Life Sciences & Pharma IP Litigation 2024 Comparisons

Infringement Action

Under Article L.615-2 of the French Intellectual Property Code (CPI), a patent infringement action can be brought by:

• the patentee(s),
• the exclusive licensee, provided that the licence agreement does not stipulate otherwise, and subject to prior notice to the patentee; and
• the non-exclusive licensee, provided that the licence agreement expressly authorises it to do so, and subject to prior notice to the patentee (further to a recent amendment of the CPI).

In order to bring legal action, the patentee and the licensee (exclusive or non-exclusive) must be recorded as such on the French patent register. However, before it is registered, a deed is enforceable against third parties who acquired rights after the date of the deed but who were aware of the deed when they acquired those rights (Article L.613-9 of the CPI).

Even though the infringement action is brought by the licensee (exclusive or not), the patentee can intervene in the procedure in order to obtain compensation for its damages. Likewise, in an action brought by the patentee, the licensee (exclusive or not) can intervene in the procedure in order to obtain compensation for its damages, even if the licence has not been registered on the French patent register.

Where multiple owners exist, a single co-owner may bring patent infringement proceedings, and must notify the other co-owners of the action that has been brought, unless otherwise provided in the co-ownership agreement.

Revocation Action

A patent revocation action may be initiated by any third party with a legitimate interest, defined as a direct and personal interest, on the date of the introduction of the action. French courts have specified that the claimant must demonstrate that the patent is likely to hinder its business activities. Recently, the French Supreme Court (Cour de cassation) upheld a Court of Appeal decision declaring inadmissible an action for invalidation of a patent covering a medicinal product brought by a group of patients and an association of patients taking the medicinal product covered by the patent, in the absence of proof of a standing to seek the revocation of the patent (Cour de cassation, 5 July 2023, 22-14.459).

Infringement Action

As for the claimant, the defendant must have standing to be sued. Any person who is allegedly infringing or threatening to infringe a patent may be sued under French law and can therefore be a defendant to a patent infringement action. In practice, in life sciences/pharma cases, patent infringement actions are most often brought against suppliers and manufacturers, provided that the acts in question were committed in France.

Health regulatory authorities may, in exceptional circumstances, be involved in patent infringement proceedings. In particular, the health authorities may be indirectly involved when an infringement seizure (saisie-contrefaçon) is carried out on their premises at the request of the patentee.

If, as a counterclaim to an infringement action brought by the licensee, the validity of the patent is challenged, the patentee must be brought as a defendant to the proceedings.

Revocation Action

A revocation action can only be brought against the patentee.

The French Patent Office (INPI) is not involved in either infringement or revocation proceedings.

Criteria

Pursuant to Article L. 615-3 of the CPI, preliminary injunction (PI) orders can be granted when evidence makes it likely that a published patent is infringed or that such infringement is about to be committed (a patent application being insufficient to request a PI, as confirmed recently – Paris Appeal Court, 22 March 2023, 22/11165). The judge also takes into consideration the validity of the asserted patent (a prima facie validity assessment).

In addition to these criteria, the judge will also assess the proportionality of the measure before granting a PI order, in order to decide, on this basis and in the light of the risks incurred by the parties, whether or not to prohibit the marketing of the allegedly infringing product. For instance, in a recent decision, the court refused to grant a PI, on the basis that:

• the patent holder did not exploit the patent and thus that the damage could be compensated by damages on the merits;
• the asserted patent was about to expire in the following weeks; and
• the measure would have entirely stopped the sales and thus would have such serious consequences that they would not be able to be compensated by damages, if the case failed on the merits (Paris first-instance court, 20 January 2020, 19/60317).

In theory, the standard is lower than on the merits for both validity and likelihood of infringement, but in practice the discussion will often be quite extensive.

There are no protective letters under French patent law.

Inter Partes PI Proceedings

It is very common for patentees to initiate inter partes PI proceedings before the French courts. The parties are allowed to exchange their briefs until the date of the hearing, which is usually scheduled for two to three months after the commencement of the proceedings before the court. The interim order is then handed down by the court one month later. 

Ex Parte PI Proceedings

Ex parte PI proceedings are theoretically available in France, but they are very rare in practice and French judges are very reluctant to grant PI orders via this procedural track. They will only be granted in cases when urgency requires the granting of a PI order without delay, and when there are no serious doubts about the validity of the asserted patent, which is difficult to assess in the absence of any adversarial debate. The court’s interim order will be handed down in the following days after the PI application is filed with the court.

Trigger for PI Proceedings

A PI order may be granted where infringement of the patent is likely or in the case of likely imminent infringement.

The provisions of the French Public Health Code (PHC) as well as French judges have provided guidance on the trigger for PI proceedings in the pharmaceuticals field. It appears that the completion of prior administrative formalities is not sufficient to characterise imminent infringement. According to the provisions of Articles L.5121-10 and L.5121-10-2 of the PHC, the granting of the marketing authorisation (MA) for a generic or biosimilar product does not infringe the rights of the patent holder. French judges also consider that the registration of the product on the list of reimbursable medicines and the obtaining of the prices and the reimbursement rates for the product from the French Economic Committee for Health Products (CEPS) do not justify the granting of a PI order. A PI order is only granted if positive actions have been taken to demonstrate the willingness to market the generic or biosimilar product before the expiry date of the patent.

Specific Considerations in Life Sciences Cases

When considering whether to grant a PI, French courts will consider whether the generic or biosimilar company sought to “clear the way” before bringing their product to the market. Parties that have not sought to clear the way are likely to be at greater risk of a PI against them.

Bifurcation System

There is no bifurcation as such before French courts: claims related to both validity and infringement are assessed in the same proceedings. Recently, however, the authors have observed a few isolated cases in which judges have decided to sequence the case and to hear the validity issues in a first step, usually when the validity of the patent appears highly questionable.

Parallel Opposition Proceedings

It is possible to initiate nullity proceedings while there are opposition proceedings ongoing in France or in front of the EPO. In addition, where the allegedly infringing patent is the subject of opposition proceedings, a stay of proceedings may be ordered by the court.

Statute of Limitations

Civil actions for patent infringement are confined in a five-year statute of limitations period that runs from the day the plaintiff knew or should have known of the last fact enabling them to initiate the infringement action.

Patent invalidity actions are not subject to any statutes of limitations since 2019 (Art L615-8-1 of the CPI).

Service

Service must be handled by a certified bailiff, and there is no specific requirement concerning the delay in doing so. When the defendant is located abroad, the bailiff must serve the writ of summons, along with a translation in the language in which the defendant is located, by the local process server abroad, who will serve the documents in conformity with their local law of service. Evidence may be filed later directly to the defendant’s legal counsel.

Timeline

Proceedings on the merits before the Paris Judicial Court typically last 18 to 24 months. However, this timeline may be extended depending on the number of patents at stake, the number of parties and the complexity of the case.

Sequencing

The most common sequencing in patent cases, when the plaintiff requests provisional damages and a right to information (if these claims are well-founded and granted), involves:

• inviting the parties to determine the final amount of damages on an amicable basis, using the information communicated under the right to information; and
• if no amicable agreement is achieved, referring the matter back to the court.

Timing

Infringement proceedings may be brought on the basis of a patent application, provided that it has been published or notified to the defendant. In all cases, the court must stay the proceedings until the patent has been granted.

Translation

There is no obligation to provide a full French translation of a European patent, as long as the French version of the claims is provided. However, in the event of a dispute relating to a European patent, the text of which is not drafted in French, the patent owner shall provide at their own expense, and at the request of the alleged infringer or at the request of the court, a full translation of the patent into French.

Burden of Proof

The first prerequisite for filing an infringement action is to gather evidence of the alleged infringement by any means available (see 1.8 Search and Seizure Orders). In this respect, Article L. 615-5-1 of the CPI provides a special procedure for assisting the plaintiff in determining infringement of a process patent. Indeed, the court can order the defendant to prove that the process used to obtain an identical product is different from the patented process. In order to obtain this reversal of the burden of the proof, the plaintiff needs to show that its product and the defendant’s product are identical and that it made efforts to prove that the defendant’s product infringes the process patent.

Where the court orders the reversal of the burden of proof, and the defendant fails to prove that its product was obtained through a different process, any identical product manufactured by the defendant is presumed to have been obtained via the patented process if:

• the product obtained by the patented process is new; or
• while the patentee could not, despite reasonable efforts, determine which was used, it is highly likely that the identical product was obtained by the patented process.

US-style pretrial discovery is not available in France. Although there is no duty of disclosure under French law, a judge can order or facilitate submission of evidence at any stage of the proceedings.

In France, the search and seizure procedure is known as saisie-contrefaçon and is a very specific and efficient probative measure. It is performed as a first step in almost all life sciences and pharma patent cases. It allows any claimant to instruct a bailiff to enter any location and write a detailed description of the alleged infringing product (with or without taking samples) or process. The bailiff may also be assisted by experts (for example, patent attorneys and/or IT experts) designated in the seizure order at the request of the claimant. The order defines the scope of the power granted to the bailiff. They can generally:

• request and collect relevant documents;
• ask questions;
• take notes; and
• draw and physically seize samples of the alleged infringing product.

The order is obtained in the context of ex parte proceedings, either before the introduction of an infringement action (most common) or during the court proceedings. The claimant only needs to prove that they are entitled to bring an infringement action and that the patent is in force. Generally, the claimant brings “reasonably available evidence of infringement” to the courts.

In the order, the judge will usually grant the possibility for the bailiff to keep seized documents covered by trade secrets under escrow, if requested by the seized party.

The infringement action must then be filed within 20 working days or 31 calendar days following the seizure; otherwise, the seizure will be deemed void and the defendant will be entitled to damages.

Seized materials can also be used in proceedings abroad, if that is allowed by local law.

The declaration of non-infringement procedure is available in France under Article L.615-9 of the CPI. Under that procedure, a third party will write to the patentee, describing its product or process and requesting the patentee to confirm that such product/process is not infringing in light of its patent, duly identified.

In the absence of a satisfactory response from the patentee, the third party may introduce a legal action to request a declaratory judgment from the court. Such action does not prevent the requesting party from subsequently seeking the invalidity of the patent.

If the patentee does not respond within three months, the third party can apply in court for the declaratory relief.

Infringement by equivalents is available under Article L. 613-2 of the CPI, which specifies that the scope of protection of the patent is not limited by literal meaning.

French courts apply a broad doctrine of equivalents: “two means are equivalent when, although different in form, they perform the same function with a view to achieving a result of the same nature if not of the same degree; that identity of function, which must be understood as the production of the same primary technical effect, alone characterises equivalence.”

Moreover, the non-obviousness of the accused means is irrelevant, but equivalence will be dismissed if the function was already known from the prior art.

There is no obligation to “clear the way” ahead of a new product launch in France. However, as underlined in 1.3 Preliminary Injunction Proceedings, the behaviour of a third party who did not clear the way before launching its product is often taken into account when assessing PI.

French courts rarely request the assistance of experts. They might do so if they consider that a question of fact requires the explanation of a technician (Article 232 of the French Code of Civil Procedure).

Parties may request written reports from an expert on specific topics (either technical or legal issues).

Oral cross-examination is not available under French procedural law; experts provide their inputs through written reports. 

When requesting the assistance of an expert, the latter will, most commonly, be chosen from among experts certified within the Paris Court of Appeal, to guarantee their impartiality.

Under Article L.615-5 of the CPI, proof of infringement can be provided by any means, including by providing test results from experiment either conducted by the claimant or by an independent laboratory. Experiment results will have greater probative value if they have been conducted by an independent laboratory and if the experiments are realised from samples seized during infringement seizure and sealed by the bailiff.

Article L.615-5 of the CPI provides that proof of infringement can be provided by any means. The main evidence used includes:

• the bailiff’s reports from the infringement seizure;
• the sample seized during said seizure;
• the defendant’s commercial or advertising documents;
• technical reports drawn up by an industrial property attorney; and
• testimonials, etc.

The most common defence to patent infringement is the invalidity of the opposed patent – ie, owing to:

• lack of novelty;
• lack of inventive step;
• no industrial application;
• added matter; and
• insufficiency.

Exceptions to the patentee monopoly are provided by Articles L.613-5 and L.613-7 of the CPI, namely:

• private and non-commercial use;
• experimental use;
• preparation of medicines prescribed and acts concerning such medicines;
• prior use by a party, which in good faith was in possession of the patented invention, before the filing date of the patent (or priority date);
• use of products on foreign vessels, aircrafts and land vehicles; and
• preparatory acts for obtaining regulatory approval from authorities.

When the patentee has consented to a first sale of the patented product within the European Economic Area, the defendant can rely on the exhaustion doctrine if the infringement action is based on the importation and commercialisation of such product in France (Article 613-6 of the CPI).

The defendant can also rely on the lack of respect of procedural aspects – ie:

• the claimant’s lack of standing;
• statute of limitations defence; and
• nullity of the writ of summons.

A stay of proceedings may be ordered by the judge in the context of an infringement or invalidity procedure, if required by the facts of the case, to ensure good administration of justice (Article 378 of the French Procedural Code). The most common scenario is when opposition proceedings are also pending.

Opposition proceedings (either before the EPO or the French Patent Office) and national invalidity proceedings can be pursued in parallel. If the opposition proceedings are already pending when the invalidity claim is brought (either as a main action or as a counterclaim), the court can stay the proceedings.

To determine whether to grant the stay, the court will consider:

• the strength of the opposition’s arguments;
• the stage of the opposition proceedings; and
• the existence of any harmful consequences owing to a possible stay for both the patentee and alleged infringer.

French courts usually do not take into account foreign decisions, but may consider decisions handed down by the UK, German, Dutch or Italian courts when the issue in question has not been settled by national law.

A patent may be amended at any stages of the proceedings and thus during the litigation (including during appeal), but that is rare. Usually, the patentee will limit its patent just before commencing the infringement proceedings.

Pursuant to Article L. 613-25 of the CPI, in the context of an invalidity procedure, the patentee may take the initiative of limiting its ownership by amending the claims. The patent thus limited constitutes the new subject matter of the invalidity action brought. The effects of the waiver or limitation are retroactive to the date of filing of the patent application, and must be registered in the patent register.

To proceed with such amendment, the patentee must file an application for limitation with the French Patent Office (which will only concern the French patent or French part of the European patent) or the European Patent Office (which will concern the entire European patent).

Paris courts have exclusive jurisdiction over patent litigation, regarding French national patents or European patents. Therefore, there is no forum shopping available for either preliminary injunctions or actions on the merits.

French judges do not have technical backgrounds, but all patent cases are allocated to specific chambers of the Paris Judicial Court and Paris Court of Appeal, which only deal with intellectual property (IP) cases.

Infringement Triggers

Launching a generic product on the market before the expiry of the patentee’s rights triggers an infringement action. However, an infringement action may also be brought before the generic product is placed on the market if it is found that acts not covered by the Bolar exemption have been carried out.

Examples of Infringing and Non-infringing Acts

The application for MA, the granting of MA or the granting of a price do not in themselves constitute acts of infringement as seen in 1.3 Preliminary Injunction Proceedings. However, if there are indications that the product will be marketed before the expiry date of the rights, this constitutes a basis for commencing an infringement action.

In addition, French courts interpret the act of bidding on a tender as an act of infringement. For instance, the Paris first-instance court has held that answering to a tender before the expiry date of a patent constitutes an act of infringement (Paris first-instance court, 25 September 2014, 13/08315).

Regarding the particularities related to second medical-use patents, contributory infringement could be characterised in the context of skinny label cases, and in particular if generic companies have not taken steps to prevent the supply of generic products for the patented indications (Paris first-instance court, 2 December 2016, 16/57469).

Data Exclusivity

As a matter of principle, an authorised reference medicinal product benefits from an eight-year period of data protection (from the granting of the MA). During this period, the MA holder has exclusive rights to the results of pre-clinical tests and clinical trials on the medicine. In this regard, an applicant for another MA is not able to rely on the data of the reference MA to submit its application for an MA.

All MAs for a new dosage pharmaceutical form, route of administration and presentation of the initial reference medicinal product, as well as any modifications and extensions, are considered to be part of a single global MA – ie, the concept of global MA. The CJEU adopts a broad assessment of the concept of global MA, considering that subsequent developments of the initial medicinal product, whatever their form (modification of MA or new MA), are included in the concept of global MA. Therefore, in principle, data protection is linked to the medicinal product itself, and not just to its initial MA.

However, fixed-dose combinations are not considered to be included in the same global MA of the already authorised mono-components.

The period of data exclusivity can be extended in some specific cases. When an application is made for a new indication for a well-established substance, a non-cumulative period of one year of data exclusivity shall be granted, provided that significant pre-clinical or clinical studies were carried out in relation to the new indication. A period of one-year data exclusivity may also be granted when a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials. In this case, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant or holder of an MA for a change of classification of the same substance for one year after the initial change was authorised.

Market Protection

The data exclusivity principles should be distinguished from those of market protection. In addition to the data exclusivity mentioned above, the authorised reference medicinal product benefits from a market protection period of ten years. During said market protection period, a generic, a hybrid or a biosimilar of the concerned reference MA cannot be placed on the market.

Generic pharmaceutical companies can file abbreviated applications after the expiry of the eight-year protection period. However, a generic medicinal product which has been authorised cannot be marketed until an additional period of two years has passed, a period known as “commercial exclusivity” or “market protection”. This rule aims at protecting innovative medicinal products against the marketing of generics for ten years after the first MA of the reference medicinal products. This period can be extended by an additional year if the MA holder obtains, during the exclusivity period, an MA for one or more new therapeutic indications that provide a significant clinical benefit compared to existing therapies (the so-called 8+2+1 rule).

Orphan Market Exclusivity

Orphan medicinal products may benefit from a market exclusivity period of ten years from the delivery of the MA. The medicinal product concerned should have an indication of its benefiting from an orphan designation.

Market exclusivity provided in orphan regulation runs in parallel with classic rules related to data exclusivity and market protection.

Paediatrics

An additional two-year period of market protection may be granted for an orphan medicinal product, for the completion of a fully compliant paediatric investigation plan if the results of specific studies are reflected in the summary of product characteristics addressing the paediatric population.

It should also be noted that medicinal products developed specifically for children that are already authorised, but that are not protected by a patent or supplementary protection certificate, are eligible for a paediatric-use MA (PUMA). Where a PUMA is granted, the concerned medicinal product benefits from a market protection period of ten years.

Preparatory acts for obtaining and maintaining an MA are covered by the Bolar exemption according to Article L. 613-5 d) of the IPC, which states that the rights conferred by the patent shall not extend to the studies and trials required to obtain an MA for a medicinal product, as well as to the acts necessary for their completion and for obtaining the MA.

The acts carried out with a view towards obtaining an MA for a medicinal product outside the EU also appear to be covered by the Bolar exemption in France, pursuant to an order (Paris first-instance court, 15 December 2014, 14/58023). French case law is not, however, specifically settled regarding the beneficiaries eligible for the exemption.

Also, generic companies will have no a priori interest in relying on the experimental use exception, since the Bolar exemption is fully enshrined in French law and is quite extensive.

There is no orange book under French law.

The French national agency for the safety of medicines and health products (ANSM) publishes, on the Register of Pharmaceutical Specialties, the information related to authorised medicinal products, in particular including:

• the date of the MA;
• the name of the MA holder;
• the type of procedure used; and
• whether the medicinal product is currently marketed.

In France, pursuant to Article R. 5121-5 of the PHC, the General Director of the ANSM should inform the MA holder of the reference medicinal product within one month of the delivery of an MA for a generic medicinal product. At the end of a sixty-day period following this information, the General Director of the ANSM will register the generic medicinal product in the register of generic groups.       

Delivery of an MA

As mentioned in 1.3 Preliminary Injunction Proceedings, in the case of a generic or hybrid product, an MA may be granted before expiry of the patent rights associated with the reference product concerned. Moreover, when the ANSM has issued an MA for a generic or hybrid medicinal product, it notifies the MA holder of the reference medicinal product.

The granting of the MA is not related to the status of the patent.

The General Director of the ANSM registers the generic medicinal product in the public register of generic groups after a period of 60 days, after having informed the MA holder of the reference medicinal product of the granting of the MA for the generic medicinal product. However, this generic product may not be marketed until the patent rights have expired, except with the approval of the holder of these rights.

Solely for the purpose of ensuring publicity, the General Director of the ANSM shall make available to the public the list of patent rights attached to a reference proprietary medicinal product if the holder of the MA for this proprietary medicinal product has communicated it to the ANSM for this purpose. The company is entirely responsible for the accuracy of the information provided.

Pricing/Reimbursement

The agreement signed between the CEPS and the union representing the pharmaceutical industry in France (LEEM) provides for the following rules related to patent and supplementary protection certificates (SPCs):

• companies exploiting chemical or biological medicinal products for which they hold one or more patents or SPCs declare, on an indicative basis, to the CEPS the relevant rights and their expiry date for the three years following the initial signature of the agreement with the CEPS and that of each update;
• the CEPS makes its statements available to any pharmaceutical companies that request them; and
• no registration of a generic or biosimilar product on the list of reimbursable medicinal products is published more than six months before the declared date of cessation of IP rights, if these have been notified to the CEPS.

However, any pharmaceutical company which considers that it can market the generic or biosimilar medicinal products concerned without infringing the declared IP rights may request that such products be included in the list of reimbursable medicinal products. In this case, the pharmaceutical company must inform the CEPS in writing, which immediately informs the reference medicinal product exploitant. The CEPS initiates the procedure for registration of such generic/biosimilar on the list of reimbursable medicinal products.

The assessment of acts of infringement will be the same for both generic and biosimilar medicines. However, in the case of a biosimilar, the nature of the medicinal product involves additional preparatory steps in obtaining and maintaining the MA, which will be taken into account indirectly by French courts. Provided that these additional measures are necessary for obtaining and maintaining an MA, they will be covered by the Bolar exemption.

See section 2.2 Regulatory Data and Market Exclusivity.

See 2.3 Acceptable Pre-launch Preparations. The Bolar extension covers both generic and biological medicines, so the acts covered by the Bolar exemption will be the same for both generic and biosimilar medicinal products.

According to Article R.5121-9-2 and R.5121-9-4 of the PHC, when an MA is granted for a biological medicine which can be identified as a similar biological medicine, the Director General of the ANSM:

• identifies it as a similar biological medicine, mentioning the corresponding reference medicine, by a decision, which they may supplement with recommendations and warnings, and which they notify to the holder of the MA issued for this similar biological medicine; and
• informs, within one month following this notification, the holder of the MA for the reference biological medicine of the issuance of an MA for the similar biological medicine mentioned above.

After a period of sixty days following the receipt of the information by the holder of the authorisation, the Director General of the ANSM includes the similar biological medicine on the reference list of similar biological groups.

Decisions to include a medicine on the reference list of similar biological groups, to modify these decisions, and to remove them from this list are published on the website of the ANSM.       

Delivery of an MA

As mentioned in 1.3 Preliminary Injunction Proceedings, according to Article L. 5121-10-2 of the PHC, for a similar biological medicinal product, the MA may be issued before the expiry of the IP rights attached to the reference biological medicinal product. In such case, the applicant for the MA must inform the holder of these rights at the same time as submitting the MA application.

According to the same Article, prior to marketing, the MA holder of the similar biological medicinal product must inform the General Director of the ANSM of the indications, pharmaceutical forms and dosage of the reference biological medicinal product for which the IP rights have not expired. For the sole purpose of ensuring publicity, the General Director of the ANSM shall make available to the public the list of IP rights attached to a reference biological medicinal product, if the MA holder of this medicinal product has communicated it to the ANSM for this purpose. The pharmaceutical company is solely responsible for the accuracy of the information provided.

Pricing/Reimbursement

See section 2.5 Reimbursement and Pricing/Linkage Markets.

Under Article L.611-3 of the CPI, any owner of a patent effective in France and covering a medicinal product, a process for obtaining a medicinal product, a product necessary for obtaining such a medicinal product, or a process for manufacturing such a product, may obtain an SPC when these products are used to produce a pharmaceutical speciality covered by an MA. SPCs are thus used exclusively in the pharmaceuticals sector.

The validity requirements of SPCs are provided by EU Regulation No 469/2009, CJEU case law and national case law. The SPC takes effect when the basic patent expires, and it is valid for five years. The general protection that a patent and an SPC can offer cannot exceed 15 years from the date on which the first marketing authorisation is obtained.

SPCs may only be granted to the patent owner of the product covered by the SPC application. If several patents cover the same product, all the patent owners may benefit from an SPC for that product. Likewise, if a patent covers several products, which can all benefit from an SPC, several SPCs may be granted for each product.

An SPC for a combination product may be granted provided that such combination is covered by the basic patent.

The term of an SPC may be extended by six months if the SPC owner provides the results of studies carried out in accordance with a paediatric investigation plan, provided that the results of these studies are reflected in the product characteristics of the MA (Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, Article 36.1).

However, this extension is not available if the medicinal product targets a paediatric orphan disease, since a marketing exclusivity is already granted (Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, Article 36.4).

Pursuant to Article L. 615-3 of the CPI, the court may subject the execution of the measures ordered to the provision of guarantees by the plaintiff to ensure the possible compensation of the defendant if the infringement action is later found to be groundless or if the measures are revoked. This mechanism is an option available to French judges, but in practice is not often used.

There is no mechanism under French law for the automatic payment of a guarantee in order to enforce the PI. The PI order is enforceable by service.

Final injunctions are enforceable as soon as the opposing party is served with the decision ordering the final injunction. The decision is served by a bailiff and this procedure is very swift if the opposing party is located in France. On the other hand, service will take longer if it has to be effected against a company located overseas.

There is no time limit as such for serving the decision on the opposing party.

Alternative to Injunction

Pursuant to Article L. 615-3 of the CPI, French courts can prevent the continuation of acts of infringement by issuing an injunction, but they can also make the continuation of acts of infringement subject to the provision of guarantees designed to ensure that the claimant is compensated, if necessary.

Public Interest

When assessing the appropriateness of injunctions, French judges may take into account the public interest. For instance, in a recent decision, a judge denied the granting of a PI given that the defendant had raised serious arguments regarding the invalidity of the asserted patent; though judges have also been sensitive to public interest when invoking the prolongation of patients’ lives (Paris first-instance court, 12 May 2021, 21/53136).

French law implies the use of several criteria for determining damages, in order to offer total repair; although punitive damages are prohibited under French law.

There are two approaches to calculating the amount of damages to be paid by the infringer. Firstly, the judge may rely on the negative economic consequences to determine the amount of damages, including the loss of profits suffered by the injured party and the profits made by the infringer. Alternatively, the judge may calculate the amount of damages by determining a lump sum that may not be less than the amount of royalties that would have been payable if the infringer had requested authorisation to use the infringed patent.

Under French law, the successful party will be reimbursed for all or part of its legal costs (attorney’s fees) via Article 700 of the French Procedural Code. This mechanism allows the winning party to be compensated. Court-related costs are non-existent or insignificant, so they are not covered by Article 700.

The governing principle in French law is full reparation of the damage. Thus, French courts are not supposed to take into account the claimant’s conduct in order to reduce the damages awarded and to be paid by the infringer.

Nevertheless, the defendant will always be able to ask the judge for damages if the defendant believes that the claimant’s conduct resulted in prejudice.

In addition, a French court may indirectly take the claimant’s conduct into account when determining the amount under Article 700 of the French Procedural Code, by reducing such amount if it considers, for example, that the claimant did not show a high level of loyalty during the proceedings. In this way, negative conduct on the part of the claimant could be sanctioned by a reduction under Article 700 of the French Procedural Code.

Trade mark disputes are relatively common in the life sciences and pharma sector.

The relevant sources of law are the French CPI and the EU regulations for EUTMs, as well as the French PHC. In addition, the ANSM, which is in charge of assessing and authorising medicine names and packaging as well as promotional materials, has published recommendations on how to select a name for a pharmaceutical product, which are followed and applied by pharmaceutical companies.

For ease of reference, please see below:

• for recommendations for the names of the medicinal products and packaging, see here; and
• for recommendations on promotional materials, see here.     

According to these provisions and recommendations, the name of a medicine can either be:

• a fantasy name; or
• the common or scientific name of the medicine, combined with a trade mark, the name of the MA holder or of the firm marketing the medicine, with the status of “exploitant” (operator).

The fantasy name must not be confusing with:

• the common name of the medicine;
• any other medicines or other products with a therapeutic purpose (such as medical devices) or a cosmetic purpose; or
• food products.

In addition, the fantasy name must not be deceptive as to the quality, properties or composition of the medicine.

In terms of labelling, the ANSM checks that the labelling meets the EU recommendations provided in the “Guideline on the readability of the labelling and package leaflet of medicinal products for human use”, available here (see above for the ANSM’s recommendations in this respect).

In addition, the ANSM prohibits the practice of pluri-status umbrella brands (ie, the use of the same mark for medicines and other products, such as medical devices, cosmetics, food supplements, etc)  and strongly advises against the practice of mono-status umbrella brands (ie, the use of the same mark for medicines for different therapeutic indications).

Copyright disputes regularly arise, generally when the packaging or communication materials are similar to that of a competitor or third party. These issues may arise in standalone litigation or alongside a trade mark infringement claim. A claimant will generally look at labelling and packaging when there is a likelihood of confusion between the marks to check if there is also copyright infringement.

Copyright disputes can also involve pharmaceutical companies and their providers (eg, advertising or marketing agencies) and usually relate to contractual breaches or claims regarding the ownership of the relevant work.

The relevant source of law is the CPI. As indicated in relation to trade marks, the ANSM, which is notably in charge of assessing and authorising medicine packaging as well as promotional materials, has published recommendations which are followed and applied by pharmaceutical companies (See 6.1 Trade Marks).

In terms of labelling, the ANSM ensures that the labelling meets the EU recommendations provided in the “Guideline on the readability of the labelling and package leaflet of medicinal products for human use”, as mentioned in 6.1 Trade Marks.

Issues Related to Trade Secrets

Trade secrets disputes are not that common in the life sciences and pharma sector in France. However, trade secret protection is often raised by pharmaceutical companies in order not to disclose sensitive information about their products or activities, particularly in the context of infringement seizures and requests for investigatory measures. Protective measures can also be taken upstream by the claimant or the judge in order to preserve trade secrets of the seized party.

The ANSM also relies on trade secrets to limit the level of information disclosed to a third party who requests the disclosure of an MA dossier (for example, in the context of a claim against a pharmaceutical product).

Disputes on trade secrets per se generally arise between pharmaceutical companies and their former consultants or employees, where the challenge will be to demonstrate that the confidential proprietary information is being used by the third party.

Sources

The relevant sources of law are the French Commercial Code and the CPI.

Preliminary Injunctions

The right moment for requesting a PI before the Paris first-instance court is a key element of the patent/SPC owner’s strategy. Indeed, a PI can be requested before any action on the merits, and then, even if successful, an appeal may be lodged within a period of 15 days following the PI order, with the appeal decision being rendered four to six months after the PI order – ie, while the action on the merits before the Paris judiciary court is still pending. With a strong case, in which validity and infringement are not disputable, this is something to contemplate since urgency is key to forbidding any marketing in France of a competing medicinal product. The risk, though, is that the balance of interests may play against the claimant (patent/SPC owner) and that the alleged infringing medicine may be marketed with the authorisation of the court, while waiting for a final decision on the merits and potential related financial damages.

Another option would be to first start an action on the merits for infringement, and during said action request a PI which, if successful, will only be appealable with the first decision on the merits – meaning one year (or even more) later. The impact is thus stronger, with the risk of the PI being overturned by the Paris Court of Appeal.

Said PI appeal, whenever it takes place, will be de novo, with every element (validity, priority, infringement, etc) being discussed again in depth before the Paris Court of Appeal.

Decision on the Merits

According to Article 538 of the French Procedural Code, applicable to patent actions (infringement, validity, etc), the time limit for lodging an appeal is one month from the service of the first-instance decision. If an appeal is lodged, a new examination of the merits takes place and every argument will be discussed again in depth before the Paris Court of Appeal, including new evidence and witness reports, if need be.

Effects of the Appeal Procedure

If the patent is revoked or if a preliminary or final injunction is overturned on appeal, the prior injunctions are lifted, being thus deprived of grounds. A claim for financial compensation may then be brought by the defendant, depending on the damages suffered.

The Paris Court of Appeal has exclusive jurisdiction in patent matters, and patent disputes are assigned to judges who are highly specialised in patent law.

The panel of judges overseeing patent cases is made up of three judges, and they can use the assistance of an expert.

Specific Rules Regarding SPCs

In France, specific rules govern the granting of an SPC by the French Patent Office (INPI), with appeal possible before the Paris Court of Appeal, and then before the Commercial Chamber of the French Supreme Court. Before the INPI, all the evidence (including witness statements) must be produced and discussed, since the following appeal will rest solely on the basis of the elements and arguments discussed before the INPI.

Customs Detention

Customs may seize and retain infringing products (and more specifically, infringing medicines) at the request of the patent/SPC owner, on the basis of EU law or French law. According to Article L.614-32 of the IPC, after a written request from said owner, the French customs can hold the alleged infringing medicines, with immediate notification to the claimant and to the goods holder. Article R. 614-37 also provides the opportunity to the French customs to take limited samples, when possible, of the alleged infringing medicines or related chemical compounds. However, no samples may be given to the patent/SPC owner.

Opposition Procedure at the National Level, and Strengthening of the Quality of National Patents

As regards French national patents, new measures have recently been introduced by the so-called PACTE law, in order to make the French patent system more attractive. The patent examination process before the INPI is strengthened as the inventive step is now examined. Said law also introduced an opposition procedure similar to that carried out before the European Patent Office for European patents. French national patents may be a strategical option for smaller life sciences companies, or for life sciences companies mainly doing business in France.

UPC System

Last but not least, the Unified Patent Court (UPC) opens up new possibilities and patent litigation strategies. It is important to consider the possibilities offered by the UPC as well as the impact of parallel jurisdiction between the UPC and national courts in the context of the pending transitional period (the courts having parallel jurisdiction in the event that no opt-out notice has been filed or in the event that the opt-out notice is withdrawn). In the case of parallel jurisdiction of the UPC and national court, the different strategic options will have to be considered before a decision is taken, in particular taking into account the costs and the timing.

Life sciences patent disputes mainly concern invalidity actions brought by generic and biosimilar manufacturers to anticipate the launch of a medicinal product on the market and clear the path. PI actions aim to prevent the launch of a medicinal product on the market; and infringement actions concern this on the merits, on the basis of a patent and/or on the basis of an SPC and litigation related to SPCs in order to benefit from an extension of rights.

Such disputes do not generally lead to negotiation between the parties via mediation or arbitration mechanisms, given that it will be difficult for each of the parties involved to make concessions, and given that such agreements could present a risk from the standpoint of competition law. 

However, the Paris first-instance court (tribunal judiciaire), which is the only court with jurisdiction over patent litigation, typically offers the parties a mediation procedure at the first case management hearing (orientation hearing) to explore any mediation options. Mediation remains an interesting option for settling a dispute, since it is rather quick (potentially around three months) and is comparatively cheap. It can be more appropriate for a patent claim ownership dispute rather than for any other types of life sciences patent disputes.

Even if antitrust considerations were key in the life sciences sector (eg, when a dominant position is involved), there is no particular scrutiny in France regarding pharma/biopharma settlements, as confirmed by the authors’ antitrust colleagues and mutual experience of life sciences patent disputes.