Introduction
The European Patent Office (EPO) plays a crucial role in the protection of biopharmaceutical inventions, which are a significant segment of the biotechnology sector. Here, we delve into the key insights regarding the patentability, enforceability, and scope of claims for biopharmaceutical patents within the EPO framework.
Patentability of Biopharmaceutical Inventions
General Principles
Biotechnological inventions, including those in the biopharmaceutical field, are generally patentable under the European Patent Convention (EPC) provided they meet the standard criteria of novelty, inventive step, and industrial applicability[1][5].
Specific Considerations for Biopharmaceuticals
- Gene Sequences and Partial Sequences: The patentability of gene sequences or partial sequences is subject to the same criteria as other technological areas. The industrial application of the sequence must be disclosed in the patent application as filed[1].
- Antibodies: Antibody inventions can be patented, but broad claims are increasingly rare. Claims are typically allowed where the invention lies in the target, such as a newly identified molecule, a molecule to which it has previously been difficult to raise an antibody, or a molecule with an unappreciated role in a disease[3].
Plants and Animals Obtained by Essentially Biological Processes
- Current EPO Stance: Despite earlier controversies, the EPO has returned to granting patents for plants or animals exclusively obtained by essentially biological processes, as seen in the decision T1063/18. However, this stance may change, and national laws in some EU countries (e.g., Austria, Germany, France, the Netherlands, and Portugal) may exclude these products from patentability[2].
Enforceability of Biopharmaceutical Patents
Jurisdictional Considerations
- National Courts: European patents are subject to the jurisdiction of national patent courts in the European Patent Organisation's member states. This means their validity can be challenged in these courts[5].
- Unified Patent Court: With the advent of the Unitary Patent system, challenges to the validity of EPO-granted patents can also be brought before the Unified Patent Court, a specialized international court[5].
Cross-Border Enforcement
- EU Directive and National Laws: While the EPO may grant patents for certain biopharmaceutical inventions, enforcement can be complicated by differing national laws. For example, some EU countries have specific provisions excluding products obtained by essentially biological processes from patentability[2].
Scope of Claims for Biopharmaceutical Patents
Functional Definitions and "Reach-Through" Claims
- Sufficiency of Disclosure: Claims defined solely by their functional activity (e.g., "reach-through" claims) are generally not acceptable under the EPC unless they provide sufficient technical disclosure. This means the claim must not invite the skilled person to perform a research program to identify the compounds[4].
Antibody Claims
- Broad Claims: Broad antibody claims are rare but can be allowed if the invention lies in the target, such as a newly identified molecule or a molecule with an unappreciated role in a disease. The claims must be supported by evidence showing the target's role in the disease mechanism[3].
- Narrower Filings: A comprehensive filing strategy may include initial broad filings followed by narrower filings directed to individual antibodies with specific characteristics, such as bispecific antibodies, combinations, or formulations[3].
Plant-Related Inventions
- Product Claims: Product claims directed to plants or plant material obtained by an essentially biological process are currently patentable under the EPO's latest guidance, but this is subject to change and may not be enforceable in all jurisdictions[2].
Transparency and Public Access
- Publication of Applications: Patent applications are published 18 months after filing, providing detailed information about the latest technical improvements. This facilitates transparency and allows competitors to build on the disclosed information[5].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable if they meet the criteria of novelty, inventive step, and industrial applicability.
- Enforceability: Patents can be challenged in national courts and the Unified Patent Court, and their enforceability may vary across different EU countries.
- Scope of Claims: Claims must provide sufficient technical disclosure, and broad functional claims are generally not acceptable. Antibody claims require evidence of the target's role in disease mechanisms.
- Transparency: The patent system ensures transparency through the publication of applications and the ability for public inspection and third-party observations.
FAQs
What are the main criteria for the patentability of biopharmaceutical inventions at the EPO?
The main criteria are novelty, inventive step, and industrial applicability, similar to other technological areas.
Can plants or animals obtained by essentially biological processes be patented at the EPO?
Currently, yes, but this is subject to change and may not be enforceable in all EU countries due to differing national laws.
What types of antibody claims are typically allowed by the EPO?
Claims are typically allowed where the invention lies in the target, such as a newly identified molecule, a molecule to which it has previously been difficult to raise an antibody, or a molecule with an unappreciated role in a disease.
How does the EPO handle "reach-through" claims in biopharmaceutical patents?
The EPO generally does not accept "reach-through" claims unless they provide sufficient technical disclosure to avoid inviting the skilled person to perform a research program.
Where can the validity of EPO-granted biopharmaceutical patents be challenged?
The validity can be challenged in national patent courts of the European Patent Organisation's member states and the Unified Patent Court.
Sources
- European Patent Office. Patentable biotechnological inventions - European Patent Office. [Online]. Available: https://www.epo.org/en/legal/guidelines-epc/2024/g_ii_5_2.html
- Cooley. EPO’s Approach to the Patentability of Plant-Related Inventions. [Online]. Available: https://www.cooley.com/news/insight/2019/2019-03-19-epo-approach-to-patentability-of-plant-related-inventions
- J A Kemp. Antibodies in the European Patent Office - Basic Principles. [Online]. Available: https://www.jakemp.com/en/briefings/antibodies-in-the-european-patent-office-basic-principles/
- European Patent Office. 9. "Reach-through" claims - European Patent Office. [Online]. Available: https://www.epo.org/en/legal/guidelines-epc/2024/f_iii_9.html
- European Patent Office. The role of the EPO | epo.org - European Patent Office. [Online]. Available: https://www.epo.org/en/news-events/in-focus/biotechnology-patents/the-role-of-the-epo
