Introduction to the Irish Patent System
In Ireland, the patent system is governed by the Patents Act 1992 and is administered by the Intellectual Property Office of Ireland (IPOI). Understanding the nuances of this system is crucial for biopharmaceutical companies seeking to protect their inventions.
Patentability Criteria
For a biopharmaceutical invention to be patentable in Ireland, it must meet several criteria:
Novelty
The invention must be new and not form part of the state of the art. This means it must not have been disclosed to the public before the filing date of the patent application[4].
Inventive Step
The invention must involve an inventive step, meaning it must be non-obvious to a person skilled in the relevant field. This ensures that the invention is not merely an obvious improvement over existing technology[4].
Industrial Applicability
The invention must be capable of industrial application, meaning it can be made or used in any kind of industry[4].
Types of Patents
Full-Term Patents
Full-term patents in Ireland offer protection for up to 20 years from the filing date of the patent application. These patents require a full examination process to ensure the invention meets the patentability criteria[1].
Short-Term Patents
Short-term patents, also known as utility models, provide protection for a maximum of 10 years. These patents have a simpler and faster application process, but they do not require evidence of novelty. However, they are limited to a maximum of five claims[1][4].
Enforceability of Biopharmaceutical Patents
Direct and Indirect Infringement
Under the Patents Act 1992, sections 40 and 41 govern direct and indirect infringement, respectively. A patentee can prevent third parties from carrying out specific acts related to the patented invention, such as making, using, or selling the invention without permission. The onus of proving infringement rests on the patentee[2].
Preliminary Injunctions
In cases of patent infringement, particularly in the pharmaceutical sector, preliminary injunctions can be sought. The Supreme Court of Ireland has recalibrated the test for preliminary injunctive relief, making it more stringent. However, the UPC (Unified Patent Court) system, though not currently applicable in Ireland, offers different procedural measures like protective letters and orders to preserve evidence, which could be beneficial in future patent litigation[2].
Scope of Claims
Claim Drafting
The claims in a patent application define the scope of protection sought. For biopharmaceutical patents, claims must be clear and concise, defining the matter for which protection is sought. They must not speculate on the perceived advantages of the invention but instead focus on the technical features and embodiments of the invention[4].
Sufficiency of Claims
The sufficiency of claims is a critical issue, especially in pharmaceutical patents. The Court of Appeal in Ireland has clarified that claims defined in both structural and functional terms must be sufficient for a skilled person to readily perform the invention without undue burden or inventive skill. This ruling has provided clarity and strengthened the position of pharmaceutical manufacturers by making broad chemical formulae less vulnerable to sufficiency attacks[3].
Supplementary Protection Certificates (SPCs)
Extension of Protection
For biopharmaceutical products, Supplementary Protection Certificates (SPCs) can extend the period of protection beyond the 20 years of patent protection. SPCs are governed by the EU SPC Regulation (EC) No. 469/2009 and are designed to compensate patentees for delays in bringing their products to market while awaiting marketing authorization approval. The product must be "protected by a basic patent in force" to qualify for an SPC[1].
International Protection
European Patents
Applications for European patents can be filed directly with the IPOI or the European Patent Office (EPO). These patents need to be validated by the national patent office in each country where protection is required[1].
Patent Co-operation Treaty (PCT)
The PCT allows applicants to seek patent protection in over 150 countries simultaneously. An international application is filed with the IPOI or directly with the World Intellectual Property Organisation (WIPO), providing a unified procedure for the initial stages of patent protection[1][5].
Challenges and Considerations
Ambiguity in SPC Regulation
The condition that the product must be "protected by a basic patent in force" in the SPC Regulation has led to ambiguity and challenges in the validity of SPCs in Ireland. This has resulted in several referrals to the Court of Justice of the European Union (CJEU)[1].
Procedural Measures
The UPC system, though not currently applicable in Ireland, offers procedural measures like protective letters and orders to preserve evidence, which can be strategic tools in patent litigation. These measures highlight the importance of staying updated with evolving legal frameworks[2].
Key Takeaways
- Patentability Criteria: Biopharmaceutical inventions must meet novelty, inventive step, and industrial applicability criteria.
- Types of Patents: Full-term and short-term patents offer different durations and requirements for protection.
- Enforceability: Direct and indirect infringement are governed by the Patents Act 1992, with preliminary injunctions available in cases of infringement.
- Scope of Claims: Claims must be clear, concise, and define the technical features and embodiments of the invention.
- SPCs: Can extend protection for biopharmaceutical products beyond the standard 20-year patent term.
- International Protection: European patents and PCT applications provide avenues for broader protection.
FAQs
Q: What is the duration of protection for a full-term patent in Ireland?
A: A full-term patent in Ireland offers protection for up to 20 years from the filing date of the patent application[1].
Q: Can short-term patents be used for biopharmaceutical inventions?
A: Yes, short-term patents can be used, but they are limited to a maximum of 10 years and five claims. They do not require evidence of novelty[1][4].
Q: How do Supplementary Protection Certificates (SPCs) work?
A: SPCs extend the protection period for biopharmaceutical products by up to five years, compensating for delays in marketing authorization approval. The product must be "protected by a basic patent in force"[1].
Q: What is the significance of the Court of Appeal's ruling on sufficiency of claims in pharmaceutical patents?
A: The ruling clarified that claims defined in both structural and functional terms must be sufficient for a skilled person to readily perform the invention without undue burden or inventive skill, strengthening the position of pharmaceutical manufacturers[3].
Q: How can biopharmaceutical companies seek international patent protection?
A: Companies can file European patent applications or use the Patent Co-operation Treaty (PCT) to seek protection in multiple countries simultaneously[1][5].
Sources
- Pinsent Masons: Patent litigation in Ireland: Irish patent system[1].
- Pinsent Masons: Patent litigation in Ireland: patent infringement and preliminary injunctions[2].
- Pinsent Masons: Court clarifies law on pharma patent claims[3].
- Intellectual Property Office of Ireland: Patents for Inventions[4].
- WIPO: PCT Applicant's Guide Ireland[5].
