Historical Context of Pharmaceutical Patents in France
France has a complex history regarding the patentability of pharmaceutical products. Until 1960, pharmaceutical products were excluded from patentability due to public health concerns, such as the fight against charlatanism. However, during the inter-war period, the French patent office (INPI) began examining and issuing process patents for a broad range of health products, including biological preparations like hormones and vaccines[1].
Current Patentability Criteria
Patentable Subject Matter
In France, biotechnological inventions, including those related to biopharmaceuticals, are patentable under certain conditions. The European Patent Convention (EPC) and the French Patent Office guidelines dictate that inventions concerning plants or animals are patentable if the application is not technically confined to a single plant or animal[4].
Unity of Invention
For a patent to be granted, the application must comply with the unity of invention principle. This means that the application can contain claims directed to a product, its manufacturing process, and its use, or claims directed to a process and a machine used in that process[5].
Formal Examination
The French Patent Office conducts a formal examination of all patent applications. The application must include a description of the invention and claims defining the scope of protection. The claims should be drafted in two parts: a preamble defining the generic object and a characterizing part stating the novel technical features[5].
Scope of Claims
Purpose-Limited Product Claims
In the context of biopharmaceuticals, purpose-limited product claims are significant. These claims, such as those under Article 54(5) EPC, seek protection for a specific medical use of a known substance. This type of claim is allowed if it represents a new medical indication of the substance[3].
Swiss-Type Claims
Swiss-type claims, which are purpose-limited process claims, also play a role. These claims confer less protection than purpose-limited product claims and are considered an exception under the old EPC 1973 provisions. They are used for the manufacture of a medicament for a specific therapeutic use[3].
Enforceability of Biopharmaceutical Patents
Infringement Actions
In France, patent infringement actions can be brought against any person allegedly infringing or threatening to infringe a patent. These actions are often directed against suppliers and manufacturers. The defendant must have committed the infringing acts within France to be sued under French law[2].
Standing to Sue
For a third party to initiate a patent revocation action, they must demonstrate a direct and personal interest that is likely to be hindered by the patent. French courts have specified that patients or patient associations do not have standing to seek the revocation of a patent unless they can prove a legitimate interest[2].
Preliminary Injunctions (PI)
French courts consider whether a generic or biosimilar company has sought to “clear the way” before bringing their product to market when deciding on preliminary injunctions. The granting of marketing authorization, registration on the list of reimbursable medicines, and obtaining prices and reimbursement rates do not justify a PI order unless positive actions have been taken to demonstrate the willingness to market the product before the patent expiry date[2].
Specific Considerations in Life Sciences Cases
Bifurcation System
Unlike some jurisdictions, France does not have a bifurcation system where validity and infringement are assessed in separate proceedings. However, in some cases, judges may decide to sequence the case and hear validity issues first if the patent's validity is highly questionable[2].
Parallel Opposition Proceedings
It is possible to initiate nullity proceedings while opposition proceedings are ongoing in France or before the European Patent Office (EPO). A stay of proceedings may be ordered by the court if required by the facts of the case[2].
Statute of Limitations and Exhaustion Doctrine
Exhaustion Doctrine
If 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 commercialization of such a product in France[2].
Statute of Limitations
The French Procedural Code allows for a stay of proceedings in the context of an infringement or invalidity procedure to ensure good administration of justice. This is often the case when opposition proceedings are also pending[2].
Amendment of Patent Claims
Limitation of Patent Claims
The patentee can limit the claims of a patent by filing an application for limitation with the French Patent Office or the EPO. This limitation can be made during an invalidity procedure, and the effects are retroactive to the date of filing the patent application[2].
Jurisdiction and Procedure
Exclusive Jurisdiction
Paris courts have exclusive jurisdiction over patent litigation regarding French national patents or European patents. This eliminates the possibility of forum shopping for preliminary injunctions or actions on the merits[2].
Health Regulatory Authorities
Involvement in Patent Infringement Proceedings
Health regulatory authorities may be indirectly involved in patent infringement proceedings, particularly when an infringement seizure is carried out on their premises at the request of the patentee. However, the completion of prior administrative formalities is not sufficient to characterize imminent infringement[2].
Key Takeaways
- Historical Context: France has evolved from excluding pharmaceutical products from patentability to allowing process patents and eventually product patents.
- Patentability Criteria: Biopharmaceutical inventions are patentable if they meet the unity of invention principle and are not technically confined to a single plant or animal.
- Scope of Claims: Purpose-limited product claims and Swiss-type claims are crucial in defining the protection scope for biopharmaceuticals.
- Enforceability: Infringement actions are common against suppliers and manufacturers, and standing to sue requires a direct and personal interest.
- Preliminary Injunctions: Clearing the way before market entry is essential for generic or biosimilar companies to avoid PI orders.
- Bifurcation and Opposition Proceedings: While bifurcation is not standard, judges may sequence cases, and parallel opposition proceedings can be initiated.
- Statute of Limitations and Exhaustion Doctrine: The exhaustion doctrine and statute of limitations play significant roles in defending against infringement actions.
- Amendment of Claims: Patentees can limit claims during invalidity procedures, with retroactive effects.
- Exclusive Jurisdiction: Paris courts have exclusive jurisdiction over patent litigation.
Frequently Asked Questions (FAQs)
1. What was the historical stance of France on pharmaceutical patents?
France excluded the patentability of pharmaceutical products from 1844 to 1960, primarily to combat charlatanism and ensure public health safety[1].
2. How does the unity of invention principle apply to biopharmaceutical patents in France?
The unity of invention principle requires that the application contains claims directed to a single invention, such as a product, its manufacturing process, and its use, or claims directed to a process and a machine used in that process[5].
3. What is the difference between purpose-limited product claims and Swiss-type claims?
Purpose-limited product claims seek protection for a specific medical use of a known substance, while Swiss-type claims are purpose-limited process claims that confer less protection and are used for the manufacture of a medicament for a specific therapeutic use[3].
4. Under what conditions can a third party initiate a patent revocation action in France?
A third party must demonstrate a direct and personal interest that is likely to be hindered by the patent to initiate a patent revocation action[2].
5. How do French courts determine the granting of preliminary injunctions in biopharmaceutical cases?
French courts consider whether the generic or biosimilar company has sought to “clear the way” before bringing their product to market and whether positive actions have been taken to demonstrate the willingness to market the product before the patent expiry date[2].
Sources:
- Cassier, M. (2018). Patents and Public Health in France: Pharmaceutical Patent Law in France. HAL.
- Chambers and Partners. (2024). Life Sciences & Pharma IP Litigation 2024 - France. Practice Guides.
- European Patent Office. (2022). 7.2.3 Purpose-limited product claims and Swiss-type claims. Case Law.
- European Patent Office. (2024). 5.2 Patentable biotechnological inventions. Guidelines for Examination.
- CASALONGA. (n.d.). Patents in France. Documentation.
