Last updated: July 28, 2025
Introduction
The French patent system offers a strategic landscape for biopharmaceutical companies seeking intellectual property protection. Ensuring patentability, enforceability, and comprehensive claim scope demands a nuanced understanding of France’s legal and regulatory frameworks. This article delineates critical considerations for securing robust biopharmaceutical patents within the French patent office (INPI — Institut National de la Propriété Industrielle), aligning with European Patent Office (EPO) standards, and addressing unique aspects pertinent to biotechnology innovations.
Patentability of Biopharmaceutical Innovations in France
1. Novelty and Inventive Step
Biopharmaceutical patents in France are evaluated under the same criteria as across Europe. The invention must be novel, meaning it has not been disclosed publicly before the filing date or priority date, and involve an inventive step that is non-obvious to a person skilled in the art. Prior disclosures, including scientific publications, public use, or regulatory filings, can jeopardize novelty.
Implication: Patents must be filed early, before any public disclosures, to secure the earliest possible protection.
2. Industrial Applicability
The invention must be susceptible of industrial application. For biopharmaceuticals, this criteria is generally met if the claimed compound, process, or use can be applied in pharmaceutical manufacturing or therapeutic contexts.
3. Patentable Subject Matter
The French Patent Act aligns with European standards, explicitly excluding certain discoveries and mere discoveries of natural substances from patentability [1]. However, isolated and purified natural products with industrial applications are patentable if they exhibit specific, novel properties or uses.
Key nuance: Claims directed to naturally occurring substances are patentable when they involve a novel, inventive application or a specific new use, arguably overcoming the "discovery" barrier.
4. Exceptions and Clarifications
Under French law, inventions that contravene ordre public or morality are unpatentable. Additionally, biotechnological inventions involving human embryonic stem cells remain controversial, with legal restrictions in place.
Regulatory context: The European Directive 98/44/EC significantly influences France’s approach, broadening the scope of patentable biotechnological inventions but maintaining certain moral and ethical restrictions.
Enforceability Considerations in France
1. Validity as a Prerequisite for Enforcement
In France, patent enforcement is predicated on the patent’s validity. A patent deemed valid can be enforced through infringement litigation, whereas an invalid patent cannot.
Key point: Ensuring comprehensive and robust prosecution reduces risks of invalidation, bolstering enforceability.
2. Grounds for Patent Nullity
Post-grant challenges in France can be initiated via nullity proceedings, which may contest the patent’s validity based on formal deficiencies, lack of inventive step, lack of novelty, or unpatentable subject matter.
Tip: Conducting thorough freedom-to-operate (FTO) and validity opinions pre-litigation mitigates enforcement risks and enhances enforcement confidence.
3. Patent Litigation Landscape
French courts apply the European Patent Convention (EPC) standards in patent disputes. Enforcement actions often involve preliminary injunctions and damages claims. The courts assess claim scope, prior art, and patent validity meticulously.
Notable: The Cour de cassation has emphasized the importance of precise claim interpretation, especially for biopharmaceuticals where claim language directly impacts scope and infringement scope.
Scope of Claims for Biopharmaceutical Patents
1. Claim Drafting Strategies
Effective claims in biopharmaceutical patents must balance breadth with validity. Overly broad claims risk invalidation, while narrow claims may limit enforcement.
Best practice: Draft a core set of broad claims covering the composition or invention, complemented by dependent claims specifying particular embodiments, polymorphs, or methods.
2. Patent Claims for Biological Materials
French and broader European practice allow claims directed to isolated biological substances, methods of producing them, and their medical uses. For example:
- Product claims: Covering specific proteins, DNA sequences, or cell lines.
- Method claims: Covering processes for producing biopharmaceuticals.
- Use claims: Covering new therapeutic uses, in line with the second medical use concept.
Note: Claims to naturally occurring substances require demonstrating a specific, inventive application to meet patentability standards.
3. Patent Term and Extensions
Standard patent duration in France is 20 years from the filing date. Supplementary Protection Certificates (SPCs) may extend protection for biopharmaceutical products, contingent upon regulatory approval processes.
Strategy: Proactively seek SPCs post-grant to extend exclusivity, aligning with the European Medicines Agency (EMA) approval timeline.
4. Handling Patent Clarity and Sufficiency
Claims must be clear and supported by the description. Ambiguous “Markush” group claims or overly broad wording risk invalidation. The description should contain sufficient detail enabling a person skilled in the art to replicate the invention.
Regulatory and Ethical Considerations
Biopharmaceutical patent strategy in France must align with ethical laws and EU directives, especially concerning gene editing, stem cell inventions, and patenting of personalized medicine. Proper legal counsel ensures compliance while maintaining patent robustness.
Conclusion
Securing biopharmaceutical patents in France requires meticulous adherence to patentability criteria, tailored claim drafting, and rigorous prosecution to withstand validity challenges. A nuanced understanding of French and European standards enhances enforceability and broadens claim scope, ultimately supporting market exclusivity and commercial success.
Key Takeaways
- Prioritize early filing: To safeguard novelty and inventive step, avoid public disclosures before patent filing.
- Tailor claims strategically: Balance broad claims with specific embodiments to maximize infringement coverage and ensure validity.
- Ensure robust prosecution: Preempt invalidity defenses through comprehensive patent drafting, thorough descriptions, and validity analyses.
- Leverage SPC protections: Extend product exclusivity beyond 20 years with effective SPC applications.
- Navigate ethical boundaries: Comply with French and EU regulations concerning biotechnological and genetic inventions to avoid legal and moral pitfalls.
FAQs
1. Can naturally occurring substances be patented in France?
Yes, but only when isolated and purified with demonstrated specific, novel industrial applications or therapeutic uses, meeting the requirements for inventive step.
2. How does France handle patent disputes involving biopharmaceuticals?
French courts, guided by EPC standards, evaluate infringement based on claim interpretation, validity challenges, and prior art, often resolving disputes through litigation with an emphasis on claim scope.
3. Are Swiss-type claims permissible for pharmaceutical methods in France?
European and French standards have largely moved away from Swiss-type claims; instead, claims to second medical use are preferred, aligning with Directive 98/44/EC.
4. What role do ethical restrictions play in biopharmaceutical patentability in France?
Inventions that violate public order or moral standards are unpatentable. Specific restrictions apply to stem cell or human embryo-related inventions, requiring careful assessment during patent drafting.
5. How can patent holders extend protection beyond expiry in France?
Applying for SPCs during the regulatory approval process allows patent holders to extend effective market exclusivity up to five years, or in some cases, up to 15 months beyond patent expiry.
References
[1] French Intellectual Property Code, Art. L. 611-10.
