Introduction
The Eurasian Patent Organization (EAPO) provides a regional system for the protection of inventions, including biopharmaceutical patents, across its member states. Understanding the key insights into patentability, enforceability, and the scope of claims is crucial for stakeholders in the biopharmaceutical industry.
Patentability Requirements
To be patentable, an invention must meet the standard criteria of novelty, inventive step, and industrial applicability.
Novelty
The invention must be new and not form part of the state of the art. This includes ensuring that the biopharmaceutical product or process has not been disclosed publicly before the patent application date[2].
Inventive Step
The invention must involve an inventive step, meaning it must be non-obvious to a person skilled in the art. This requires that the biopharmaceutical invention provides a significant improvement or innovation over existing technologies[2].
Industrial Applicability
The invention must be capable of industrial application, meaning it can be made or used in any kind of industry. Biopharmaceutical products, such as antibodies and other biotechnological products, must demonstrate practical utility[2].
Specific Requirements for Biopharmaceutical Patents
Characterization of Antibodies
In the EAPO, antibody claims are subject to specific requirements. Claims must specify the antibody’s name, biological function, amino acid sequence, or other physicochemical characteristics that distinguish it from other antibodies. This detailed characterization is essential for ensuring the patentability of antibody-related inventions[2].
Types of Claims
Biopharmaceutical patents can include various types of claims, such as:
- Product Claims: For the biopharmaceutical product itself, including chemical compounds and biotechnological products.
- Composition Claims: For formulations of active pharmaceutical ingredients (APIs).
- Process Claims: For the production methods of APIs.
- Use Claims: For the medical uses of APIs.
- Method-of-Treatment Claims: Although these are allowed, they are difficult to enforce due to the lack of recognition of indirect infringement in Russian and Eurasian patent law[2].
Enforceability of Biopharmaceutical Patents
Challenges with Method-of-Treatment Claims
Method-of-treatment claims, while allowed, are challenging to enforce because Russian and Eurasian patent law does not recognize indirect infringement. This makes it difficult to prevent third parties from using the patented method without direct infringement[2].
Patent Term Extension
Biopharmaceutical patents, including antibody claims and corresponding composition claims, are eligible for patent term extension (PTE) in EAPO member states. This can extend the protection period, providing additional time for the patent holder to recoup investments[2][5].
Scope of Claims
Multiple Independent Claims
A Eurasian patent application can contain multiple independent claims relating to different categories of inventions. For example, an application can include claims for a device, a substance, a biotechnological product, and the processes for making or using these inventions[3].
Variants of the Invention
The application can also include multiple independent claims characterizing variants of the same invention, as well as part and whole relationships. This allows for comprehensive protection of different aspects of the biopharmaceutical invention[3].
The EAPO Pharmaceutical Register
Purpose and Contents
The EAPO Pharmaceutical Register is a searchable database containing information on Eurasian patents related to active pharmaceutical ingredients (APIs) with International Nonproprietary Names (INNs). It includes details such as patent numbers, titles of inventions, patentees’ data, patent terms, renewal information, and drug registrations in EAPO member states[1][5].
Benefits
The Register simplifies freedom to operate (FTO) searches, helps patentees enforce their rights, and facilitates the making of license agreements. It also aids in the registration of generic drugs and stimulates development in the pharmaceutical industry[5].
Submission and Maintenance of the Register
Application Process
Patent holders can submit applications to include their patents in the Register. The application must include the Eurasian patent number, INN, identification of claims relating to pharmacologically active products, and information about relevant medicinal products registered in EAPO member states[5].
Updating and Revision
The Register is updated based on conformity examinations performed by EAPO’s examiners. Patents are removed upon expiration, lapse, or invalidation, and data can be revised under third-party observations[1].
Practical Considerations
Recommended Practices
When drafting claims, it is essential to ensure each step is clearly defined and contributes to the practical application of the invention. This is particularly important for method-of-treatment claims and other process-related claims to ensure they meet patent eligibility criteria[2].
External and Internal Sources
The EAPO Pharmaceutical Register is formed from both internal EAPO sources and external specialist databases, as well as information provided by patent holders. This comprehensive approach ensures the Register is accurate and useful for a wide range of stakeholders[1].
Impact on the Pharmaceutical Industry
Simplification of Processes
The EAPO Pharmaceutical Register simplifies several processes, including FTO searches and the registration of generic drugs. This can lead to increased efficiency and reduced costs for pharmaceutical companies operating in the region[5].
Investment Climate
The Register is expected to have a positive impact on the investment climate in the region by providing clear and accessible information on patent rights and drug registrations. This transparency can attract more investment into the pharmaceutical sector[5].
Key Takeaways
- Patentability: Biopharmaceutical inventions must meet the criteria of novelty, inventive step, and industrial applicability.
- Specific Requirements: Detailed characterization of antibodies and other biopharmaceutical products is necessary.
- Enforceability: Method-of-treatment claims are challenging to enforce due to the lack of indirect infringement recognition.
- Scope of Claims: Multiple independent claims can be included to cover different aspects of the invention.
- EAPO Pharmaceutical Register: A valuable resource for FTO searches, patent enforcement, and license agreements.
FAQs
What are the key requirements for patenting biopharmaceutical inventions in the EAPO?
Biopharmaceutical inventions must be novel, involve an inventive step, and have industrial applicability. Additionally, detailed characterization of antibodies and other biopharmaceutical products is required.
How does the EAPO Pharmaceutical Register benefit the pharmaceutical industry?
The Register simplifies FTO searches, aids in patent enforcement, facilitates license agreements, and helps in the registration of generic drugs, thereby stimulating industry development and improving the investment climate.
Can method-of-treatment claims be enforced in the EAPO?
Method-of-treatment claims are allowed but are difficult to enforce due to the lack of recognition of indirect infringement in Russian and Eurasian patent law.
What types of claims can be included in a Eurasian patent application for biopharmaceuticals?
Claims can include product claims, composition claims, process claims, use claims, and method-of-treatment claims.
How is the EAPO Pharmaceutical Register maintained and updated?
The Register is maintained through conformity examinations by EAPO examiners and updated based on information from patent holders and external databases.
Sources
- WIPO: EAPO Pharmaceutical Register, WIPO, SCP thirty-third session, Geneva, 8 December 2021.
- AIPLA: Patents for Antibodies in Russia: Make your Protection Stronger.
- WIPO: Eurasian Patent Office, WIPO, Subject to Rule 4 of the Regulations.
- Mintz: Understanding the 2024 USPTO Guidance Update on AI Patent.
- FICPI: Eurasian Patent Office launches its pharmaceutical register - FICPI.
