developments?

In recent years, the phenomenon of counterfeiting has grown significantly, facilitated by the development of the internet and e-commerce. In France, customs seizures have increased from 73,741 counterfeit medicines intercepted in 2019 (figures provided by Customs in ‘Agir pour protéger – résultats 2019’ – Direction générale des douanes et droits indirects) to 128,000 medicines in 2020 (figures provided by Customs in the press file ‘Presentation du plan contrefaçons 2021-2022’ – Direction générale des douanes et droits indirects – February 2021). 

One of the last operations conducted in 2022 by international authorities, including France, in Interpol member countries, resulted in the seizure of illicit narcotics and precursor chemicals worth more than USD 717,000,000 and the arrest of 1,333 suspects worldwide.

The covid-19 pandemic has led to an increase in the trafficking of counterfeit drugs and other medical products (eg, masks), as evidenced by the first seizures of counterfeit vaccines made by the South African authorities after an Interpol alert (www.interpol.int/News-and-Events/News/2021/Fake-COVID-vaccine-distribution-network-dismantled-after-INTERPOL-alert).

The falsification of medicines is a scourge whose consequences on public health can be dramatic. The impact is not only sanitary but also socio-economic and environmental. This is a global phenomenon that affects all countries and spares no therapeutic area.

The French, European and global key stakeholders (eg, governments, customs, professional organisations, brand owners, lawyers, judges) remains, therefore, mobilised against counterfeiting (through cooperation, training and awareness programmes, implementation of the serialisation of medicines at the European level, etc). The French government has thus adopted, in February 2021, a new plan to fight against counterfeiting for 2021-2022, which is broken down in four objectives:

• better cooperation with all the actors in the fight against counterfeiting;
• reinforcement of the collection and processing of intelligence;
• strengthening the policy of controls and investigations; and
• adapting the litigation policy and prosecutions to the strategic stakes.

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