A Q&A guide to life sciences law in France.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.
The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
The French Public Health Code (FPHC) strictly regulates the manufacture, distribution and sale of pharmaceutical products. The Social Security Code regulates pricing and product reimbursement rates (total or partial) by the French healthcare system.
A French law reforming pharmaceutical and health products regulations was published on 30 December 2011 (Law no. 2011-2012 of 29 December 2011). This law is mainly aimed at:
Improving transparency of relations between healthcare professionals (HCPs) and the healthcare industry.
Strengthening monitoring of medicinal products.
The entry into force of some of its provisions is still subject to specific decrees that are proposed to be adopted by the government in the first half of 2013.
Pharmaceutical products are supervised by the National Agency for the Safety of Medicinal and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé) (ANSM) (see box, Regulator details).
Pharmaceutical products can be placed on the French market provided they have been granted marketing authorisation (MA) either by the:
ANSM under the national procedure.
European Medicines Agency (EMA) under the centralised procedure. The centralised procedure is compulsory for (Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation)):
biotechnological procedures;
new chemical compounds for the treatment of AIDS, cancer, neurodegenerative disorder, diabetes, auto-immune diseases and other immune dysfunctions, and viral diseases; and
treatment of rare diseases.
Biological medicinal products have been defined by Law no. 2007-248 of 26 February 2007. These biological products are subject to the provisions that apply to medicinal products (that is, they must obtain an MA granted by the ANSM).
However, the FPHC contains certain provisions that specifically apply to biosimilar products. In particular, if a biological medicinal product that is similar to a reference biological product does not meet the conditions for generic products, appropriate pre-clinical tests or clinical trials relating to these conditions must be provided (Article R. 5121-28, FPHC).
The structure and funding of the national healthcare system is delegated to the Ministry of Health and various bodies, such as:
ANSM.
The Public Health Agency (Haute Autorité de Santé).
The Biomedicine Agency.
Social security schemes are managed by professional union representatives under government supervision.
Social security schemes are financed from specific contributions paid by employers, employees and other salaried professionals, and from other sources. The healthcare budget is adopted annually under the Social Security Financing Act (SSFA). SSFA also determines the government's yearly public health objectives (for example, public campaigns addressing cancer).
The price of pharmaceutical products is generally freely determined by pharmaceutical companies. However, this is not the case for products that are prescription-only medicines and/or are reimbursed by social security schemes. The price of these products is determined after negotiations between the pharmaceutical company and the Economic Committee for Health Products (Comité économique des produits de santé) (CEPS), acting under the supervision of the Ministry of Health. If no agreement can be reached, the price is determined unilaterally by the CEPS. The applicable rate for reimbursement by social security schemes is also determined by public authorities (see Question 4).
For reimbursement by social security schemes, pharmaceutical products must meet a certain degree of efficacy (Amélioration du Service Rendu) and must be registered on a specific list of products. The reimbursement rate for each product is evaluated by the Transparency Commission (Commission de la Transparence) under the supervision of the Ministry of Health. The reimbursement rate depends on the product's efficacy improvement (as compared to therapies that are already available) and is applied to the price of the product (from 15% to 65%, or in certain circumstances 100%).
The application for the product to be registered on the list is filed with the Ministry of Health and a copy of the application is sent to the Transparency Commission for its opinion. The decision must be made within 180 days of receiving the completed application.
Following a decree adopted on 2 October 2012, the Transparency Commission is now required to perform medico-economic assessment of the reimbursed drug, each time the financial impact for social security schemes is likely to be significant.
Pharmaceutical product users are generally reimbursed, as they pay directly for the products. However, in recent years, French authorities have set up a new system under which the reimbursed price is advanced by pharmacies, which are then reimbursed by social security schemes (tiers payant).
Since 2008, annual franchises, whose final cost is borne by patients, have been implemented for certain categories of products. Patients must pay a fixed amount each time they are prescribed the relevant products (except if they have been admitted to hospital).
Prior authorisation must be obtained to manufacture pharmaceutical products. Each manufacturing site must be authorised by the ANSM and any variation of an authorised site, technical equipment or the nature of the manufactured products or process must also be authorised. Changes concerning the authorisation holder (corporate name or corporate form) or transfer of the authorised establishment to a new owner must be declared to the ANSM.
Any pharmaceutical establishment that manufactures pharmaceutical products must both:
Meet regulated quality and safety conditions, and good manufacturing practices (GMP).
Have a qualified pharmacist as head pharmacist (pharmacien responsable) involved in its management.
There are no specific restrictions.
Manufacturing authorisation is subject to the opinion of the relevant professional board of pharmacists and to an investigation performed by ANSM inspectors. The decision must be given within 90 days of receipt of the application.
Initial authorisation is not subject to a fee.
Manufacturing authorisation is not subject to a time limit. However, any modification to one of the elements on which the authorisation is based requires, depending on the type of modification concerned, a declaration or a new authorisation (see above, Application). In addition, periodic inspections are performed by ANSM to enforce compliance with the terms of the authorisation.
ANSM inspectors can perform periodic inspections to force the pharmaceutical establishment's activities to comply with the terms of the authorisation and FPHC requirements. In addition, they control pharmaceutical establishments' compliance with GMP. Inspectors can take and analyse samples of manufactured products, and they can be authorised by a court to seize products.
After the ANSM inspection, a specific report is issued.
If any breach of a manufacturing authorisation, or non-conformity with applicable regulations, is discovered, the ANSM can require the establishment to provide justifications and/or to implement corrective measures. The ANSM can also suspend authorisation until compliance with requirements has been reached. In addition, criminal prosecutions can be pursued. Any breach of regulations is punished by up to two years' imprisonment and by a fine of EUR30,000, or EUR150,000 if a legal entity is held responsible.
Clinical trials are strictly regulated by specific legislation. Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive) was implemented by Law no. 2004-806 on 9 August 2004 and by Decree no. 2006-477 on 26 April 2006. In addition, any clinical trials performed must comply with good clinical practices implemented by the decree.
All clinical trials must be submitted to the relevant public ethic committees (Comité de protection des personnes) and obtain a favourable opinion. In addition, the clinical trial must then be authorised by the ANSM. The application for an opinion and for authorisation is filed by the sponsor of the clinical trial. The review of the application by the ANSM cannot exceed a time period of 60 days from the date of receipt. If there is no response on expiry of the 60 days, authorisation is considered granted.
Risks to subjects of clinical trials must generally not be disproportionate to the potential benefit of the scientific research. Informed consent of any person involved in the trial must be obtained before participation. The FPHC requires certain information to be communicated to the subject, such as the:
Purpose of the trial and the procedures to be followed.
Foreseeable risks that could arise from the trial.
Reasonably expected benefits.
In addition, the written consent form must be revised when new important information becomes available that may be relevant to the subject's consent.
Certain other conditions must be met before the clinical trial begins. The sponsor must ensure adequate compensation for all damages or injuries arising from the performance of the trial. The sponsor must obtain insurance to cover its civil liability before the clinical trial begins. In addition, if the site where the trial is expected to be performed is not usually used for the healthcare activities envisaged by the trial, the site must be authorised by ANSM.
The sponsor must notify the relevant ethics committees of all information concerning serious adverse drug reactions, and must report all adverse reactions to the committees and to the ANSM. At the end of the trial and within 90 days from its termination, the sponsor must notify the ANSM and the relevant ethics committees of the effective date of termination of the trial. In addition, within one year from the termination or suspension of the trial, a final report of the research, including its results, must be sent to the ANSM.
Current regulations have been amended by Law no. 2012-300 of 5 March 2012 organising research and clinical trials involving human subjects. The purpose of the law is to simplify and clarify the legal framework of research applicable to research on human subjects, and to ensure that non-interventional studies are subject to minimum requirements. This new law determines three categories of studies which are subject to different rules, depending on the level of risks for the study subjects:
Interventional studies.
Interventional studies that do not involve drugs and only involve minor risks and constraints for the subjects.
Non-interventional studies.
However, this law will only enter into force when its implementation decrees are published.
Every pharmaceutical product must be granted French or centralised MA before it is placed on the market. French MAs are granted by the ANSM. After the MA has been granted, the authorisation holder must inform the ANSM of the actual marketing of the product. Any modification of the terms of the MA must be approved by the ANSM. Any person placing products on the market that have not been duly granted MA can incur criminal sanctions of:
Up to two years' imprisonment.
A fine of up to EUR30,000 for individuals.
A fine of up to EUR150,000 for legal entities.
To be granted MA, all pharmaceutical products must meet certain conditions of quality, safety and efficacy as shown by the applicant. The authorisation cannot be granted by the ANSM if either the:
Risk-benefit balance is not considered favourable.
Therapeutic efficacy of the product is insufficiently substantiated by the applicant.
Under Law no. 2011-2012, the ANSM will be entitled to request the applicant or the holder of an MA, at any time, to provide comparative studies (that is, not only studies versus placebo, but also studies versus active comparator).
The MA of a product is automatically withdrawn if the product concerned has not been marketed during a three-year period. Also, for medicinal products used in connection with serious pathologies, pharmaceutical companies:
Must inform the ANSM before any decision to suspend marketing of the product(s).
Provide the ANSM with information on any circumstances likely to involve suspension of marketing.
The application for MA is filed by the pharmaceutical company and submitted to the ANSM. The application must contain all required administrative information and scientific information concerning the product (that is, the information listed in the summary of the product's characteristics, and in particular the qualitative and quantitative composition of the product). The application is assessed by an expert called a rapporteur, who advises an expert commission (Commission d'autorisation de mise sur le marché) on the application. During its review of the application, the ANSM can order any inspection, survey or test it considers necessary. The decision is made within 210 days from receipt of the completed application.
The application is subject to a progressive fee, that cannot exceed EUR45,000. In addition, each authorised pharmaceutical product is subject to an annual tax that cannot exceed EUR26,000. The tax is calculated on the amount of sales of each pharmaceutical product in the preceding financial year, excluding export sales.
MA is granted for five years. It can then be renewed for an unlimited period of time unless the ANSM considers that additional monitoring is necessary. Renewal is subject to assessment that no modification has been made to the elements in the first application. In addition, the pharmaceutical establishment must adapt the manufacturing and safety of its authorised product to the latest scientific knowledge. If there is no response at the end of the authorisation period, the renewal is considered approved.
If the product has not been marketed during a three-year period, the corresponding MA is automatically withdrawn.
The holder of an MA must provide the ANSM with a periodic report of all information concerning adverse reactions in relation to its product. Under Law no. 2011-2012:
The MA holder must inform the ANSM immediately of any prohibition or restriction imposed by competent authorities of any other country on the product. In case of breach of this obligation, ANSM can impose an administrative fine that cannot exceed 10% of the company's turnover (up to a limit of EUR1 million) (Article L. 5421-8 2°, FPHC). A penalty payment of up to EUR2,500 for each day of delay can be added (Article L. 5421-9, FPHC).
The MA holder must provide any new information likely to influence the evaluation of the benefits and risks of the product. If it fails to do so, ANSM can impose an administrative fine (Article L. 5421-8 6°, FPHC).
The ANSM will be able to require the MA holder to conduct post-authorisation studies on the safety and efficacy of its product.
The ANSM can grant MAs through an abridged procedure. Under this abridged procedure, the applicant is exempt from providing the pharmacological, toxicological and clinical data to the ANSM. The abridged procedure can be used, in particular, for the following pharmaceutical products:
Generics of a pharmaceutical product authorised for no less than ten years in France or another EU member state. However, reference products benefit from protection periods (that is, data protection of eight years and marketing exclusivity for up to three additional years), where the MA application was submitted after 30 October 2005 (Directive 2004/27/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Second Amendment Directive)).
Pharmaceutical products making reference to the file of another pharmaceutical product already authorised, provided that:
the two products have the same qualitative and quantitative composition; and
the MA holder for the reference medicinal product consents to the use of data and information contained in the reference product's file.
Those with well-established medicinal use, with efficacy recognised by detailed scientific literature.
A pharmaceutical product is deemed to be the generic of another product if:
It has the same qualitative and quantitative composition in active substances.
It has the same pharmaceutical form.
Its bioequivalence with the reference medicinal product has been shown by appropriate bioavailability studies.
If reference is made to a generic product, the applicant can rely on the documentation provided by the holder of the reference product MA if the:
Holder has consented to this reference.
Protection time period for the documentation provided for the reference product MA has expired (see above).
The period of time required for establishing "well-established medicinal use" must be at least ten years from the first use of that substance as a medicinal product in the EU (Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive)). If reference is made to a well-established medicinal use, the documents submitted by the applicant must refer to all relevant literature, taking into account pre- and post-marketing studies and published scientific literature.
The mutual recognition procedure allows MAs granted in other EU member states to be recognised in France. Under this procedure, the MA holder can submit an application to the ANSM for the pharmaceutical product's approval in France. The holder must inform the member state that has issued the authorisation (reference member state) of this application and the reference member state must forward the assessment report to the concerned member states. Within 90 days of receipt of the assessment report, the concerned member states must either:
Recognise the decision of the reference member state.
Consider that the medicinal product may present a risk to public health.
If required, a conciliation procedure can be initiated before the EMA.
In addition, the Code for Human Medicines Second Amendment Directive establishes a new decentralised procedure for simultaneous applications in the EU. These provisions were transposed into French law in December 2007.
The ANSM can monitor compliance with MAs through periodic inspections and surveys at any pharmaceutical site. ANSM inspectors are authorised to take and analyse samples of manufactured products and can seize products if granted judicial authorisation.
For breach of an MA, the ANSM can require justifications and corrective measures from the MA holder. The MA holder has the right to defend itself by following a written appeals procedure. If the holder does not remedy the breach or the ANSM still believes it is not complying, the ANSM can either:
Suspend MA for up to one year.
Withdraw the authorisation.
Parallel imports (that is, distributing pharmaceutical products outside the manufacturer's official channels) are permitted under the FPHC, but are subject to a five-year authorisation granted by the ANSM. The authorisation is granted provided the:
Product has been granted MA in France.
The imported product is identical to the authorised product in the following ways:
qualitative and quantitative composition of active substances;
pharmaceutical form; and
therapeutic effects.
Authorisation can be refused for public health reasons, but not for intellectual property rights (IPR) reasons. Under the principle of exhaustion of rights conferred by a patent or trade mark (épuisement des droits), the holder of an IPR protected by law cannot rely on that right to prevent the import of a product that has been marketed in another EU member state by the holder itself (or with its consent). However, for trade marks this principle does not apply if there are legitimate reasons for the holder to oppose further commercialisation of the product, particularly where the nature of the product has been changed or impaired after being put on the market.
Pharmaceutical companies that produce or market products or services reimbursed by social security schemes are prohibited from granting free advantages, directly or indirectly, to HCPs (Article L. 4113-6, FPHC). However, pharmaceutical companies can provide advantages or compensation to HCPs in the form of:
Advantages granted in the context of research and scientific evaluation activities.
Hospitality offered in the context of scientific or promotional congresses.
Reasonable compensation for services performed by the HCPs.
Advantages granted in the context of research and scientific evaluation activities and hospitality offered in the context of scientific or promotional congresses must be:
Provided for in a written contract.
Submitted to the relevant professional bodies for review and opinion.
French Law no. 2011-2012 has extended this obligation to any agreements executed between pharmaceutical companies and HCPs (that is, including contracts executed for consultancy activities).
The distribution of free samples is also limited. Pharmaceutical companies can provide free samples to HCPs on request only, and the number of samples is limited to ten samples of a given product per professional per year.
Gifts or donations to a medical institution to finance research activities or training of HCPs are acceptable provided that the pharmaceutical company makes a specific declaration to the Préfecture, (that is, the administrative body representing the state in the département) and these gifts or donations do not provide any individual advantage to HCPs (that is, they are intended for collective use only). However, gifts to associations representing HCPs are prohibited by Law no. 2011-2012.
Charitable donations do not need to be declared to the Préfecture.
French criminal law prohibits payment or receipt of any bribe and influence peddling in both the public and private sector. This prohibition applies to the healthcare sector. Any breach of anti-bribery legislation is punishable by:
Up to ten years' imprisonment and EUR150,000 for bribery in the public sector.
Up to five years' imprisonment and EUR75,000 for bribery in the private sector.
Although French anti-bribery legislation is not specifically intended to apply outside France, corruption practices involving French people outside France can be prosecuted.
Further to the publication of Ordonnance no. 2012-1427 of 19 December 2012, online sale of over-the-counter (OTC) medicines by retail pharmacists has been authorised and organised. Pharmacists established in other EU member states can also sell OTC medicines to French patients through their website, but they must comply with the requirements set out by the FPHC.
Medicinal product advertising in France is regulated by the following:
Code for Human Medicines Directive.
Provisions of the FPHC concerning the promotion of pharmaceutical products.
Guidelines issued by the ANSM.
Although the ANSM guidelines are not legally binding, French courts consider they must be taken into account by pharmaceutical companies.
Advertising for medicinal products must strictly comply with the product's MA. The FPHC distinguishes between advertising directed to the general public and advertising directed to HCPs.
Advertising directed at the general public:
Is not generally allowed, if the product is subject to prescription or is reimbursed by social security.
Is allowed for other medicinal products, provided prior authorisation has been granted by the ANSM.
All medicinal product advertising must contain objective information and be consistent with appropriate use (bon usage) of the product. More specifically, advertising directed at HCPs must contain both:
Information set out in Article R. 5122-3 et seq. of the FPHC.
All relevant information for professionals to form their own opinion of the therapeutic worth of the product.
The information must be accurate, up to date, verifiable and exhaustive. The price of the product (if determined by the authorities), the daily cost of the treatment and its reimbursement by social security schemes must be mentioned in any promotional material directed at HCPs. Under Law no. 2011-2012 advertising directed at HCPs must be submitted to the ANSM for prior authorisation (promotional visa, as provided for by Article R 5122-12 of the FPHC).
Violations of mandatory provisions regulating advertising of medicinal products can incur criminal penalties of:
Up to two years' imprisonment.
Fines of up to EUR30,000 or EUR37,500 for individuals.
Fines of up to EUR150,000 or EUR187,500 for legal entities.
In addition to the above restrictions, the advertising of medicinal products on the internet is subject to specific recommendations that have been adopted by the ANSM and professional organisations. In particular, the ANSM and the Professional Association of the Pharmaceutical Industry in France (les enterprises de médicament) (LEEM) published the Charte de la communication des enterprises sur Internet, which contains recommendations applicable to the promotion of medicinal products on the internet. However, these recommendations are not binding on pharmaceutical companies.
The packaging and labelling of pharmaceutical products is subject to specific regulations provided by the FPHC (for example, Article R. 5121-137 et seq.). The ANSM controls compliance of pharmaceutical products' packaging and labelling.
All packages and leaflets are part of the MA granted by the ANSM. The following information must appear on, among other things, the outer packaging of pharmaceutical products:
Name of the medicinal product.
Qualitative and quantitative composition in relation to active substances.
Pharmaceutical form and contents by weight.
Route of administration.
List of excipients.
Expiry date.
Special storage precautions.
Instructions for disposal of unused medicinal products or waste materials.
Authorisation number and manufacturing batch number.
Special warnings.
If the required information is not on the outer packaging, it must be on the inner packaging. The information must be legible, understandable and indelible. For reimbursable medicinal products, the outer packaging must also mention information related to price and the conditions for reimbursement by social security schemes.
The information must appear on packaging in French. Other languages can be used, provided identical information appears in all languages.
The manufacture and marketing of traditional herbal pharmaceutical products is regulated by the FPHC. These pharmaceutical products can be authorised through the abridged procedure of MA used for products with well-established medicinal use by means of detailed scientific literature. Directive 2004/24/EC on traditional herbal medicinal products (Traditional Herbal Medicines Directive), implemented in France, contains provisions to facilitate marketing of these products. Certain listed products can be authorised under a special and simplified registration procedure. The application for registration is made to the ANSM.
Patentability is subject to the following conditions:
Novelty involving an inventive step.
Potential industrial application.
In addition, the invention must not be contrary to public order or ethics, or human dignity.
The Intellectual Property Code contains conditions for patentability.
The patentability of pharmaceutical products is subject to general regulations on patents. Any medicinal product or related substance can be patented provided conditions required by the Intellectual Property Code are met (see above, Conditions and legislation).
Some categories are not patentable, such as:
Discoveries, scientific theories, mathematical methods, aesthetic creations, games or computer programs.
The human body, at various stages of its formation and development, including the embryo.
Only inventions that combine a natural element with a technical process enabling it to be isolated or produced for an industrial application can be the subject of a patent application. However, the situation is likely to change in the future. The review of the French bioethical laws is currently being discussed and one of the topics is the amendment of the provisions applicable to the patentability of elements isolated from the human body (for example, the sequence of a gene).
In addition, specific regulations apply to pharmaceutical products' protection. As the active ingredient of a pharmaceutical product is usually patented long before its effective marketing, the parts of the patent that correspond to the authorisation can be protected for an additional period of time by a supplementary protection certificate (certificat complémentaire de protection) (SPC) (see Question 20).
An application for a patent is filed with the National Institute of Industrial Property (Institut National de la Propriété Industrielle) (INPI).
The INPI website (www.inpi.fr/fr/brevets.html) provides guidance on the application procedure and fees. The following fees apply:
EUR36 must be paid within one month of filing a patent application. The fees increase progressively up to EUR760 per year for the 20th year.
The annual fee for an SPC is EUR500.
Additional fees must be paid for the review of the application by the INPI (that is, EUR500 for the search report and EUR86 for granting the patent).
The application must contain all information relating to the invention, including:
A description of the invention, accompanied by drawings where appropriate.
One or more claims to define the scope of protection the inventor is applying for.
An abstract of the technical content of the invention.
Within 18 months of the application date, the INPI must publish notification of filing of the application in the Official Bulletin of Industrial Property. This aims to ensure that third parties are informed of the patent application.
The INPI issues a search report (rapport de recherche). The search report summarises the elements of prior art that can be considered when assessing the patentability of the invention. After the search report is issued, the INPI will grant the patent. A reference to the grant of a patent is published in the Official Bulletin of Industrial Property.
The INPI carries out a formal review of the application before accepting it. The INPI verifies that the application is complete and meets the formal requirements. However, the INPI does not examine the validity of the patent (that is, whether the legal requirements of novelty and industrial applicability are met) (see Question 21).
Patents are granted for a term of 20 years from the day of the application and are not renewable.
SPCs can be granted for pharmaceutical products, for a period of no more than five years from the end of the patent (Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products (Medicinal Products Supplementary Protection Certificate Regulation)).
The granting of a patent is subject to limited investigations by the INPI (see Question 19). Once the patent has been granted, a subsequent more complete investigation can be initiated and the patent revoked in court. Any person with an interest can ask a civil court for revocation of the patent if the patent does not comply with the substantial requirements of the Intellectual Property Code (that is, the invention is not disclosed in a manner sufficiently clear and complete to be used by a person skilled in the art).
In addition, patent protection is subject to payment of annual fees. If the fees are not paid when due, the holder has an additional six-month period to pay them, as well as a surcharge. If they are still not paid after this period, the patent holder loses rights to the patent.
The patent gives the holder the right to prohibit direct use of the invention, in particular:
Manufacturing.
Offering.
Putting on the market, or importing.
All indirect uses of the invention (through supplying it).
Any violation of these rights is an infringement and the infringer is civilly liable.
Infringement proceedings must be brought by the patent holder before the court of first instance (Tribunal de Grande Instance) of Paris. At the holder's request, the judge can order seizure of the infringing products and subsequent measures to stop the infringement. In addition, damages can be awarded to the patent holder.
Infringement can be a criminal offence if the holder can prove the counterfeiter acted dishonestly. Any breach of these rules is punishable by:
Three months' imprisonment and a fine of EUR300,000.
Five years' imprisonment and a fine of up to EUR500,000 if the infringing goods are considered hazardous to human health.
Innovative products are protected by an eight-year data exclusivity period, covering the data in the product's file. This applies to reference products for which an application for an MA has been submitted after 30 October 2005. This protection period is further extended by:
Two years of marketing exclusivity.
One year of additional marketing exclusivity, if certain conditions are met.
To obtain trade mark registration, a sign must be capable of graphic representation that serves to distinguish the goods or services of a natural or legal person (Intellectual Property Code).
The registration of pharmaceutical product brands is subject to the general regulations regulating trade marks. The FPHC contains specific additional rules concerning trade marks. The name of the pharmaceutical product can be:
An invented name.
A common name.
A scientific name followed by the trade mark or the name of the manufacturer.
To be accepted, the registered mark must not create any confusion with other pharmaceutical products.
An application for registration of a trade mark is filed with the INPI. The INPI website (www.inpi.fr/fr/marques.html) provides guidance on the application procedure and fees.
The fee depends on the number of international classes of products and services for which protection is required. The initial application is subject to payment of EUR225 for the first three classes, and EUR40 for each additional class.
Ownership of a trade mark is acquired by registration. The application must contain, in particular:
Administrative information related to the applicant's identity.
A sample of the item to be trade marked.
A list of the goods and services to which it applies.
A registration number is then assigned to the application and within six weeks the INPI publishes notification of the filing in the Official Bulletin of Industrial Property.
Within two months of the date of publication, any concerned person can submit observations to the Director of the INPI or lodge a formal opposition to contest the trade mark registration (for example, if the trade mark has already been registered).
If it is not contested and the trade mark complies with the Intellectual Property Code, the trade mark is registered in the National Register of Marks and published in the Official Bulletin of Industrial Property.
Trade mark protection lasts for ten years and starts from the date the application was filed. The trade mark protection can be renewed for successive ten-year periods, without limitation.
The trade mark can be revoked in the following circumstances:
The owner of the registered trade mark can renounce the effects of the registration for all or part of the goods or services to which the trade mark applies (by a notice of renunciation).
The registration can be declared void if it does not comply with the legal requirements.
An owner who has not exploited his trade mark during an uninterrupted period of five years, without good reason, is liable to revocation of his rights by court order.
Trade mark registration provides the holder with exclusivity of use (for the goods and services designated in the application) and a right to prevent all third parties from using the mark in the course of trade without its consent.
An offender can be civilly liable for any infringement of the holder's rights. Infringement can consist of:
Use or reproduction of an identical trade mark, for example use of an identical trade mark for goods or services identical to those designated in the trade mark registration.
Use by imitation implying a risk of confusion, for example:
use of an identical trade mark for goods or services that are similar to those designated in the registration; or
use of an imitative trade mark for goods or services that are similar or identical to those designated.
The trade mark holder can pursue infringement proceedings before the civil courts, which can order the seizure of infringing products and subsequent measures to terminate the infringement. Damages can be awarded to the trade mark holder. As with patent infringement, criminal prosecution can also be pursued. Any breach of these regulations is punishable by three months' imprisonment and a fine of EUR300,000.
There is no requirement for a patent or trade mark licence agreement to be approved by any government or regulatory authority.
There is no requirement for remittance of royalties payable under a patent or trade mark licence agreement to a foreign licensor to be approved by any government or regulatory authority.
France is a party to the following conventions:
WIPO Paris Convention for the Protection of Industrial Property 1883.
WIPO Madrid Agreement Concerning the International Registration of Marks 1891 (Madrid Agreement).
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989.
Patent Cooperation Treaty (PCT) 1970.
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure 1977.
Singapore Treaty on the Law of Trademarks 2006.
WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957.
Strasbourg Agreement Concerning the International Patent Classification 1971.
Liability can arise under tort, contract and defective products liability law. Under tort law, a fault can result from an act or omission. The claimant must establish:
A fault.
An injury.
A causal link between the fault and the injury.
Under contract law, a party to a contract is liable for the damage caused by the non-performance of its contractual obligations, unless it proves the non-performance resulted from an external cause. Courts have also established specific obligations, such as to deliver the product, a safety obligation, a counsel or advice obligation and a guarantee against latent defects (for example, latent defects that make the product improper for its intended use).
Defective product liability stems from Directive 85/374/EEC on liability for defective products (old Product Liability Directive), which was implemented in France by Law no. 98-389 on 19 May 1998 and established a specific defective product liability regime.
In addition, claimants can also pursue pharmaceutical companies under criminal law. A manufacturer of a dangerous product can be liable for involuntary homicide or infliction of an involuntary injury resulting in the victim's total incapacity for more than three months.
Under tort liability, the claimant must give evidence of an existing fault, an injury and a causal link between fault and injury. Fault can be negligence in the conception or manufacture of the product.
Under contract law, the claimant must prove either that:
The product does not comply with the contract or was affected by a manufacturing vice or defect that made it improper for its intended use.
Information delivered concerning the product was incomplete.
Under defective product liability, the product is considered to be defective when it does not provide the safety that a person is legitimately entitled to expect. The claimant must give evidence of the actual damage, the defect in the product and the causal link between the damage and the defect.
Under tort liability, any person can be liable provided that a fault, an injury and a direct causal link are proven. However, the manufacturer is generally liable.
Under contract law, the supplier (for example, the physician, pharmacist or hospital) usually bears responsibility for the default or defect (except for safety obligations where the manufacturer can also be responsible).
Under defective product liability, the principle is that the producer, when acting in a professional capacity, bears ultimate responsibility for the defect. A producer is defined as any of the following:
The manufacturer of a finished product.
The producer of any raw material.
The manufacturer of a component part.
If the producer is unknown, the seller or any professional supplier is responsible for defective products under the same conditions as the manufacturer, unless it discloses the name of its supplier or producer, within three months of notification by the claimant.
The common law time limit for bringing an action for bodily damage or injury is five years from the date when the cause of action arose.
A specific time period is provided for the contractual guarantee against latent defects. Liability claims must be brought within two years of discovery of the defect (Article 1648, Civil Code).
Under defective product liability, the limitation period is ten years after the product was put into circulation. Proceedings for damages based on defective product law are time-barred after three years from the date on which the claimant became aware, or should have become aware, of the damage, defect and identity of the producer.
Class action procedures do not exist in France. However, registered consumer associations can bring legal proceedings in all courts for compensation for damages sustained by consumers collectively (Article L. 421 et seq., Consumer Code). Damages are claimed for loss sustained by the community of consumers, to the extent that such loss is distinct from losses sustained by individual consumers.
In 2006, a draft law was presented by the government on this issue. Its purpose was to maintain the mandate requirement, while allowing consumer associations to publicly solicit such mandates, therefore favouring group actions. This new form of collective action, if adopted, would have only applied to economic damages and not medical liability and bodily harm. However, the draft law was not adopted.
Under contract law, valid defences are that the defect or fault arose as a result of:
A force majeure (Act of God).
An external cause (third party action).
The buyer's own fault.
Under tort liability, the defendant must prove that the defect or fault arose as a result of external causes or conduct of the victim (that is, fault or consent of the victim). Under defective product liability, the producer is not responsible if it can prove one of the following:
It did not place the product into circulation.
The defect that caused the damage did not exist at the time the product was placed into circulation or the defect arose after it was put into circulation.
The product was not manufactured for distribution or sale.
The state of scientific or technical knowledge at the time the product was placed into circulation was not such as to enable the discovery of the defect (except for injuries caused by pharmaceutical products using compounds from human bodies, such as blood).
The defect was due to compliance of the product with mandatory provisions or regulations emanating from public authorities.
In addition, the producer of a component is not responsible if it can prove that the defect in the component is attributable to the design of, or the directions given by, the producer of the product in which the component has been fitted.
Under tort and contract law:
Monetary damages resulting from material damage are recovered if the damage is certain, direct and foreseeable. This includes loss incurred, as well as missed gain or loss of opportunity.
Damages for bodily injuries are also recoverable.
Remedies for moral damage are also recoverable, but are difficult to evaluate.
Under defective product liability, compensation is limited to all damages resulting from harm to a person or goods other than the defective product itself.
Punitive damages do not exist under French law. Under French civil law, damages awarded to the claimant by French courts must exclusively compensate the harm suffered (that is, they must not enrich the claimant).
Some of the provisions of Law no. 2011-2012 are still subject to the adoption of specific decrees before they come into force. For example, decrees for provisions governing the French "Sunshine Act" are expected to be adopted during the first half of 2013.
Main areas of responsibility. These include:
T +33 1 5757 8080
F +33 1 5757 8081
E alain.decombe@dechert.com
W www.dechert.com
Qualified. Paris, 1991
Areas of practice. Corporate and healthcare law; international M&A; commercial transactions including life sciences.
Recent transactions
T +33 1 5757 8080
F +33 1 5757 8081
E anne-laure.marcerou@dechert.com
W www.dechert.com
Qualified. Paris, 1997
Areas of practice. Corporate; commercial; M&A; pharmaceutical law including clinical trials, promotional and advertising activities, pricing and reimbursement issues, MAs, data protection and contract manufacturing.
Recent transactions
