An extract from The Patent Litigation Law Review, 3rd Edition
Types of patent
The French Intellectual Property Code (IPC) provides three types of titles that protect inventions and confer upon their owners an 'exclusive right of exploitation'. These are patents, utility certificates and supplementary protection certificates. An invention can be protected under one of these titles if the relevant patent, utility model or supplementary protection certificate is delivered by the French Intellectual Property Office (IPO).i PatentsNational patents
French national patents are granted for inventions that are new, inventive and capable of industrial application. Such patents last for 20 years.
Under French law, various fields of inventions are expressly excluded from patentability, including:
- the human body (and notably the total or partial sequence of a gene);
- methods of surgical or therapeutic treatment of the human or animal body and diagnostic methods applied to the human or animal body; and
- inventions whose commercial exploitation would be contrary to the dignity of the human person, public policy or morality.
Contrary to the case law of the European Patent Office (EPO), the patentability of a dosage regime remains unsettled. Although one decision indicated that a particular dosage could be patented where the purpose of such dosage is to achieve a specific technical effect, it is usual for patent applications for dosage regimes to be rejected to allow doctors freedom and flexibility in their provision of treatment.
The PACTE law provides some very significant changes with respect to the examination and opposition proceedings before the IPO. Indeed, it will notably introduce the reinforcement of the examination process by the IPO, which will be entitled to assess inventive step of French patent applications and an opposition procedure before the IPO, so that the latter can review the main grounds of validity (including inventive step).
The IPO will continue to verify that the application conforms to other classical substantive conditions: the application should relate to a technical invention, respect the principle of unity of the invention, and the claims should be based on the description. Once this examination has been carried out, the IPO provides a search report to the applicant that lists patents and documents relevant to the invention that is the subject of the application, along with an indicative opinion on the patentability of the invention. The applicant then has the option to respond and amend its claims. Following any submissions or amendments from the applicant in response to the IPO's first search report, the IPO will grant or reject the application.European patents
France is a party to the European Patent Convention (EPC) and can consequently be a designated jurisdiction in a European Patent.International applications
France is a party to the Patent Cooperation Treaty (PCT) and can be designated in a PCT application, as a member of the EPC.ii Utility certificates
Utility certificates are issued by the IPO for six years, without the need for a search report. However, such report will be required if infringement proceedings are initiated.
A patent application can be converted into a utility certificate application. The PACTE law provides that a utility certificate application will last for 10 years and can be converted into a patent application.iii Supplementary protection certificates (SPCs)
SPCs are governed by Regulation (EC) No. 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products.
SPCs can be filed at the IPO by any owner of a patent that has effect in France and that relates to:
- a medicinal product;
- a process for obtaining a medicinal product;
- a product necessary for the production of that medicinal product; or
- a process for the manufacture of such a medicinal product, and that is the subject of a marketing authorisation (MA).
SPCs must be filed within six months after the grant of the first MA (or within six months of the grant of the patent if the MA is granted before the patent).
The IPO has implemented both the Seattle Genetics and the Incyte Corporation decisions of the European Court of Justice, regarding the definition of the date of the first MA in the Community (notification date). However, in the case of a French MA, the starting date of the six-month time limit is still the date on which the MA is granted.
SPCs enter into force once the basic patent expires. They last for the duration specified in Article 13 of Regulation (EC) No. 469/2009, and up to a maximum of five years. The maximum term of an SPC can be extended by six months if the medicinal product obtains a paediatric extension.
Several questions regarding SPCs remain unsettled. The question of whether an SPC can be granted for a new application or new formulation of an active ingredient when the latter is already the subject matter of a previous SPC remains open following the Abraxis decision. The scope of protection of an SPC covering a combination of active ingredients has also generated significant litigation in France.
New Regulation (EU) No. 2019/933 entered into force on 1 July 2019 and modified former Regulation (EC) No. 469/2009 by introducing waivers to the protection conferred by an SPC. These waivers allow for the manufacturing of medicinal products and all 'related acts', within the territory of protection of an SPC, for holding and export (outside the EU) purposes. The notion of 'related acts' being undefined in the regulation, we may expect some litigations in the near future on this topic.
Substantive lawi InfringementActs constituting infringement
The IPC broadly defines acts constituting patent infringement as:
- the manufacture, supply, placing on the market, use, importation, exportation, transshipment or holding of, for the aforementioned purposes, the product subject to the patent;
- the use of a process subject to the patent or, where the third party knows or where circumstances make it clear that the use of the process is prohibited without the consent of the owner of the patent, the offer of its use on French territory; and
- the supply, placing on the market, use, importation, exportation, transshipment or possession for the aforementioned purposes of the product obtained directly by the process subject of the patent.
Contributory infringement is also prohibited under French law.
As regards pharmaceutical patents covering an active ingredient, the fact that a generic company obtains an MA for its generic product does not indicate imminent infringement for the purposes of obtaining a preliminary injunction. However, additional circumstances, for example arising from correspondence with regulatory authorities or advertising, may help prove imminent infringement. The standard of proof is nevertheless quite high.Doctrine of equivalents
In principle, a patent is a self-contained title where the sole purpose of claim construction is to understand the exact scope of the monopoly right granted under the patent, taking into account description and drawings, after examination or opposition procedures.
File wrapper estoppel is not applied under French law, although a patentee's declarations before the relevant authorities, including patent offices, in foreign jurisdictions can be taken into consideration to assess the overall credibility of the patentee's assertions.
Construction must be true to the claims and must not change the nature of the patent, but it must also not be too literal. Under the doctrine of equivalents, a party might be held liable for patent infringement even though the infringing device or process does not fall within the literal scope of the claims of a patent, but is nevertheless equivalent to the claimed invention. The doctrine considers that two means are equivalent if, despite being of a different shape, they perform the same function in view of the same result, provided the function exercised by the patented device or process is novel.ii Invalidity and other defencesInvalidity
A French or European patent can be revoked for:
- a lack of novelty;
- a lack of inventive step;
- a lack of industrial application;
- excluded subject matter;
- added matter beyond the content of the application as filed;
- an extension of the scope of the patent claims after limitation or amendment; or
- if the proprietor of the patent is not the inventor nor his or her successor in title (taking into account relevant employment law).
If the grounds of invalidity affect only part of a patent, nullity is affected by limiting the relevant claims.
A trend of French case law is to consider, in the context of inventive step or insufficiency, whether the patent solves the technical problem it is supposed to and if the patent presents a plausible way of solving the technical problem at the date the patent was filed across the breadth of the claims.
In this respect, some decisions have required patents to include tests or data to show that the technical effect or effects of the patent can be reached. In the absence of any such tests, post-filing evidence should be dismissed. This case law was ambiguous and relied on the vague notion of a 'speculative' patent. A more classical approach of plausibility seems to have been adopted by the Paris courts since 2018. The Supreme Court has confirmed that there is no legal requirement to provide for clinical data within the description, but admitted that, in specific cases where a patent covers a new therapeutic application of a known compound, the patent application must reflect directly and unambiguously the claimed therapeutic application. How this general ruling will be applied in practice remains uncertain.Acts that cannot infringe a patent monopoly
Patent rights cannot be infringed by:
- acts done privately and for non-commercial purposes;
- acts done for experimental purposes relating to the subject matter of the patented invention;
- the extemporaneous preparation for individual cases in a pharmacy of a medicine in accordance with a medical prescription, or acts concerning the medicine so prepared;
- studies and tests required for the granting of an MA for a medicinal product, as well as for the acts necessary for their realisation, for obtaining said authorisation and for obtaining the required advertising (the Bolar exemption); and
- acts related to extra-atmospheric space vessels introduced into French territory.
The French Bolar exemption is not limited to generic drugs, but applies to any drug, including biosimilar drugs. The Bolar exemption also covers the allocation of medical drugs to patients in the framework of temporary use authorisation (by name or cohort).Personal prior possession
Any person who, in good faith on the date of filing or priority of a patent, was in possession of the invention subject of the patent, has the personal right to exploit the invention despite the existence of the patent. However, this right is limited and cannot be transferred.Exhaustion of rights
The rights conferred by the patent do not extend to acts concerning the product covered by that patent carried out on French territory after the product has been placed on the market in France or on the territory of a state party to the Agreement on the European Economic Area by the proprietor of the patent or with his or her express consent.
Such a solution stems from the principles of free movement of merchandise, goods and services within the EU. Provided that the patent owner has agreed to the marketing of its products in the EU, he or she will not be able to rely on its patent to prevent the circulation of such goods within the EU.Competition law
Competition law can be used as a defence in patent litigation. In some cases, patent rights may be limited by the courts to prevent anticompetitive behaviours (such as an abuse of a dominant position).
Notably, the Paris courts will take into consideration fair, reasonable, and non-discriminatory (FRAND) issues related to standard-essential patents before granting an injunction on the basis of such rights.Good faith is irrelevant
Infringement will be found irrespective of any good faith on the part of the infringer. However, indirect infringers cannot be held liable for carrying out acts that they did not know infringed a third party's patent rights.